苯达莫司汀单药治疗复发/难治B细胞非霍奇金淋巴瘤：一项前瞻、多中心、单臂、Ⅱ期临床研究

OBJECTIVE: To evaluate the efficacy and safety of bendamustine monotherapy in Chinese patients with relapsed/refractory（R/R）B cell non-Hodgkin lymphoma（B-NHL）. METHODS: This prospective, multicenter, open label, single-arm, phase Ⅱ study investigated bendamustine's efficacy and safety in Chinese patients with R/R B-NHL. A total of 78 patients with B-NHL in 11 hospitals in China from March 2012 to December 2016 were included, and their clinical characteristics, efficacy, and survival were analyzed. RESULTS: The median age of all patients was 58（range, 24–76）years old, and 69（88.4％）patients had stage Ⅲ/Ⅳ disease. 61（78.2％）patients were refractory to previous treatments. Patients received a median of 4（range, 1–10）cycles of bendamustine treatment. The overall response rate was 61.5（95％ CI 49.8–72.3）％, the median response duration was 8.3（95％ CI 5.5–14.0）months, and the complete remission（CR）rate was 5.1（95％ CI 1.4–12.6）％. In the full analysis set, median progression-free survival（PFS）and median OS were 8.7（95％CI 6.7–13.2）months and 25.5 months（95％CI 14.2 months to not reached）, respectively, after a median follow-up of 33.6（95％CI 17.4–38.8）months. Lymphopenia（74.4％）, neutropenia（52.6％）, and leukopenia（39.7％）, thrombocytopenia（29.5％）and anemia（15.4％）were the most common grade 3–4 hematologic adverse events（AE）. The most frequent non-hematologic AEs included nausea（43.6％）, vomiting（33.3％）, and anorexia（29.5％）. Univariate and multivariate analysis showed that <4 cycles of bendamustine treatment was a poor prognostic factor for PFS（P＝0.003）, and failure to accept fludarabine containing regimen was a poor prognostic factor for OS（P＝0.009）. CONCLUSION: Bendamustine monotherapy has good efficacy and safety in the treatment of patient with R/R B-NHL.