硼替佐米联合氟达拉滨和环磷酰胺治疗复发或难治性套细胞淋巴瘤：LYM-4003 研究结果。
Bortezomib in combination with fludarabine plus cyclophosphamide for patients with relapsed or refractory mantle-cell lymphoma: results of the LYM-4003 study.
机构信息
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Department of Medical Oncology, Sun Yat-Sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, Guangdong, China.
出版信息
Ann Hematol. 2021 Dec;100(12):2961-2968. doi: 10.1007/s00277-021-04619-4. Epub 2021 Jul 31.
This study aimed to identify the maximum-tolerated dose (MTD) of cyclophosphamide when combined with bortezomib and fludarabine (B-FC) in a phase 1b trial, and to assess the efficacy and safety of this combination in a phase 2 trial in patients with relapsed or refractory MCL (rrMCL). Forty patients were enrolled between April 8, 2011, and October 10, 2015. The MTD of cyclophosphamide was identified to be 250 mg/m days 1-2. At a median follow-up of 31.6 months (13.5-47.4), among 32 patients in phase 2, 10 (31%) had a complete response and 13 (41%) had a partial response. The median progression-free survival was 21 months (95% CI 7.3-34.7), and the median overall survival was 32.4 months (95% CI 17.8-47.0). Grade 3-4 hematologic AEs included neutropenia (27%) and thrombocytopenia (39%). The B-FC regimen has satisfactory responses and manageable toxicities in rrMCL patients (ClinicalTrials.gov NCT01322776).
本研究旨在确定硼替佐米联合氟达拉滨和环磷酰胺（B-FC）在 1b 期试验中的最大耐受剂量（MTD），并在复发或难治性套细胞淋巴瘤（rrMCL）患者的 2 期试验中评估该联合方案的疗效和安全性。40 例患者于 2011 年 4 月 8 日至 2015 年 10 月 10 日入组。确定环磷酰胺的 MTD 为 250mg/m2，第 1-2 天。在中位随访 31.6 个月（13.5-47.4）时，在 32 例 2 期患者中，10 例（31%）达到完全缓解，13 例（41%）达到部分缓解。中位无进展生存期为 21 个月（95%CI 7.3-34.7），中位总生存期为 32.4 个月（95%CI 17.8-47.0）。3-4 级血液学不良反应包括中性粒细胞减少（27%）和血小板减少（39%）。B-FC 方案在 rrMCL 患者中具有令人满意的缓解率和可管理的毒性（ClinicalTrials.gov NCT01322776）。
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