First-line physician’s choice (PC1) or standard of care (SOC) then second-line PC2 chemotherapy (CT) in metastatic esophago-gastric adenocarcinoma (MEGA): BC Cancer Agency experience

Abstract

15158 Background: The BCCA GI Tumor Group supports 1 CT regimen for MEGA: weekly 5FU-cisplatin [FUC] (Shah, ASCO 1992, A530) for first line SOC CT. All other regimens (PC) require “undesignated” approval for public funding. Reasons for PC requests include prior CT, results of modern CT trials, and contra-indications to FUC. Objectives: to examine response, toxicity and survival in pts. receiving either first-line PC1 CT , or SOC and second line PC2 CT. Methods: BCCA Pharmacy records (Dec. 1999 to April 2006) were searched for PC MEGA pts, charts abstracted, database constructed and KM survival analyses undertaken. Treatment responses, serious toxicities and hospitalizations were recorded. Results: Demographic summary (N = 85): 32 esophageal (10 GEJ), 53 (62%) gastric primary, 61 M, 24 F, median age 56.2 (range 28.7 - 81.8) yrs., 68 Caucasian, 15 Asian, 2 Fijian descent, 55 stage M1 at diagnosis. Prior therapy: 14 CTRT, 3 adjuvant CT, 34 radical surgery. 50 pts received PC1 of whom 25, 9 and 2 received 2nd, 3rd and 4th line CT respectively; of 35 SOC/PC2 pts, 35, 10 and 2 received 2nd, 3rd and 4th line CT for a total of 133 patient-courses of PC (including 4 repeat FUC). Docetaxel and irinotecan regimens accounted for 34% and 36%, 5% and 55%, 16% and 32% of 1st, 2nd and 3rd line PC CT regimens respectively. Partial responses were seen with SOC (11/35) and PC1 (6/50) [chi square p = 0.05]. Four responses were seen with 2nd line CT (2 SOC/PC2, and 2 PC1). Grade 3+ toxicity rates: 19/49 (39%) and 6/36 (17%) with SOC and PC1 with initial CT (p = 0.02). There were 20 hospitalizations with PC and 2 with SOC CT (p = 0.02). Median follow-up time was 8.9 months. Survival analyses are presented below. Multivariate analysis results: primary site, SOC, gender, ethnicity, prior CT, p values were 0.15, 0.23, 0.23, 0.25 and 0.25 resp. Conclusions: Benefits and risks of non-SOC chemotherapy in MEGA need careful consideration before routine adoption as primary or subsequent therapy. [Table: see text] No significant financial relationships to disclose.