GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma:: a phase II study
GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma:: a phase II study
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DOI：
10.1111/j.1600-0609.2007.00996.x
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发表时间：
2008-02-01
影响因子：
3.1
通讯作者：
Rodriguez, Jose
中科院分区：
文献类型：
--
作者：
Lopez, Andres;Gutierrez, Antonio;Rodriguez, Jose
目的：老年或免疫功能低下的难治性或复发性弥漫性大细胞淋巴瘤（dcl）患者的预后非常差，因为目前标准的自体干细胞移植（ASCT）挽救治疗对大多数患者来说是不可行的。需要具有可接受毒性的新活性方案。我们的目标是报告一项针对dcl的GEMOX-R方案的II期试验结果。方法：共有32例患者在可行的情况下每2周或每3周接受一次GEMOX-R方案，计划6至8个疗程。结果：患者的中位年龄为69岁，41%的患者为原发性难治性，59%的患者复发。在GEMOX-R治疗中，75%的患者处于III-IV期，69%的患者达到调整后的国际预后指数bbb1。有效率为43%，完全有效率为34%。43%的患者出现中性粒细胞减少和III-IV级血小板减少，7%的患者出现III-IV级神经毒性。存活患者的中位随访时间为13个月，中位生存期为9.1个月。12个月时，总生存率和无进展生存率分别为41%和29%。结论：GEMOX-R是一种新的dcl挽救方案，具有高活性和相对安全的毒性，可提供给非ASCT巩固候选人的老年患者。该方案在这一不利人群和免疫功能低下的情况下的高效率值得进一步研究该方案在这类淋巴瘤的所有挽救情况下。
Objectives: The prognosis of old or immunocompromised patients with refractory or relapsing diffuse large-cell lymphoma (DLCL) is very poor as the current standard of salvage therapy with autologous stem cell transplantation (ASCT) is not feasible for most of them. New active regimens with an acceptable toxicity profile are needed. We aim to report the results of a phase II trial of the GEMOX-R regimen in DLCL. Methods: A total of 32 patients received GEMOX-R regimen in 2-wk intervals if feasible or every 3 wk for a planned six to eight courses. Results: Median age of the population was 69 yr. Forty-one percent of the patients were primary refractory and 59% after relapsing. At GEMOX-R, 75% of patients had a stage III-IV and an adjusted International Prognostic Index > 1 was observed in 69%. The response rate was 43% with 34% complete response. Neutropenia and thrombopenia grade III-IV were observed in 43% of the patients and neurotoxicity grade III-IV in 7% of cases. Median follow-up for alive patients was 13 months and the median survival was 9.1 months. At 12 months, the overall survival and progression-free survival were 41% and 29%, respectively. Conclusions: GEMOX-R is a new salvage regimen for DLCL with high activity and relatively safe toxicity profile, which can be offered to elderly patients not candidates of ASCT consolidation. The high efficacy of the regimen in this unfavorable population and also in immunocompromised situations warrant further investigation of this regimen in all salvage situations of this type of lymphomas.