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PubMed · 42636548

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.

Shota Omori·Hirotsugu Kenmotsu·Shogo Nomura·Hideyuki Harada·Satoshi Ishikura·Masahiro Konno·Masahiko Ando·Hiroki Izumi·Yuki Shinno·Masahide Oki·Takeshi Masuda·Toshihide Yokoyama·Yukio Hosomi·Yukiko Nakamura·Shuji Murakami·Takashi Kurosaki·Hiroshige Yoshioka·Koichi Azuma·Kazuya Tsubouchi·Hiroshi Nokihara·Satoru Miura·Haruko Daga·Hironori Yoshida·Satoshi Hirano·Noriko Mitome·Haruhiko Fukuda·Isamu Okamoto·Toshiaki Takahashi
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Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: Daily low-dose carboplatin with concurrent thoracic radiotherapy remains the standard treatment for older patients with unresectable LA-NSCLC in Japan.

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HumansCarboplatinCarcinoma, Non-Small-Cell LungLung NeoplasmsFemalePaclitaxelAlbuminsAgedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyMaleAged, 80 and overJapanCarboplatin plus nab-paclitaxelDaily low-dose carboplatinLocally advancedOlder patientsnon-small cell lung cancer (NSCLC)Journal ArticleRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study

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Shota Omori, Hirotsugu Kenmotsu, Shogo Nomura, Hideyuki Harada, Satoshi Ishikura, Masahiro Konno, Masahiko Ando, Hiroki Izumi, Yuki Shinno, Masahide Oki, Takeshi Masuda, Toshihide Yokoyama, Yukio Hosomi, Yukiko Nakamura, Shuji Murakami, Takashi Kurosaki, Hiroshige Yoshioka, Koichi Azuma, Kazuya Tsubouchi, Hiroshi Nokihara, Satoru Miura, Haruko Daga, Hironori Yoshida, Satoshi Hirano, Noriko Mitome, Haruhiko Fukuda, Isamu Okamoto, Toshiaki Takahashi. 2026-08-14. 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.. https://doi.org/10.1016/j.lungcan.2026.109583

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Aged subjectAged, 80 and over subjectAntineoplastic Combined Chemotherapy Protocols subjectClinical Trial, Phase III subjectFemale subjectHumans subjectJapan subjectJournal Article subjectLung Neoplasms subjectMale subjectMulticenter Study subjectRandomized controlled trials study

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