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The British Columbia Cancer Agency Compassionate Access Program (CAP)

机译:不列颠哥伦比亚省癌症局同情者获取计划(CAP)

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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.
机译:背景:BCCA胃肠道肿瘤小组支持一种针对转移性食管胃腺癌的护理标准(SOC)化疗(CT)方案。每周顺铂和5FU输注。所有其他方案都需要获得同情者访问计划(CAP)的批准才能获得公共资金。目的:检查一线CAP CT(CAP1)或SOC和二线CAP CT(CAP2)后的反应,毒性和生存率。材料和方法:检索CAP记录(1999年12月至2006年4月),提取图表,构建数据库并进行生存分析。记录治疗反应,严重毒性和住院情况。结果:共有32例食管癌(10 GEJ)和53例(62%)胃癌患者:55例诊断为M1期。先前的治疗包括放化疗(n = 14),辅助CT(n = 3),根治性手术(n = 34)。 50名患者接受了CAP1和35 SOC / CAP2。多西他赛和伊立替康方案分别占一线,二线和三线CAP要求的34%和36%,5%和55%,16%和32%。 SOC(11/35,31%)和CAP1(6/50,12%)记录了部分响应。 CAP1和SOC CT的3+级毒性率为19/50(38%)和6/35(17%)。 CAP CT住院20例,SOC CT住院2例。对于所有患者,中位随访时间和生存时间分别为8.9和9.7个月。局限性:这是对被认为适合接受非SOC化疗方案或不适合接受SOC化疗的患者的回顾性分析。结论:CAP化疗方案的毒性很大。生存时间与食管胃癌国际2期和3期试验的结果一致。

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