摘要: |
目的:评估CD20单抗联合苯达莫司汀一线治疗初诊滤泡性淋巴瘤(FL)患者疗效和安全性。方法:回顾性分析浙江省中医院2020年03月至2024年03月47例(BR组27例,GB组20例)接受CD20单抗联合苯达莫司汀一线治疗的初诊FL临床资料。评估治疗后完全缓解率(CR)、总体反应率(ORR)、无进展生存期(PFS)、总体生存期(OS)和不良事件(AEs)。结果:47例FL中位年龄55(29~77)岁,93.6%的患者分期为III~IV期,3a级FL占14.9%。45例(95.7%)患者完成≥4周期诱导治疗,34例(72.3%)患者进入维持阶段。中期评估,所有患者获得ORR,40.0%获得CR(BR组34.6%,GB组47.4%)。在诱导结束时,86.4%的患者获得CR(BR组87.5%,GB组83.3%)。中位随访27.8个月,PFS 为88.2%(BR组86.3%,GB组100%),OS为94.7%(BR组94.1%,GB组100%),两组患者PFS和OS无统计学差异。BR组3a级FL患者PFS和OS与1~2级FL患者相比预后不佳,OS有统计学差异(P=0.037)。在诱导化疗期间,95.7%患者发生至少一次不良事件(AEs),主要为1/2级。27.7%的患者发生3/4级血液学AEs,中性粒细胞减少,血小板减少和贫血分别占19.1%、10.6%和2.1%。非血液学AEs主要见于转氨酶升高(38.3%)和感染(34.0%),两者3/4级AEs发生率分别为4.3%和8.5%。维持期间,3/4级AEs中有2例感染和1例皮疹,无3/4级血液学AE。结论:以上结果表明,CD20单抗联合苯达莫司汀一线治疗初诊FL展现出可耐受的安全性和良好的疗效。 |
关键词: 滤泡淋巴瘤 苯达莫司汀 CD20单抗 一线治疗 |
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基金项目:浙江省中医药科学研究基金项目(2020ZB096) |
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Analysis of the Efficacy and Safety of CD20 Antibody Combined with Bendamustine as First-line Therapy for Follicular Lymphoma |
bei liye, liu wenbin
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The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
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Abstract: |
Objective: To evaluate the efficacy and safety of combination therapy with CD20 monoclonal antibody and bendamustine as the first-line treatment for patients with follicular lymphoma (FL) at diagnosis. Method: A retrospective analysis was conducted on the clinical data of 47 patients (BR group 27, GB group 20) who received CD20 monoclonal antibody combined with bendamustine as the first-line treatment for newly diagnosed FL in Zhejiang Provincial Hospital of Chinese Medicine from March 2020 to March 2024. Evaluate the complete response rate (CR), overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs) after treatment. Results: In the 47 cases of FL, the median age was 55 (rang: 29~77) years, with 93.6% of patients being staged III-IV, and 14.9% having stage 3a. A total of 45 patients (95.7%) completed at least four cycles of induction therapy, while 34 patients (72.3%) progressed to the maintenance phase. At interim assessment, all patients achieved ORR and 40.0% achieved CR(BR group 34.6%, GB group 47.4%). At the end of induction, 86.4% of patients achieved CR (BR group 87.5%, GB group 83.3%). With a median follow-up of 27.8 months, the PFS was 88.2% (BR group 86.3%, GB group 100%), and the OS was 94.7% (BR group 94.1%, GB group 100%), with no statistically significant difference in PFS and OS between the two groups. The prognosis of PFS and OS in grade 3a FL patients in BR group was worse than that in grade 1~2 FL patients, with a statistically significant difference in OS (P=0.037). During the induction chemotherapy, 95.7% of the patients experienced at least one adverse event (AEs), mainly of grades 1/2. 27.7% of the patients experienced grade 3/4 hematological AEs, with neutropenia (19.1%), thrombocytopenia (10.6%), and anemia (2.1%) being the most common. Non-hematological AEs were mainly seen in elevated transaminases (38.3%) and infections (34.0%), with the incidence rates of grade 3/4 AEs being 4.3% for transaminases and 8.5% for infections. During the maintenance phase, there were 2 cases of infection and 1 case of rash among the 3/4 AEs, with no grade 3/4 hematological AEs. Conclusion: The results above indicate that the combination of CD20 antibody and bendamustine as a first-line treatment for newly diagnosed FL is associated with tolerable safety and good efficacy. |
Key words: Follicular lymphoma Bendamustine CD20 monoclonal antibody First-line treatment |