12月12日，一项在线发表在J Clin Oncol杂志上的一项II / III期研究"Randomized Phase II/III Trial Assessing Gemcitabine/Carboplatin and Methotrexate/Carboplatin/Vinblastine in Patients With Advanced Urothelial Cancer Who Are Unfit for Cisplatin-Based Chemotherapy: EORTC Study 30986"显示，当一些晚期尿路上皮癌患者不能接受顺铂治疗时，卡铂为基础的方案同样有效。
研究者发现，在两种卡铂类方案中，吉西他滨/卡铂（GC）比甲氨蝶呤/卡铂/长春碱 (M-CAVI)更加耐受。领导这次试验的Maria De Santis博士讲到，这是首次明确界定不能通过顺铂化疗获益的人群。顺铂是标准疗法，但是因为肾功能不全和身体状态不佳导致一半以上的病人不能使用。
为了评估替代顺铂的方案，研究人员随机分配了238名未化疗病人使用GC或M-CAVI治疗，这些患者来自29所医院。所有患者都不符合顺铂为基础化疗的资格。
中位随访期超过4.5年，41.2%的GC组病人有完全或部分缓解（包括6个未经证实的反应），M-CAVI组为30.3%（包括11个未经证实的反应）。
总体和无进展生存期无组间差异，但是只考虑明确的反应时，是有统计学差异的。
意向性治疗分析显示，GC组的中位总体生存期为9.3个月，M-CAVI为8.1个月。无进展生存期分别为5.8和4.2个月。
尽管在整体结局上有相似性，但在M-CAVI组有更为严重的不良事件，该组的死亡率、血小板减少伴出血、肾毒性和其他突发事件发生率显著升高（21.2% vs 9.3%）。
De Santis博士说，吉西他滨/卡铂毒性小于M-CAVI，将来或许成为不能用顺铂治疗患者的首选治疗方案或是将来临床试验的参考方案。（生物谷Bioon.com）
doi:10.1200/JCO.2011.37.3571
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Randomized Phase II/III Trial Assessing Gemcitabine/Carboplatin and Methotrexate/Carboplatin/Vinblastine in Patients With Advanced Urothelial Cancer Who Are Unfit for Cisplatin-Based Chemotherapy: EORTC Study 30986.
De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Gil T, Marreaud S, Daugaard G, Skoneczna I, Collette S, Lorent J, de Wit R, Sylvester R
PURPOSEThis is the first randomized phase II/III trial comparing two carboplatin-based chemotherapy regimens in patients with urothelial cancer who are ineligible ("unfit") for cisplatin chemotherapy. PATIENTS AND METHODSThe primary objective of the phase III part of this study was to compare the overall survival (OS) of chemotherapy-naive patients with measurable disease and an impaired renal function (glomerular filtration rate < 60 but > 30 mL/min) and/or performance score of 2 who were randomly assigned to receive either gemcitabine/carboplatin (GC) or methotrexate/carboplatin/vinblastine (M-CAVI). To detect an increase of 50% in median survival with GC compared with M-CAVI (13.5 v 9 months) based on a two-sided log-rank test at error rates α = .05 and β = .20, 225 patients were required. Secondary end points were overall response rate (ORR), progression-free survival (PFS), toxicity, and quality of life.ResultsIn all, 238 patients were randomly assigned by 29 institutions over a period of 7 years. The median follow-up was 4.5 years. Best ORRs were 41.2% (36.1% confirmed response) for patients receiving GC versus 30.3% (21.0% confirmed response) for patients receiving M-CAVI (P = .08). Median OS was 9.3 months in the GC arm and 8.1 months in the M-CAVI arm (P = .64). There was no difference in PFS (P = .78) between the two arms. Severe acute toxicity (death, grade 4 thrombocytopenia with bleeding, grade 3 or 4 renal toxicity, neutropenic fever, or mucositis) was observed in 9.3% of patients receiving GC and 21.2% of patients receiving M-CAVI. CONCLUSIONThere were no significant differences in efficacy between the two treatment groups. The incidence of severe acute toxicities was higher for those receiving M-CAVI.
