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Abstract：
BACKGROUND: Neoadjuvant cisplatin-based chemotherapy is standard care prior to radical cystectomy in patients with muscle-invasive bladder cancer (MIBC).
OBJECTIVE: To assess efficacy and safety of two commonly used neoadjuvant schedules with different total doses and dose-intensities of gemcitabine and cisplatin (GC).
METHODS: Data were collected retrospectively from all patients treated between 2010 and 2018 with neoadjuvant chemotherapy according to clinical routine at seven centres in Sweden and Denmark. Patients in Sweden received three cycles of a 4-week schedule (GC-4w: cisplatin 70 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1, 8, 15, q 28 days) and in Denmark four cycles of a 3-week schedule (GC-3w: cisplatin 70 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1, 8, q 21 days). Primary endpoint was pathological response at cystectomy (pT0N0 and < pT2N0).
RESULTS: A total of 251 patients were treated with GC-4w and 455 with GC-3w. pT0N0 was significantly higher for patients treated with GC-3w compared to GC-4w, 46% versus 32% (adjusted odds ratio [aOR] 1.80; 95% confidence interval [CI] 1.16-2.80; P = 0.009); and for < pT2N0 60% versus 47% (aOR 1.08; 95% CI 0.70-1.66; P = 0.743). There were no significant differences between GC-4w and GC-3w regarding survival parameters. GC-3w patients discontinued treatment more frequently and showed a higher degree of neutropenia.
CONCLUSIONS: A significantly higher complete response-rate was observed in the patient group treated with the more cisplatin-dose-intense 3-week schedule. The side-effect profile was in favor of the 4-week approach while relapse-free and overall survival were similar.
OBJECTIVE: To assess efficacy and safety of two commonly used neoadjuvant schedules with different total doses and dose-intensities of gemcitabine and cisplatin (GC).
METHODS: Data were collected retrospectively from all patients treated between 2010 and 2018 with neoadjuvant chemotherapy according to clinical routine at seven centres in Sweden and Denmark. Patients in Sweden received three cycles of a 4-week schedule (GC-4w: cisplatin 70 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1, 8, 15, q 28 days) and in Denmark four cycles of a 3-week schedule (GC-3w: cisplatin 70 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1, 8, q 21 days). Primary endpoint was pathological response at cystectomy (pT0N0 and < pT2N0).
RESULTS: A total of 251 patients were treated with GC-4w and 455 with GC-3w. pT0N0 was significantly higher for patients treated with GC-3w compared to GC-4w, 46% versus 32% (adjusted odds ratio [aOR] 1.80; 95% confidence interval [CI] 1.16-2.80; P = 0.009); and for < pT2N0 60% versus 47% (aOR 1.08; 95% CI 0.70-1.66; P = 0.743). There were no significant differences between GC-4w and GC-3w regarding survival parameters. GC-3w patients discontinued treatment more frequently and showed a higher degree of neutropenia.
CONCLUSIONS: A significantly higher complete response-rate was observed in the patient group treated with the more cisplatin-dose-intense 3-week schedule. The side-effect profile was in favor of the 4-week approach while relapse-free and overall survival were similar.
摘要：
背景：以顺铂为基础的新辅助化疗是肌层浸润性膀胱癌（MIBC）患者根治性膀胱切除术前的标准治疗。
目的：评估吉西他滨和顺铂（GC）两种常用的新辅助治疗方案的疗效和安全性。
方法：回顾性收集了2010年至2018年在瑞典和丹麦7个中心根据临床常规接受新辅助化疗的所有患者的数据。瑞典患者接受了三个周期的4周时间表（GC-4w：顺铂70mg/m2第1天，吉西他滨1000mg/m2第1、8、15、q28天），丹麦患者接受了四个周期的3周时间表（GC-3w：顺铂70mg/m2第1天，吉西他滨1000mg/m2第1天，8天，21天）。主要终点是膀胱切除术时的病理反应（pT0N0和结果：共251例患者接受GC-4w治疗，455例患者接受GC-3w治疗。用GC-3w治疗的患者的pT0N0明显高于GC-4w，46%对32%（调整后比值比[aOR]1.80；95%置信区间[CI]1.16-2.80；P=0.009）；结论：在接受更多顺铂剂量密集的3周方案治疗的患者组中观察到明显更高的完全缓解率。副作用情况有利于4周方法，而无复发和总生存期相似。
目的：评估吉西他滨和顺铂（GC）两种常用的新辅助治疗方案的疗效和安全性。
方法：回顾性收集了2010年至2018年在瑞典和丹麦7个中心根据临床常规接受新辅助化疗的所有患者的数据。瑞典患者接受了三个周期的4周时间表（GC-4w：顺铂70mg/m2第1天，吉西他滨1000mg/m2第1、8、15、q28天），丹麦患者接受了四个周期的3周时间表（GC-3w：顺铂70mg/m2第1天，吉西他滨1000mg/m2第1天，8天，21天）。主要终点是膀胱切除术时的病理反应（pT0N0和
