Department of Medical Oncology, Regina Elena Cancer Institute, Rome.
Division of Medical Oncology, Belcolle Hospital, Viterbo.
Ann Oncol. 2012 Mar;23(3):695-700. doi: 10.1093/annonc/mdr354. Epub 2011 Aug 22.
The purpose of the study was to evaluate the benefit of adjuvant chemotherapy (AC) versus surgery alone in patients with muscle-invasive bladder cancer (MIBC).
One hundred and ninety-four patients with pT2G3, pT3-4, N0-2 transitional cell bladder carcinoma were randomly allocated to control (92 patients) or to four courses of AC (102 patients). These latter patients were further randomly assigned to receive gemcitabine 1000 mg/m(2) days 1, 8 and 15 and cisplatin 70 mg/m(2) day 2 or gemcitabine as above plus cisplatin 70 mg/m(2) day 15, every 28 days.
At a median follow-up of 35 months, the 5-year overall survival (OS) was 48.5%, with no difference between the two arms [P = 0.24, hazard ratio (HR) 1.29, 95% confidence interval (CI) 0.84-1.99]. Mortality hazard was significantly correlated with Nodes (N) and Tumor (T) stage. The control and AC arms had comparable disease-free survival (42.3% and 37.2%, respectively; P = 0.70, HR 1.08, 95% CI 0.73-1.59). Only 62% of patients received the planned cycles. A significant higher incidence of thrombocytopenia was observed in patients receiving cisplatin on day 2 (P = 0.006). A similar global quality of life was observed in the two arms.
The study was underpowered to demonstrate that AC with cisplatin and gemcitabine improves OS and disease-free survival in patients with MIBC.
本研究旨在评估辅助化疗（AC）与单纯手术相比在肌层浸润性膀胱癌（MIBC）患者中的获益。
194 例 pT2G3、pT3-4、N0-2 移行细胞膀胱癌患者被随机分配至对照组（92 例）或接受 4 个疗程的 AC（102 例）。后者患者进一步随机接受吉西他滨 1000mg/m²，第 1、8 和 15 天和顺铂 70mg/m²，第 2 天或吉西他滨如上所述，加上顺铂 70mg/m²，第 15 天，每 28 天一次。
中位随访 35 个月时，5 年总生存率（OS）为 48.5%，两组之间无差异[P=0.24，风险比（HR）1.29，95%置信区间（CI）0.84-1.99]。死亡率风险与淋巴结（N）和肿瘤（T）分期显著相关。对照组和 AC 组的无病生存率相当（分别为 42.3%和 37.2%；P=0.70，HR 1.08，95%CI 0.73-1.59）。仅 62%的患者接受了计划的周期治疗。接受第 2 天顺铂治疗的患者血小板减少症发生率显著升高（P=0.006）。两组患者的整体生活质量相似。
该研究未证明 AC 联合顺铂和吉西他滨可改善 MIBC 患者的 OS 和无病生存率。
