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首页> 外文期刊>Journal of Clinical Oncology >Phase 1b study of dulanermin (recombinant human Apo2L/TRAIL) in combination with paclitaxel, carboplatin, and bevacizumab in patients with advanced non-squamous non-small-cell lung cancer.
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Phase 1b study of dulanermin (recombinant human Apo2L/TRAIL) in combination with paclitaxel, carboplatin, and bevacizumab in patients with advanced non-squamous non-small-cell lung cancer.

机译：dulanermin（重组人Apo2L / TRAIL）与紫杉醇，卡铂和贝伐单抗联合治疗晚期非鳞状非小细胞肺癌患者的1b期临床研究。

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PURPOSE: To determine the safety, pharmacokinetics (PK), and maximum-tolerated dose (MTD) up to a prespecified target dose of dulanermin in combination with paclitaxel, carboplatin, and bevacizumab (PCB) in patients with previously untreated, nonsquamous, stage IIIb (with pleural effusion)/IV or recurrent non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: In this phase 1b study, patients (n = 24) received PCB on day 1 of each 21-day cycle then dulanermin at 4 or 8 mg/kg/d for 5 consecutive days or 15 or 20 mg/kg/d for 2 consecutive days per assigned treatment cohort. Incidence of dose-limiting toxicities (DLTs), adverse events, and antidulanermin antibodies were assessed. PK parameters were recorded for each agent. Tumor response was measured by modified Response Evaluation Criteria in Solid Tumors. RESULTS: Twenty-four patients received at least one dose of dulanermin plus PCB, six in each treatment cohort. There were no DLTs. An MTD was not reached, and the drug combination was well tolerated. Treatment-emergent adverse events were generally as expected for the PCB regimen. Adverse events attributed to dulanermin were grade 1/2; no significant hepatotoxicity occurred. There was minimal impact of PCB on the PK of dulanermin. There was one confirmed complete response and 13 confirmed partial responses. The overall response rate was 58% (95% CI, 37 to 78). Median progression-free survival was 7.2 months (95% CI, 4.7 to 10.3). CONCLUSION: Dulanermin plus PCB was well tolerated with no occurrence of DLTs and demonstrated antitumor activity in this patient population. Dulanermin at 8 mg/kg/d for 5 days and 20 mg/kg/d for 2 days every 3 weeks in combination with PCB is being studied in a phase II trial.
机译：目的：确定之前未经治疗的非鳞状IIIb期患者的安全性，药代动力学（PK）和最大耐受剂量（MTD），以达兰明的预先确定的目标剂量联合紫杉醇，卡铂和贝伐单抗（PCB） （有胸腔积液）/ IV或复发性非小细胞肺癌（NSCLC）。患者和方法：在此1b期研究中，患者（n = 24）在每个21天周期的第1天接受PCB，然后连续5天连续4或8 mg / kg / d或15或20 mg / kg / d接受dulanermin d每个指定的治疗队列连续2天。评估了剂量限制毒性（DLT），不良事件和抗杜拉明胺抗体的发生率。记录每种药剂的PK参数。通过修改的实体瘤反应评估标准测量肿瘤反应。结果：24例患者接受了至少一剂dulanermin加PCB，每组共6例。没有DLT。未达到MTD，并且药物组合耐受良好。突发治疗的不良事件通常与PCB方案预期的一样。归因于dulanermin的不良事件为1/2级;没有明显的肝毒性发生。 PCB对dulanermin PK的影响最小。有1例证实完全缓解，有13例证实部分缓解。总体缓解率为58％（95％CI，37至78）。中位无进展生存期为7.2个月（95％CI，4.7至10.3）。结论：Dulanermin加PCB具有良好的耐受性，没有DLT发生，并且在该患者人群中显示出抗肿瘤活性。 II期试验正在研究以8 mg / kg / d的剂量持续5天和20 mg / kg / d的剂量每3周2天与PCB联用的Dulanermin。

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