晚期鳞状非小细胞肺癌一线治疗：RATIONALE-307 随机 III 期试验的最终分析。

IF 7.1 2区医学 Q1 ONCOLOGY

ESMO Open Pub Date : 2024-10-01 DOI:10.1016/j.esmoop.2024.103727

J. Wang , S. Lu , X. Yu , Y. Hu , J. Zhao , M. Sun , Y. Yu , C. Hu , K. Yang , Y. Song , X. Lin , L. Liang , S. Leaw , W. Zheng

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引用次数: 0

摘要

研究目的在III期RATIONALE-307试验的中期分析中，在晚期鳞状非小细胞肺癌（sq-NSCLC）患者中，一线替赛珠单抗联合化疗与单纯化疗相比可显著改善无进展生存期（PFS）。我们将介绍该试验的最终分析结果：未经治疗的 IIIB/IV 期 sq-NSCLC 患者被随机（1:1:1）分配到 21 天周期的静脉注射：替舒瑞单抗加紫杉醇和卡铂（A 组）；替舒瑞单抗加纳布-紫杉醇和卡铂（B 组）；或紫杉醇和卡铂（C 组）。主要终点是独立审查委员会评估的PFS；总生存期是次要终点：共有 360 名患者接受了随机治疗，其中 355 人接受了治疗。在最终分析（中位随访时间：16.7个月）中，替赛珠单抗联合化疗的安全性良好，与中期分析结果一致。A组和B组与C组相比，PFS的改善幅度保持不变{危险比（HR）分别为0.45[95%置信区间（CI）0.33-0.62]和0.43（95% CI 0.31-0.60）}。A组和B组与C组相比，总生存率分别为0.68（95% CI 0.46-1.01）和0.75（95% CI 0.50-1.12）：RATIONALE-307的最终分析表明，在化疗基础上加用替斯利珠单抗可获得更好的临床疗效，且安全性可控，可作为晚期sq-NSCLC的一线治疗药物。

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Tislelizumab plus chemotherapy versus chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer: final analysis of the randomized, phase III RATIONALE-307 trial

Purpose

First-line tislelizumab plus chemotherapy significantly improved progression-free survival (PFS) versus chemotherapy alone in advanced squamous non-small-cell lung cancer (sq-NSCLC) at the interim analysis of the phase III RATIONALE-307 trial. We present the final analysis of this trial.

Patients and methods

Patients with treatment-naive, stage IIIB/IV, sq-NSCLC were randomized (1 : 1: 1) to 21-day cycles of i.v.: tislelizumab plus paclitaxel and carboplatin (arm A); tislelizumab plus nab-paclitaxel and carboplatin (arm B); or paclitaxel and carboplatin (arm C). The primary endpoint was independent review committee-assessed PFS; overall survival was a secondary endpoint.

Results

In total, 360 patients were randomized; 355 received treatment. At the final analysis (median study follow-up: 16.7 months), tislelizumab plus chemotherapy had a manageable safety profile, consistent with that at the interim analysis. Improvement in PFS was maintained for arms A and B versus C {hazard ratio (HR) 0.45 [95% confidence interval (CI) 0.33-0.62] and 0.43 (95% CI 0.31-0.60), respectively}. Overall survival HRs for arms A and B versus C were 0.68 (95% CI 0.46-1.01) and 0.75 (95% CI 0.50-1.12), respectively.

Conclusions

The RATIONALE-307 final analysis demonstrated superior clinical benefit with addition of tislelizumab to chemotherapy, and a manageable safety profile, as first-line treatment of advanced sq-NSCLC.

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来源期刊

ESMO Open Medicine-Oncology

CiteScore

11.70

自引率

2.70%

发文量

255

审稿时长

10 weeks

期刊介绍： ESMO Open is the online-only, open access journal of the European Society for Medical Oncology (ESMO). It is a peer-reviewed publication dedicated to sharing high-quality medical research and educational materials from various fields of oncology. The journal specifically focuses on showcasing innovative clinical and translational cancer research. ESMO Open aims to publish a wide range of research articles covering all aspects of oncology, including experimental studies, translational research, diagnostic advancements, and therapeutic approaches. The content of the journal includes original research articles, insightful reviews, thought-provoking editorials, and correspondence. Moreover, the journal warmly welcomes the submission of phase I trials and meta-analyses. It also showcases reviews from significant ESMO conferences and meetings, as well as publishes important position statements on behalf of ESMO. Overall, ESMO Open offers a platform for scientists, clinicians, and researchers in the field of oncology to share their valuable insights and contribute to advancing the understanding and treatment of cancer. The journal serves as a source of up-to-date information and fosters collaboration within the oncology community.