目的 探讨替雷利珠单抗联合泽布替尼治疗难治弥漫大B细胞淋巴瘤（DLBCL）的疗效和安全性。 方法 前瞻性观察性研究。前瞻性选取2020年11月至2023年2月中国医学科学院肿瘤医院专科医联体北京市朝阳区三环肿瘤医院收治的10例至少接受过含利妥昔单抗一线全身系统性治疗的难治DLBCL患者。所有患者接受替雷利珠单抗（200 mg静脉滴注，第1天）和泽布替尼（160 mg口服，2次/d，第1天至第21天）治疗，21 d为1个周期，其中6例2线治疗，4例≥3线治疗。后续研究方案补充可同时联合利妥昔单抗（375 mg/m2静脉滴注，第1天）。如果未发生疾病进展或其他需要退出研究的事件，则入组后12个月达到主要终点。随访至2023年3月，总结随访结果时疗效，采用Kaplan-Meier法进行生存分析，总结不良反应发生情况。 结果 10例患者中，男性6例，女性4例；年龄[M（Q1，Q3）]55岁（50岁，69岁）；均为Ⅲ～Ⅳ期。10例共完成替雷利珠单抗联合泽布替尼90个周期治疗，治疗周期数为8个（2个，24个）。完全缓解4例，部分缓解3例，疾病稳定1例；随访时间19个月（11个月，28个月），无进展生存时间为8.5个月（1.3个月，27.0个月），中位缓解持续时间和中位总生存时间均未达到。治疗相关不良反应包括中性粒细胞减少（2例）、贫血（1例）、丙氨酸氨基转移酶及天冬氨酸氨基转移酶升高（1例），均为1～2级。 结论 替雷利珠单抗联合泽布替尼治疗难治DLBCL具有良好的临床效果和安全性。 Objective To explore the efficacy and safety of tislelizumab combined with zanubrutinib in the treatment of refractory diffuse large B-cell lymphoma (DLBCL). Methods A prospective observational study was conducted. A total of 10 patients with refractory DLBCL admitted to Beijing Chaoyang District Third Ring Cancer Hospital, a specialist medical consortium of Cancer Hospital Chinese Academy of Medical Sciences from November 2020 to February 2023 were prospectively collected. All the 10 refractory DLBCL patients at least received first-line systemic therapy containing rituximab and they were given tislelizumab 200 mg, intravenous infusion, on day 1 and zanubrutinib 160 mg, orally, twice a day, day 1-day 21, with 21 days as 1 cycle 6 patients received second-line therapy and 4 patients received ≥ third-line therapy. Subsequent regimens were added with rituximab (375 mg/m2, intravenous infusion on day 1). The primary endpoint will be reached 12 months after enrollment if there was no disease progression or other events that were scheduled to withdraw from the study. The therapeutic efficacy was summarized at the end of the follow-up in March 2023. Kaplan-Meier method was used to make survival analysis and the adverse reactions were summed up. Results There were 6 males and 4 females, all at stage Ⅲ-Ⅳ and age [M (Q1, Q3)] was 55 years (50 years, 69 years). All 10 patients completed 90 cycles of treatment with tislelizumab and zanubrutinib, with the cycle number of 8 cycles (2 cycles, 24 cycles). The follow-up time was 19 months (11 months, 28 months) 4 cases achieved complete remission, 3 cases achieved partial remission and 1 case had the stable disease. The progression-free survival was 8.5 months (1.3 months, 27.0 months) the median remission duration time and median overall survival time were not reached. Treatment-related adverse reactions included 2 cases of neutropenia, 1 case of anemia, and 1 case of elevated alanine aminotransferase and aspartate aminotransferase, all of which were grade 1-2. Conclusions Tislelizumab combined with zanubrutinib has good clinical efficacy and safety in the treatment of refractory DLBCL.
Abstract
Objective To explore the efficacy and safety of tislelizumab combined with zanubrutinib in the treatment of refractory diffuse large B-cell lymphoma (DLBCL). Methods A prospective observational study was conducted. A total of 10 patients with refractory DLBCL admitted to Beijing Chaoyang District Third Ring Cancer Hospital, a specialist medical consortium of Cancer Hospital Chinese Academy of Medical Sciences from November 2020 to February 2023 were prospectively collected. All the 10 refractory DLBCL patients at least received first-line systemic therapy containing rituximab and they were given tislelizumab 200 mg, intravenous infusion, on day 1 and zanubrutinib 160 mg, orally, twice a day, day 1-day 21, with 21 days as 1 cycle 6 patients received second-line therapy and 4 patients received ≥ third-line therapy. Subsequent regimens were added with rituximab (375 mg/m2, intravenous infusion on day 1). The primary endpoint will be reached 12 months after enrollment if there was no disease progression or other events that were scheduled to withdraw from the study. The therapeutic efficacy was summarized at the end of the follow-up in March 2023. Kaplan-Meier method was used to make survival analysis and the adverse reactions were summed up. Results There were 6 males and 4 females, all at stage Ⅲ-Ⅳ and age [M (Q1, Q3)] was 55 years (50 years, 69 years). All 10 patients completed 90 cycles of treatment with tislelizumab and zanubrutinib, with the cycle number of 8 cycles (2 cycles, 24 cycles). The follow-up time was 19 months (11 months, 28 months) 4 cases achieved complete remission, 3 cases achieved partial remission and 1 case had the stable disease. The progression-free survival was 8.5 months (1.3 months, 27.0 months) the median remission duration time and median overall survival time were not reached. Treatment-related adverse reactions included 2 cases of neutropenia, 1 case of anemia, and 1 case of elevated alanine aminotransferase and aspartate aminotransferase, all of which were grade 1-2. Conclusions Tislelizumab combined with zanubrutinib has good clinical efficacy and safety in the treatment of refractory DLBCL.
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