Phase II Trial of Tremelimumab (CP-675,206) in Patients with Advanced Refractory or Relapsed Melanoma
Phase II Trial of Tremelimumab (CP-675,206) in Patients with Advanced Refractory or Relapsed Melanoma
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DOI：
10.1158/1078-0432.ccr-09-2033
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发表时间：
2010-02-01
影响因子：
11.5
通讯作者：
Bulanhagui, Cecile A.
中科院分区：
文献类型：
--
作者：
Kirkwood, John M.;Lorigan, Paul;Bulanhagui, Cecile A.
目的：该II期研究评估了tremelimumab（一种全人抗CTL相关抗原4单克隆抗体）在melanoma患者中的抗肿瘤活性。实验设计：难治性/复发性黑素瘤患者每90天接受15 mg/kg tremelimumab。4次给药后，肿瘤缓解或疾病稳定的患者有资格接受20个月的治疗; 5例（63%）患者仍然存活。临床获益率（总缓解+疾病稳定）为21%（16例部分缓解和35例疾病稳定），中位总生存期为10.0个月。6个月时的无进展生存率为15%，12个月时的生存率为40.3%，24个月时的生存率为22%。常见的治疗相关不良事件通常为轻度至中度，3/4级不良事件包括腹泻（n = 28，11%）、疲劳（n = 6，2%）和结肠炎（n = 9，4%）。结论：曲美木单抗显示出6.6%的客观反应率，所有反应自登记以来持续>= 170天，表明曲美木单抗在黑色素瘤中的潜在作用。Clin Cancer Res; 16（3）; 1042-8. (C)2010年AACR。
Purpose: This phase II study assessed the antitumor activity of tremelimumab, a fully human, anti-CTL-associated antigen 4 monoclonal antibody, in patients with melanoma.Experimental Design: Patients with refractory/relapsed melanoma received 15 mg/kg tremelimumab every 90 days. After 4 doses, patients with tumor response or stable disease were eligible to receive 20 months; 5 (63%) remained alive. Clinical benefit rate (overall response + stable disease) was 21% (16 partial responses and 35 stable disease), and median overall survival was 10.0 months. Progression-free survival at 6 months was 15%, and survival was 40.3% at 12 months and 22% at 24 months. Common treatment-related adverse events were generally mild to moderate, and grade 3/4 adverse events included diarrhea (n = 28, 11%), fatigue (n = 6, 2%), and colitis (n = 9, 4%). There were 2 (0.8%) treatment-related deaths.Conclusions: Tremelimumab showed an objective response rate of 6.6%, with all responses being durable >= 170 days since enrollment, suggesting a potential role for tremelimumab in melanoma. Clin Cancer Res; 16(3); 1042-8. (C) 2010 AACR.