Hospital Pharmacy Volume 42, Number 3, pp 191–198 2007 Wolters Kluwer Health, Inc.
Cancer Chemotherapy Update Docetaxel and Capecitabine (DC) Regimen for Solid Tumors Matthew R. Rutledge, BSc, BCOP,* Dominic A. Solimando, Jr, MA, FAPhA, FASHP, BCOP, and J. Aubrey Waddell, PharmD, FAPhA, BCOP The increasing complexity of cancer chemotherapy increases the requirement that pharmacists be familiar with these highly toxic agents. This column will review various issues related to preparation, dispensing, and administration of cancer chemotherapy, and review various agents, both commercially available and investigational, used to treat malignant diseases. Questions or suggestions for topics should be addressed to Dominic A. Solimando, Jr., President, Oncology Pharmacy Services, Inc., 4201 Wilson Blvd #110-545, Arlington, VA 22203, E-mail:
[email protected]; or J. Aubrey Waddell, Associate Professor, University of Tennessee College of Pharmacy; Oncology Pharmacist, Pharmacy Department, Blount Memorial Hospital, 907 E. Lamar Alexander Parkway, Maryville, TN 37804, E-mail:
[email protected]. *Mr. Rutledge is Chief, Hematology-Oncology Pharmacy Service, Department of Pharmacy, Madigan Army Medical Center, Tacoma, WA.
Regimen Name: Docetaxel and Capecitabine (DC) Origin of Name: Acronym for the two drugs in the regimen (Docetaxel and Capecitabine) INDICATION(S) Docetaxel and Capecitabine (DC) has been used as initial or second-line therapy for advanced and/or metastatic breast cancer,1-8 adjuvant therapy for locally advanced breast cancer,9 for gastric,10-14 esophageal,15 prostate,16,17 and non-small cell lung cancer,18,19 and solid malignancies.20 It is recommended for treatment of recurrent or metastatic breast cancer21 The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or reflecting the views of the US Department of the Army or the Department of Defense.
and may be more cost effective than alternative regimens.2,22 DRUG PREPARATION A. Capecitabine 1. Follow institutional policies for preparation of hazardous medications when dispensing capecitabine. 2. Capecitabine is available as 150 and 500 mg tablets. 3. Capecitabine tablets are unscored and filmcoated; breaking or cutting the tablets is difficult and not recommended. B. Docetaxel 1. Follow institutional policies for preparation of hazardous medications when preparing docetaxel. 2. Use docetaxel 40 mg/mL injection. 3. Prepare docetaxel according to the package instructions, using the provided diluent to make a 10 mg/mL concentration. 4. Caution should be exercised when preparing docetaxel. a. The Institute for Safe Medication Practices has reported instances in which, because the label on the diluent vial emphasizes the name of the active drug, the diluent was accidentally dispensed instead of the reconstituted drug.23 b. Errors in the reconstitution of docetaxel, related to overfill in the drug and diluent vials, have also been reported. The 80 and 20 mg vials contain 94.4 and 23.6 mg of docetaxel, respectively. The diluent vials are also overfilled. When reconstituted properly, the final solution contains docetaxel 10 mg/mL. The proper volume needed to obtain the required dose should be measured, rather than merely withdrawing the entire contents of the vial.24 5. Dilute with 0.9% sodium chloride injection or
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Table 1. Docetaxel and Capecitabine (DC) Regimen Dose
Dose
Docetaxel1,2,4,9,10 Capecitabine
Route of Administration
Administered on Day(s)
Total Dose/ Cycle
IV
1
75 mg/m2
1,250 mg/m
PO
1 through 14
35,000 mg/m2
75 mg/m2
IV
1
75 mg/m2
1,000 mg/m2
PO
1 through 14
28,000 mg/m2
75 mg/m2 2
OR Docetaxel5,8,11,12,15 Capecitabine
Cycle repeats: every 3 weeks Variations 1. Docetaxel 35 mg/m2 IV days 1, 8, and 15, capecitabine 625 mg/m2 PO, twice daily, days 8 through 21 every 28 days.3 2. Docetaxel 30 mg/m2 IV weekly, capecitabine 900 mg/m2 PO, twice daily, days 1 through 14 every 21 days.6 3. Docetaxel 50 mg/m2 IV day 1, capecitabine 750 mg/m2 PO, twice daily, days 1 through 10 every 14 days.7 4. Docetaxel 36 mg/m2 IV days 1,8, and 15, capecitabine 625 mg/m2 PO, twice daily, days 5 through 18 every 28 days.13,16-18 5. Docetaxel 36 mg/m2 IV days 1, 8, capecitabine 1,000 mg/m2 PO, twice daily, days 1 through 14 every 21 days.14,19 6. Docetaxel 30 mg/m2 IV days 1, 8, capecitabine 825 mg/m2 PO, twice daily, days 1 to 14 every 21 days.20 IV = intravenous; PO = oral
5% dextrose injection. The final concentration should be 0.3 to 0.9 mg/mL. 6. Contact between the undiluted injection and plasticized polyvinyl chloride (PVC) equipment or devices is not recommended. Docetaxel solutions should be dispensed in glass, polypropylene, or polyolefin containers. DRUG ADMINISTRATION: A. Capecitabine: 1. Capecitabine is administered orally (PO), usually in two divided doses taken 12 hours apart. 2. The dose is usually listed as the total daily dose, which is twice the individual dose (eg, 2,000 mg/m2/day = 1,000 mg/m2 twice daily). 3. Care should be taken to ensure the intended daily dose is not taken twice daily.
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4. To minimize gastric irritation, capecitabine should be taken after meals with milk or a small snack. B. Docetaxel should be administered by intravenous (IV) infusion over 1 to 2 hours through a non-PVC (low-sorbing) infusion set. No filter is necessary. SUPPORTIVE CARE A. Acute Emesis Prophylaxis: The DC regimen is predicted to cause acute emesis in 30% to 90% of patients.25 The studies reviewed reported grade 3 nausea or vomiting in 3% to 8% of patients.1,5,6,11,18,20 Park et al reported nausea or vomiting (all grades) in 72% of patients, but grade 3 in only 5% of patients.10 Day 1 prophylactic antiemetic therapy with a serotonin antagonist in combination with dexamethasone is recommended. Some experts also recommend use of a neurokinin inhibitor,26-28 but the corticosteroid used to suppress
hypersensitivity or pulmonary reactions may be the only antiemetic required.26-28 One of the following regimens may be given 30 minutes prior to therapy: 1. Ondansetron 8 to 16 mg PO ± dexamethasone 12 mg PO, given 30 minutes before DC on day 1 only. 2. Granisetron 1 to 2 mg PO ± dexamethasone 12 mg PO, given 30 minutes before DC on day 1 only. 3. Dolasetron 100 to 200 mg PO ± dexamethasone 12 mg PO, given 30 minutes before DC on day 1 only. 4. Palonosetron 0.25 mg IV and dexamethasone 12 mg PO or IV, given 30 minutes before DC on day 1 only. A meta-analysis of several trials of serotonin antagonists recommends against prolonged (greater than 24 hours) use of these agents; making a steroid or steroid-anddopamine antagonist combination
Cancer Chemotherapy Update
most appropriate for follow-up therapy.29 One of the following regimens is suggested: 1. Dexamethasone 4 mg PO, twice daily, for 3 days, ± metoclopramide 0.5 to 2 mg/kg PO, every 4 to 6 hours, ± diphenhydramine 25 to 50 mg PO every 6 hours if needed, starting on day 2. 2. Dexamethasone 4 mg PO, twice daily, for 3 days, ± prochlorperazine 10 mg PO, every 4 to 6 hours, ± diphenhydramine 25 to 50 mg PO, every 6 hours if needed, starting on day 2. 3. Dexamethasone 4 mg PO, twice daily, for 3 days, ± promethazine 25 to 50 mg PO, every 4 to 6 hours, ± diphenhydramine 25 to 50 mg PO, every 6 hours if needed, starting on day 2. On days 2 through 14, when capecitabine is given alone, the expected emetogenicity is very low25; most patients will not require prophylactic antiemetic therapy.26-28 Patients who experience significant nausea or vomiting with one of the above regimens should receive an agent from a different pharmacologic category.26-28 A few small studies suggest substituting granisetron for ondansetron in subsequent treatment cycles; however, none of these reports found the improvement to be statistically significant.30-34 B. Breakthrough Nausea and Vomiting25-28: Patients should receive an antiemetic prescription to treat breakthrough nausea. One of the following regimens is suggested: 1. Metoclopramide 0.5 to 2 mg/kg PO, every 4 to 6 hours if needed, ± diphenhydramine 25 to 50 mg
PO, every 6 hours, if needed. 2. Prochlorperazine 10 mg PO, every 4 to 6 hours, if needed ± diphenhydramine 25 to 50 mg PO, every 6 hours, if needed. 3. Prochlorperazine 25 mg rectally, every 4 to 6 hours, if needed ± diphenhydramine 25 to 50 mg PO, every 4 to 6 hours, if needed. 4. Promethazine 25 to 50 mg PO, every 4 to 6 hours, if needed ± diphenhydramine 25 to 50 mg PO, every 4 to 6 hours, if needed A few small studies suggest that higher doses of granisetron (3 mg IV or 40 to 240 mcg/kg) may be effective in treating breakthrough nausea; however, none of these reports found the improvement to be statistically significant.30-34 C. Hydration: No special precautions are required. D. Hypersensitivity Precautions: Docetaxel is likely to cause hypersensitivity reactions in up to 13% of patients; the manufacturer recommends administration of dexamethasone 8 mg PO, twice daily, for 3 days, beginning the day before the docetaxel infusion.35 Some clinicians recommend a histamine2 antagonist ± a histamine1 antagonist in addition to the steroid.36 If additional prophylaxis against hypersensitivity is chosen, the following regimen is suggested: 1. Cimetidine 300 mg or ranitidine 50 mg. 2. Diphenhydramine 50 mg. Both given IV over 30 minutes prior to docetaxel. E. Hematopoietic Growth Factors: Accepted practice guidelines and pharmacoeconomic
analysis suggest that an antineoplastic regimen has a greater than 20% incidence of febrile neutropenia before prophylactic use of colony stimulating factors is warranted. For regimens with an incidence of febrile neutropenia between 10% and 20%, use of colony stimulating factors should be considered. For regimens with an incidence of febrile neutropenia less than 10%, routine prophylactic use of colony stimulating factors is not recommended.37,38 Because febrile neutropenia was reported in 3% to 16% of patients, and severe (grade 3 or 4) neutropenia was reported in 3% to 82% of patients in the trials of docetaxel and capecitabine reviewed, prophylactic use of colony-stimulating factors is recommended. F. Extravasation: No special precautions are required.39 G. Pulmonary: Docetaxel can cause fluid retention (including pleural effusion, ascites, and peripheral edema) in up to 60% of patients.35 In the DC trials reviewed, fluid retention or edema was reported in 3% to 8% of patients.14,18,20 Patients should be treated with a steroid (eg, dexamethasone 8 to 10 mg PO twice daily) for 3 to 5 days, beginning the day before docetaxel administration.35,36 MAJOR TOXICITIES Most of the following toxicities are presented according to their degree of severity. Higher grades represent more severe toxicities. Although, there are several grading systems for cancer chemotherapy toxicities, all are similar. One of the frequently used systems is the National Cancer Institute (NCI) Common Terminology Criteria for
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Adverse Events (http://ctep. info.nih.gov). Oncologists generally do not adjust doses or change therapy for grade 1 or 2 toxicities; but make or consider dosage reductions or therapy changes for grade 3 or 4 toxicities. Incidence values are rounded to the nearest whole percent unless incidence was less than or equal to 0.5%. A. Cardiac: Atrial fibrillation (grade 3) 15%.12 B. Central Nervous System: Dizziness (grade 3) 15%.12 C. Dermatologic: Alopecia (grade 3) 6% to 15%1,6; hand-andfoot syndrome (grade 3/4) 24% to 50%,4,9,10 (grade 3) 3% to 47%1,5,6,8,11,12,15; oncholysis (all grades) 81%,10 (grade 3) 45%.6 D. Endocrine/Metabolic: Hyperglycemia (grade 3) 13%, (grade 4) 1%.1 E. Gastrointestinal: Anorexia (grade 3) 3%11; diarrhea (grade 3) 3% to 20%,1,5,6 (grade 3/4) 13% to 17%4,9,15; mucositis and stomatitis (all grades) 45%,10 (grade 3) 3% to 17%,1,5,6,11,12 (grade 3/4) 6% to 16%4,9; nausea (all grades) 72%,10 (grade 3) 3% to 6%1,5,6,11; taste disturbance (grade 3) 10%.6 F. Hematologic: Anemia (grade 3) 7% to 8%10,12; neutropenia (grade 3) 5% to 37%,1,5,11 (grade 4) 3% to 47%,1,5,10,11 (grade 3/4) 42% to 82%8,9,15; thrombocytopenia (grade 3) 3% to 7%.10,11 G. Hepatic: Hyperbilirubinemia (grade 4) 2%,1 (grade 3) 3% to 7%1,5; ALT/AST elevations (grade 3) 2%, (grade 4) 3%.1 H. Neurologic: Fatigue/asthenia (grade 3) 3% to 30%,1,5,6,11 (grade 4) 0.4% to 3%,1,5 (grade 3/4) 8% to 9%9,15; myalgia and muscle weakness (grade 3) 7% to 12%1,5; neuropathy (all grades) 31%,10 (grade 3) 3%,5
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(grade 3/4) 13%15; peripheral neuropathy (grade 3) 5%.6 I. Other: Lacrimation (grade 3) 5%6; rhinorrhea (grade 3) 5%6; pulmonary embolism (grade 4) 8%.12 J. Treatment-Related Deaths: Enterocolitis 0.4%1; pulmonary edema 0.4%1; cause unspecified 1%.4 PRETREATMENT LABORATORY STUDIES NEEDED A. Baseline 1. Aspartame aminotransferase/alanine aminotransferase (AST/ALT) 2. Total bilirubin 3. Serum creatinine 4. Complete blood cell count (CBC) with differential B. Prior to Each Treatment 1. CBC with differential C. Recommended Pretreatment Values: The minimally acceptable pretreatment CBC values required to begin a cycle with full-dose therapy in the protocols reviewed were: 1. Absolute neutrophil count (ANC): a. Greater than 1,400 cells/mcL1,10 b. Greater than 1,200 cells/mcL5 2. White blood cell count: greater than or equal to 4,000 cells/mcL11 3. Hemoglobin a. Greater than or equal to 8 g/dL1 b. Greater than 9 g/dL11 4. Platelet count: greater than or equal to 100,000 cells/mcL1,5,10,11 5. Serum creatinine a. Less than or equal to one and a half times the upper limit of normal (ULN)1 b. Less than 1.5
mg/dL5,10,11 6. Creatinine clearance: greater than or equal to 50 mL/min5,11 7. ALT/AST a. Less than or equal to five times ULN1 b. Less than one and a half times ULN5 c. Less than three times ULN; or less than five times ULN if hepatic metastases10,11 8. Alkaline phosphatase a. Less than or equal to five times ULN1 b. Less than two and a half times ULN5 9. Serum bilirubin a. Less than ULN1 b. Less than 1.4 mg/dL5 c. Less than 1.5 mg/dL10 d. Less than 2 mg/dL11 In clinical practice, a pretreatment ANC of 1,000 cells/mcL and platelets of 75,000 cells/mcL are usually considered acceptable. DOSAGE MODIFICATIONS A. Hepatic Function: 1. Capecitabine: No guidelines are available.40,41 2. Docetaxel: a. Bilirubin - greater than or equal to the ULN – do not give the drug35 b. ALT/AST – greater than one and a half times ULN, and alkaline phosphatase greater than two and a half times the ULN – do not give the drug35 c. ALT or AST greater than or equal to one and a half times to three and a half times ULN and alkaline phosphatase greater than or equal to two and a half times to five
Cancer Chemotherapy Update
times ULN - reduce dose 25%41 d. Some clinicians recommend no adjustment42 B. Myelosuppression: 1. Capecitabine: a. Any grade 2 clinical adverse event coinciding with neutropenia, and the patient hospitalized – discontinue drug1 b. ANC less than 500 cells/mcL for greater than 5 days; or a single platelet count less than 20,000 cells/mcL decrease dose by 25%5 2. Docetaxel: a. ANC less than or equal to 500 cells/mcL - reduce dose to 55 mg/m2.1 b. Recurrent neutropenia despite previous dose reduction - discontinue drug.1 c. ANC less than 500 cells/mcL for greater than 5 days, or a single platelet count less than 20,000 mm3 decrease dose by 20% to 25%.5 c. Grade 4 neutropenia for greater than 7 days, or associated with a temperature greater than 38ºC — reduce dose 25% in subsequent cycles.10 C. Neurologic: Docetaxel 1. Grade 2 neuropathy — delay docetaxel therapy until improvement to grade 1; resume at 75% of original dose.20 2. Grade 3/4 — do not give the drug.10 D. Renal Function: 1. Capecitabine: Creatinine clearance:43 a. 30 to 50 mL/min —
reduce dose 25%. b. Less than 30 mL/min — do not give drug. 2. Docetaxel: No dose modifications required.35,43 REFERENCES 1. O’Shaughnessy J, Miles D, Vukelja S, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002;20:28122823. 2. Verma S, Maraninchi D, O’Shaughnessy J, et al. Capecitabine plus docetaxel combination therapy. Cancer. 2005;103:2455-2465. 3. Puglisi F, Scalone F, Minisini AM, et al. A phase II study of capecitabine and weekly docetaxel combination chemotherapy in patients with metastatic breast cancer. Proc Am Soc Clin Oncol. 2005 (abstract 804). Available at: http://www.asco.org. Accessed February 9, 2007. 4. Chan S, Romieu G, Huober J, et al. Gemcitabine plus docetaxel (GD) versus capecitabine plus docetaxel (CD) for anthracycline-pretreated metastatic breast cancer (MBC) patients (pts): results of a European phase III study. Proc Am Soc Clin Oncol. 2005 (abstract 581). Available at: http://www.asco.org. Accessed February 9, 2007. 5. Lebowitz PF, Eng-Wong J, Swain SM, et al. A phase II trial of neoadjuvant docetaxel and capecitabine for locally advanced breast cancer. Clin Cancer Res. 2004;10:6764-6769. 6. Mackey JR, Tonkin KS, Koski SL, et al. Final results of a phase II clinical trial of weekly docetaxel in combination with capecitabine in anthracycline-pretreated metastatic breast cancer. Clin Breast Cancer. 2004;5:287-292. 7. Llorca C, Mayordomo J, Adrover E, et al. Activity and safety of biweekly docetaxel plus capecitabine as first-line treatment of patients with metastatic breast cancer. Proc Am Soc Clin Oncol. 2004 (abstract 788). Available at: http://www.asco.org. Accessed February 9, 2007. 8. Lim H-S, Lee HG, Chun JH, Lee JJ, Lee JS, Ro J. A phase II study of docetaxel (T) and capecitabine (X) combination chemotherapy as first-line
chemotherapy for patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol. 2005 (abstract 889). Available at: http://www.asco.org. Accessed February 9, 2007. 9. Bellet M, Muñoz M, Suárez M, et al. Phase II study of capecitabine (C) in combination with docetaxel (D) as neoadjuvant treatment in patients with locally advanced breast cancer (IIIA and IIIB stage). Correlation between clinicopathological response and fluoropyrimidine-enzyme profile. Early results. Proc Am Soc Clin Oncol. 2005 (abstract 735). Available at: http://www.asco.org. Accessed February 9, 2007. 10. Park YH, Ryoo BY, Choi SJ, Kim HT. A phase II study of capecitabine and docetaxel combination chemotherapy in patients with advanced gastric cancer. Br J Cancer. 2004;90:1329-1333. 11. Kim JG, Sohn SK, Kim DH, et al. Phase II study of docetaxel and capecitabine in patients with metastatic or recurrent gastric cancer. Oncology. 2005;68:190-195. 12. Thuss-Patience PC, Kretzschmar A, Loew A, et al. Capecitabine and docetaxel in advanced gastric adenocarcinoma, an ongoing phase II study. Proc Am Soc Clin Oncol. 2005 (abstract 4224). Available at: http://www.asco.org. Accessed February 9, 2007. 13. Catalano G, Orditura M, Diadema MR, Aurilio G, Ciardiello F, de Vita F. Phase II study of weekly docetaxel and capecitabine in patients with metastatic gastric cancer (GC). Proc Am Soc Clin Oncol. 2005 (abstract 4207). Available at: http://www.asco.org. Accessed February 9, 2007. 14. Chun JH, Kim HK, Lee JS, et al. Weekly docetaxel in combination with capecitabine in patients with metastatic gastric cancer. Am J Clin Oncol. 2005;28:188-194. 15. Lorenzen S, Duyster J, Lersch C, et al. Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial. Br J Cancer. 2005;92:2129-2133. 16. Vaishampayan UN, Heilbrun L, Eliason J, Pontes E, Powell I, Forman J. Docetaxel and capecitabine in metastatic androgen independent prostate cancer (AIPC): phase II trial to detect clinical efficacy of a synergistic combination. Proc Am Soc Clin Oncol. 2005 (abstract
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4703). Available at: http://www. asco.org. Accessed February 9, 2007. 17. Friedman JD, Vaishampayan U, Montie J, et al. Neoadjuvant docetaxel and capecitabine in patients with high risk/locally advanced prostate cancer: Preliminary results of a phase II study. Proc Am Soc Clin Oncol. 2005 (abstract 4742). Available at: http://www. asco.org. Accessed February 9, 2007. 18. Kindwall-Keller T, Otterson GA, Young D, et al. Phase II evaluation of docetaxel-modulated capecitabine in previously treated patients with nonsmall cell lung cancer. Clin Cancer Res. 2005;11:1870-1876. 19. Han JY, Lee DH, Kim HY, et al. A phase II study of weekly docetaxel plus capecitabine for patients with advanced nonsmall cell lung carcinoma. Cancer. 2003;98:1918-1924. 20. Ramanathan RK, Ramalingam S, Egorin MJ, et al. Phase I study of weekly (day 1 and 8) docetaxel in combination with capecitabine in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2005;55:354360. 21. National Cancer Comprehensive Network. NCCN Clinical Practice Guidelines – Invasive Breast Cancer. V.2.2006. Available at: http://www. nccn.org. Accessed February 9, 2007. 22. Verma S, Ilersich AL. Populationbased pharmacoeconomic model for adopting capecitabine/docetaxel combination treatment for anthracycline-pretreated metastatic breast cancer. Oncologist. 2003;8:232-240.
25. Hesketh PJ, Kris MG, Grunberg SM et al. Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol. 1997;15:103-109. 26. National Comprehensive Cancer Network. NCCN antiemesis practice guidelines. Available at: http://www. nccn.org/. Accessed February 9, 2007. 27. Kris MG, Hesketh PJ, Somerfield MR et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006;24:2932-2947. 28. Multinational Association for Supportive Care in Cancer. Antiemetic Guidelines. 2005. Available at: http://www.mascc.org/. Accessed February 9, 2007. 29. Geling O, Eichler HG. Should 5Hydroxytryptamine-3 receptor antagonists be administered beyond 24 hours after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications. J Clin Oncol. 2005;23:1289-1294. 30. Terrey JP, Aapro MS. The activity of granisetron in patients who had previously failed ondansetron antiemetic therapy. Eur J Clin Res. 1996;8:281-288. 31. Carmichael J, Keizer HJ, Cupissol D, Milliez J, Scheidel P, Schindler AE. Use of granisetron in patients refractory to previous treatment with antiemetics. Anticancer Drugs. 1998;9:381-385.
23. Cohen MR, Smetzer J. Preparing for a damaging medication error. ISMP Medication Safety Alert! 1999;4:14.
32. de Wit R, de Boer AC, vd Linden GH, Stoter G, Sparreboom A, Verweij J. Effective cross-over to granisetron after failure to ondansetron, a randomized double blind study in patients failing ondansetron plus dexamethasone during the first 24 hours following highly emetogenic chemotherapy. Br J Cancer. 2001;19;85:1099-1101.
24. Cohen MR, Smetzer J. Preparing for a damaging medication error. ISMP Med Safety Alert! 2001;6:3.
33. Smith IE. A dose-finding study of granisetron, a novel antiemetic, in patients receiving cytostatic chemothera-
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py. The Granisetron Study Group. J Cancer Res Clin Oncol. 1993;119:350-354. 34. Soukop M. A dose-finding study of granisetron, a novel antiemetic, in patients receiving high-dose cisplatin. Granisetron Study Group. Support Care Cancer. 1994;2:177-183. 35. Taxotere [package insert]. Bridgewater, NJ: Aventis Pharmaceuticals, Inc.; 2006. 36. Zanotti KM, Markham M. Prevention and management of antineoplasticinduced hypersensitivity reactions. Drug Saf. 2001;24:767-779. 37. Smith TJ, Khatcheressian J, Lyman GH, et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006;24:3187-3205. 38. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology - Myeloid Growth Factors. v.1.2006. Available at: http://www.nccn.org/. Accessed February 9, 2007. 39. Mullin S, Beckwith MC, Tyler LS. Prevention and management of antineoplastic extravasation injury. Hosp Pharm. 2000;35:57-74. 40. Xeloda [package insert]. Nutley, NJ: Roche Laboratories Inc.; 2005. 41. Bruno R, Hille D, Riva A, et al. Populations pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol. 1998;16:187-196. 42. King PD, Perry MC. Hepatotoxicity of chemotherapy. Oncologist. 2001; 6:162-176. 43. Kintzel PE, Dorr RT. Anticancer drug renal toxicity and elimination: dosing guidelines for altered renal function. Cancer Treat Rev. 1995;21:33-64. ■
