New drugs and pharmacology /Palliative and ...

New drugs and pharmacology /Palliative and supportive care the combination of both drugs when locally instilled providing high kxoregional platinum levels and slower clearance from the pleura! cavity than from the systemic circulation. Both In plasma and pleural fluid the total free platinum levels was the additive result of the individual CBDCA and pt-species from DDP concentrations derived from the combined treatment Conclusion: the I.P. platinum drug combination may have Important clinical Implications since it might allow an Increase of the total dose of administered platinum and enhance tumor cell kill without inducing the excessive toxlcity of high doses of each single agent.

PALLIATIVE AND SUPPORTIVE CARE 6 4 5 0 | Efficacy of Ondansetron (O), Methylprednlsolone (M) Plus Metoplmazlne (MPZ) in Patients Previously Uncontrolled with Dual Therapy in Cisplatin Containing Chemotherapy A. Deplen-e1. B. Lebeau 2 , B. Chevalller3, B. Votan 4 .' Centre Hospitaller Unlversitalre, Besancon, France;2 HopHal St Antoine, Paris, France;3 Centre Becquerel, Rouen, France; * Glaxo Wellcome, France

646O Granlsetron (GRA) 1 Mg + Dexamethasone (DEX) Vs. GRA 3 Mg + DEX In the Prevention of Platinum (P)-)nducod Acute Emesis: Preliminary Results of an Open Randomized Cross-Over Study A. Martoni. E. Piana, E. Strocchi, B. Angelelll, M. Guaraldl, F. Pannuti. Medical Oncology Division, S. Orsoia-Malpighl Hospital, 40138 Bologna, Italy Aim: to compare the standard dose of GRA (3 mg) with a lower dose (1 mg) both combined with DEX in the prevention of P-lnduced acute emesis Methods: Consecutive chemotherapy-naive cancer patients (pts) were randomized at their first cycle to receive either GRA 1 mg + DEX 20 mg or GRA 3 mg + DEX 20 mg as l.v. bolus prior to chemotherapy with cross-over on the second cycle. The cytotoxlc treatment Included different mutB-drug regimens containing cis-Platin (median dose 60 mg/m 2 , range 50-70) or Carbo-Platin (median dose 300 mg/m 2 , range 300-400) administered on day 1 and repeated every 21-28 days. Results: At present 184 pts entered the study. Complete protection of acute emesis with GRA 1 and GRA 3 was observed after the 1st + 2nd cycles as follows: nausea 74% and 79%, vomiting 9 1 % and 96%, respectively (no statistically significant difference). The cross-over analysis comprising 141 pts confirmed no difference between the two antiemetic treatments. Thirty-eight (27%) pts preferred GRA 1, 45 (32%) preferred GRA 3, while 58 (41%) expressed no preference (P = 0.45). Conclusion: This preliminary analysis shows that, In the above conditions, 1 mg and 3 mg of GRA are similarly elective when combined with DEX 20 mg In the prevention of P-induced acute emesis.

6 4 7 O | Determinants of Postchemotherapy Nausea and Vomiting (PCNV) in Cancer Patients D. Osoba. B. Zee, J. Pater, D. Warr, J. Latreille, L Kaizer for the Quality of Life and Symptom Control Committees of the NCIC Clinical Trials Group. Department of Quality of Ufe Program, 600 West 10th Avenue, V5Z 4E6, Vancouver, Canada Aim: To assess the relationship of prechemotherapy health-related quallty-ofBfe (HQL) and other patient variables with PCNV.

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6480

Development of a Tiredness-Assessment-Questionnaire (TAQ) for Cancer Patients

Agnes Glaus 1 . Rosemary Crow 2 , Christel Bohme 1 , Bemhard Jung 3 , Rudolf Maibach3, Sean Hammond 2 , Hansjorg Senn 1 . 1 Department of Medicine C (Oncology), Kantonsspltal, 9007 St. Gallon, CH;2 University of Guildford, European Institute of Health and Medicine Sciences, Guiktford/Sumy, UK;3 Schweiz. Artettsgmppe fur Angewandte Klinische Krebsforschung, Bern, CH The basis of the new Tiredness Assessment Questionnaire (TAQ) were desertptore of fatigue/tiredness as Identified In a previous, qualitative interview-study wtth cancer patients and healthy individuals. These descriptors were then used to construct a self-assessment questionnaire to measure tiredness In cancer patients. Aim of this study was to test reliability and validity, acceptability and feasibility of the TAQ and to analyse the underlying theoretical concept Setting, Population, Methods: The study was carried out In the Department of Medicine C (Oncology) at the Kantonsspital St Gallen, Switzerland A non-randomised, prospective, cross-sectional, study design was used to test the instrument In 77 cancer patients and 77 healthy individuals. Additionally used instruments were the Hospital Anxiety and Depression Scale (HAD Scale) and the Kamofsky Index. Demographic and biomedical data were assessed. Results: The analysis identified significant discrimination in specific Items of the TAQ between cancer patients and healthy individuals. Intensity and distress of fatigue were significantly different between the two sub-populations as measured with a linear analogue scale with a newry defined tiredness continuum. Factor analysis by varimax rotation suggested a two factor solution of the fatigue concept A major physical component of tiredness, including a viscous-cycle with a rest/acttvtty-lmbalance was hypothesised. Reliability in terms of internal consistency of the questionnaire was supported with a reliability coefficient of 0.88 (Cronbach alpha). Validity was supported by significant differences of the tool Items between the two study sub-populations and by Item generation from qualitative Interviews Acceptability and feasibility was confirmed. Conclusions: With minor adaptations, the 22 rtems-TAQ (German version) can reliably be used for further epidemiologlcal fatigue-research in cancer patients.

6490 Living with Advanced Breast Cancer: Development & Application of a Clinical Checklist for Patients on Endocrine Therapy (C-PET) P. Hoowood for the Working Group on Living with Advanced Breast Cancer Hormone Treatment (WGLABCHT). CRC Psychological Medicine Group, Christie Hospital NHS Trust, Manchester, M20 4BX, UK Aim: To develop a checklist to assess patients experience with hormonal therapy and aid disclosure and discussion of troublesome side effects during routine consultations. Despite widespread use of hormonal agents In the management of advance breast cancer there has been little published data on the impact of side effects on patient well-being and such therapies are assumed to be well-tolerated. This Is challenged by the findings of a European Survey of 190 doctors and nurses carried out by the WGLABCHT which revealed that doctors underestimate both the prevalence and distress to patients of drug related side effects. (Progestins, aminoglutethimide, formestane). Results: Pilot testing in France, Germany, Italy and the UK Involving 109 patients and 9 clinicians showed that 86% of patients & 89% of doctors found the checklist useful and would continue to use it. Hot flushes, weight gain and tow energy were common, occurring In 50%, 44% & 4 1 % of patients respectively. These were worrying to the patients and led to discussion with the doctor In 10-12% cases. Conclusion: C-PET is a useful communication tool for patients and doctors. The main application of C-PET will be to monitor the tolerability of therapy and help inform clinical decisions about treatment

Annals of Oncology 7 (SuppL 5), 1996

C 1996 Kluwer Academic Publishers, Printed in the Netherlands

Downloaded from http://annonc.oxfordjournals.org/ by guest on March 27, 2016

Aim: To study the benefit of the addition of MPZ to the combination of O + M in the prevention of cisplatin Induced emesis and nausea In patients who experienced at least one emetic episode or nausea during their previous course of chemotherapy despite a combined anti-emetic regimen with a 5-HT3 receptor antagonist plus cortlcosteroid. Methods: A total of 338 patients (pts) were randomised In this double-blind study, and received either the combination O + M + MPZ (168 pts): O (8 mg) intravenously (iv) on D1 and orally ( 2 x 8 mg) on D2 to D4, M (120 mg) iv on D1 and orally (2 x 16 mg) on D2 to D4 plus MPZ (40 mg) Iv on D1 and orally ( 2 x 1 5 mg) on D2 to D4, or the combination O + M (170 pts): O and M were administered as described above. Results: A complete control of emesis (0 emetic episode) over the whole course of chemotherapy was achieved In 53% patients receiving O + M + MPZ and in 38% receiving O + M (p = 0.008). Furthemore, there was a significant difference between the two treatment regimens in favour of group O + M + MPZ for the nausea (p = 0.03) and for the patient's global satisfaction (p = 0.001). Both treatment regimens were well tolerated. Conclusion: The addition of MPZ to the combination O + M is an effective and well tolerated anti-emetic treatment In patients not controlled dunng their previous course of chemotherapy despite a combined anti-emetic treatment with a 5-HT3 receptor antagonist plus cortlcosteroid.

Methods: Eight hundred and thirty-two chemotherapy-naive patients about to receive 5-HT3 antiemetics ± dexamethasone completed self-report nausea/vomiting (NV) diaries and the EORTC QLQ-C30 before and 1 week after moderately- or hlghly-emetogenlc chemotherapy. Prechemotherapy HQL scores and patient characteristics were analyzed initially in a unrvariate and subsequently In a multivarfate (stepwlse logistic regression) analysis to derive the risk factors associated with PCNV. The predictive accuracy of the risk factors in the final model was calculated. Results: The risk factors for PCNV in the multtvariate model were low social functioning, prechemotherapy nausea and female gender. Also, a history of low alcohol use was associated with PCV while high fatigue scores and a lower performance status were associated with PCN. Treatment variables associated with PCNV were hlghly-emetogenic chemotherapy and the lack of maintenance antiemetics (5-HT3 antagonists and dexamethasone). The Incidence of PCV Increased from 20% in patients having no risk factors for PCV to 75 7% in those having all 4 risk factors. Conclusions: Pretreatment HQL and patient characteristics are important determinants of PCNV. If these results are confirmed In further studies, antiemetic therapy should be adjusted to prevent PCNV In patients at high risk for PCNV.

Palliative and supportive care 650O Outpatient Management of Low-Risk Post-Chemotherapy Fever and Neutropenla (F + N) with Oral Ofloxacin: Results of a Randomized Clinical Trial M. Hidalgo. J. Homedo, A. Ruiz, J.M. Trigo, I. Garcta-Castro, R. Colomer, R. Garcfa-Carbonero, J_A. Guerra, J. Calzas, H. Cortes Furtes. Division of Medical Oncology, Hospital Univ. 12 de Octubre, Madrid, Spain

Conclusion: Outpatient management with oral O of tow-risk pis with FN Is equally effective than standard Inpatient treatment with CA with considerable cost savings.

6 5 2 P | Persistence of Efficacy of Two Antiemetic Regimens and Prognostic Factors In Cisplatin-Treated Patients V. De Anqells. F. Roila, S. Ricct, A. Contu, F. Cognetti, S. Tateo, M. Cterico, S. Cascinu, M.T lonta, G. Lelli, E. Ballatori for the Italian Group for Antiemetic Research. Medical Oncology Division, PolicBnkx) Monteluce V.toBrunamont, 06112, Perugia, Italy Aim: To evaluate antiemetic efficacy and toterability of ondansetron (OND) and granlsetron (GRAN) combined to dexamethasone (DEX) over 3 subsequent courses of clsplatin (> 50 mg/m2) and the Influence of the prognostic factors on occurrence of nausea and vomiting. Methods: 973 consecutive cancer patients (pts) entered a multicenter, randomized double-Wind study comparing OND 8 mg tv vs GRAN 3 mg rv. DEX 20 mg iv was added to the 5-HT3 antagonists. Occurrence of nausea, retching and vomiting was monitored during 24 hours after cisplatin administration. Results: 956 pts (478 receiving OND+DEX and 478 GRAN+DEX) were evaluable for clinical efficacy at first, 526 (254 and 272) at second and 406 (195 and 211) at third cycle of chemotherapy. The cause of the great loss of pts from first to second cycle was the non participation of some centers to the persistence evaluation. Complete protection from acute vomiting/nausea was not significantly different between the two antiemetic treatments during the 3 cycles of chemotherapy; In particular was obtained In 79.7%/72.4% at first. In 84 3%/70.1% at second and 83.6%/64.1% at third cycle wtth OND+DEX and In 79.7%/71.8%, in 81.6%/69.1% and 83.4%/69.7%, respectively, with GRAN+OEX. Complete protection from vomiting/nausea did not significantly decrease during the 3 cycles with both the antiemetic treatments. Protection obtained In the previous cycle of chemotherapy was the most important prognostic factor In the occurrence of nausea and vomiting. Conclusion: Both antiemetic combinations offer a similar antiemetic protection and their activity is maintained in the subsequent cycles of chemotherapy; therefore, the choice between them should be made on the basis of acquisition costs In every country.

653P Can We Use Apache II and Saps II Scores for 651P

Comparison of Granlsetron Vs Ondansetron Vs Tropisetron In the Prophylaxis of Acute Nausea and Vomiting Induced by High-Dose Clsplatin for Treatment of Primary Head and Neck Cancer: An Open Randomized Controlled Trial

A. Bianchl. A. Macdo, L Currell, M. Ghlani, M.C. Santona, G. Astara, B. Lampis, D. Dess), A. Testa', V. Gebbia 1 , G. Mantovani. Dept. of Medical Oncology, University of Cagliarf, 09124 Cagliari, Italy:1 Chair and Serv. of Chemotherapy, University of Palermo, 90127 Palermo, Italy A two-centre prospective randomized open study to compare granlsetron (Gra) vs ondansetron (Ond) vs tropisetron (Tro) in the prevention of high-dose (80 to 100 mg/sqm) cisplatin-lnduced acute (24 hours) nausea and vomiting was carried out 172 patients (166 men and 6 women, mean age 58.6 years, range 31-79; PF ECOG 0-3), all with primary head and neck cancer (stage I: no. 1, stage II: no. 6, stage III: no. 44, stage IV: no. 121) and all chemotherapy-naTve were randomized to receive 24 mg of Ond Intravenously (i.v.) or 3 mg of Gra l.v. or 5 mg of Tro I.v., all as a single dose. At the start of first chemotherapy cycle each patient was randomly assigned to one of the three arttiemetics and prosecuted the following chemotherapy cycles with the same antiemetic coverage, unless experienced a failure: In this last case the patient was crossed-over randomly to one of the other two antiemetics. In case of further failure, the patient was assigned to the third antiemetic. In such a way 31 patients were crossed-over to a second antiemetic and 3 patients to the third antiemetic. The treatment groups were well matched in terms of age, gender, performance status, stage of disease. Verbal Informed consent was required. A total number of 645 chemotherapy cycles was evaluated. In the Gra group In 165 out of 227 cycles (72.7%) the patients experienced a complete response (CR), in 37 cycles (16.3%) a major response (MR), In 11 cycles (4.8%) a minor response (MIR) and In 14 cycles (6.2%) a failure (F). In the Ond group In 147 out of 196 cycles (75%) the patients experienced a CR, in 34 cycles (17.3%) an MR, in 5 cycles (2.6%) a MIR and in 10 cycles (5.1 %) a F. In the Tro group in 148 out of 222 cycles (66.7%) the patients experienced a CR, in 39 cycles (17.6%) a MR, in 21 cycles (9.4%) a MiR and In 14 cycles (6.3%) a F. The major efficacy (CR + MR) was achieved In 202 out of 227 cycles (89%) for Gra, in 181 out of 196 cycles (92.3%) for Ond and in 187 out of 222 cycles (84%) for Tro. The statistical analysis could detect a significant difference as for major efficacy only between Ond and Tro (p < 0.05, Cl 95%: +2/+14.2%): the Ond Indeed was more effective than Tro. Moreover, as far as the MiR was concerned, Ond was more effective than Tro (p < 0.05, Cl 95%: -11.3/-2.5%). All other comparisons between the three antiemetics did not show significant differences. Our results, although achieved In an 'open' trial, show that Gra, Ond and Tro are equally effective antiemetic agents against Annals of Oncology 7 (SuppL 5), 1996

Predicting Outcome of Cancer Patients (PTS) Admitted In Emergency in a Medical Intensive Care Unit (ICU)? M. Paesmans. E. Marldewicz, J.P. Sculier. Instttut Jules Bordet, Bruxelles. Belgium Between October 1992 and August 1995, we prospectfvely measured the parameters required to calculate the Apache II and SAPS II scores for all the cancer patients admitted In emergency in the medical ICU of a cancer hospital as well as some specific variables related to the underlying neoplasm such as disease phase, status or extent. The primary objective of this prognostic index study was to analyze mortality at the ICU. We followed 261 pts, wtth a median age of 69 years (from 15 to 86). Tumor was hematotogical In 61 cases (23%). At the time of admission, 52 patients were in remission of their cancer, 110 were under induction treatment and 77 did not respond to treatment or were in progression. Causes of admission were cardiac problems In 28%, respiratory in 25%, Infectious In 2 1 % , metabolic In 13%, neurologic in 12% and digestive In 6%. Median Apache II and SAPS II scores were 16 (2 to 51) and 38 (6 to 92). In-ICU mortality rate was 23%. Wtth a median follow-up of more than one year, actuarial survival rates at 1, 6 and 12 months were 66%, 39% and 25%. By adjusting the data with univariate logistic regression models, Apache II and SAPS II scores were found to have a significant Impact on mortality at the ICU wtth estimated odds ratios of 1.10(1.06-1.15) and 1.05 (1.03-1.08); In a multtvariate setting, we could not identify any other variable improving the unsatisfactory goodness of fit of the models (high chi square statistics by comparing expected and predicted deaths, p < 0.05). Using the logistic equations given by the authors to estimate probability of death at the ICU, we found sensitivity and specificity rates of 27% and 92% for Apache II, 35% and 88% for SAPS II. In conclusion, If both scores have a significant prognostic Impact on mortality at the ICU, their discriminant ability Is not powerful enough and there Is a need to design more specific indexes for cancer patients.

1654P | Impact of Postchemotherapy Nausea and Vomiting (PCNV) on Quality of Life (QOL) D. Osoba, J. Rusthoven. C. Butts, L Yelle, H. Flndlay, A. Grenville. Vancouver, Hamilton, and Nova Scotia Cancer Centres, Institut du Cancer do Montreal and Angus Reid Group, Canada Aim: to determine the Impact of PCNV on QOL In a clinic practice setting. Assessment of drug efficacy was not an endpdnt. Methods: One hundred and nineteen patients, recruited from 5 centres across Canada, received moderately emetogenic chemotherapy and standard

O 1996 Kluwcr Academic Publishers, Printed in the Netherlands

135


Aim: To study the efficacy, safety and cost of oral ofloxacin (O) In the outpatient management of patients (pts) with solid tumors and post-chemotherapy induced low-risk neutropenla and fever (F + N). Method: Pts with solid tumors treated with conventional dose chemotherapy who presented with fever (axillary temperature > 38°c) and neutropenia (absolute neutrophll count, ANC, < 500/ul) wtth low-risk criteria as defined by Talcott et al (J Clin Oncol 1992; 1a 316-322) were randomized to: ceftazidime 2 gr/iv/q8h plus amikacln 500 mgr/lvq12 (CA), Group /; or O 400 mpr/po/q 12, Group II. Pts in group I were admitted to the Hospital. Pts in group II were followed after randomization the outpatient clinic every other day. The definitions of success, success with treatment modification and treatment failure were as usual. Pts in group II who failed therapy were admitted to the Hospital. DaDy costs in ECUs Included medications and hospital costs. Results: From 1/95 to 4/96 there were 130 consultations for F + N (111 pts). Seventy episodes (53.8%) were randomized (34 CA & 36 O). Five pts are not evaluable: 3 did not show < 500 cells/ul and 2 did not meet inclusion criteria 31 pts in Group I and 34 in Group II are evaluable. Both groups were well balanced for age, sex, type of cancer, CT regimen and days since CT. Forty five percent of pts in group I and 38.2% in group II had less than 100 ANC/ul at randomization (p = 0.5). Mean (SO) days with neutropenia (< 500 ANC/ul) were 3.6 (1.6) In group I and 3.7 (1.5) in group II (p = 0.7). The proportion of patients with clinically or microbiology documented Infection were also similar between groups. Ninety percent of pts in the two groups became afebrile 24 h after antibiotics had been Initiated. Treatment outcome did not show statistical differences (p = 0.9): 90% of pts In Group I and 85.5% In Group II had an uneventful recovery and were considered treatment success, three pts In group II (8.8%) and none in group I required antibiotic modification, three pts In group I (10%) and 2 pts in group II (5.9%) were considered treatment failures. No pts had severe complications or died. One day treatment in group I cost 300 ECUs compared wtth 4 in group II

acute nausea and vomiting as for complete control. Gra and Ond are equally effective as for major efficacy, whereas Tro Is slightly less effective than Ond. All three antiemetics can be safely administered to patients undergoing highly emetogenic chemotherapy. Work supported by CNR, Rome, A.P. ACRO, Contract No. 95.00389.PF39.

Palliative and supportive care antiemetlcs. They completed the EORTC QLQ-C30 just before chemotherapy and on days 2 and 6 postchemotherapy. On days 2 and 6, patients experiencing nausea (PCN) and/or vomiting (PCV) also completed 2 adaptions of the C30 (the N28 and V28), designed to assess the extent to which either PCN or PCV affects QOL Results: During the first 2 days postchemotherapy, 29% of patients had PCN onty and 22% had PCV; during days 3-6, these proportions were 35% and 10% respectively. On day 2, the greatest changes in QOL scores from baseline were In patients having PCV, as compared to those not havfng PCV, with statistically significantly greater decreases In physical, role and social functioning, global QL and Increases In fatigue and anorexia Patients having onty PCN aJso showed a significantly greater Increase in insomnia In those having either PCN or V between days 3 and 6, similar decreases from baseline were seen in functioning scores, but Increases in fatigue and anorexia were less striking. From their N28 and V28 scores, It is apparent that patients attribute some, but not all, of the deterioration in QOL to PCNV.

Gralla schedule (6-10 IV infusion) is better than Thuriimann in all the settings. 3- No patient required a central venous catheter 4- According to this study the standard form of administration of NVB In ambulatory patients is a short IV Infusion over 6-10 minutes.

Conclusions: Current antiemetic protocols used In clinic practice in this study did not comptetety control PCNV after moderately-emetogenic chemotherapy. PCNV explains some but not all, of the deterioration In QOL in the first 6 days after chemotherapy.

Objective: To evaluate the efficacy and safety of oral DOL + oral DEX compared to IV ONDAN and IV DOL. Methods: 75 patients (pts) receiving > 70 mg/m2 ctsplatin received a single dose regimen of 200 mg oral DOL + 20 mg oral DEX 30 minutes before cisplatln or a two dose regimen by adding a second dose of each drug 16 hours after cisplatln infusion. Comparison was made of results of another study with 609 pts treated with either 1.8 mg/kg IV DOL, 2.4 mg/kg IV DOL or 32 mg IV ONDAN. Results: The oral combinations show a clinically relevant longer time to first emetic episode (EE) than the IV agents alone for those pts with EEs.

655P Characteristics of Transfusion Need in a Medical Oncology Department

Transfusion of red blood cells Is a major tool in supportive care of patients with solid tumors and anemia. Other treatments as the use of erythropoietin may become an Important factor In the prevention of anemia In these patients. It Is crucial to define patient populations In which such a treatment would be beneficial since the cost of this treatment Is high. In 1995, 130 patients with solid tumors, treated at the department of medical oncology were transfused because of anemia. The median number of units of packed cells transfused was 3 (range 2-19). The cause of anemia was tumor-related In 24 patents, 2 patients developed a gastrointestinal bleeding due to non steroidal anti-Inflammatory drugs and in 104 patients the anemia was caused by the chemotherapeutic treatment. The majority of these last patients (65%) received cteplatin or carboplatin containing regimens; 11 % received standard non clsplatin containing regimens. Newer chemotherapeutic agents accounted for the remaining 24% of patients needing transfusions (docetaxel: 14%; paclitaxel: 2%, temozotomtde: 1%, CPT 11:5%, topotecan: 1% and methoxymorfolino doxorublcln: 1%). Anemia is mainly seen In patients treated with cisplatln containing regimens and the median number of packed cells transfused is relatively taw. Newer drugs such as the taxoids account for an Important part of the patients needing a transfusion.

| 656P I Gralla (G) vs Thurilmann (T): A Randomized Cross-Over Trial of Two Methods for Effective Prevention of Navelbine (NVB) Related Phlebitis M. Lozano, H. Muro. E. Triguboff, A. Schmilovich, M. Reale, E. Gil Deza. Buenos Aires, Argentine From 10-93 to 12-95 61 patients (pts) treated with mono or pollchemotherapy were randomized to receive NVB 25 mg/m2 diluted in 500 cc of saline solution to be delivered In 2 hours plus heparin 5000 U (T) (EJC 3: 311, 1992) or the same doses diluted In 50 cc of saline solution to be delivered in 10 minutes (G) (Proc ASCO Vol 12 N2 (Abst 1122) 1993) both arms also received dexametasone 16 mg, 1 cc of diluted bicarbonate 1/6 M and 500 cc of saline solution with the aim to uniform the total time of Infusion. All the patients were cross-over in an alternate design to the other arm. Characteristics of population: A total of 258 courses were delivered: 7:123, G: 135.25 pts receive T as first course and 36 Gas first course. Lung cancer: 21 pts (first line chemotherapy (fte) 20 pts: 7; 45: - G: 44 - second line chemotherapy (sic): 1 pts: T: 2 - Q: 3) Breast cancer 40 pts (sic: 29 pts: T: 62: - G: 67 - third line chemotherapy (Be): 11 pts: T: 16 - G: 24). All the courses were asessed for pain and cutaneous reaction from grade O to 4 according de WHO scale. Results: Pain (P) and cutaneous (C) toxidty according the schedule of administration ThOrfmann

Gralla

pvalu*

Toxlctty

GO

Q1

G2

GO

G1

G2

Global P Global C Lung cancer (Be) p Lung cancer (flc) c Breast cancer (tic) p Breast cancsr (tic) c Breast cancer (tic) p Breast cancer (tic) c

65 88 26 39 34 41 5

50 29 18 5 22 17 10 7

8 6

128 124 44 42 60

5 10 0 1 5 7 0 2

2

8

1 1 6 4 1 1

60 24 22

1 0 1 2 0 0 0

(Chitq) (Chlsq) (Vats.) Orates) (Chltq) (CW«q) (Fisher) Orates)

0.00000001 0.0000208 0.00000042 026 0.0000094 0.00126 0.0000019 0.0001

Conclusion: 1. Both schedules were useful to prevent Grade 3-4 phlebitis 2-

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R.M. Navari. K.B. Pendergrass, T.H. Grote, M.G. Kris, W.F. Hahne, S.B. ChemoS. Memorial Sloan-Kettering Cancer Center, NY, NY; Research Medical Center, KC, MO; Simon Williamson Clinic, Birmingham, AU Salem Research Group, Winston-Salem, NC; Hoechst Marion Roussel, Inc., KC, MO, USA

AntiemitJc regimen

Time to 1stEE(hrs)

200 mg Ofal DOL + 20 mg oral DEX 200 mg oral DOL + 20 mg oral DEX time*, 2 1.8 mg/kg IV DOL 2.4 moAfl IV DOL 32 mg IV ONDAN

18.5 17.3 12.3 12.3 13.7

Conclusion: Time to 1st emetic episode was Increased and the drop in efficacy seen at 4-8 hrs with IV 5HT3s was prevented. Oral Dolasetron + oral Dexamethasone are effective for use with high-dose dsplatin.

658P Time Trade-Off Interviews Vs Subjective Health Estimation (SHE) In Advanced Breast Cancer M. Bacchi. B. van Wegberg, J. Bemhard, M. Castiglione, O. Real, B. Thuertimann, L Perey, H. Bonnefoi, A. Coates, C. HOmy for the Swiss Group for Clinical Cancer Research (SAKK). Slak Coordinating Center, Department of Statistics, Konsum Str. 13, 3077, Bern, Switzerland We tested feasibility and validity of 2 scales of 'subjective health estimation' as utility value Indicators to be applied in Quality Adjusted Survival Analysis In breast cancer (BC). The aims were: to compare the 2 scales and to explore a simple measure feasible for mulbcenter trials In BC as an alternative to a standard Time Trade-Off (TTO) Interview. Patients and Methods: 3 TTO scenarios (modified for advanced BC) and 2 single-item visual analogue scales were Investigated in 84 patients with advanced BC. The 2 scales asked an utility question anchored at "perfect health-death" (SHED) and a new one at "perfect health-worst health" (SHE). We measured comparability of the 2 scales and tested the expected relationship with the 3 TTOs wtth tests for trend across groups. The impact of Womedical factors on SHE was analysed with ANOVA. Results: Feasibility: 75% of the patients found the scales easier than the TTO questions Comparability of scales: the mean values were: 34.1 (SHED) and 38.7 (SHE). The mean individual difference (SHED-SHE) was -4.7 ("relative bias"; p = 0.31). Patients felt more reluctant to assess themselves badly when confronted with the word 'death'. Validity: The expected SHE relationship wtth the 3 TTOs was confirmed with tests for trend across groups. The SHE score was significantly influenced by age (p = 0.03), type of treatment (p = 0.02) and time from diagnosis (p = 0.02). Conclusions: There Is strong supportive evidence that SHE and SHED are equivalent for clinical purposes. SHE Is more appropriate for our objectives arid may be a feasible and valid alternative to lengthy TTO interviews. We are further investigating the SHE properties.

1659P | Empiric Antibiotic Treatment In Cancer Patients with Fever and Neutropenla: Validation of the Talcott Model for Risk Groups H. Gomez. R. Cotomer, O. Mejfa, W. Rodriguez, J. Otero, C. Carracedo, C. Vallejos. Instituto de Enfermedades Neopldsicas, Lima, Pen/; Hospital 12 de Octubm, Madrid, Spain Purpose: Talcott el al developed a clinical model to identify low-risk patients with fever and neutropenia (JC010:316-322). We have performed a validation of the model in our hospital. Methods: Between June 1992 and June 1994, 175 patients with 177 febrile episodes (oral temperature > 38.3°C) and neutropenia (ANC < 500/uL) induced by conventional chemotherapy were enrolled at our institution In two




D. Schrilvers. V. Skxrtmaekers, A. Kamper, R. Brys, L Dirix, A. Prove, A.T. Van Oosterom. Depf Medical Oncology, University Hospital of Antwerp, Edegem, Belgium

657P Oral Dolasetron (DOL) Plus Dexamethasone (DEX) Delays Time to Emesis More Effectively than IV Ondansetron (ONDAN) or IV Dolasetron Alone In High-Dose Clsplatin Treated Patients

Palliative and supportive care open clinical trials that evaluated the therapeutic efficacy of empiric antibiotics In febrile neutropenla lasting less than 10 days in patients with solid tumors. Therapeutic efficacy was defined as fever disappearance for more than 4 days, and absence of any evidence of clinical signs of Infection. Deaths were recorded only during the period of parenteral antibiotic treatment Results: The median age of patients was 48 years (range, 18-75 years); 50 patients were male (28.6%) and 125 were female (71.4%); 61 patients (34.8%) had breast carcinoma, 57 (32.6%) lymphoma and 32.6% other solid tumors. The medUin ANC at presentation was 300/ML (range: 25-500) and median lowest ANC was 175/ML (range: 25-500). The median duration of neutropenla was 5 days (range: 2-16 days). The rate of microbiologically documented Infection was 90/177 (50.8%), including 48 bacteremlas (27.1%), and clinically evident Infections without positive cultures in 38.9%. The overall complete response rate was 73.4% (130/177). To evaluate the role of Talcott system, all the patients were classified in four groups for analysis: GroupriskTalcott mode)

Patients

Response

Deaths

l(Wgh) II (high)

32(18%) 15(83%) 26(14.7%) 104(58.75)

19(59%) 5(33%) 18(69%) 88(85%)

2(6%) 6(40%) 2(8%) 5(5%)

III (high) rv(tow)

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A Double Blind Randomized Study Comparing Intramuscular (I.M.) Granlsetron (G) Vs I.M. Granlsetron + Dexamethasone (D) in the Prevention of Delayed Emesls Induced by Claplatin

A. Antonuzzo 1 . S.R. Rtacl1, S. Palazzo2, L Manzkxie 3 , F. Di Costanzo4, F. Montinari 6 , S. Danese", M.C. Locatelli7 for the Italian MultJcentre Study. 1 S. Chiarn Hospital, Pisa;2 Oncological Centre, Cosenza;3 S. Carlo Hospital, Potenza; * Temi Hospital, Teml;5 Oesio Hospital, Deslo;' S. Anna Hospital, Torino;7 S. Carlo Hospital, Milano, Italy Aim: Delayed emesis starting 24 hours (h) after high-dose clsplatin administration occurs in up to 90% of patients. This is the first study aimed at evaluating the efficacy and safety of l.m. G, administered alone or associated to l.m. D, In the prevention of delayed emesls following highly emetogenic chemotherapy. Methods: A total of 532 chemotherapy-naive patients were given 3 mg i.v. G and 20 mg I v. D as prophylactic antiemetics, prior to receiving cisptatin (on a single-day dose > 50 mg/m2). 24 h after chemotherapy patents were randomly allocated to two treatment groups: those in Group I were administered 3 mg i.m. G (plus placebo) every 24 h on days 1, 2, 3; patients In Group II were given 3 mg l.m. G every 24 h on days 1, 2, 3, plus 8 mg l.m. D every 12 h on days 1, 2 and 4 mg l.m. D every 12 h on day 3. Results: Preliminary results obtained In the first 344 evaluate patients suggest the eficacy of treatment in the control of delayed emesls: the range of complete response on days 1, 2 and 3 was 65-70% for patients In Group I and 82-86% for patients in Group II. A good control of acute emesls was observed (complete response = 78.8%). The local and systemic tolerablltty was fully satisfactory. Conclusions: These data IrxScate that G Is safe and suggest efficacy In delayed emesls, with an advantage when combined with D.

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Adoption of an All Oral Antiemetic Regimen for Prevention of Acute Chemotherapy-Induced Emesls (CIE): Assessment of Clinical and Economic Outcomes

C. Undtev. J. McCune, M. Oertel, W. Sawyer, D. Pfetffer. University of North Carolina Hospitals, Chapel Hill North Carolina, USA Background & Rationale: Availability of an oral dosage formulation of the 5HT3 antagonist granlsetron (GRAN) and data supporting Its safety and efficacy in preventing CIE with moderate to highly emetogenic regimens prompted revision of UNC Therapeutic Guidelines for CIE which previously had included varying doses of IV ondansetron (OND) based on emetogenic potential of the chemotherapy regimen. Methods: Patients receiving IV OND or PO GRAN for prevention of acute CIE one month prior to and following adoption of new CIE Guidelines where Included. Information regarding demographics, regimen emetogenic potential and antiemetics administered was obtained from the medical record. Number of emesls episodes, nausea severity, effect of nausea and vomiting on function, actions taken and unable to take due to CIE, overall quality of life for the 24-hour period post chemotherapy, satisfaction Annals of Oncology 7 (SuppL 5), 1996

| 6 6 2 P | Analysis of Pulmonary Infections during High-Dose Chemotherapy (HOC) and Peripheral Blood Stem Cell Autologous Transplantation (PBSCT) C. Sola. P. Maroto, R. Salazar, J.M. Tabemero, G. Huldobro, V. Valentf, J. Brunet B. Ojeda, M.C. Atonso, G. Verger1, J.J. Lopez Lopez. Medical Oncology Service, Barcelona, Spain;1 Infectious Disease Unit, Sant Pau Hospital, Barcelona, Spain Background and Objectives: Pulmonary infections (PI) are frequent and serious events in the course of bone marrow transplantation. We analyze PI associated to PBSCT which is a new technique of hematopoletlc support. Patients and Methods: One hundred and one pts (7 lymphomas and 97 solid tumors) were treated with HDC and PBSC. A minimum of 2 x 10° CD34+ cells/kg was Infused with G-CSF 5 ^g/kc/d. All pts received an antimicrobial prophylaxis with Ciprofloxacln 500 mg/12 h po, Acyclovir 200 mg/6 h po, Itraconazole200mg/12 h po and stayed in single rooms with HEPA. Imlpenem 500 mg/6 h was started when temperature was > 38°. H fever persisted Vancomycln 1 g/12 h and Amikacln 7.5 mg/Vg/12 h were added after 2-3 and 5 days respectively. Amphotericin 1 mg/kg/d was started after 7-8 days of fever. When a pneumonia was diagnosed, pts received Imlpenem, Vancomycln and Amikaan. Bronchoatveolar lavage (BAL) was performed after 48 h if there was no response and addition of new antibiotic was evaluated: Erythromycin +/— Cotrimoxazole +/— Amphotericin. Results- The median recovery days to 0.5 x 109 neutrophils/L was 9 (7-32) and to 20 x 109 platelets/L 9 (5-41). Nine pts (9%) developed a PI: 8 pneumonias and 1 aspergillosls. Two had a lymphoma and 7 a solid tumor. One pt had positive blood cultures for Pseudomonas alcallgenes BAL was performed in 4 pts, 3 were negative and one positive for Aspergillus. Erythromycin was added to 4 pts, Cotrimoxazole to 2 pts and Amphotericin to 2 pts. The only case of aspergillosls received Itraconazole during 3 months and was resolved. Only one pt required mechanical ventilation, no germens were Isolated and she died in the Intensive Care Unit, being the only toxic death In our serie of PBSCT (1%). Conclusions: 1. PI persist as a serious event in pts submitted to HDC with PBSCT. 2. Mortality is lower than previously reported, probably due to a short period of neutropenla provided by PBSCT and an early aggressive empirical antibiotherapy.

6 6 3 P | Quality of Life In Cancer Patients: The Influence of Patients' "Natural Theories0 on the Communication between Medical Staff and Patients M.G. Strepparava'. M. Baroni, G.C. Secchi. DepL Internal Medicine, Istituti Ctlnict Perfezionamento Milano, Italy,11nstitute of Psychology, Medical Faculty, Milano, Italy Aim: To evaluate to what extent patients' 'natural theories' (naive-theories) concerning the cancer might Influence or cflstort the information given by the medical staff about diagnosis, therapy and prognosis of neoptastic diseases. Methods: 20 patients were studied by repeated Interviews performed by a psychologist from the time of the first diagnosis. We looked at: I) the difference between the Information communicated by the medical staff and the level of understanding on the part of the patients, II) to what extent the patients' "natural theories' could play a role in Inducing this difference. Results: The "natural theories" are very heterogeneous between different subjects but In all patients the 'natural theories' play an important role In the ability to understand medical Information correctly. Conclusions. A questionnaire may be prepared to highlight the effect of the •natural theories" on the communication between medical staff and patients. Such research could contribute to improving the quality of Ufa of cancer patients.

C 1996 Kluwcr Academic Publishers, Printed in the Netherlands

137


Low risk group (IV) showed significant better response rate (p < 0.005) and lower mortality (p < 0.03) compared to the high risk groups (HMII), but there was no difference in mortality rate (p = 0.5). There were significative differences among the high-risk groups, group II (serious independent comorbidlty) had more deaths (40%) than groups I or III. Conclusions: The Talcott model for the identification of low risk febrile neutropenic cancer patients, using clinical information available In the first day of the episode was useful In our setting, especially when group IV is compared with group II.

with CIE control and side effects of antiemetics were obtained via patient interview conducted in person or by telephone within 48 hours of chemotherapy administration. Statistical tests Included regression, Kruskal-Wallis and chi-square analysis. Results: 432 patient Interviews were conducted (291 OND, 141 GRAN). Age, gender, and frequency of concomitant dexamethasone use did not differ between the two groups. No difference was found in total control and major response between patients receiving OND (56%: 10%) or GRAN (60%: 13%). No significant differences were noted in any of the outcome variables (p > 0.05). Subset analysis of outcomes In patients receiving moderately hkjh-hlghly emetogenic regimens revealed no dtBerences between OND and GRAN groups. Subset analysis of outcomes in patients who received OND and were subsequently crossed over to GRAN revealed no significant differences In cUrrical outcome parameters. Physician compliance with the all oral antiemetic guidelines was 60% during the first six weeks which translates into 33% cost saving per treatment Conclusions: All oral antiemetic regimens are equally efficacious and cost-effective in the prevention of acute CIE.

Palliative and supportive care 6 6 4 P | High Occupational Fitness Following Integrated Rehabilitation (R) In Patients Who Have Recently been Surgically Treated for Breast Cancer M.R. Strada. G. Bernardo, E. Lodota, A. Bernardo, M. Plastina, I. Giorgio 1 , P. Betta 2 , G. Bottero 3 . Serv. of Oncol. & Rehabii, "S. Maugeri' Found., Pavia, Italy,1 Serv. of Psycho!., 'S. Maugeri' Found., Pavia, Italy;2 Serv. Pathoi. Anatomy, S. Spirito H., Casale M. to, Italy;3 Drv. Ftadlotherapy, City H., Alessandria. Italy 68 pts entered a programme of integrated R (physical + psychological) starting 2-3 weeks after surgery for breast cancer; 60 of them were assessable for physical outcome, psychological function by means of Cognitive Behavioural Assessment (CBA 2.0) and working activity; 40% and 3 1 % pts are involved in heavy and moderate homework respectively; 4 1 % are involved In ofl-home work and on the whole 81 % (mean age: 49.5 yr; range: 26-65) are very actively full time. Results: 1. a statistically significant (p < 0.001) Improvement was found when considering all pts with respect to articular impairment assessed by means of a grade-based geometric device, and to strength assessed by the Kendall system; 2. only 15.3% pts revealed worsening psychological distress; 3. recovery of working capability homework in 87.5%, offhouse work in 88%. Conclusions: our rehabilitation programme does appear effective with respect to the physical recovery, psychological improvement and occupational fitness In a group of pts In a still active age; the social fallout of these results Is remarkable.

665P

Consumer Satisfaction: Its Relation with Treatment Adherence In Young Cancer Patients

A. Meseguer', M. Pastor. M P. Barreto, J. Montalar, J. Gomez-Codina, A. Ottra. Medical Oncology Unit, Hospital La Fe, Valencia;1 Department of Personality, University of Valencia Aim: To analyse the individual satisfaction with health care and its relationship with treatment adherence in young and adolescent cancer patients, a subgroup with frequent problems in therapeutic compliance. Methods: Satisfaction levels (15 VA Scales referred to the health system: physicians, nurses and hospital) were registered 5 times through their therapeutic course in 59 oncotoglc patients aged 14 to 30 years who were seen at our center from June-91 to May-95. Treatment adherence at the middle and at the end of treatment was recorded by the medical staff. Relations between both variables were then studied. Results: Satisfaction levels with health care were high (x = 88 at the middle, and x = 85.1 at the end of treatment). Some differences are noticeable among the three entities analysed: higher scores for physicians and nurses (X = 92.6 and 84.4 at the end of treatment, respectively) and significantly lower for hospital performance (X = 64.6 at the same time). According to patient treatment adherence levels, it is remarkable a direct correlation between good adherence and positive perception of hospital performance. In contrast, a high satisfaction with the attending physician at diagnosis is associated later with a worse treatment compliance (Inverse correlation). Conclusions: We confirm the Importance of a empathy communication between the patient and the medical staff for treatment adherence. However, hospital organisation and comfort should be optimised. The inverse correlation noted could be explained by the fact that initial expectations of support or treatment tolerance at diagnosis have not been satisfied.

Oskar Andrysek. 1" Clinic of Surgery, V Medical Faculty, Charles University, Prague, Czech Republic Patients with advanced involvement of the liver with tumour metastases demand often despite the serious prognosis to corrtinuate in the treatment of their disease. Only patients with more than 50% of the parenchyma involved with the tumor, where neither surgical resection nor start or continuation in the intraarterial chemotherapy could be performed, were Included in the study. Most of them suffered from the colorectal cancer, the minority from other gastrointestinal or mammary one. We used two regimes of chemotherapy, crossover after failure of any of them was allowed: 1. Ftorafur 0.8 g in suppository twice dally for 20 days with leucovorin 20 mg p.o. in the morning of each day of per rectum medication. After 10 days pause a new cycle was started. 2. Etoposld (Lastet 25 mg caps.) three times dally p.o. for 13 days, new cycle started in 4 weeks. In heavily pretreated cases we observed surprisingly more than 40% of objective responses with median of 6 months and In many other cases subjective Improvement with tumour marker decrease (46 patients). Conclusion: The use of per rectum ftorafur with per os leucovorin and low dose per os etoposld are effective measures in very advanced Involvement of the liver with metastases of gastrointestinal and mammary cancer.

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Factors and Parameters Determining the Effect of Antlemetic Treatment with Ondansetron (Z) In Patients Undergoing Cisplatln-Based Chemotherapy: A Retrospective Study

N. Tsavaris. G. Kallergls, Ch. Bendenldls, V. lakovWIs, N. MylonaWs, Ch. Bacoyiannls, N. Karvounls, C. Kosmas, P. Kosmkfls. Athens University School of Medicine, Lalkon General Hospital, and Hellenic Anticancer Institute, Athens, Greece Aim: The efficacy of anttemetic treatment with HT3 antiagonists and other medications is known to be affected by various disease-associated or psychological and personality parameters. We aimed at investigating these parameters in patients receiving Z as antiemetic medication for cisplatin-induced emesis. Methods: In 298 patients receiving various antiemetic combinations based on Z at 24 mg/24 hr, we studied various factors reported to affect the outcome of antiemetic therapy. These consisted of: sex (209 males, 89 females), age, previous chemotherapy (206 patients), radiotherapy (36 patients), type of cancer (lung: 88, head & neck: 119 patients), anxiety (179 patients, Hamilton's scale), depression (88 patients, Hamilton's scale), severe family and personal problems (119 patients, modified Holms & Rahe's scale), weight toss (35 patients, WHO scale), non-reversrble psychological state (46 patients), Performance status (Kamofsky 90-10Ch 187, 70-80:111 patients). Number of emetic episodes with (E+) or without (E-) gastric content and nausea duration were evaluated by the medical stall. Results: Multivariate analysis of the above paramstrs revealed that nausea duration was Increased in women (P = 0.034), patients with anxiety (P < 0.0001), depression (P < 0.001), severe personal problems (P = 0.008). Increased E+ episodes was observed In women (P = 0.046), patients with head & neck cancer (P = 0.047) and patients with anxiety (P = 0.018). Increased E - episodes were observed in younger patients (< 50 years) (P < 0.0001). Conclusion: Of the factors examined In the present study, female sex and anxiety were found to provide statistically significant prognostic power.

138

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Improved Bone Marrow Protection during High-Dose Carboplatin by Combination of G-CSF (Granocyte®) with Amlfostlne (Ethyol®)

K Hoekman. C.J.A. Punt', C M . Eeltink, L van Maanen 1 , W. Oster 2 , M.D. van Houten 3 , J.B. Vermorken. Univ. Hosp. VU, Amsterdam, NL;1 Univ. Hosp., Nljmegen, NL;2 USB Pharma Ltd, London, UK;3 NDDO-EORTC. Amsterdam, NL Alm:7o evaluate the effect on bone marrow protection of adding G-CSF (Granocyte9) to amlfostlne (AMI) in solid tumor patients (pts) treated with high-dose carboplatin (CARBO). The rationale for this approach is the suggestion from preclinlcaJ studies that AMI protects stem/progenitor cells responsive to G-CSF. Methods: Based on results of a phase I study (Vermorken et al, EJC, 31A [suppJ 5]: 200), chemotherapy-naive pts with a normal renal function were treated with CARBO 720 mg/m2 and 3 xAMI-740 mg/m2. AMI was given 15 min before, 2 hr after and 4 hr after the start of CARBO. Both AMI and CARBO were given over 15 min. Planned treatment interval was 4 weeks When grade 3 or 4 myelotoxiclty occurred during one of the cycles we continued the same treatment at the same dose in one patient group (group 1; n = 9). In a second nonrandomlzed group (group 2; n «= 8) the subsequent cycle Included also G-CSF (Granocyte*), which was given subcutaneously at a dose of 263 meg starting 24 hrs after the administration of CARBO until hematopoietlc recovery. Toxlclty grading followed WHO criteria. Results: the results in the 2 groups are summarized below Group 1 1 2 2

Cycle X X+1 X X+1

f Pts 9 9 8 8

AMI

G-CSF

+

+ +

+

+

Nsutropenla

Thrombocytoperta

0

1

2

3

4

0

1

2

3

4

2 2 0

0 1 1 0

3 2 2 2

3 2 1 1

1 2 4 1

0 0 0 0

0 0 0 0

2 2 2 3

6 3 4 3

1 4 2 2

4

Conclusion: Our preliminary data suggest that during high-dose CARBO, the addition of G-CSF to AMI not only decreased grade 4 neutropenia but may have had a beneficial effect on preventing the cumulative thrombocytopenia seen In group 1 pts. Further studies are warranted.

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Home Health Care Unit: A Report on Two Years of Activity

F. Castkjlione, M. Deslefanls, S. Ferro, A. Dalla Mola, G. Pordle. Medical Oncology Service, Ospedale S. Lazzaro V. Belli rP26, 12051 Alba Introduction: Since April 1994 we started a programme of Home Care (H.C) on neoplastic patients of our geographical district (named USL 18 Alba-Bra) in Piedmont (Italy) with a population of 150,000. 134 cancer pts. (83 males and 51 females), all pts. were In terminal or very advanced stage of disease. Resufts; The number of H.C. days was 6171, with an average of 52.2 (range 1-328). Median duration of H.C. has been correlated to hlstotogtaal type of the tumor with the following results: haematoiogic neoplasla = 125 days; headneck = 78; genitaKinnary apparatus = 59; lung = 49, gastroenteric apparatus and pancreas = 47; breast = 35; others = 24.


O 1996 Kluwcr Academic Publishers, Printed in the Netherlands


Pallattve Chemotherapy In Patients with Advanced Tumour Involvement of the Liver

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Palliative and supportive care The rate of deceased pts. is 118: 95 pts. died at home (80%) and 23 pts. in hospital (20%). 27 pts required hospitalization for a total of 323 days (average of 12 days for pt). In 52 pts. (39%) we emptoied continuous parenteral system of administration of analgesic, antiemetic drugs and nutritional support the use of venous central catheters was well tolerated by the pts. and no negative Influence on the quality of fife was observed. A study on 24 pts. suffering from pain has been led to value the Tramadol compliance and curative effectiveness: this drug has shown a good analgesic efficacy, a discreet handy, a tow toxldty and an elevated compliance of the pt. The H.C. operators have administered to 35 relatives of followed pts. a questlonary composed by 30 questions with the main aim of testing utility of the service and the professional abilities of the staff. The questionary has shown that in the 97% of the cases pts. relatives would counsel this service to other pts. in terminal stage of disease and that In the 75% of the cases the medical and nursing staff activity was retained excellent. Conclusion: Home health care unit is an efficient and agreeable assistance form; Ifs still to clarify the evaluation of cost-benefit ratio.

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Selecting the Optimal Dolasetron Dose for Antlemesis after Emetogenlc Chemotherapy (ECT): A Pooled Analysis

K. Penderorass. B. Audhuy, A. Fauser, M. Cramer, J. Whitmore, W. Hahne. Research Medical Center, KC, MO; Hopitaux CMIs de Colmar, France; Klmik fOr Onkologle, Idar-Obersteln, Germany; Hoechst Manon Roussel, KC, MO

DM dose

hour 4

hourS

hour 12

hour 18

hour 24

p value

0.6 mg/kg 1.8 mg/kg

91% 97%

74% 87%

67% 78%

56% 66%

41% 51%

0.027

12 mgAg LBrng/kg

93% 92%

78% 78%

70% 73%

63% 67%

50% 59%

0.042

1.8mg/Vg 2.4 mg/kg

94% 93%

79% 77%

72% 72%

59% 58%

49% 43%

0.277

Results from the comparison of the 1.8 mg/kg DM dose to the 2.4 mg/kg dose Indicate no additional efficacy achieved with the higher dose. We conclude from the pooled data that a single 1.8 mg/kg DM dose is the optimal weight-based IV dose to prevent acute emesis brought on by ECT.

6 7 1 P | Oral Granlsetron (Kytrll* Tablets) Given as a Single 2-mg Dose Is Effective In the Prevention of Nausea and Vomiting Associated with High-Dose Clsplatin J. Wada 1 , E. Miranda 2 , G. Justice 3 , P. Eisenberg4, R. Navari 5 , C. Friedman ° for the Granlsetron Protocol 438 Study Group.' Qlendale, CA; 2 Phoenix, AZ;3 Fountain Valley, CA; * Greenbrae, CA;5 Birmingham, AU 8 SmtthKUne Beecham Pharmaceuticals, Upper Providence, PA, USA This mufticenter, open-labelled study evaluated the efficacy and safety of oral granisetron (Kytrll* Tablets) given as a single 2 mg dose prior to chemotherapy In the prevention of nausea and vomiting In 30 patients receiving high-dose ctepiattn. Adult patients (mean age 68 yrs) with malignant disease, who were naive to emetogenic chemotherapy, were administered two 1 mg granlsetron tablets one hour before Initiation of cisplatin > 60 mg/m2 (mean cisplatin dose was 77.6 mg/m 2 , range of 60.0-100.5 mg/m2). Use of prophylactic antiemetic agents including dexamethasone was prohibited. Efficacy was assessed over the 24 hour period after receiving cisplatin. Complete protection from vomiting was obtained in 70% of patients (21/30). The percentage of patients with no worse than mfld nausea was 83% (25/30 pts). Complete response, defined as no vomiting and no greater than mild nausea, was achieved In 67% of patients. Granlsetron was well tolerated with headache reported in only 5 patients (17%). In conclusion, a single 2 mg oral dose of granisetron Is effective in preventing nausea and vomiting In patients treated with high dose clsplatin.

Annals of Oncology 7 (Suppl 5J, 1996

A Survey of Appetite Disturbance in Terminally III Patients and Consequent Anxiety for Patients and Relatives

C. Hawtdns. J.L Riley. Meadow House Hospice, London, UK Alms: To quantify appetite disturbance In patients known to a palliative care unit and to assess the consequent anxiety for patients and their relatives. Method: Using a set questionnaire, patients and their relatives were asked about the patient"s appetite and about their concerns If the appetite was altered. Demographic details were noted. To date, 56 Inpatients and 22 patients In the community have been recruited, with a total of 61 sets of relatives. All patients had Incurable cancer with variable duration of Illness. Statistical significance was assessed using Chl-squared tests with Yates' correction. flssufts; 62 patients (79%) reported a reduced or absent appetite with only 16 (21%) feeling their appetite was unchanged. 50 (82%) of relatives were aware of a diminished appetite with 11 (18%) reporting no change. Of the anorexic patients 21 (34%) felt anxiety related to this symptom compared with 43 (86%) of their relatives. There was no difference in the proportions of patients and their relatives reporting a reduced appetite. However, there were significant differences between patients and their relatives regarding anxiety consequent to anorexia (p < 0.0001). Conclusions: Anorexia Is widespread amongst terminally ill patients. Subsequent anxiety affects a proportion of patients and the majority of their relatives. This may represent a deficiency of appropriate explanation and counselling. We are now evaluating whether time is spent with patients and relatives to discuss appetite disturbance and whether this alters their anxiety levels.

6 7 3 P | Early Results of a Pilot Study of an All-Oral Antiemetic Regimen for Patients Undergoing High-Dose Chemotherapy (HDC) with Peripheral Blood Progenitor Cell Transplant (PBPCT) LFrakes. M. Kosty, W Miller, R. McMillan, B. Meisenberg. Bone Marrow Transplant Program, Scripps Clinic and Research Foundation, La Jolla, CA, USA Aim:To assess the safety and efficacy of an oral, combination regimen including a 5-HT3 receptor antagonist in the setting of highly-emetogenlc conditioning chemotherapy for stem cell transplant. Methods: Patients received a novel antiemetic regimen of oral granlsetron (GRAN) 2 mg once daily, dexamethasone (DEX) 4 mg p.o. q6h and procnlorperazine (PRO) 10 mg p.o. q6h. The first doses of antiemetic were given one hour prior to HDC on each of four days of infusion and for one day after. The HDC consisted of either CVP (Cydopbosphamide 6 g/m 2 , VP-16 1800 mg/m2 and Carboplatin 1200 mg/m2) or CTP (Thiotepa 500 mg/m2 in place of VP-16), in four daily doses delivered over 4 hours from days - 4 to - 1 . PBPC were collected and cryopreserved with 10% DMSO and reinfused on day + 1 . All adverse events, rescue medications, nausea rating by visual analog scale and emetic episodes were recorded on a dally diary. Emetic responses were graded as complete response (CR ° no emetic episodes (EE) In 24 hours), major response (MR = 1-3 EE/24 hrs) or failure (> 3 EE/24 hrs). Nausea was defined as absent minor (graded 1-4 on visual analog scale) or severe (graded 5-10). Results: To date, 21 patients (15 female, 6 male) are evaluate. 62% (13 pts) achieved CR (no emesis) on all of the five study days. The combined complete and major response for emesis was 95% (20 pis), 90% (19 pts), 86% (18 pts), 76% (16 pts), and 76% (16 pts) on Days -A, - 3 , - 2 , - 1 and 0, respectively. Nausea was absent or minor on all days In 57% (12 pts). Severe delayed emesis occurred In three patients; two failed on Day +2, and one on Day +3. No significant toxlcifes have been observed and sedation is not noted. Conclusions: An all-oral antiemetic regimen of GRAN, DEX and PRO shows promising results In previously treated cancer patients receiving multiple, dally high-dose chemotherapy regimens. This regimen Is advantageous due to Its cost-saving potential, tow side-effect profile and ease of administration In the predominately outpatient setting of HDC with stem cell rescue.

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Perspectives of the EMF-Exposure in Oncology

L I . Korvtova. O.P. Resunkova, S.D. Ivanov. Radiology Division 70 mg/m2) and 17% (27071587) received cyclopbosphamlde and/or doxorublcln or other anthracycllnes. The analysis compared trials studying doses In the range of 0.6 to 2 4 mg/kg, using only trials where the doses were dlrectty compared. The 8 pooled trials were similar In design (24 hour, parallel, multicenter) and had the same primary endpoint (complete response [CR]: no vomiting/retching or rescue meds) and patient enrollment criteria. DM was Infused * 30 min before ECT In all trials. An analysis of time to failure was done using survival analysis methodology. Results: Pairwise comparisons of the pooled data for 0 6 vs 1.8 mg/kg DM and 1.2 vs 1.8 mg/kg DM demonstrate a dose response relationship for efficacy and a dose-duration relationship within the 24-hour study. The 1.8 mg/kg dose produced significantly higher CR rates by 4-hour period:

| 672P

Palliative and supportive care eptdermit zone resulted In an eptthellzation after 8-10 performances of EMF. The stimulating course consisted of 10 performances usually. Conclusion: The EMF-use having promising in the radiological practice for the profilaxis and the treatment of the postradiation reactions, and some injuries.

675P

Cefepime (C) Monotherapy in Febrile Patients (PTS) with Chemotherapy Induced Neutropenla. (Preliminary Results)

I. Varthalltls. M. Papadopoukxj, V. Vlachopoulos, D. Pectasides, M. Dlmltrladis, A.E. Athanasstou. 1st Dept of Medical Oncology. Metaxa Cancer Hospital, Piraeus, Greece

Conclusion: Cefepime monotherapy has proven equivalent to standard antibiotic combinations, as empiric therapy in these febrile neutropenic pts. Intrigulnaly, the lower dose C arm was equally effective and safe compared with the higher dose C, with the advantages of simplicity (2 Infusions Instead of 3), and tower cost Furthermore, G-CSF, given as corrective treatment, significantly, reduced the duration of neutropenla following chemotherapy. The study is continued

| 6 7 6 P I CeftazJdime (CFZ) Monotherapy as Empirical Initial Treatment of Febrile Neutropenla In Cancer Patients (Pts) A. Papachristodoulou. M. Vaslamatzis, S. Xynogalos, A. Papacharalambous, C.G. Alexopoulos. Dot of Medical Oncology, Evangetismos Hospital, Athens, Greece Aim: To evaluate prospectivefy the effectiveness of CFZ monotherapy as empirical initial treatment of febnle neutropenla due to cancer chemotherapy. Patients-Methods: Seventy seven pts who developed 85 febrile episodes (temperature > 38°C & ANC < 1000/mm3) were randomly assigned to two groups. Group A, comprising 35 pts or 39 episodes, received CFZ 6 gr/d. Amikadn (AMK) was added if pyrexla (> 38°C) persisted (or 72 hrs. Group B, comprising 42 pts or 46 episodes, received from the beginning CFZ 6 gr/d plus AMK 1 gr/d. There were no significant differences among the two groups concerning age, ANC & duration of neutropenia. Antibiotics were continued for 48 hrs after fever resolution provided the ANC was > 1000/mm3. Persistence of pyrexia for >7d, In the presence of an ANC > 1000, was considered as failure. Results: In group A, 36/39 (92%) febrile neutropentas responded eventually, satisfactorily compared with 39/45 (85%) of group B (P = NS). We observed no significant differences In duration of pyrexla and duration of antibiotic administration between the two groups. AMK had to be added In 19 of 39 episodes, in group A (48.7% of cases). One death was observed In each group of pts. Conclusions: a CFZ monotherapy as Initial treatment with the addition of AMK when needed Is a safe & effective empirical therapeutic policy In febrile cancer neutropenia. b. Combining CFZ and AMK from the beginning means unnecessarily administering AMK in well over 50% of cases.

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Analysis of Emesls In Patients with Breast Cancer Undergoing High Dose Chemotherapy with Cyclophosphamlde, Thlotepa and CarboplarJn (CTCb) Followed by Peripheral Blood Stem Cell Transplant (PBSCT)

M A CSment, J. Palau, V. Soriano. V. Guillem. Unidad de QuirrAoterapta a altas dosls, Servido de Oncohgla Mikllca, Instituto Valendano de Oncotogla, Valencia, Spain New antiserotonlnlc drugs have been advocated as the best treatment for nausea and vomiting. Emetic episodes have been analyzed in 24 breast cancer patients undergoing high dose chemotherapy treatment with CTCb followed by PBSCT Antiemetic treatment consisted In an anteiserotoninic agent (tropisetron [tro] 5 mg tid or granlsetron [gra] 3 mg bid), haloperidol 0.5 mg bid, dexametasone 12 mg and kxacepam 1 mg once daily. Nausea and emetic episodes were evaluated every 6 h from the first day of treatment up to the 8th day after. Antiemetic response was evaluated as complete response If no emetic episodes were present, partial response If patients had 1 to 3 episodes and no response if more than 4 episodes were present. The number of total episodes were also evaluated every day of the study. 24 patients are evaluated. 13 treated with tro. and 11 with gra. Median age was 42.9. 4 out of 24 patients presented complete response (3 with tro. and 1 with gra.) for the whole treatment days. Every day response and median emetic episodes are showed in the following table.

Chemot days

CR(%)

PR(%)

NR(%)

Median emetic episodes

1st day 2nd day 3rd day 4th day

20 (83.3) 11 (45 8) 7(29.2) 7(29 2)

4(16.7) 6(25) 11 (45.8) 7(29 2)

0(0) 7(29.2) 6(25%) 10(47.6)

02 1.85 1 9 32

5th 6th 7th 8th

day day day day

4(16 7) 6(25) 11 (45 8) 13(54 2)

7 (29.2) 9 (37.5) 9 (37 5) 9 (37.5)

13(54.1) 9 (37.5) 4(16.7) 2 (8.3)

3.92 2.96 1.8 09

1st-8thday

4(167)

1(4 2)

19(79.2)

Vomiting is an Important problem in patients undergoing high dose chemotherpy treatment and it can be only completely controlled in 16.7 of patients, even with heavy antemetic treatment Vomiting frequency is higher at the end of treatment and even days after, so antiemetic treatment needs to be continued even after the end of chemotherapy treatment

678P

Ondansetron (O), Metoclopramlde (M) and Methylprednlsolone (MP) P.O.: A Good Combination Against Delayed Emesls In Highly Emetogenlc Chemotherapy

G. Mustaochi, R. Ceccherinl, S. Milani. P. Sandri, M.L Letta. Centre Oncologlco, Unrversita dl Trieste, ASS Triestina, Italy Introduction and aim: 5-HT3 antagonists plus steroids are the standard for acute emesls control wich is about 80% at the first cycle of chemotherapy, falling to 60-70% In subsequent cycles. About 80% of patients suffer delayed emesis and antiemetics drugs are of Prttie value. Some patients benefit from 5-HT3, others from metociopramide, in both cases steroids add a little Improvement Our aim was to test If the administration of the three drugs after the chemotherapy could Improve the complete control (CC) of acute and delayed emesis. Methods: we treated 71 cancer patients candidates to a highly emetogenlc chemotherapy with O 8 mgs e.v. + Dexametasone 20 mgs e.v. for the acute emesls prophflaxis. Patients were randomized to receive the day after, for three days A) M 10 mg x 3/day + MP 4 mg/day p.o. or B) the same + O 8 mgs x 3/day p.o.. Patients recorded on a diary any symptom for five days, for 3 chemotherapy cycles. Results: acute emesls CC was 87.5% and 84.6% at the 1 st cycle, at the 2nd 62.5% and 87.2% (p = 0.02), at the 3rd 68.8% and 89.7% (p = 0.01), without or with O, respectively. Similarly the CC (acute and delayed) over 3 cycles was 12 5% and 38.5% (p = 0.02). The number of days wtth some (any grade) emesis was 294/576 (51%) without O and 212/714 (29.7%) wtth O (p = 0.000). Conclusions: Ondansetron, when added to Metociopramide and low dose Methytprednisolone p.o. for 3 days after chemotherapy improves significantry the CC of the delayed emesis over subsequent cycles and consequently the CC of acute emesis too, at a reasonable cost, in lack of toxlctty.

Annais of Oncology 7 (SuppL 5), 1996

© 1996 Kluwer Academic Publishers, Printed in the Netherlands


Aim: To determine the safety and efficacy of as well as the relative cost of C monotherapy, including low dose C therapy, as empiric antibiotic treatment of febrile neutropenic solid tumor pts. Methods: Between May 1995 and April 1996 In a prospective-randomised study, sixty one (61) episodes of fever (>38 C) and granulocytopenia (absolute neutrophil count, ANC < 1000/mm3), occurring in 46 pts, were empirically treated with C 2 gr twice dally [arm A: 28 episodes], or C 2 gr every 8 hours [arm B: 33 episodes]. All pts received corrective treatment with G-CSF 5 /ig/kg/day SC beginning on the day of detected febrile neutropenla and until ANC recovery. Treatment failure was defined as a lack of clinical improvement and persistant fever after 72 h of monotherapy. If C had to be modffied, It was replaced with imipenem, and this was considered a failure. Results: In the A and B arms respectively, median age was 65 (range 22-82) and 64 (22-84) years, 16/28 (57%) and 20/33 (61%) were men, 18/28 (64%) and 22/33 (67%) had ANC < 500/mm3. Bacteremia and clinically documented Infection were documented in 5 and 16 episodes [arm A], and in 7 and 14 [arm B]. The rest 7/28 (25%, a m A) and 12/33 (36%, arm B) were considered fever of unknown origin. Of the microbiologicaly documented infections, 6 were gram positive cocci (4 Staph. Epl., 1 Staph Aureus, 1 Staph. Hominls), and 16 were gram negative rods (8 E. Coli, 3 Pseud. Aerugjnosa, 2 Klebs. Pneumonia, 1 Pseud. Stutzeri, 1 E. Aerogenes, 1 Chryseomonas Luteola). Neutropenla lasted 3 days on average (range 1 to 9 days In arm A and 1 to 14 days in arm B). At 72 hours, response without modification occurred in 21/28 (75%) episodes [arm A] and In 21/33 (64%) [arm B]. The success rate of eradicating the documented bacteremias, was 60% (3/5, arm A) and 7 1 % (5/7, arm B). The salvage success rate obtained by switching to imipenem was 100% (4/4, and 7/7 respecttvefy) No adverse events or superlnfecttons occurred. One pt in ami A and 3 pts in arm B died because of treatment failure.

677P

Palliative and supportive care 679P The Influence of the Number of Transplanted Progenitor Cells on Haematologlcal Recovery in Patients Treated with High Dose Chemotherapy (H. D. CHE) and Peripheral Blood Stem Cell (PBSC) Rescue G. Koumalds. J. Fills, M. Vassilomanolakis, K Papanastastou, H. Hatzichristou, V. Barbounis, M. Stamatellou, A. EfremWls. BUT Unit, Hellenic Cancer Institute, St Savas Oncology Hospital, Athens, Greece The aim of the study Is to investigate the relation between the haematological recovery In patients after H. D. CHE and PBSC rescue and the number of relnfused previously collected stem cells assessed by the number of MNCs, CFU-GMs and CD34{+) cells in the harvest. Forty nine patients were mobilized wtth different ways and 1-5 leukapheresls were performed. The target number for MNC and CD34{+) collection was 2 x 1O"/kg and 2x10°/kg respectively. The collected reinfused cells and the haematologlcal recovery following PBSC rescue are shown in the table below: MNC (x10»/kg) Msdan 4.3 Flange (056-12.0)

CRI

CD34 2 weekly cases) 51 evaluations about health-service post mortem (> 2 weekly cases) and a median of the verification and planning of the interventions of 3 weeks (range 0/9). The median presence of the professional nurses to the weekly reunions has been of 7.5 unity (range 4/10). The problems and the arguments dtecussed during the meetings have prevalently been of psycho-social sort and ethical followed from those of dlnicals sort In health service To give space to the emerge of the dlfferents problems, to have an adeguate and recognized leadership, and also an adeguate emotional bracket, they have been revealed the essential elements to guarantee a good degree of satisfaction of the operators that it Is translated In a constant parteclpatlon to the weekly team meetings. The comparison Into the differents operators has furnished the stimulus for a better formation also In the sanitary sphere of the palliative cares that In the relation's sphere The motivation and the cultural flexibility that our work's group demonstrates to have they are the requisites to consent that continuous readjustment of the operational formalities so necessary to the attainment of the objectives In the introduction.

704 Phase II Study of Procarbazine (PCZ) In Patients (Pts) with Recurrent Malignant Glioma (MG). Grup D'Estudl de Gllomes de L'Area de Barcelona (GEGAB) M. Gil. F. Graus 1 , N. Vifiolas 1 , M. Martinez Vlllacampa, S. Villa, F. Losa. Hospital Duran I Reynals: Institut Catala (fOncotogia, Barcelona, Spain; 1 Hospital Duran I Reynals: Hospital Clnlc i Provincial, Barcelona, Spain Aim: To evaluate efficacy, toxicfty and feasibility of a treatment wtth PCZ In heavily pretreated pts wtth MG. Methods: Between 1/1994 and 1/1996, 16 pts were enrolled on a phase II study using PCZ 150 mg/m2 po/d x 28 days every 8 weeks (w). Pts eteglbiliry: HistotogicaJly confirmed MG, age > 18 years, Karnofsky (KS) > 40 and failure after radiotherapy (RXT). Pts characteristics: 10 mates/6 females; median age was 48 years (R: 20-169), histotoglc type: glloblastomas (GB) 10, anaplastic astrocitomas (AA) 5 and gemistocytic astrocttoma 1; KS: 50 In 4 pts, 60 In 4 pts, 70 in 4 pts and 80 in 4 pts. The median time from de first diagnosis was 12 months (R 4-43). Previous treatment was surgery in 15 pts and RXT In all pts, 13 pts had received chemotherapy (CXT) with BCNU at median accumulated doses of 800 mg/m2 (R 200-1400). All pts were In progression before inclusion. Response was evaluated every 2 months according to McDonald's criteria. Mean follow up for pts still alive Is 38 w (3+-56+). Results: Total number of cycles administered was 42, mean 2.6 (R 1-6). 15 pts were evaluable for response. We observed 3 PR (20%): 2 GB and 1 AA (all wtth KS 80), 8 SD (53%) and 4 PD (26%). None of 2 pts without previous CXT responded. Median time to tumor progression (MTP) for all pts was 21 w (1-56+) and MTP for respondere was 39 w (16-56+). Medan survival (MS) for all the pts was 26 w (R 4-56+); MS for GB was 22 w and for AA 34 w; pts who achieved PR had a MS of 31 w (12-56+). None of the pts showed improvement of KS. According to NCI criteria grade (G) 3/4 neutropenia occurred in 4 pts (26%), thrombopenla G 2/3 in 3 pts (20%), anaemia G 2 In 2 pts (13%), no pts experienced febrile neutropenia. Dose of PCZ had to be reduced due to hematotogical toxictty in 16/42 cycles (38%). Nausea and vomiting G 1/2 occurred In 4 pts (26%) and G 3 hepatic toxictty In 1. No toxic deaths were observed.


145


The aim of the study Is to evaluate the efficacy and toxlcity of treatment with H.D.CTX In advanced cancer of different type. A total of 38 patients with advanced carcinoma of breast, ovary, lung and NHL were enrolled in the study. All patients had hlstotoglcalfy proven metastatic malignancy in which therapy with an alkyfating agent was Indicated and they had received prior chemotherapy ± radiotherapy To be eligible patients wore required to have a predicted life expectancy at least 2 months and an ECOG PS 0-3. Cytoxan 4.5 gr/m2 was administered in two divided 4 hour Infusions over 48 h period accompanied with an equal daily dose of Mesna for urotheliai protection and intravenous hydration (3 L/m2) G-CSF was administered at 5.0 ng/kg per day In different timing schedule after H.D.CTX. Sixty seven H.D.CTX cycles for the 38 patients were evaluabte. Results:

| 703 | Methodologies and Results about Work-Team in Integrated Domiciliary Oncology Health-Service

Palliative and supportive care Conclusion: PCZ Is well tolerated with a modest response rate In a heavily pretreated, poor prognosis group of pts wtth recurrent MG. However neither survival or perfomance status Improved. New agents or more active schedules are needed.

705 Cardiac Tamponade (CT) as Presenting Feature of Malignancy M. Iraburu, L Calvo. D. Martinez, F. Portela, N. Malmlerca, L M . Anton. Hospital 'Juan Canalejo', La Corufta, Spain

146

706 Central Venous Catheter with Reservory. Our Experience U. Bonn'. J. Aouiar'. J. Pulido. E. Qorry. 1 Medical Oncology and Vascular department of the Hospital Nuestra Sedora del Pino, Las Palmas of Gran Canaria, Canary Islands, Spain; Interventlonal Radiology department of the Hospital Nuestra Seflora del Pino, Las Palmas of Gran Canaria, Canary Islands, Spain From January 1990 to December 1995, a central venous catheter with reservory were Implanted to 264 oncologlc patients The median age was 50 years (range 29-69 years) and the perfomance status Kamosfky was > 80%. The most frecuent pathologies were breast cancer, non hodgkln lynphoma, cotorrectal and esofagous cancer. Methods. Two types of devices were implanted: PORT-A-CATH (PC) 222 and PAS-PORT (PP) 42. The subclavlan and the antetxaquial vein were most frecuentty used for the implantation of PC and PP devices. The procedure was performed on outpatient program exepted In 10 (10%) cases who were hospitalized. Results. The global percentage of complications were 12.7%. Two types of complicationes were observed. During the first 72 hours 2 (0.75%) neumothorax and 4 (1.5%) local Infections were seen. The percentage of later complications were 10.45% and the order of frequence was: Febrile episodes (4.9%), thrombosis (3%), migration (0.37%) and substances precipitations (0.37%). Conclusions: The use of PORT-A-CATH and PAS-PORT catheters are safe with low percent of complications.


C 1996 Kluwer Academic Publishers, Primed in the Netherlands


Pericardial involvement with metastatic tumor Is a frequent complication in cancer patients. Although It can remain asymptomatic, malignant pericardial effusion may lead to life threatening CT. We report 8 patients (7 males and 1 female), aged 53 ± 9 years, admitted to our hospital in the last three years due to symptoms of CT. None of them had a previous diagnosis of cancer, except for the female patient who underwent surgery for breast cancer, and remained free from disease for an Interval of 3 years. Echocardiography revealed severe pericardial effusion with collapse of right cardiac cavities In all patients. In 4 patients a pertcarcDocentesis was done under echocardiography control and a percutaneous catheter was placed until total drainage. In the other 4 cases a subxyphotd pericardial window was performed. CT was resolved In every case, and no complications were observed as a result of either procedures. The pericardal fluid obtained was an hemorragic exudate in all 8 cases. Malignant cells were found in 5 of these, finally diagnosed as lung cancer (1 adenocarcinoma, and 1 epldermold), breast cancer (1), adenccarclnoma of unknown primary (1), and papilar thyroid cancer (1). The remaining 3 cases with unspecffic fluids were diagnosed as oat-cell, epldermoid and uncfifererv dated lung cancer. Only one out of four pericardial biopsy specimens showed malignant Infiltration (adenocarcinoma). Conclusions: U n a patient with a CT, a malignancy-related cause has to be ruled out

2. Lung cancer was the main cause of CT as presenting feature of disease. 3. The sensitivity of pericardial fluid cytology for diagnosis of cancer was higher than that of pericardial biopsy (75% versus 25%). 4. Both perlcardtocentesis and pericardial window, are reliable procedures for the treatment of patients with CT due to malignancy.