The BC Cancer Agency Compassionate Access Program: outcome analysis of patients with esophagogastric cancer

BACKGROUND The BC Cancer Agency Gastro-intestinal Tumor Group supports one standard of care (SOC) chemotherapy regimen for metastatic esophagogastric adenocarcinoma-specifically, weekly cisplatin and 5-fluorouracil (5FU) infusion. All other regimens require Compassionate Access Program (CAP) approval for public funding. OBJECTIVES We examined response, toxicity, and survival after first-line cap chemotherapy (CAP1), or soc and second-line cap chemotherapy (CAP2). PATIENTS AND METHODS We searched cap records for December 1999 to April 2006, abstracted charts, constructed a database, and undertook survival analyses. Treatment response, serious toxicities, and hospitalizations were recorded. RESULTS We identified 32 esophageal (10 gastroesophageal junction) and 53 gastric cancer (62%) patients, 55 of whom were stage M1 at diagnosis. Prior therapy consisted of chemoradiotherapy (n = 14), adjuvant chemotherapy (n = 3), and radical surgery (n = 34). Of these 85 patients, 50 received CAP1, and 35 received soc, then CAP2. Docetaxel and irinotecan regimens accounted for 34% and 36%, 5% and 55%, 16% and 32% respectively of first-, second-, and third-line cap requests. Partial responses were documented with soc (11/35, 31%) and CAP1 (6/50, 12%). Grade 3+ toxicity rates were 19/50 (38%) and 6/35 (17%) with CAP1 and soc chemotherapy. With cap chemotherapy, 20 hospitalizations occurred, and with soc chemotherapy, 2 hospitalizations. For all patients, median follow-up and survival times were 8.9 months and 9.7 months respectively. LIMITATIONS This is a retrospective analysis of patients deemed suitable to receive non-soc chemotherapy regimens or unsuitable to receive soc chemotherapy. CONCLUSIONS Toxicities in cap chemotherapy regimens were substantial. Survival times were consistent with results of international phase II and III trials in esophagogastric cancer.