Gemcitabine and cisplatin versus methotrexate vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: Results of a large randomized, multinational, multicenter, phase III study
Gemcitabine and cisplatin versus methotrexate vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: Results of a large randomized, multinational, multicenter, phase III study
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DOI：
10.1200/jco.2000.18.17.3068
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发表时间：
2000-09-01
影响因子：
45.3
通讯作者：
Conte, PF
中科院分区：
文献类型：
--
作者：
von der Maase, H;Hansen, SW;Conte, PF
目的：比较吉西他滨联合顺铂 (OC) 和甲氨蝶呤、长春碱、阿霉素和顺铂 (MVAC) 在局部晚期或转移性尿路上皮移行细胞癌 (TCC) 患者中的作用。 患者和方法：IV 期 TCC 且既往未接受全身化疗的患者被随机分配至 OC（吉西他滨 1,000 mg/m(2) 第 1、8 天和15；顺铂 70 mg/m(2) 第 2 天）或标准 MVAC 每 28 天一次，最多六个周期。结果：405 名患者被随机分组（GC，n = 203；MVAC，n = 202）。各组在预后因素方面具有良好的平衡性。两组的总生存率相似（风险比 [HR]，1.04；95% 置信区间 [CI]，0.82 至 1.32；P =.75），疾病进展时间（HR，1.05；95% CI，0.85 至 1.30）、治疗失败时间（HR，0.89：95% CI，0.72 至 1.10），和缓解率（GC，49%；MVAC，46%）。更多的 OC 患者完成了六个治疗周期，剂量调整也更少。 GC 组的中毒性死亡率为 1%，MVAC 组的中毒性死亡率为 3%。与 MVAC 患者相比，GC 患者更多患有 3/4 级贫血（分别为 27% 和 18%）和血小板减少症（分别为 57% 和 21%）。双臂的红细胞输注率为 100 个周期中的 13 个，3/4 级出血或血尿率为 2%； GC 和 MVAC 的血小板输注率分别为每 100 个周期 4 名患者和每 100 个周期 2 名患者。与 GC 患者相比，更多 MVAC 患者患有 3/4 级中性粒细胞减少症（分别为 82% vs 71%）、中性粒细胞减少性发热（分别为 14% vs 2%）、中性粒细胞减少性败血症（分别为 12% vs 1%）、3/4 级粘膜炎（分别为 22% vs 1%）和脱发（分别为 55% vs 11%）。双臂治疗期间维持生活质量；然而，更多接受 GC 治疗的患者在体重、体能状态和疲劳方面表现更好。结论：GC 提供了与 MVAC 类似的生存优势，并且具有更好的安全性和耐受性。这种更好的风险效益比应该会改变局部晚期和转移性 TCC 患者的护理标准，从 MVAC 改为 OC。 (C) 2000 年美国临床肿瘤学会。
Purpose: Gemcitabine plus cisplatin (OC) and methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were compared in patients with locally advanced or metastatic transitional-cell carcinoma (TCC) of the urothelium.Patients and Methods: Patients with stage IV TCC and no prior systemic chemotherapy were randomized to OC (gemcitabine 1,000 mg/m(2) days 1, 8, and 15; cisplatin 70 mg/m(2) day 2) or standard MVAC every 28 days for a maximum of six cycles.Results: Four hundred five patients were randomized (GC, n = 203; MVAC, n = 202). The groups were well-balanced with respect to prognostic factors. Overall survival was similar on both arms (hazards ratio [HR], 1.04; 95% confidence interval [CI], 0.82 to 1.32; P =.75), as were time to progressive disease (HR, 1.05; 95% CI, 0.85 to 1.30), time to treatment failure (HR, 0.89: 95% CI, 0.72 to 1.10), and response rate (GC, 49%; MVAC, 46%). More OC patients completed six cycles of therapy, with fewer dose adjustments. The toxic death rate was 1% on the GC arm and 3% on the MVAC arm. More GC than MVAC patients had grade 3/4 anemia (27% v 18%, respectively) and thrombocytopenia (57% v 21%, respectively). On both arms, the RBC transfusion rate was 13 Of 100 cycles and grade 3/4 hemorrhage or hematuria was 2%; the platelet transfusion rate war four patients per 100 cycles and two patients per 100 cycles on GC and MVAC, respectively. More MVAC patients, compared with GC patients, had grade 3/4 neutropenia (82% v 71%, respectively), neutropenic fever (14% v 2%, respectively), neutropenic sepsis (12% v 1%, respectively), and grade 3/4 mucositis (22% v 1%, respectively) and alapecia (55% v 11%, respectively). Quality of life was maintained during treatment on both arms; however, more patients on GC fared better regarding weight, performance status, and fatigue.Conclusion: GC provides a similar survival advantage to MVAC with a better safety profile and tolerability. This better-risk benefit ratio should change the standard of care for patients with locally advanced and metastatic TCC from MVAC to OC. (C) 2000 by American Society of Clinical Oncology.