The British Columbia Cancer Agency Compassionate Access Program (CAP)

K.S. Wilson, J.B. Barnett, A. Shah, K.E. Khoo

Abstract


Background: The BCCA Gastro-intestinal Tumor Group supports one standard of care (SOC) chemotherapy (CT) regimen for metastatic esophago-gastric adenocarcinoma viz. weekly cisplatin and 5FU infusion. All other regimens require Compassionate Access Program (CAP) approval for public funding.

Objectives: To examine response, toxicity and survival after first-line CAP CT (CAP1), or SOC and second line CAP CT (CAP2).

Materials and Methods: CAP records (Dec. 1999 - April 2006) were searched, charts abstracted, database constructed and survival analyses undertaken. Treatment responses, serious toxicities and hospitalisations were recorded.

Results: There were 32 esophageal (10 GEJ) and 53 (62%) gastric cancer patients: 55 stage M1 at diagnosis. Prior therapy consisted of chemoradiotherapy (n = 14), adjuvant CT (n = 3), radical surgery (n = 34). Fifty patients received CAP1 and 35 SOC/CAP2. Docetaxel and irinotecan regimens accounted for 34% and 36%, 5% and 55%, 16% and 32% of 1st, 2nd and 3rd line CAP requests respectively. 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 CT. There were 20 hospitalisations with CAP CT and 2 with SOC CT. For all patients, median follow-up and survival times were 8.9 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 of CAP chemotherapy regimens were substantial. Survival times were consistent with results of international phase 2 and 3 trials in esophago-gastric cancer.


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DOI: http://dx.doi.org/10.3747/co.v16i5.369






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