2024 年第 8 期 第 19 卷

泽布替尼治疗老年初诊套细胞淋巴瘤的效果及不良反应分析

Analysis of efficacy and adverse reactions of zanubrutinib in elderly patients with previously untreated mantle cell lymphoma

作者：彭小娟崔杰刘鹏

英文作者：Peng Xiaojuan Cui Jie Liu Peng

单位：甘肃省肿瘤医院血液科，兰州730050

英文单位：Department of Hematology Gansu Provincial Cancer Hospital Lanzhou 730050 China

关键词：套细胞淋巴瘤；泽布替尼；初诊

英文关键词：Mantlecelllymphoma;Zanubrutinib;Previouslyuntreated

• 摘要：

• 目的 探究泽布替尼一线治疗老年初诊套细胞淋巴瘤（MCL）的有效性及安全性。方法 回顾性收集甘肃省肿瘤医院血液科自2020年8月至2022年7月收住经泽布替尼治疗的13例老年初诊MCL患者临床资料。13例患者给予泽布替尼初始剂量为160 mg/次，2次/d，治疗时间均大于4个周期（1个月为1个周期），记录患者疗效，计算客观缓解率（ORR）、无进展生存期（PFS）、总生存期、6及12个月无进展生存率和总生存率，分析不同因素对PFS、总生存期的影响。结果 随访截至2022年11月1日，13例患者中，7例完全缓解(53.8%)，2例部分缓解(15.4%)，4例疾病进展(30.8%)；ORR为69.2%(9/13)；中位PFS为8个月（范围4～28个月），中位总生存期为10个月（范围5～28个月），6个月无进展生存率和总生存率分别为68.0%、92.0%，12个月无进展生存率和总生存率分别为23.0%、31.0%。单因素分析显示，美国东部肿瘤协作组评分、Ki-67指数、乳酸脱氢酶可能影响患者PFS，年龄、Ki-67指数、乳酸脱氢酶可能影响患者总生存期（均P＜0.05），但多因素Cox回归分析结果未观测到有统计学意义的影响PFS、总生存期的因素（均P＞0.05）。13例患者中，1例血液学毒性为轻度，4例非血液学毒性包括感染、继发恶性肿瘤、关节痛、恶心，所有不良反应经减量、停用泽布替尼及对症处理均安全可控，无治疗相关死亡发生。结论 泽布替尼单药一线治疗老年初诊MCL，特别是对于体能状态差不能耐受化疗及个人意愿拒绝化疗的患者有较高的ORR、完全缓解率及较好的耐受性。

• Objective To explore the effect and adverse events of zanubrutinib first line treatment of elderly patients with previously untreated mantle cell lymphoma(MCL). Methods  The clinical data of 13 elderly patients with previously untreated MCL treated with zanubrutinib from August 2020 to July 2022 in Gansu Provincial Cancer Hospital were retrospectively reviewed. Patients were given zanubrutinib for more than 4 cycles (1 month as a cycle), and the initial dose was 160 mg twice daily. The objective response rate (ORR), progression free survival (PFS), overall survival (OS), 6-month and 12-month PFS rate and OS rate were recorded, and the effects of different factors on PFS and OS were analyzed. Results  Follow-up until November 1, 2022, among the 13 patients, 7 cases achieved completely response(53.8%), 2 cases achieved partially response (15.4%) and 4 cases achieved progressive disease(30.8%). The ORR was 69.2%(9/13). The median PFS was 8 (4-28) months, and the median OS was 10 (5-28) months. The 6-month PFS rate and the OS rate were 68.0% and 92.0%. The 12 month PFS rate and the OS rate were 23.0% and 31.0%. Univariate analysis showed that the Eastern Cooperative Oncology Group score, Ki-67 index and lactic dehydrogenase(LDH) were the probable effect factors for PFS, the age, Ki-67 index and LDH were the probable effect factors for OS (all P<0.05). However, no statistically significant factors affecting PFS and OS were observed in the multivariate Cox regression analysis results (all P＞0.05). Among the 13 patients, one patient with hematological toxicity was mild, while four patients with non hematological toxicity included infection, secondary malignant tumors, joint pain, and nausea. All adverse reactions were safe and controllable after reduction, discontinuation of zanubrutinib, and symptomatic treatment, with no treatment-related deaths. Conclusions  Zanubrutinib first line monotherapy had higher ORR, completely response rates and better tolerance in elderly patients with previously untreated MCL. Especially for patients with poor physical status can not tolerate chemotherapy and personal willingness to refuse chemotherapy.