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氟达拉滨、环磷酰胺和米托蒽醌(FCM)方案用于既往未治疗的晚期滤泡性淋巴瘤患者的长期安全性及疗效:一项2期试验的12年随访

Long-term safety and outcome of fludarabine, cyclophosphamide and mitoxantrone (FCM) regimen in previously untreated patients with advanced follicular lymphoma: 12 years follow-up of a phase 2 trial.

作者信息

Magnano Laura, Montoto Silvia, González-Barca Eva, Briones Javier, Sancho Juan Manuel, Muntañola Ana, Salar Antonio, Besalduch Joan, Escoda Lourdes, Moreno Carol, Domingo-Domenech Eva, Estany Cristina, Oriol Albert, Altés Albert, Pedro Carmen, Gardella Santiago, Asensio Antoni, Vivancos Pilar, Fernández de Sevilla Alberto, Ribera Josep María, Colomer Dolors, Campo Elias, López-Guillermo Armando

机构信息

Department of Hematology, Hospital Clinic, IDIBAPS, CIBERONC, Villarroel, 170, 08036, Barcelona, Spain.

Department of Hematology, Barts Cancer Institute, QMUL, London, UK.

出版信息

Ann Hematol. 2017 Apr;96(4):639-646. doi: 10.1007/s00277-017-2920-2. Epub 2017 Jan 18.

DOI:10.1007/s00277-017-2920-2
PMID:28101592
Abstract

Fludarabine combinations are very affective in follicular lymphoma (FL) with high rates of complete response and prolonged survival. However, late toxicities could be a concern. The aim of the present study was to analyze the long-term impact on survival, relapse and late toxicities of a trial of treatment with fludarabine, mitoxantrone and cyclophosphamide (FCM regimen) for untreated patients with advanced stage FL. One hundred and twenty patients enrolled in a phase 2 trial of treatment with FCM regimen between 2000 and 2003 were evaluated. After a median follow-up of 12 years, 52 patients eventually relapsed/progressed with 10 year progression-free survival (PFS) of 46 %. Ten patients showed histological transformation to aggressive lymphoma with a risk of transformation of 2 and 9 % at 5 and 10 years, respectively. Three patients developed therapy-related myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) and seven solid neoplasms with an overall risk of 3 and 8 % at 5 and 10 years, respectively. Twenty-six patients eventually died during the follow-up. Overall survival at 10 years was 83 %. In conclusion, FCM regimen allows excellent long-lasting response in previously untreated patients with FL. The incidence of late events including histological transformation and secondary neoplasia is low but not negligible.

摘要

氟达拉滨联合方案在滤泡性淋巴瘤(FL)中疗效显著,完全缓解率高且生存期延长。然而,晚期毒性可能是一个问题。本研究的目的是分析氟达拉滨、米托蒽醌和环磷酰胺治疗方案(FCM方案)对晚期FL未治疗患者的生存、复发及晚期毒性的长期影响。对2000年至2003年间参加FCM方案2期治疗试验的120例患者进行了评估。中位随访12年后,52例患者最终复发/进展,10年无进展生存率(PFS)为46%。10例患者发生组织学转化为侵袭性淋巴瘤,5年和10年时转化风险分别为2%和9%。3例患者发生治疗相关的骨髓增生异常综合征/急性髓系白血病(MDS/AML),7例发生实体瘤,5年和10年时总体风险分别为3%和8%。26例患者在随访期间最终死亡。10年总生存率为83%。总之,FCM方案在既往未治疗的FL患者中可产生优异的持久缓解。包括组织学转化和继发性肿瘤形成在内的晚期事件发生率较低,但并非可以忽略不计。

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