A phase II study of weekly carboplatin and concurrent radiotherapy in older adults with locally advanced non-small cell lung cancer (LOGIK1902).

IF 2.3 3区医学 Q3 ONCOLOGY

Thoracic Cancer Pub Date : 2024-10-01 Epub Date: 2024-09-08 DOI:10.1111/1759-7714.15444

Taishi Harada, Tomonari Sasaki, Hidenobu Ishii, Shinnosuke Takemoto, Yasushi Hisamatsu, Haruhiro Saito, Yasuto Yoneshima, Kazutoshi Komiya, Kosuke Kashiwabara, Katsuhiko Naoki, Tomohiro Ogawa, Hiroaki Takeoka, Koichi Saruwatari, Kensaku Ito, Yuko Tsuchiya-Kawano, Keiko Mizuno, Takayuki Shimose, Yoshiyuki Shioyama, Isamu Okamoto

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引用次数: 0

Abstract

Background: Concurrent chemoradiotherapy is the standard therapy for locally advanced non-small cell lung cancer (NSCLC). However, there is little evidence supporting its use in older adults. Low-dose daily carboplatin combined with thoracic radiotherapy is considered a standard regimen for this population. To establish a simple and feasible carboplatin administration method, we conducted a study of weekly carboplatin and concurrent radiotherapy for older adults with locally advanced NSCLC.

Methods: This prospective, single-arm, multicenter, phase II clinical trial included patients aged ≥75 years with unresectable stage III NSCLC and Eastern Cooperative Oncology Group performance status 0-1. Patients received chemoradiotherapy (60 Gy/30 fractions plus concurrent weekly carboplatin at an area under curve of 2 mg mL^-1 min^-1). The primary endpoint was the overall response rate (ORR). Key secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

Results: From July 2020 to June 2022, 37 patients were enrolled from 15 institutions, and 36 patients were evaluable for efficacy and safety. The ORR was 63.9% (95% confidence interval [CI] = 47.6-77.5). Median PFS was 14.6 months (95% CI = 9.1-18.1). Median OS was 25.5 months (95% CI = 17.4-not reached). Grade 4 leucopenia, neutropenia, and thrombocytopenia were observed in one patient (2.8%) each.

Conclusion: Weekly carboplatin and concurrent radiation therapy was safe in older adults with locally advanced NSCLC, and promising activity was observed.

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针对局部晚期非小细胞肺癌老年患者的每周卡铂和同期放化疗 II 期研究（LOGIK1902）。

背景：同期化放疗是局部晚期非小细胞肺癌（NSCLC）的标准疗法。然而，很少有证据支持将其用于老年人。每日低剂量卡铂联合胸部放疗被认为是此类人群的标准治疗方案。为了建立一种简单可行的卡铂给药方法，我们对患有局部晚期 NSCLC 的老年人进行了每周一次卡铂和同期放疗的研究：这项前瞻性、单臂、多中心、II期临床试验纳入了年龄≥75岁、不可切除的III期NSCLC患者和东部合作肿瘤学组表现状态0-1级的患者。患者接受化放疗（60 Gy/30 次分次治疗，同时每周一次卡铂治疗，曲线下面积为 2 mg mL-1 min-1）。主要终点是总反应率（ORR）。主要次要终点包括无进展生存期（PFS）、总生存期（OS）和安全性：2020 年 7 月至 2022 年 6 月，15 家机构共招募了 37 名患者，其中 36 名患者的疗效和安全性接受了评估。ORR为63.9%（95%置信区间[CI] = 47.6-77.5）。中位 PFS 为 14.6 个月（95% 置信区间 = 9.1-18.1）。中位OS为25.5个月（95% CI = 17.4-未达到）。观察到4级白细胞减少症、中性粒细胞减少症和血小板减少症患者各一名（2.8%）：结论：对于患有局部晚期NSCLC的老年人来说，每周卡铂和同期放疗是安全的，而且观察到了良好的活性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Thoracic Cancer ONCOLOGY-RESPIRATORY SYSTEM

CiteScore

5.20

自引率

3.40%

发文量

439

审稿时长

2 months

期刊介绍： Thoracic Cancer aims to facilitate international collaboration and exchange of comprehensive and cutting-edge information on basic, translational, and applied clinical research in lung cancer, esophageal cancer, mediastinal cancer, breast cancer and other thoracic malignancies. Prevention, treatment and research relevant to Asia-Pacific is a focus area, but submissions from all regions are welcomed. The editors encourage contributions relevant to prevention, general thoracic surgery, medical oncology, radiology, radiation medicine, pathology, basic cancer research, as well as epidemiological and translational studies in thoracic cancer. Thoracic Cancer is the official publication of the Chinese Society of Lung Cancer, International Chinese Society of Thoracic Surgery and is endorsed by the Korean Association for the Study of Lung Cancer and the Hong Kong Cancer Therapy Society. The Journal publishes a range of article types including: Editorials, Invited Reviews, Mini Reviews, Original Articles, Clinical Guidelines, Technological Notes, Imaging in thoracic cancer, Meeting Reports, Case Reports, Letters to the Editor, Commentaries, and Brief Reports.