US Oncology Research Inc, The Woodlands, TX, USA.
Blood. 2010 Jan 21;115(3):475-80. doi: 10.1182/blood-2009-08-233155. Epub 2009 Nov 19.
This study evaluated the efficacy and safety of single-agent bortezomib in indolent B-cell lymphoma that had relapsed from or was refractory to rituximab. Sixty patients enrolled: 59 were treated with bortezomib 1.3 mg/m(2) on days 1, 4, 8, and 11 for up to eight 21-day cycles; responders could receive 4 additional cycles; maintenance was optional. Fifty-three evaluable patients completed more than 2 cycles. The median age was 70 years, 53% female, Ann Arbor stage III-IIIE (28%) and IV (65%); 43 patients (72%) had more than 2 prior regimens; and 6 patients went on to maintenance. Overall responses are as follows: 1 complete response (1.9%), 3 unconfirmed complete response (5.7%), 3 partial response (5.7%), 34 stable disease (64.2%), and 12 progressive disease (22.6%). Median time to response = 2.2 months (range, 1.2-5.3 months); duration of response = 7.9 months (2.8-21.3 months); 1-year survival was 73% and 2-year survival was 58%; median survival = 27.7 months (range, 1.4-30.9 months); median progression-free survival = 5.1 months (range, 0.2-27.7 months), median time to progression = 5.1 months (range, 0.2-27.7 months), and median event-free survival = 1.8 months (range, 0.2-27.7 months). Treatment-related grade 3 or 4 adverse events included: thrombocytopenia (20%), fatigue (10%), neutropenia (8.5%), and neuropathy and diarrhea (6.8% each). This study demonstrates that bortezomib has modest activity against marginal zone and follicular lymphoma; it has the potential for combination with other agents in low-grade lymphomas. Maintenance therapy should be explored further.
这项研究评估了单药硼替佐米治疗复发或对利妥昔单抗耐药的惰性 B 细胞淋巴瘤的疗效和安全性。60 名患者入组：59 名患者接受硼替佐米 1.3mg/m(2)，于第 1、4、8 和 11 天给药，最多进行 8 个 21 天周期；缓解者可接受 4 个额外周期；维持治疗为可选。53 名可评估患者完成了超过 2 个周期。中位年龄为 70 岁，53%为女性，Ann Arbor 分期 III-IV 期（28%）和 IV 期（65%）；43 名患者（72%）有超过 2 种先前的治疗方案；6 名患者进行了维持治疗。总体缓解情况如下：1 例完全缓解（1.9%），3 例未确认的完全缓解（5.7%），3 例部分缓解（5.7%），34 例疾病稳定（64.2%），12 例疾病进展（22.6%）。中位起效时间为 2.2 个月（范围：1.2-5.3 个月）；缓解持续时间为 7.9 个月（范围：2.8-21.3 个月）；1 年生存率为 73%，2 年生存率为 58%；中位生存时间为 27.7 个月（范围：1.4-30.9 个月）；中位无进展生存期为 5.1 个月（范围：0.2-27.7 个月），中位进展时间为 5.1 个月（范围：0.2-27.7 个月），中位无事件生存期为 1.8 个月（范围：0.2-27.7 个月）。与治疗相关的 3 级或 4 级不良事件包括：血小板减少症（20%）、乏力（10%）、中性粒细胞减少症（8.5%）、周围神经病变和腹泻（各 6.8%）。本研究表明硼替佐米对边缘区和滤泡性淋巴瘤具有一定的活性；它有可能与其他低级别淋巴瘤药物联合使用。维持治疗应进一步探索。
