Integrated therapy for locally advanced bladder cancer: Final report of a randomized trial of cystectomy plus adjuvant M-VAC versus cystectomy with both preoperative and postoperative M-VAC
Integrated therapy for locally advanced bladder cancer: Final report of a randomized trial of cystectomy plus adjuvant M-VAC versus cystectomy with both preoperative and postoperative M-VAC
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DOI：
10.1200/jco.2001.19.20.4005
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发表时间：
2001-10-15
影响因子：
45.3
通讯作者：
Logothetis, C
中科院分区：
文献类型：
--
作者：
Millikan, R;Dinney, C;Logothetis, C
目的：我们进行了一项III期试验，以研究可切除但高危的尿路上皮癌患者手术相关的化疗时机。该试验还旨在评估局部晚期癌症患者临床分期的准确性以及化疗诱导的降期的预后意义。
患者与方法：对140例经过统一评估的局部晚期尿路上皮癌患者进行了研究。计划的治疗方案是5个周期的化疗（M - VAC：甲氨蝶呤、长春碱、多柔比星和顺铂）加根治性膀胱切除术和盆腔淋巴结清扫术。患者被随机分配接受两种方案：要么先接受两个疗程的新辅助M - VAC化疗，然后进行手术，再加上三个额外周期的化疗；要么先进行初始膀胱切除术，然后接受五个周期的辅助化疗。
结果：两组之间的结果没有显著差异。按意向性治疗分析，81例患者（58%）无疾病复发，中位随访时间为6.8年。我们证实该队列中临床分期偏低的比例较高，尤其是在活检显示有淋巴管血管浸润的患者中。新辅助化疗后膀胱切除术中无残留肌层浸润性疾病的患者有可能被治愈。
结论：这些结果进一步支持了小型随机试验的观点，即在高危队列中，多药联合化疗和手术相结合可提高治愈率，尽管我们未发现有更优的治疗顺序。重要的是，可以根据临床分期信息选择适合此类治疗的患者。这些结果为该队列建立了一个结果基准。
Purpose: We conducted a phase III trial to investigate the timing of chemotherapy with respect to surgery for patients with resectable but high-risk urothelial cancer. The trial was also designed to evaluate the accuracy of clinical staging in patients with locally advanced cancer and the prognostic significance of chemotherapy-induced downstaging.Patients and Methods: A total of 140 uniformly evaluated patients with locally advanced urothelial cancer were studied. Planned treatment was five cycles of chemotherapy (M-VAC: methotrexate, vinblastine, doxorubicin, and cisplatin) plus radical cystectomy and pelvic lymph node dissection. Patients were randomly assigned to receive either two courses of neoadjuvant M-VAC followed by surgery plus three additional cycles of chemotherapy, or, alternatively, to have initial cystectomy followed by five cycles of adjuvant chemotherapy.Results: There were no significant differences in outcome between the two groups. By intent-to-treat, 81 patients (58%) remain disease-free, with median follow-up of 6.8 years. We confirmed a high rate of clinical understaging in this cohort, especially among patients showing lymphovascular invasion on biopsy. Patients with no residual muscle-invasive disease at cystectomy after neoadjuvant chemotherapy were likely to be cured.Conclusion: These results lend further support to the impression from small randomized trials that, in a high-risk cohort, there is an improved cure fraction by the combination of multiagent chemotherapy and surgery, although we found no preferred sequence. Importantly, it is possible to select appropriate patients for such therapy on the basis of clinical staging information. These results establish a benchmark of outcome for this cohort.