单臂多中心II期研究：针对伴有寡转移的IV期非小细胞肺癌，采用积极局部巩固治疗联合全身化疗——CURE-OLIGO（TORG1529）
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).
作者信息
Tokito Takaaki, Yamada Kazuhiko, Ishii Hidenobu, Takiguchi Yuichi, Saito Go, Minato Koichi, Imai Hisao, Tanaka Hiroshi, Miura Satoru, Watanabe Kageaki, Koreeda Yoshifusa, Ono Akira, Furuya Naoki, Misumi Toshihiro, Hayakawa Kazushige, Ogo Etsuyo, Okamoto Hiroaki
机构信息
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
Department of Respiratory Medicine, Shin-Koga Hospital, Temjin-machi, Kurume, Fukuoka, 830-8577, Japan.
出版信息
Radiat Oncol. 2025 Jan 4;20(1):2. doi: 10.1186/s13014-024-02577-5.
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).
引言
伴有寡转移的IV期非小细胞肺癌（NSCLC）有可能通过根治性治疗治愈。本研究旨在评估放化疗（CRT）治疗胸部疾病（包括原发灶和淋巴结转移）联合局部巩固治疗（LCT）治疗寡转移的疗效和安全性。
方法
这是一项针对伴有寡转移的IV期NSCLC患者的多中心II期试验，对于这些患者，胸部疾病的CRT是可行的。治疗程序包括对胸部疾病采用含铂双药联合的CRT以及在开始或完成CRT的8周内对寡转移进行LCT。主要终点是2年生存率。
结果
2016年6月至2020年5月期间，我们纳入了19例患者。中位年龄为68岁（范围：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（分别为n = 9、7、2、1和1）。所有患者均在对所有寡转移进行LCT的同时完成了CRT。有11例部分缓解，缓解率为58%（95%置信区间[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%）出现新的病灶进展。未发生严重不良事件，毒性反应可耐受。
结论
对于伴有寡转移的NSCLC，化疗联合积极的LCT可能延长生存期并实现局部控制。
临床试验注册
日本大学医院医学信息网络（方案识别号：UMIN000022431，首次注册日期：2016年6月1日）。
Zotero 插件