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Phase II randomized trial of carboplatin, paclitaxel, bevacizumab with or without cixutumumab (IMC-A12) in patients with advanced non-squamous, non-small-cell lung cancer: a trial of the ECOG-ACRIN Cancer Research Group (E3508).
Annals of Oncology ( IF 56.7 ) Pub Date : 2017-12-01 , DOI: 10.1093/annonc/mdx534
A Argiris 1, 2 , J W Lee 3 , J Stevenson 4 , M G Sulecki 5 , V Hugec 6 , N W Choong 7 , J N Saltzman 8 , W Song 9 , R M Hansen 10 , T L Evans 11 , S S Ramalingam 12 , J H Schiller 13
Affiliation  

Background Cixutumumab is a fully human IgG1 monoclonal antibody to the insulin-like growth factor type I receptor that can potentially reverse resistance and enhance the efficacy of chemotherapy. Methods Bevacizumab-eligible patients with stage IV or recurrent non-squamous, non-small-cell lung cancer and good performance status were randomized to receive standard doses of paclitaxel, carboplatin, and bevacizumab to a maximum of six cycles followed by bevacizumab maintenance (CPB) until progression (arm A) or CPB plus cixutumumab 6 mg/kg i.v. weekly (arm B). Results Of 175 patients randomized, 153 were eligible and treated (78 in arm A; 75 in arm B). The median progression-free survival was 5.8 months (95% CI 5.4-7.1) in arm A versus 7 months (95% CI 5.7-7.6) in arm B (P = 0.33); hazard ratio 0.92 (95% CI 0.65-1.31). Objective response was 46.2% versus 58.7% in arm A versus arm B (P = 0.15). The median overall survival was 16.2 months in arm A versus 16.1 months in arm B (P = 0.95). Grade 3/4 neutropenia and febrile neutropenia, thrombocytopenia, fatigue, and hyperglycemia were increased with cixutumumab. Conclusions The addition of cixutumumab to CPB increased toxicity without improving efficacy and is not recommended for further development in non-small-cell lung cancer. Both treatment groups had longer OS than historical controls which may be attributed to several factors, and emphasizes the value of a comparator arm in phase II trials. ClinicalTrials.gov Identifier NCT00955305.

中文翻译:

卡铂、紫杉醇、贝伐单抗联合或不联合 cixutumumab (IMC-A12) 在晚期非鳞状非小细胞肺癌患者中的 II 期随机试验:ECOG-ACRIN 癌症研究组 (E3508) 的试验。

背景 Cixutumumab 是一种针对胰岛素样生长因子 I 型受体的全人源 IgG1 单克隆抗体,可以潜在地逆转耐药性并增强化疗的疗效。方法 符合贝伐单抗条件的 IV 期或复发性非鳞状、非小细胞肺癌且体能状态良好的患者随机接受标准剂量的紫杉醇、卡铂和贝伐单抗治疗,最多 6 个周期,然后进行贝伐单抗维持治疗 (CPB) ) 直至进展(A 组)或 CPB 加 cixutumumab 6 mg/kg iv 每周一次(B 组)。结果 在随机分组的 175 名患者中,153 名符合条件并接受了治疗(A 组 78 名;B 组 75 名)。A 组的中位无进展生存期为 5.8 个月(95% CI 5.4-7.1),而 B 组为 7 个月(95% CI 5.7-7.6)(P = 0.33);风险比 0.92 (95% CI 0.65-1.31)。客观反应为 46。A 组与 B 组分别为 2% 和 58.7%(P = 0.15)。A组的中位总生存期为16.2个月,B组为16.1个月(P = 0.95)。cixutumumab 增加了 3/4 级中性粒细胞减少症和发热性中性粒细胞减少症、血小板减少症、疲劳和高血糖症。结论 在 CPB 中添加 cixutumumab 会增加毒性,但不会提高疗效,不推荐用于非小细胞肺癌的进一步开发。两个治疗组的 OS 都比历史对照组长,这可能归因于几个因素,并强调了比较组在 II 期试验中的价值。ClinicalTrials.gov 标识符 NCT00955305。cixutumumab 会增加疲劳和高血糖。结论 在 CPB 中添加 cixutumumab 会增加毒性,但不会提高疗效,不推荐用于非小细胞肺癌的进一步开发。两个治疗组的 OS 都比历史对照组长,这可能归因于几个因素,并强调了比较组在 II 期试验中的价值。ClinicalTrials.gov 标识符 NCT00955305。cixutumumab 会增加疲劳和高血糖。结论 在 CPB 中添加 cixutumumab 会增加毒性,但不会提高疗效,不推荐用于非小细胞肺癌的进一步开发。两个治疗组的 OS 都比历史对照组长,这可能归因于几个因素,并强调了比较组在 II 期试验中的价值。ClinicalTrials.gov 标识符 NCT00955305。
更新日期:2017-12-10
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