Holmsten Karin, Omland Lise Høj, Als Anne Birgitte, Agerbæk Mads, Dohn Line Hammer, Lindberg Henriette, Jensen Niels Viggo, Carus Andreas, Moe Mette, Hosseini Abolfazl, Radkiewicz Cecilia, Pappot Helle, Ullén Anders
Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden.
Department of Oncology, Capio Sankt Görans Hospital, Stockholm, Sweden.
Bladder Cancer. 2022 Mar 11;8(1):71-80. doi: 10.3233/BLC-211556. eCollection 2022.
Neoadjuvant cisplatin-based chemotherapy is standard care prior to radical cystectomy in patients with muscle-invasive bladder cancer (MIBC).
To assess efficacy and safety of two commonly used neoadjuvant schedules with different total doses and dose-intensities of gemcitabine and cisplatin (GC).
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/m day 1, gemcitabine 1000 mg/m days 1, 8, 15, q 28 days) and in Denmark four cycles of a 3-week schedule (GC-3w: cisplatin 70 mg/m day 1, gemcitabine 1000 mg/m days 1, 8, q 21 days). Primary endpoint was pathological response at cystectomy (pT0N0 and < pT2N0).
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; = 0.009); and for < pT2N0 60% versus 47% (aOR 1.08; 95% CI 0.70-1.66; = 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.
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.
对于肌层浸润性膀胱癌（MIBC）患者，基于顺铂的新辅助化疗是根治性膀胱切除术之前的标准治疗方法。
评估吉西他滨和顺铂（GC）两种常用新辅助化疗方案在不同总剂量和剂量强度下的疗效和安全性。
回顾性收集2010年至2018年间在瑞典和丹麦七个中心按照临床常规接受新辅助化疗的所有患者的数据。瑞典的患者接受为期4周的三个周期化疗方案（GC-4w：顺铂70mg/m²第1天，吉西他滨1000mg/m²第1、8、15天，每28天一次），丹麦的患者接受为期3周的四个周期化疗方案（GC-3w：顺铂70mg/m²第1天，吉西他滨1000mg/m²第1、8天，每21天一次）。主要终点是膀胱切除术后的病理反应（pT0N0和＜pT2N0）。
共有251例患者接受GC-4w治疗，455例接受GC-3w治疗。与GC-4w相比，接受GC-3w治疗的患者pT0N0显著更高，分别为46%和32%（调整优势比[aOR]1.80；95%置信区间[CI]1.16 - 2.80；P = 0.009）；对于＜pT2N0，分别为60%和47%（aOR 1.08；95%CI 0.70 - 1.66；P = 0.743）。在生存参数方面，GC-4w和GC-3w之间没有显著差异。GC-3w患者更频繁地中断治疗，且中性粒细胞减少程度更高。
在接受顺铂剂量强度更高的3周方案治疗的患者组中观察到显著更高的完全缓解率。副作用方面更倾向于4周方案，而无复发生存期和总生存期相似。
