Single-arm multicenter phase II study on aggressive local consolidative therapy in combination with systemic chemotherapy for stage IV non-small cell lung carcinoma with oligometastases: CURE-OLIGO (TORG1529).

IF 3.3 2区医学 Q2 ONCOLOGY Radiation Oncology Pub Date : 2025-01-04 DOI:10.1186/s13014-024-02577-5

Takaaki Tokito, Kazuhiko Yamada, Hidenobu Ishii, Yuichi Takiguchi, Go Saito, Koichi Minato, Hisao Imai, Hiroshi Tanaka, Satoru Miura, Kageaki Watanabe, Yoshifusa Koreeda, Akira Ono, Naoki Furuya, Toshihiro Misumi, Kazushige Hayakawa, Etsuyo Ogo, Hiroaki Okamoto

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Abstract

Introduction: Stage IV non-small cell lung carcinoma (NSCLC) with oligometastases is potentially curable by radical treatment. This study aimed to evaluate the efficacy and safety of chemoradiotherapy (CRT) for thoracic disease, including the primary lesion and lymph node metastases, combined with local consolidative therapy (LCT) for oligometastases.

Methods: This was a multicenter Phase II trial for patients with Stage IV NSCLC with oligometastases for whom CRT for thoracic disease was feasible. The treatment procedures included CRT containing platinum-doublet for thoracic disease and LCT for oligometastases within 8 weeks of starting or completing CRT. The primary endpoint was the 2-year survival rate.

Results: We enrolled 19 patients between June 2016 and May 2020. The median age was 68 (range: 51-74) years. Twelve patients had adenocarcinoma, and 6 had squamous cell carcinoma. The metastasis sites included the brain, bone, adrenal gland, lung, and cervical lymph node (n = 9, 7, 2, 1, and 1, respectively). All patients completed CRT concurrently with LCT for all oligometastases. There were 11 partial responses, resulting in a response rate of 58% (95% confidence interval [CI] 33.5-79.7%). Median progression-free survival and overall survival were 8.6 (95% CI 7.0-10.2) and 42.1 (80% CI 13.6-not reached) months, respectively. The 2-year survival rate was 68.4% (80% CI 52.6%-79.9%). Fourteen patients (74%) showed progression with newly observed lesions. There were no severe adverse events, and toxicities were tolerable.

Conclusion: Chemotherapy in combination with aggressive LCT for NSCLC with oligometastases might extend survival and achieve local control.

Clinical trial registration: University Hospital Medical Information Network, Japan (protocol identification number: UMIN000022431, first registration date: 01/JUN/2016).

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IV期非小细胞肺癌伴低转移灶的侵袭性局部巩固治疗联合全身化疗的单臂多中心II期研究：CURE-OLIGO （TORG1529）。

IV期非小细胞肺癌（NSCLC）伴寡转移灶是可以根治的。本研究旨在评估放化疗（CRT）治疗胸部疾病的疗效和安全性，包括原发性病变和淋巴结转移，结合局部巩固治疗（LCT）治疗低转移灶。方法：这是一项多中心II期试验，针对具有低转移性的IV期非小细胞肺癌患者，这些患者的CRT治疗胸部疾病是可行的。治疗程序包括胸部疾病的含铂双药CRT和开始或完成CRT后8周内的低转移性肿瘤的LCT。主要终点是2年生存率。结果：我们在2016年6月至2020年5月期间入组了19例患者。中位年龄为68岁（51-74岁）。12例为腺癌，6例为鳞状细胞癌。转移部位包括脑、骨、肾上腺、肺和颈部淋巴结（n = 9、7、2、1和1）。所有低转移患者均完成了CRT和LCT治疗。有11个部分应答，应答率为58%（95%可信区间[CI] 33.5-79.7%）。中位无进展生存期和总生存期分别为8.6个月（95% CI 7.0-10.2）和42.1个月（80% CI 13.6-未达到）。2年生存率为68.4% （80% CI 52.6% ~ 79.9%）。14例患者（74%）出现新观察到的病变进展。没有严重的不良事件，毒性是可容忍的。结论：化疗联合侵袭性LCT治疗非小细胞肺癌寡转移患者可延长生存期，实现局部控制。临床试验注册：日本大学医院医疗信息网（方案识别号：UMIN000022431，首次注册日期：2016年6月1日）。

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

Radiation Oncology ONCOLOGY-RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

CiteScore

6.50

自引率

2.80%

发文量

181

审稿时长

3-6 weeks

期刊介绍： Radiation Oncology encompasses all aspects of research that impacts on the treatment of cancer using radiation. It publishes findings in molecular and cellular radiation biology, radiation physics, radiation technology, and clinical oncology.