Ibrutinib as monotherapy versus combination therapy in Chinese patients with relapsed/refractory mantle cell lymphoma: A multicenter study

作者：Zhang, Yuchen; Liu, Panpan; Cai, Jun; Jing, Hongmei; Zou, Liqun; Huang, Huiqiang; Wu, Yuanbin; Li, Wenyu; Zhong, Liye; Jin, Xueli; Ye, Xu; Feng, Ru; Zhang, Huilai; Zhang, Liling; Lin, Lie; Sun, Xiuhua; Tian, Yuyang; Xia, Zhongjun; Li, Zhiming; Huang, He; Xia, Yi; Cai, Qingqing^*

来源：Cancer Medicine, 2022, 11(22): 4134-4145.

DOI：10.1002/cam4.4765

• combination therapy
• ibrutinib
• mantle cell lymphoma
• relapsed
• refractory

Background Ibrutinib has revolutionized the treatment of mantle cell lymphoma (MCL). Both ibrutinib monotherapy and ibrutinib-based combination therapy are important salvage options for patients with relapsed/refractory (R/R) MCL. The real-world efficacy and safety profile of the two strategies in Chinese patients with R/R MCL remain unclarified. Methods In the present study, data of 121 R/R MCL patients who received either ibrutinib monotherapy (N = 68) or ibrutinib combination therapy (N = 53) in 13 medical centers in China were retrospectively reviewed. Results With a median follow-up of 20.5 months, the overall response rate was 60.3% versus 84.9% (p = 0.003), complete remission rate was 16.2% versus 43.4% (p < 0.001), and median progression-free survival (PFS) was 18.5 months (95% confidence interval [CI], 12.1-21.8) vs. 30.8 months (95% CI, 23.5-NR) (hazard ratio, 0.53 [95% CI, 0.30-0.93]; p = 0.025), with ibrutinib monotherapy and ibrutinib-based combination therapy, respectively. Subgroup analysis showed that patients with male gender, no refractory disease, Ki67 <30%, previous line of therapy = 1, non-blastoid subtype, and the number of extranodal sites involved <2 might benefits more from the combination therapy. Treatment-emergent adverse events were similar, except for a higher incidence of all grade neutropenia in the ibrutinib combination group (12.7% vs. 32.0%, p = 0.017). Conclusions Ibrutinib combination therapy demonstrated potentially superior efficacy and comparable tolerability to ibrutinib monotherapy. Ibrutinib-based combination therapy could be one of the prominent treatment options for R/R MCL patients.

• 单位
  广州医学院; 北京大学; 南方医科大学; 四川大学; 广东省人民医院; 华中科技大学; 中山大学; 浙江大学