Randomized phase II study of daily and alternate-day administration of S-1 for adjuvant chemotherapy in completely-resected stage I non-small cell lung cancer: results of the Setouchi Lung Cancer Group Study 1301

Norihito Okumura, Junichi Soh, Hiroyuki Suzuki, Masao Nakata, Toshiya Fujiwara, Hiroshige Nakamura, Makoto Sonobe, Takuji Fujinaga, Kazuhiko Kataoka, Kenichi Gemba, Masafumi Kataoka, Katsuyuki Hotta, Hiroshige Yoshioka, Keitaro Matsuo, Junichi Sakamoto, Hiroshi Date, Shinichi Toyooka

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The aim of this multicenter, randomized phase II study was to analyze the feasibility and safety of alternate-day S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in patients with completely resected pathological stage I (tumor diameter > 2 cm) non-small cell lung cancer (NSCLC). Methods: Patients were randomly assigned to receive adjuvant chemotherapy for 1 year comprising either alternate-day oral administration of S-1 (80 mg/m2/day) for 4 days a week (Group A) or a 2-week oral administration of S-1 (80 mg/m2/day) followed by 1 week of rest (Group B). The primary endpoint was feasibility, which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more. Results: Ninety-three patients were enrolled of whom 90 patients received S-1 treatment. Median follow-up was 66.9 months. The treatment completion rate based on an RDI of 70% or more for 6 months was 84.4% (95%CI; 70.5–93.5%) in group A and 64.4% (95%CI; 48.8–78.1%) in group B. There were no grade 4 adverse events in either group. Moderate or severe adverse events (grade 2 or grade 3) were significantly more frequent in group B (67%) compared with group A (29%, P = 0.001). The 5-year relapse-free survival rate was 87.0 and 80.9% for group A and B, respectively (P = 0.451). The 5-year overall survival rate for all patients (n = 93) was 100 and 89.4% for group A and B, respectively (P = 0.136). Conclusion: Alternate-day oral administration of S-1 for 1 year as adjuvant chemotherapy was demonstrated to be feasible with low toxicity in completely resected stage I (tumor diameter > 2 cm) NSCLC. Trial registration: Trial registration number: UMIN000011994. Date of registration: 10/8/2013.

Original languageEnglish
Article number506
JournalBMC cancer
Volume21
Issue number1
DOIs
Publication statusPublished - Dec 2021
Externally publishedYes

Keywords

  • Adjuvant chemotherapy
  • Alternate-day administration
  • Non-small cell lung cancer
  • S-1

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

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