Single Institution Experience of Ipilimumab 3 mg/kg with Sargramostim (GM-CSF) in Metastatic Melanoma
Single Institution Experience of Ipilimumab 3 mg/kg with Sargramostim (GM-CSF) in Metastatic Melanoma
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DOI：
10.1158/2326-6066.cir-15-0066
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发表时间：
2015-09-01
影响因子：
10.1
通讯作者：
Hodi, F. Stephen
中科院分区：
文献类型：
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作者：
Luke, Jason J.;Donahue, Hilary;Hodi, F. Stephen
在一项随机的II期试验中，ipilimumab，10 mg/kg与沙拉莫替姆(GM-CSF；GM)一起使用，改善了晚期黑色素瘤患者的总体存活率(OS)和安全性。FDA批准的3毫克/公斤的ipilimumab剂量尚未用GM(IPI-GM)进行评估。对在同一机构接受IPI-GM治疗的连续患者进行回顾。治疗包括伊匹单抗，每3周×4次，GM，250亩，皮下注射。每次注射ipilimumab周期的第1至14天。评估疗效、临床特征、毒性和肿瘤负担的放射学盲法回顾。32名患者被确认，其中25名(78%)有免疫相关反应标准(IRRC)可测量的疾病，41%有中枢神经系统转移。总共给予了88.6%的转基因剂量。12周时IRRC的有效率为20%，疾病控制率为44%(中位随访37周)。免疫相关不良事件(IRAE)10例(31.3%)，其中3例(9.4%)为3级。3级irAEs患者既往有自身免疫性，年龄较高，运动状态较差。首次使用ipilimumab的中位OS为41周。IPI-GM治疗是可行的，在这一低风险晚期黑色素瘤人群中，与历史上单独使用ipilimumab相比，疗效似乎相似，但安全性似乎有所改善。(C)2015年AACR。
Ipilimumab, 10 mg/kg with sargramostim (GM-CSF; GM), improved overall survival (OS) and safety of patients with advanced melanoma over ipilimumab in a randomized phase II trial. The FDA-approved dose of ipilimumab of 3 mg/kg has not been assessed with GM (IPI-GM). Consecutive patients treated with IPI-GM at a single institution were reviewed. Treatment included ipilimumab every 3 weeks x 4 and GM, 250-mu g s.c. injection days 1 to 14 of each ipilimumab cycle. Efficacy, clinical characteristics, toxicities, and blinded radiology review of tumor burden were evaluated. Thirty-two patients were identified with 25 (78%) having immune-related response criteria (irRC) measurable disease and 41% with central nervous system metastases. A total of 88.6% of GM doses were administered. Response rate by irRC and disease control rate at 12 weeks were 20% and 44%, respectively (median follow-up 37 weeks). Immune-related adverse events (irAE) were observed in 10 (31.3%) patients, with 3 (9.4%) grade 3 events. Patients with grade 3 irAEs had prior autoimmunity, advanced age, and poor performance status. The median OS from first dose of ipilimumab was 41 weeks. Ipi-GM treatment is feasible and in this poor-risk advanced melanoma population, efficacy appeared similar but safety appeared improved relative to historical ipilimumab alone. (C) 2015 AACR.