BACKGROUND Both gemcitabine and bendamustine have been evaluated in patients with recurrent/refractory Hodgkin lymphoma but to the authors' knowledge not as a doublet. The authors completed a phase 1/2 trial to identify the optimal dose and frequency of administration and to assess the efficacy of this combination in patients with recurrent/refractory Hodgkin lymphoma. METHODS Patients were treated up to a maximum dose of gemcitabine (1000 mg/m2 on day 1) and bendamustine (120 mg/m2 on days 1 and 2), which was determined to be the recommended phase 2 dose, administered every 21 days for up to 6 cycles. Patients could discontinue study therapy after 2 cycles to proceed with autologous or allogeneic stem cell transplantation. RESULTS No dose-limiting toxicities were identified, but 4 patients experienced grade 3 to 5 pulmonary adverse events (toxicity was graded according to Common Terminology Criteria for Adverse Events [version 4]). A total of 26 patients were enrolled having completed a median of 4 prior lines of therapy (range, 1-7 lines), including 13 patients at the recommended phase 2 dose, in whom the overall response rate was 69% and the complete response rate was 46%. The median progression-free survival for the phase 2 patients was 11 months (95% CI, 3 months to not reached), and the median overall survival for this group had not been reached at the time of last follow-up (95% CI, 4 months to not reached). CONCLUSIONS This doublet was found to be tolerable and effective, but patients must be monitored closely for pulmonary toxicity. The authors currently are evaluating this doublet in combination with nivolumab.

中文翻译：

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对于复发性/难治性霍奇金淋巴瘤患者，吉西他滨和苯达莫司汀是一种安全有效的挽救方案：一项1/2期研究的结果。

背景技术吉西他滨和苯达莫司汀均已在复发/难治性霍奇金淋巴瘤患者中进行了评估，但据作者所知，并非双重治疗。作者完成了一项1/2期临床试验，以确定最佳剂量和给药频率，并评估这种组合在复发/难治性霍奇金淋巴瘤患者中的疗效。方法患者接受了最大剂量的吉西他滨（第1天为1000 mg / m2）和苯达莫司汀（第1和第2天为120 mg / m2）的最大剂量的治疗，该剂量被确定为推荐的第2阶段剂量，每21天服用一次最多6个周期。患者可以在2个周期后停止研究治疗，以进行自体或异体干细胞移植。结果未发现剂量限制性毒性，但是4例患者发生了3到5级的肺部不良反应（毒性根据常见不良事件术语标准[第4版]进行分级）。共有26名患者完成了中位4线以前的治疗（范围1-7线），包括13例建议的2期剂量的患者，其总缓解率为69％，完全缓解率是46％。2期患者的中位无进展生存期为11个月（95％CI，未达到3个月），而上次随访时未达到该组的总体总生存期（95％CI ，要4个月才能达到）。结论发现该双合体是可耐受的和有效的，但必须密切监测患者的肺毒性。