PLoS ONE (Jan 2023)

Randomized phase II study of daily versus alternate-day administrations of S-1 for the elderly patients with completely resected pathological stage IA (tumor diameter > 2 cm)-IIIA of non-small cell lung cancer: Setouchi Lung Cancer Group Study 1201.

  • Hiromasa Yamamoto,
  • Junichi Soh,
  • Norihito Okumura,
  • Hiroyuki Suzuki,
  • Masao Nakata,
  • Toshiya Fujiwara,
  • Kenichi Gemba,
  • Isao Sano,
  • Takuji Fujinaga,
  • Masafumi Kataoka,
  • Yasuhiro Terazaki,
  • Nobukazu Fujimoto,
  • Kazuhiko Kataoka,
  • Shinji Kosaka,
  • Motohiro Yamashita,
  • Hidetoshi Inokawa,
  • Masaaki Inoue,
  • Hiroshige Nakamura,
  • Yoshinori Yamashita,
  • Katsuyuki Hotta,
  • Hiroshige Yoshioka,
  • Satoshi Morita,
  • Keitaro Matsuo,
  • Junichi Sakamoto,
  • Hiroshi Date,
  • Shinichi Toyooka

DOI
https://doi.org/10.1371/journal.pone.0285273
Journal volume & issue
Vol. 18, no. 5
p. e0285273

Abstract

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BackgroundIt is shown that the postoperative adjuvant chemotherapy for non-small cell lung cancer (NSCLC) was associated with survival benefit in an elderly population. We aimed to analyze the feasibility and efficacy of alternate-day S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in elderly patients with completely resected pathological stage IA (tumor diameter > 2 cm) to IIIA (UICC TNM Classification of Malignant Tumours, 7th edition) NSCLC.MethodsElderly patients were randomly assigned to receive adjuvant chemotherapy for one year consisting of either alternate-day oral administration of S-1 (80 mg/m2/day) for 4 days a week (Arm A) or a daily oral administration of S-1 (80 mg/m2/day) for 14 consecutive days followed by 7-day rest (Arm B). The primary endpoint was feasibility (treatment completion rate), 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.ResultsWe enrolled 101 patients in which 97 patients received S-1 treatment. The treatment completion rate at 6 months was 69.4% in Arm A and 64.6% in Arm B (p = 0.67). Treatment completion rate in Arm B tended to be lower compared to Arm A, as the treatment period becomes longer (at 9 and 12 months). RDI of S-1 at 12 months and completion of S-1 administration without dose reduction or postponement at 12 months was significantly better in Arm A than in Arm B (p = 0.026 and p ConclusionAlthough several adverse effects were less frequent in Arm A, both alternate-day and daily oral administrations of S-1 were demonstrated to be feasible in elderly patients with completely resected NSCLC.Trial registrationUnique ID issued by UMIN: UMIN000007819 (Date of registration: Apr 25, 2012) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009128. Trial ID issued by jRCT: jRCTs061180089 (Date of registration: Mar 22, 2019, for a shift toward a "specified clinical trial" based on Clinical Trials Act in Japan) https://jrct.niph.go.jp/en-latest-detail/jRCTs061180089.