OBJECTIVES: Chemotherapy-induced nausea and vomiting (CINV) is a common debilitating adverse event of chemotherapy. Antiemesis guidelines ...
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setting. A pre-defined quota was used on the number of deceased patients that could be included (maximum 20%). Results: Of the 201 metastatic patients, 150 (74.6%) had advanced/metastatic disease at the time of initial diagnosis, while 51 (25.4%) had a history of earlier stage disease. Mean age at initial diagnosis of BC was 61.2. mBC was most often diagnosed radiographically, motivated by new symptom or abnormal lab values (60.2%). At the time of mBC diagnosis, most patients had an ECOG performance status of 1 (104, 51.7%) or 0 (76, 37.8%). Patients mostly had bone (71%) or lung (33%) metastases, with pain (62%) and fatigue (47%) being the main symptoms recorded. Patients received on average of 2.5 different therapies. In first-line, patients were treated with aromatase inhibitors (anastrozole (41.0%) and letrozole (20.5%)), while in second-line with exemestane (27.5%), fulvestrant (25.3%) and everolimus (22.5%). Median time to progression on first-line was 12.0 months (95% CI: 10.0 – 12.9) and survival probabilities at year 1, 2, 3 after diagnosis mBC were 96.7%, 87.8% and 81.8%. During first-line, 10 (5.0%) patients had at least one hospitalization for reasons directly related to mBC. Conclusions: mBC appears to have substantial disease burden, emphasizing the need for innovative therapies to alleviate the burden and improve treatment outcomes. 1895 455381 PCN25 Indirect Treatment Comparison Of Newer Treatments In Relapsed / Refractory Multiple Myeloma Gala S, Mwamburi M Market Access Solutions LLC, Raritan, NJ, USA
Objectives: Relapsed / refractory multiple myeloma (rrMM) remains challenging to treat effectively. Results of two major phase III randomized controlled trials (RCTs), ASPIRE for carfilzomib and ELOQUENT-2 for elotuzumab, both in combination with lenalidomide and dexamethasone (CLD and ELD respectively) in rrMM were compared to placebo plus lenalidomide and dexamethasone (LD). We performed an indirect treatment comparison (ITC) to compare CLD versus ELD. Methods: We evaluated clinical and safety endpoints from both trials. We derived risk ratios (RRs) and mean differences (MD) for dichotomous and continuous outcome respectively using RevMan 5.0. We further computed the ITC RRs and MDs using the Canadian Agency for Drugs and Technologies in Health (CADTH) ITC application which employs Bucher et al. (1997) method. ITC was conducted to compare CLD versus ELD for median progression-free survival (PFS) in months, median duration of response (DoR) in months and overall response rate (ORR). Results: Complete response (CR) and very good partial response (VGPR) were 8 and 2.5 times higher in CLD than ELD respectively. Overall survival (OS) was not reached in both the trials, but mortality was higher in CLD as compared to ELD. All / any grade adverse events AEs were lower in CLD than ELD while grade 3 or higher AEs were similar for both combinations. The PFS (MD= 4.20; 95% CI: -2.09, 10.49; p= 0.03) and DoR (MD= 3.29; 95% CI: -5.19, 11.78; p= 0.02) were significantly higher in CLD as compared to ELD. ORR (RR= 1.09; 95% CI: 0.97, 1.23; p= 0.73) was not significantly different between the two treatments. Conclusions: While both combinations significantly perform better than LD, our findings suggest CLD may perform better than ELD however caution should be exercised in interpreting these results. More time and trial data are needed to confirm this initial observation as well as determine any differences in overall survival. PCN26 Comparative Effectiveness Of Conservative Management Versus Cryotherapy For Patients With Localized Prostate Cancer: An Analysis Of Treatment-Related Complications And Cancer-Specific Survival Shah S, Young HN, Cobran EK University of Georgia, Athens, GA, USA
Objectives: To compare treatment related side effects and cancer specific mortality of conservative management and cryotherapy for patients with localized prostate cancer. Methods: The Surveillance, Epidemiology and End Results (SEER)Medicare data from 2000-2009 was used to identify patients with localized prostate cancer. Treatment related side effects such as urinary tract obstruction, erectile dysfunction, bleeding, hydronephrosis, bowel fistula, urinary fistula and incontinence were identified using ICD-9 and Common Procedure Terminology (CPT)/ HCPCS codes. Weighted propensity score method was used to balance the following covariates: age, race, tumor size, tumor grade, stage, tumor extension, and Charlson comorbidity index. Chi-square tests were used to compare treatment related side effects between the cohorts and a cox proportional hazard model was used to estimate cancer specific survival. All analyses were performed using SAS (version 9.4) Results: Overall, 2071 patients received conservative management and 1333 patients received cryotherapy. Patients in the conservative management cohort had significantly lower erectile dysfunction and urinary tract obstruction (p