Long-term follow-up of a phase III intergroup study of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: A cooperative group study
Long-term follow-up of a phase III intergroup study of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: A cooperative group study
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DOI：
10.1200/jco.1997.15.7.2564
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发表时间：
1997-07-01
影响因子：
45.3
通讯作者：
Trump, D
中科院分区：
文献类型：
--
作者：
Saxman, SB;Propert, KJ;Trump, D
目的：先前报道的一项随机组间试验表明，在晚期尿路上皮癌患者中，甲氨蝶呤、长春花碱、阿霉素和顺铂联合化疗(M-VAC)优于单用顺铂。我们对纳入组间试验的患者进行了长期分析，以考察与长期生存相关的因素、患者和方法：255名可评估的尿路上皮癌患者被随机分为两组，分别接受顺铂(70 mg/m(2)，第1天)或联合化疗(30 mg/m(2)，第1、15、22天)，长春花碱(2 mg/m(2)，第2、15、22天)，阿霉素(30 mg/m(2)，第2天)，顺铂(70 mg/m(2)，第2天)，每28天重复一次疗程，用COX比例风险模型评估患者特征与生存之间的关系。结果：长期随访评估，M-VAC组的生存仍然优于顺铂(P=.00015，log-ranking检验)，生存的预测因素包括表现状态、组织学和是否有肝脏或骨转移。在随机接受M-VAC治疗的患者中，只有3.7%的患者在6年内存活并连续无病，结论：组间试验的长期随访评估证实，M-VAC在晚期尿路上皮癌患者中优于单药顺铂；然而，持久的无进展生存是罕见的。非移行细胞组织学、功能状态差和/或骨或内脏受累的患者进展不佳，不太可能从M-VAC化疗中显著受益。(C)1997年，由美国临床肿瘤学会主办。
Purpose: A previously reported randomized intergroup trial demonstrated that combination chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) was superior to single-agent cisplatin in patients with advanced urothelial carcinoma, We conducted a long-term analysis of patients included in the intergroup trial to examine factors associated with long-term survival,Patients and Methods: Two-hundred fifty-five assessable patients with urothelial carcinoma were randomized to receive either single-agent cisplatin (70 mg/m(2) on day 1) or combination chemotherapy with methotrexate (30 mg/m(2) on days 1, 15, and 22), vinblastine (3 mg/m(2) on days 2, 15, and 22), doxorubicin (30 mg/m(2) on day 2), and cisplatin (70 mg/m(2) on day 2), Courses were repeated every 28 days, The association between patient characteristics and survival was assessed using Cox proportional hazards models.Results: With long-term follow-up evaluation, survival in the M-VAC arm continues to be superior to cisplatin (P = .00015, log-rank test), Predictors of survival include performance status, histology, and the presence of liver or bone metastasis. Only 3.7% of the patients randomized to M-VAC are alive and continuously disease-free at 6 years,Conclusion: Long-term follow-up evaluation of the intergroup trial confirms that M-VAC is superior to single-agent cisplatin in patients with advanced urothelial carcinoma; however, durable progression-free survival is rare. Patients with non-transitional-cell histology, poor performance status, and/or bone or visceral involvement fare poorly and are unlikely to benefit significantly from M-VAC chemotherapy. (C) 1997 by American Society of Clinical Oncology.