当前位置:
X-MOL 学术
›
J. Thorac. Oncol.
›
论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Recurrent Small Cell Lung Cancer: Results From the CheckMate 032 Randomized Cohort
Journal of Thoracic Oncology ( IF 20.4 ) Pub Date : 2020-03-01 , DOI: 10.1016/j.jtho.2019.10.004 Neal E Ready 1 , Patrick A Ott 2 , Matthew D Hellmann 3 , Jon Zugazagoitia 4 , Christine L Hann 5 , Filippo de Braud 6 , Scott J Antonia 7 , Paolo A Ascierto 8 , Victor Moreno 9 , Akin Atmaca 10 , Stefania Salvagni 11 , Matthew Taylor 12 , Asim Amin 13 , D Ross Camidge 14 , Leora Horn 15 , Emiliano Calvo 16 , Ang Li 17 , Wen Hong Lin 17 , Margaret K Callahan 18 , David R Spigel 19
Journal of Thoracic Oncology ( IF 20.4 ) Pub Date : 2020-03-01 , DOI: 10.1016/j.jtho.2019.10.004 Neal E Ready 1 , Patrick A Ott 2 , Matthew D Hellmann 3 , Jon Zugazagoitia 4 , Christine L Hann 5 , Filippo de Braud 6 , Scott J Antonia 7 , Paolo A Ascierto 8 , Victor Moreno 9 , Akin Atmaca 10 , Stefania Salvagni 11 , Matthew Taylor 12 , Asim Amin 13 , D Ross Camidge 14 , Leora Horn 15 , Emiliano Calvo 16 , Ang Li 17 , Wen Hong Lin 17 , Margaret K Callahan 18 , David R Spigel 19
Affiliation
INTRODUCTION
Nivolumab monotherapy is approved in the US for third-line or later metastatic SCLC based on pooled data from non-randomized and randomized cohorts of the multicenter, open-label, phase 1/2 trial of nivolumab ± ipilimumab (CheckMate 032; NCT01928394). We report updated results, including long-term overall survival (OS), from the randomized cohort. METHODS
Patients with SCLC and disease progression after 1-2 prior chemotherapy regimens were randomized 3:2 to nivolumab 3 mg/kg Q2W or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg Q3W for four cycles followed by nivolumab 3 mg/kg Q2W. Patients were stratified by number of prior chemotherapy regimens and treated until disease progression or unacceptable toxicity. Primary endpoint was objective response rate (ORR) by blinded independent central review. RESULTS
Overall, 147 patients received nivolumab and 96 nivolumab plus ipilimumab. Minimum follow-up for ORR/PFS/safety was 11.9 months (nivolumab) and 11.2 months (nivolumab plus ipilimumab). ORR increased with nivolumab plus ipilimumab (21.9% versus 11.6% with nivolumab; odds ratio: 2.12 [95% CI: 1.06-4.26]; p=0.03). For long-term OS, minimum follow-up was 29.0 months (nivolumab) versus 28.4 months (nivolumab plus ipilimumab); median (95% CI) OS was 5.7 (3.8-7.6) versus 4.7 months (3.1-8.3). 24-month OS rates were 17.9% (nivolumab) and 16.9% (nivolumab plus ipilimumab). Grade 3-4 treatment-related adverse event rates were 12.9% (nivolumab) versus 37.5% (nivolumab plus ipilimumab), and treatment-related deaths 1 versus 3. CONCLUSION
While ORR (primary endpoint) was higher with nivolumab plus ipilimumab versus nivolumab, OS was similar between groups. In each group, OS remained encouraging with long-term follow-up. Toxicities were more common with combination therapy versus nivolumab monotherapy.
中文翻译:
纳武单抗单药疗法和纳武单抗联合伊匹单抗治疗复发性小细胞肺癌:CheckMate 032 随机队列的结果
简介 纳武单抗单药疗法在美国被批准用于三线或晚期转移性 SCLC,基于纳武单抗 ± 伊匹单抗多中心、开放标签、1/2 期试验的非随机和随机队列的汇总数据 (CheckMate 032; NCT01928394) 。我们报告了随机队列的最新结果,包括长期总生存期 (OS)。方法 将患有 SCLC 且经过 1-2 种既往化疗方案后疾病进展的患者以 3:2 的比例随机分配至纳武单抗 3 mg/kg Q2W 或纳武单抗 1 mg/kg 加易普利姆玛 3 mg/kg Q3W,持续四个周期,然后接受纳武单抗 3 mg/kg Q2W 。患者根据既往化疗方案的数量进行分层,并接受治疗直至疾病进展或出现不可接受的毒性。主要终点是通过盲法独立中央审查得出的客观缓解率(ORR)。结果 总体而言,147 名患者接受纳武单抗治疗,96 名患者接受纳武单抗加伊匹单抗治疗。ORR/PFS/安全性的最短随访时间为 11.9 个月(纳武单抗)和 11.2 个月(纳武单抗加伊匹单抗)。纳武单抗联合易普利姆玛治疗后的 ORR 增加(纳武单抗治疗为 21.9%,纳武单抗治疗为 11.6%;比值比:2.12 [95% CI:1.06-4.26];p=0.03)。对于长期 OS,最短随访时间为 29.0 个月(纳武单抗)对比 28.4 个月(纳武单抗加伊匹单抗);中位 OS (95% CI) 分别为 5.7 (3.8-7.6) 和 4.7 个月 (3.1-8.3)。24 个月 OS 率为 17.9%(纳武单抗)和 16.9%(纳武单抗加伊匹单抗)。3-4 级治疗相关不良事件发生率分别为 12.9%(纳武单抗)和 37.5%(纳武单抗加易普利姆玛),治疗相关死亡人数为 1 比 3。各组之间的 OS 相似。在长期随访中,每组的 OS 仍然令人鼓舞。与纳武单抗单药治疗相比,联合治疗的毒性更常见。
更新日期:2020-03-01
中文翻译:
纳武单抗单药疗法和纳武单抗联合伊匹单抗治疗复发性小细胞肺癌:CheckMate 032 随机队列的结果
简介 纳武单抗单药疗法在美国被批准用于三线或晚期转移性 SCLC,基于纳武单抗 ± 伊匹单抗多中心、开放标签、1/2 期试验的非随机和随机队列的汇总数据 (CheckMate 032; NCT01928394) 。我们报告了随机队列的最新结果,包括长期总生存期 (OS)。方法 将患有 SCLC 且经过 1-2 种既往化疗方案后疾病进展的患者以 3:2 的比例随机分配至纳武单抗 3 mg/kg Q2W 或纳武单抗 1 mg/kg 加易普利姆玛 3 mg/kg Q3W,持续四个周期,然后接受纳武单抗 3 mg/kg Q2W 。患者根据既往化疗方案的数量进行分层,并接受治疗直至疾病进展或出现不可接受的毒性。主要终点是通过盲法独立中央审查得出的客观缓解率(ORR)。结果 总体而言,147 名患者接受纳武单抗治疗,96 名患者接受纳武单抗加伊匹单抗治疗。ORR/PFS/安全性的最短随访时间为 11.9 个月(纳武单抗)和 11.2 个月(纳武单抗加伊匹单抗)。纳武单抗联合易普利姆玛治疗后的 ORR 增加(纳武单抗治疗为 21.9%,纳武单抗治疗为 11.6%;比值比:2.12 [95% CI:1.06-4.26];p=0.03)。对于长期 OS,最短随访时间为 29.0 个月(纳武单抗)对比 28.4 个月(纳武单抗加伊匹单抗);中位 OS (95% CI) 分别为 5.7 (3.8-7.6) 和 4.7 个月 (3.1-8.3)。24 个月 OS 率为 17.9%(纳武单抗)和 16.9%(纳武单抗加伊匹单抗)。3-4 级治疗相关不良事件发生率分别为 12.9%(纳武单抗)和 37.5%(纳武单抗加易普利姆玛),治疗相关死亡人数为 1 比 3。各组之间的 OS 相似。在长期随访中,每组的 OS 仍然令人鼓舞。与纳武单抗单药治疗相比,联合治疗的毒性更常见。