Fiteni Frédéric, Nguyen Thierry, Vernerey Dewi, Paillard Marie-Justine, Kim Stefano, Demarchi Martin, Fein Francine, Borg Christophe, Bonnetain Franck, Pivot Xavier
Department of Medical Oncology, University Hospital of Besançon, Besançon, France; Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France.
Cancer Med. 2014 Dec;3(6):1502-11. doi: 10.1002/cam4.299. Epub 2014 Aug 11.
Cisplatin/gemcitabine association has been a standard of care for first-line regimen in advanced biliary tract cancer nevertheless oxaliplatin/gemcitabine regimen is frequently preferred. Because comparative effectiveness in clinical outcomes of cisplatin- versus oxaliplatin-containing chemotherapy is not available, a systematic review of studies assessing cisplatin/gemcitabine or oxaliplatin/gemcitabine chemotherapies in advanced biliary tract cancer was performed. Published studies evaluating cisplatin/gemcitabine or oxaliplatin/gemcitabine in advanced biliary tract cancer were included. Each study was weighted according to the number of patients included. The primary objective was to assess weighted median of medians overall survival (mOS) reported for both regimens. Secondary goals were to assess weighted median of medians progression-free survival (mPFS) and toxic effects were pooled and compared within each arm. Thirty-three studies involving 1470 patients were analyzed. In total, 771 and 699 patients were treated by cisplatin/gemcitabine and oxaliplatin/gemcitabine, respectively. Weighted median of mOS was 9.7 months in cisplatin group and 9.5 months in oxaliplatin group. Cisplatin-based chemotherapy was significantly associated with more grade 3 and 4 asthenia, diarrhea, liver toxicity, and hematological toxicity. Sensitivity analysis including only the studies with the standard regimen of cisplatin (25-35 mg/m(2) administered on days 1 and 8) showed that the weighted median of mOS increased from 9.7 to 11.7 months but Gem/CDDP regimen remained more toxic than Gemox regimen. These results suggest that the Gem/CDDP regimen with cisplatin (25-35 mg/m(2)) administered on days 1 and 8 is associated with survival advantage than Gemox regimen but with addition of toxicity.
顺铂/吉西他滨联合方案一直是晚期胆管癌一线治疗的标准方案,不过奥沙利铂/吉西他滨方案更常被选用。由于缺乏含顺铂与含奥沙利铂化疗临床疗效的对比数据,因此对评估晚期胆管癌顺铂/吉西他滨或奥沙利铂/吉西他滨化疗的研究进行了系统综述。纳入了评估晚期胆管癌顺铂/吉西他滨或奥沙利铂/吉西他滨的已发表研究。每项研究根据纳入患者数量进行加权。主要目的是评估两种方案报告的加权总生存期中位数(mOS)。次要目标是评估加权无进展生存期中位数(mPFS),并汇总和比较每组的毒性作用。分析了涉及1470例患者的33项研究。总共分别有771例和699例患者接受了顺铂/吉西他滨和奥沙利铂/吉西他滨治疗。顺铂组mOS的加权中位数为9.7个月,奥沙利铂组为9.5个月。以顺铂为基础的化疗与更多的3级和4级乏力、腹泻、肝毒性和血液学毒性显著相关。仅纳入顺铂标准方案(第1天和第8天给予25 - 35mg/m²)研究的敏感性分析显示,mOS的加权中位数从9.7个月增加到11.7个月,但吉西他滨/顺铂方案的毒性仍高于吉西他滨/奥沙利铂方案。这些结果表明,第1天和第8天给予顺铂(25 - 35mg/m²)的吉西他滨/顺铂方案与吉西他滨/奥沙利铂方案相比具有生存优势,但毒性更大。