吉西他滨治疗晚期边缘区 B 细胞淋巴瘤患者的 II 期研究：改善淋巴瘤生存联盟（CISL）试验。
Phase II study of gemcitabine for treatment of patients with advanced stage marginal zone B-cell lymphoma: Consortium for Improving Survival of Lymphoma (CISL) trial.
机构信息
Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.
出版信息
Invest New Drugs. 2010 Apr;28(2):171-7. doi: 10.1007/s10637-009-9260-6. Epub 2009 May 7.
BACKGROUND
Therapeutic approaches to marginal zone B-cell lymphoma (MZL) continue to evolve. Localized MZL responds favorably to local treatments, including surgery and/or local radiation therapy. However, MZL manifests as a disseminated disease in one-third of the cases at diagnosis. Moreover, relapses involving distant sites after local therapy have been reported previously. Therefore, the search for effective forms of systemic therapy is a critical issue. We conducted this multi-center, phase II trial to assess the efficacy and safety of gemcitabine single chemotherapy for patients with stage III/IV MZL.
METHODS
Patients received gemcitabine 1250 mg/m(2) on days 1 and 8 of each cycle. The treatment was repeated every 3 weeks and continued for 6 cycles until disease progression, withdrawal due to toxicity, or withdrawal of consent.
RESULTS
Between Sep. 2006 and Sep. 2008, a total of 16 patients were enrolled (with informed consent) into this trial from 6 institutes in Korea. Among these patients, 4 patients dropped out without evaluation. The median age of the 12 (9 males, 3 females) evaluated patients was 62 (range 25-73) years. Seven patients (58%) evidenced involvement of extranodal sites. All patients received previous treatment for MZL. The patients received a total of 69 cycles of gemcitabine chemotherapy (range 3-6 [median 6] cycles/person). There were 2 PR (17%; 95% Confidence Interval [CI], 0.0-41%), 9 SD (75%), and 1 PD (8%). There were 8/69 cycles (12%) of grade 3/4 neutropenia. Non-hematologic toxicities were mild and tolerable. There were 5 cycles (8%) of delayed chemotherapy (median 1 week) owing to neutropenia. Dose reduction was required in 12 cycles. However, no treatment-related death occurred in this study. The median TTP was 10.2 months (95% CI, 5.3-15.1). As the response rate in stage I did not justify progressing to stage II (> or = 8/15), this study had to be discontinued, in accordance with the established protocols.
CONCLUSION
Gemcitabine as a single agent, in this dosage and at this schedule, evidenced minimal clinical activity in cases of advanced MZL.
背景
边缘区 B 细胞淋巴瘤（MZL）的治疗方法仍在不断发展。局限性 MZL 对局部治疗（包括手术和/或局部放射治疗）反应良好。然而，三分之一的病例在诊断时表现为播散性疾病。此外，以前曾报道过局部治疗后远处部位的复发。因此，寻找有效的全身治疗方法是一个关键问题。我们进行了这项多中心、二期试验，以评估吉西他滨单药化疗对 III/IV 期 MZL 患者的疗效和安全性。
方法
患者在每个周期的第 1 天和第 8 天接受吉西他滨 1250mg/m²。治疗每 3 周重复一次，持续 6 个周期，直到疾病进展、因毒性而停药或患者撤回同意。
结果
2006 年 9 月至 2008 年 9 月，来自韩国 6 个机构的 16 名患者（知情同意）入组本研究。其中 4 名患者未评估即退出。12 名（9 名男性，3 名女性）可评估患者的中位年龄为 62 岁（范围 25-73 岁）。7 名患者（58%）有结外部位受累。所有患者均接受过 MZL 的既往治疗。患者共接受吉西他滨化疗 69 个周期（范围 3-6[中位数 6]个周期/人）。2 例患者获得部分缓解（17%；95%置信区间[CI]，0.0-41%），9 例患者疾病稳定（75%），1 例患者疾病进展（8%）。3/4 级中性粒细胞减少症有 8 例/69 例（12%）。非血液学毒性轻微且可耐受。由于中性粒细胞减少症，有 5 例（8%）周期延迟（中位数 1 周）。12 例需要减少剂量。然而，本研究中无治疗相关死亡。中位无进展生存期为 10.2 个月（95%CI，5.3-15.1）。由于 I 期的缓解率不足以进入 II 期（≥8/15），根据既定方案，本研究不得不停止。
结论
吉西他滨作为单一药物，在该剂量和方案下，在晚期 MZL 中显示出最小的临床活性。
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