A phase 2 study of adjuvant carboplatin plus S-1 followed by maintenance S-1 therapy for patients with completely resected stage II/IIIA non-small cell lung cancer-Japanese Northern East Area Thoracic Surgery Study Group JNETS1302 study

Takeo Hasegawa, Hiroyuki Suzuki, Jiro Abe, Akira Sakurada, Chiaki Endo, Nobuyuki Sato, Tohru Hasumi, Hiroyuki Deguchi, Hiroyuki Oura, Satomi Takahashi, Hajime Saito, Hidetaka Uramoto, Motoyasu Sagawa, Yoshinori Okada

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Abstract

Background: The standard adjuvant chemotherapy regimen for completely resected pathological stage II/IIIA non-small cell lung cancer (NSCLC) is four courses of cisplatin plus vinorelbine. However, the continuity and toxicity of cisplatin-based regimens remain problematic. Conversely, carboplatin-based chemotherapy is a less toxic and more tolerable regimen for various stages of NSCLC. In particular, the efficacy and tolerability of carboplatin plus S-1 in advanced NSCLC were confirmed by previous pivotal studies such as the LETS trail. Therefore, this phase II study assessed the feasibility, safety, and usefulness of carboplatin plus S-1 followed by maintenance S-1 as an adjuvant treatment. Methods: In this single-arm, multicenter phase II study, 40 patients who previously underwent complete resection of NSCLC were enrolled from November 2013 to January 2015. The chemotherapy protocol was four cycles of carboplatin (AUC 5 on day 1) and oral S-1 (80 mg/m2 every other day from days 1 to 21) followed by oral S-1 (80 mg/m2 every other day for 48 weeks). The primary endpoint was the treatment completion rate, and the secondary endpoints were adverse events and 2-year recurrence-free survival. Results: The treatment completion rate of the planned schedule was as low as 30.0% (90% confidence interval: 40.3-63.0%). The reasons for adjuvant chemotherapy discontinuation were adverse events, refusal, tumor recurrence, and other reasons in 13, 6, 10, and 2 patients, respectively. The 2-year progression-free survival rate was 66.7% among patients who completed maintenance chemotherapy. There were no treatment-related deaths, and most adverse events were less than grade 3. Conclusions: Carboplatin plus S-1 followed by S-1 maintenance for 1 year in the adjuvant treatment of NSCLC was not tolerable, although most adverse events were not severe. However, patients who can fully complete the regimen might experience clinical benefit.

Original languageEnglish
Pages (from-to)3591-3601
Number of pages11
JournalJournal of Thoracic Disease
Volume12
Issue number7
DOIs
Publication statusPublished - 2020 Jul 1

Keywords

  • Adjuvant chemotherapy
  • Carboplatin
  • Non-small cell lung cancer (NSCLC)
  • S-1

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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