Background: Nivolumab has shown a survival benefit compared with docetaxel as second-line treatment for patients with previously treated advanced squamous non-small cell lung cancer (NSCLC) in a randomized phase III trial. The experiences of patients and physicians in routine clinical practice are often different from those in a controlled clinical trial setting. We present data from the entire Italian cohort of patients with squamous NSCLC enrolled in a worldwide nivolumab NSCLC expanded access program.
Patients and methods: Patients with pretreated advanced squamous NSCLC received nivolumab 3 mg/kg every 2 weeks for up to 24 months. Safety was monitored throughout; efficacy data collected included objective tumor response, date of progression, and survival information.
Results: The Italian cohort comprised 371 patients who received at least one dose of nivolumab. In the overall population, the objective response rate (ORR) was 18%, the disease control rate (DCR) was 47%, and median overall survival (OS) was 7.9 months (95% confidence interval 6.2-9.6). In subgroup analyses, ORR, DCR, and median OS were, respectively, 17%, 48%, and 9.1 months in patients previously treated with two or more lines of therapy (n = 209) and 8%, 40%, and 10.0 months in patients treated beyond disease progression (n = 65). In the overall population, the rate of any-grade and grade 3-4 adverse events was 29% and 6%, respectively. Treatment-related adverse events led to treatment discontinuation in 14 patients (5%). There were no treatment-related deaths.
Conclusion: To date, this report represents the most extensive clinical experience with nivolumab in advanced squamous NSCLC in current practice outside the controlled clinical trial setting. These data suggest that the efficacy and safety profiles of nivolumab in a broad, real-world setting are consistent with those obtained in clinical trials.
Implications for practice: Nivolumab is approved in the U.S. and Europe for the treatment of advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. In this cohort of Italian patients with previously treated, advanced squamous NSCLC treated in a real-world setting as part of the nivolumab expanded access program, the efficacy and safety of nivolumab was consistent with that previously reported in nivolumab clinical trials.
摘要
背景。一项随机 III 期试验结果表明，在晚期鳞状非小细胞肺癌 (NSCLC) 患者的二线治疗中，纳武单抗与多西紫杉醇相比具有一定的生存优势。患者和医生在常规临床实践中的经验往往与对照临床试验环境中所获得的经验有所差别。本研究介绍了在世界范围内开展的纳武单抗 NSCLC 扩大受试计划中，所选择的鳞状 NSCLC 患者意大利队列的所有数据。
患者和方法。经治的晚期鳞状 NSCLC 患者每 2 周接受 3 mg/kg 的纳武单抗治疗，疗程为 24 个月。全程进行安全监测；收集的疗效数据包括客观肿瘤反应、进展日期和生存信息。
结果。意大利队列包括 371 名至少接受过一剂纳武单抗治疗的患者。总体患者治疗结果显示，客观有效率 (ORR) 为 18%，疾病控制率 (DCR) 为 47%，中位总生存期 (OS)为 7.9 个月(95% 可信区间 6.2‐9.6)。亚组分析结果显示，先前接受过两线或以上治疗的患者，ORR、DCR 和 中位OS分别为 17%、48%和9.1 个月(n = 209)，而疾病进展后接受治疗的患者的 ORR、DCR 和 中位OS 分别为 8%、40% 和 10.0个月 (n = 65)。总体患者治疗结果显示，任意级别和 3‐4 级不良事件发生率分别为 29% 和 6%。14 名患者 (5%) 因出现治疗相关的不良事件而停止治疗。无与治疗相关的死亡事件。
结论。到目前为止，本报告最为全面地介绍了当前对照临床试验环境以外的临床实践中，纳武单抗应用于晚期鳞状 NSCLC 治疗的临床经验。这些数据表明，纳武单抗在广泛的真实世界环境中，有效性和安全性与临床试验中获得的结果一致。
实践意义:纳武单抗已在美国和欧洲获批，可在患者接受铂类药物化疗失败后，用于治疗晚期非小细胞肺癌 (NSCLC)。在这支之前接受过治疗的意大利患者队列中，晚期鳞状 NSCLC 的真实世界环境治疗过程引入了纳武单抗扩大受试计划，纳武单抗的疗效和安全性与先前的纳武单抗临床试验中得出的结果一致。
Keywords: Expanded access program; Immunotherapy; Nivolumab; Real‐world; Squamous non‐small cell lung cancer; Treatment beyond disease progression.
© AlphaMed Press 2019.