logo Thoracic Weekly
2026年8月25日星期二
← 返回 全部文献

每日低剂量卡铂或每周卡铂联合白蛋白紫杉醇同步放化疗治疗老年局部晚期非小细胞肺癌(JCOG1914):一项随机III期试验

Daily low-dose carboplatin or weekly carboplatin plus nab-paclitaxel for concurrent chemoradiotherapy in older patients with locally advanced non-small cell lung cancer (JCOG1914): A randomized phase 3 trial.

期刊
Lung Cancer
PMID
42636548
原文
PubMed ↗
发布日期

作者

  • Shota Omori — Department of Respiratory Medicine and Infectious Diseases, Oita University Hospital, Oita, Japan; Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
  • Hirotsugu Kenmotsu — Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
  • Shogo Nomura — JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan; Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
  • Hideyuki Harada — Radiation and Proton Therapy Center, Shizuoka Cancer Center, Shizuoka, Japan.
  • Satoshi Ishikura — Department of Radiation Oncology, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan.
  • Masahiro Konno — Radiation and Proton Therapy Center, Shizuoka Cancer Center, Shizuoka, Japan.
  • Masahiko Ando — Department of Advanced Medicine, Nagoya University Hospital, Aichi, Japan.
  • Hiroki Izumi — Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.
  • Yuki Shinno — Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Masahide Oki — Department of Respiratory Medicine, NHO Nagoya Medical Center, Aichi, Japan.
  • Takeshi Masuda — Department of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.
  • Toshihide Yokoyama — Department of Respiratory Medicine, Kurashiki Central Hospital, Okayama, Japan.
  • Yukio Hosomi — Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
  • Yukiko Nakamura — Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan.
  • Shuji Murakami — Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan.
  • Takashi Kurosaki — Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
  • Hiroshige Yoshioka — Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan; Department of Respiratory Medicine and Clinical Immunology, Dokkyo Medical University Saitama Medical Center, Saitama, Japan.
  • Koichi Azuma — Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.
  • Kazuya Tsubouchi — Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
  • Hiroshi Nokihara — Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
  • Satoru Miura — Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
  • Haruko Daga — Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
  • Hironori Yoshida — Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
  • Satoshi Hirano — Department of Medical Oncology, Funabashi Municipal Medical Center, Chiba, Japan.
  • Noriko Mitome — JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Haruhiko Fukuda — JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Isamu Okamoto — Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
  • Toshiaki Takahashi — Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan. Electronic address: t.takahashi@scchr.jp.

作者单位

  • Department of Respiratory Medicine and Infectious Diseases, Oita University Hospital, Oita, Japan; Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
  • Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
  • JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan; Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
  • Radiation and Proton Therapy Center, Shizuoka Cancer Center, Shizuoka, Japan.
  • Department of Radiation Oncology, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan.
  • Department of Advanced Medicine, Nagoya University Hospital, Aichi, Japan.
  • Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.
  • Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Department of Respiratory Medicine, NHO Nagoya Medical Center, Aichi, Japan.
  • Department of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.
  • Department of Respiratory Medicine, Kurashiki Central Hospital, Okayama, Japan.
  • Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
  • Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan.
  • Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan.
  • Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
  • Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan; Department of Respiratory Medicine and Clinical Immunology, Dokkyo Medical University Saitama Medical Center, Saitama, Japan.
  • Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.
  • Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
  • Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
  • Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
  • Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
  • Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
  • Department of Medical Oncology, Funabashi Municipal Medical Center, Chiba, Japan.
  • JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan. Electronic address: t.takahashi@scchr.jp.

摘要

中文

在日本,每日低剂量卡铂联合胸部同步放疗是老年不可切除局部晚期非小细胞肺癌(LA-NSCLC)患者的标准治疗。这项开放标签III期试验在日本38家机构进行。年龄≥75岁、患有LA-NSCLC的患者被随机分配(1:1)接受每日卡铂(30 mg/m²)或每周卡铂(曲线下面积2 mg·min/mL)联合白蛋白紫杉醇(30 mg/m²)加胸部放疗。治疗完成后推荐度伐利尤单抗维持治疗。主要终点是总生存期,用于评估每周卡铂联合白蛋白紫杉醇相对于每日低剂量卡铂的非劣效性。2020年12月至2024年3月期间,共入组124例患者(卡铂组61例,卡铂联合白蛋白紫杉醇组63例)。在计划的中期分析中,贝叶斯预测概率显示卡铂联合白蛋白紫杉醇在最终分析中相对于卡铂的非劣效性为8.0%,导致因无效而提前终止研究。卡铂组的中位总生存期无法估计;卡铂联合白蛋白紫杉醇组的估计值为26.1个月(风险比1.56;95%CI 0.79-3.11;p=0.200)。卡铂联合白蛋白紫杉醇组发生2例治疗相关死亡和7例非癌症相关死亡。卡铂组患者在6周时的生活质量优于卡铂联合白蛋白紫杉醇组(比值比0.39;95%CI 0.18-0.81;p=0.012)。每日低剂量卡铂联合胸部同步放疗仍是日本不可切除LA-NSCLC老年患者的标准治疗。

English

Daily low-dose carboplatin with concurrent thoracic radiotherapy is the standard treatment for older patients with unresectable locally advanced non-small cell lung cancer (LA-NSCLC) in Japan. This open-label phase 3 trial was conducted at 38 institutions in Japan. Patients aged ≥ 75 years with LA-NSCLC were randomly assigned (1:1) to receive daily carboplatin (30 mg/m2) or weekly carboplatin (area under the curve, 2 mg·min/mL) plus nab-paclitaxel (30 mg/m2) with thoracic radiotherapy. Durvalumab maintenance therapy was recommended after treatment completion. The primary endpoint was overall survival, which was used to assess the non-inferiority of weekly carboplatin plus nab-paclitaxel compared to daily low-dose carboplatin. From December 2020 to March 2024, 124 patients were enrolled (carboplatin arm, 61 and carboplatin plus nab-paclitaxel arm, 63). In the planned interim analysis, the Bayesian predictive probability indicating the non-inferiority of carboplatin plus nab-paclitaxel compared with carboplatin in the final analysis was 8.0%, leading to early study termination for futility. The median overall survival was not estimable in the carboplatin arm; the estimated value in the carboplatin plus nab-paclitaxel arm was 26.1 months (hazard ratio, 1.56; 95% confidence interval, 0.79-3.11; p = 0.200). Two treatment-related and seven non-cancer-related deaths occurred in the carboplatin plus nab-paclitaxel arm. Patients in the carboplatin arm had better quality of life than those in the carboplatin plus nab-paclitaxel arm at 6 weeks (odds ratio, 0.39; 95% confidence interval, 0.18-0.81; p = 0.012). Daily low-dose carboplatin with concurrent thoracic radiotherapy remains the standard treatment for older patients with unresectable LA-NSCLC in Japan.

分类与指标

研究类型
临床研究
病种
肺癌
JCR 分区
Q1
影响因子
5.3
新锐分区
2区