VCAP-AMP-VECP compared with biweekly CHOP for adult T-Cell leukemia-lymphoma: Japan clinical oncology group study JCOG9801
VCAP-AMP-VECP compared with biweekly CHOP for adult T-Cell leukemia-lymphoma: Japan clinical oncology group study JCOG9801
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DOI：
10.1200/jco.2007.11.9958
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发表时间：
2007-12-01
影响因子：
45.3
通讯作者：
Tomonaga, Masao
中科院分区：
文献类型：
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作者：
Tsukasaki, Kunihiro;Utsunomiya, Atae;Tomonaga, Masao
目的我们先前的II期临床试验用长春新碱、环磷酰胺、多柔比星和泼尼松（VCAP）、多柔比星、雷莫司汀和泼尼松（AMP）和长春地辛、依托泊苷、卡铂和泼尼松（VECP）治疗人类嗜T淋巴细胞病毒I型相关成人T细胞白血病淋巴瘤（ATLL）显示了有希望的结果。要测试的优越性VCAP-AMP-VECP比每两周环磷酰胺，阿霉素，长春新碱，泼尼松（CHOP），我们进行了一项随机对照试验专门为ATLL.Patients和方法以前未经治疗的患者与侵略性ATLL被分配到要么6个疗程的VCAP-AMP-VECP每4周或8个疗程的每两周CHOP。两种治疗均辅以粒细胞集落刺激因子和鞘内预防。VCAP-AMP-VECP组的完全缓解（CR）率高于每两周一次的CHOP组（分别为40%和25%; P = 0.020）。VCAP-AMP-VECP组1年无进展生存率为28%，CHOP组为16%（P = 0.100，双侧P = 0.200）。VCAP-AMP-VECP组3年总生存率（OS）为24%，CHOP组为13%（P = 0.085，双侧P = 0.169）。VCAP-AMP-VECP与每两周一次CHOP相比，4级中性粒细胞减少、4级血小板减少和3级或4级感染的发生率分别为98% vs 83%、74% vs 17%和32% vs 15%。结论VCAP-AMP-VECP治疗ATLL的3年OS较CHOP方案长，CR率高，提示VCAP-AMP-VECP治疗ATLL的疗效优于CHOP方案，但毒副反应较CHOP方案高，为今后进一步研究ATLL的治疗提供了依据。
Purpose Our previous phase II trial for treating human T-lymphotropic virus type I-associated adult T-cell leukemia-lymphoma (ATLL) with vincristine, cyclophosphamide, doxorubicin, and prednisone (VCAP), doxorubicin, ranimustine, and prednisone (AMP), and vindesine, etoposide, carboplatin, and prednisone (VECP) showed promising results. To test the superiority of VCAP-AMP-VECP over biweekly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), we conducted a randomized controlled trial exclusively for ATLL.Patients and Methods Previously untreated patients with aggressive ATLL were assigned to receive either six courses of VCAP-AMP-VECP every 4 weeks or eight courses of biweekly CHOP. Both treatments were supported with granulocyte colony-stimulating factor and intrathecal prophylaxis.Results A total of 118 patients were enrolled. The complete response (CR) rate was higher in the VCAP-AMP-VECP arm than in biweekly CHOP arm (40% v 25%, respectively; P =.020). Progression-free survival rate at 1 year was 28% in the VCAP-AMP-VECP arm compared with 16% in the CHOP arm (P =.100, two-sided P =.200). Overall survival (OS) at 3 years was 24% in the VCAP-AMP-VECP arm and 13% in the CHOP arm (P =.085, two-sided P =.169). For VCAP-AMP-VECP versus biweekly CHOP, grade 4 neutropenia, grade 4 thrombocytopenia, and grade 3 or 4 infection rates were 98% v 83%, 74% v 17%, and 32% v 15%, respectively. There were three toxic deaths in the VCAP-AMP-VECP arm.Conclusion The longer OS at 3 years and higher CR rate with VCAP-AMP-VECP compared with biweekly CHOP suggest that VCAP-AMP-VECP might be a more effective regimen at the expense of higher toxicities, providing the basis for future investigations in the treatment of ATLL.