Phase II trial of galiximab (anti-CD80 monoclonal antibody) plus rituximab (CALGB 50402): Follicular Lymphoma International Prognostic Index (FLIPI) score is predictive of upfront immunotherapy responsiveness
Phase II trial of galiximab (anti-CD80 monoclonal antibody) plus rituximab (CALGB 50402): Follicular Lymphoma International Prognostic Index (FLIPI) score is predictive of upfront immunotherapy responsiveness
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DOI：
10.1093/annonc/mdr620
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发表时间：
2012-09-01
影响因子：
50.5
通讯作者：
Cheson, B. D.
中科院分区：
文献类型：
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作者：
Czuczman, M. S.;Leonard, J. P.;Cheson, B. D.
这项II期CALGB试验评估了加利昔单抗（G）加利妥昔单抗（R）的延长诱导方案在未经治疗的滤泡性淋巴瘤（FL）中的活性和安全性。既往未经治疗的FL患者（1、2、3a级）接受每周4次G + R输注，随后每2个月额外剂量4次。采用国际研讨会反应标准评价反应。61例患者接受了治疗，抗体输注耐受良好。总体缓解率（ORR）为72.1%（95%置信区间为59.2%-82.9%）：47.6%完全缓解（CR）/未确认的完全缓解（CRu）和24.6%部分缓解。中位随访时间为4.3年（范围：0.3-5.3年），中位无进展生存期（PFS）为2.9年。值得注意的是，滤泡性淋巴瘤国际预后指数（FLIPI）与ORR、CR率和PFS相关，低风险FLIPI组（n = 12）的ORR为92%，CR/CRu率为75%，3年PFS为75%。此外，该试验作为利妥昔单抗加其他新型靶向药物的额外CALGB“双重”组合方案的初始平台。
This phase II CALGB trial evaluated the activity and safety of an extended induction schedule of galiximab (G) plus rituximab (R) in untreated follicular lymphoma (FL).Patients with previously untreated FL (grades 1, 2, 3a) received 4 weekly infusions of G + R, followed by an additional dose every 2 months four times. International Workshop Response Criteria were used to evaluate response.Sixty-one patients were treated and antibody infusions were well tolerated. The overall response rate (ORR) is 72.1% (95% confidence interval 59.2% to 82.9%): 47.6% complete response (CR)/unconfirmed complete response (CRu) and 24.6% partial response. At a median follow-up time of 4.3 years (range, 0.3-5.3 years) median progression-free survival (PFS) is 2.9 years. Notably, Follicular Lymphoma International Prognostic Index (FLIPI) correlated with ORR, CR rate, and PFS, and the low-risk FLIPI group (n = 12) achieved a 92% ORR, 75% CR/CRu rate, and 75% 3-year PFS.An extended induction schedule of G + R in previously untreated FL is well tolerated and appears particularly efficacious in those patients with low-risk FLIPI scores. In addition, this trial served as the initial platform for additional CALGB 'doublet' combination regimes of rituximab plus other novel targeted agents.