A phase 2 trial of CHOP chemotherapy followed by tositumomab/iodine I 131 tositumomab for previously untreated follicular non-Hodgkin lymphoma: Southwest Oncology Group Protocol S9911
A phase 2 trial of CHOP chemotherapy followed by tositumomab/iodine I 131 tositumomab for previously untreated follicular non-Hodgkin lymphoma: Southwest Oncology Group Protocol S9911
复制标题
DOI：
10.1182/blood-2003-01-0287
复制
发表时间：
2003-09-01
期刊：
影响因子：
20.3
通讯作者：
Fisher, RI
中科院分区：
文献类型：
--
作者：
Press, OW;Unger, JM;Fisher, RI
晚期滤泡性淋巴瘤是无法治愈的常规化疗和放疗。西南肿瘤组（SWOG）在90例符合条件的既往未经治疗的晚期滤泡性淋巴瘤患者中开展了一项II期试验（S9911），该试验涉及一种新方案，包括6个周期的CHOP（环磷酰胺、多柔比星、长春新碱和泼尼松）化疗，4 - 8周后接受托西莫单抗/碘I 131托西莫单抗（抗CD 20抗体）治疗。治疗耐受性良好。可逆性骨髓抑制是主要的不良事件，CHOP化疗期间比放射免疫治疗更严重。总体来说。整个治疗方案的应答率为90%，包括67%的完全缓解（CR+未确认的CR [CRu]）和23%的部分缓解（PR）。在CHOP达到CR以下的47例完全可评价患者中，27例（57%）在托西莫单抗/碘I 131托西莫单抗治疗后缓解状态改善。中位随访时间为2.3年，2年无进展生存期（PFS）估计为81%，2年总生存期为97%。这项研究已经确定了这种方案治疗晚期滤泡性淋巴瘤患者的可行性、耐受性和疗效。与SWOG单独使用CHOP的历史经验相比，这种新型治疗似乎很有希望，目前正在随机3期试验中与CHOP加利妥昔单抗进行比较（S 0016）。
Advanced follicular lymphoma is incurable with conventional chemotherapy and radiotherapy. The Southwest Oncology Group (SWOG) conducted a phase 2 trial (S9911) of a novel regimen consisting of 6 cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy followed 4 to 8 weeks later by tositumomab/iodine I 131 tositumomab (anti-CD20 antibody) in 90 eligible patients with previously untreated, advanced stage follicular lymphoma. Treatment was well tolerated. Reversible myelosuppression was the main adverse event and was more severe during CHOP chemotherapy than following radioimmunotherapy. The overall. response rate to the entire treatment regimen was 90%, including 67% complete remissions (CRs plus unconfirmed CRs [CRu's]) and 23% partial remissions (PRs). Twenty-seven (57%) of the 47 fully evaluable patients who achieved less than a CR with CHOP improved their remission status after tositumomab/ iodine I 131 tositumomab. With a median follow-up of 2.3 years, the 2-year progression-free survival (PFS) was estimated to be 81%, with a 2-year overall survival of 97%. This study has established the feasibility, tolerability, and efficacy of this regimen for patients with advanced follicular lymphoma. This novel treatment appears promising compared with the SWOG's historical experience using CHOP alone and is currently being compared with CHOP plus rituximab in a randomized phase 3 trial (S0016).