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
Affiliations
Norihito Okumura
Department of Thoracic Surgery, Kurashiki Central Hospital
Junichi Soh
Department of Surgery, Division of Thoracic Surgery, Kindai University Faculty of Medicine
Hiroyuki Suzuki
Department of Chest Surgery, Fukushima Medical University
Masao Nakata
Department of General Thoracic Surgery, Kawasaki Medical School
Toshiya Fujiwara
Depatment of Thoracic Surgery, Hiroshima City Hiroshima Citizens Hospital
Hiroshige Nakamura
Division of General Thoracic Surgery, Tottori University Hospital
Makoto Sonobe
Department of Thoracic Surgery, Kyoto University
Takuji Fujinaga
Department of General Thoracic Surgery, National Hospital Organization Nagara Medical Center
Kazuhiko Kataoka
Department of Thoracic Surgery, National Hospital Organization Iwakuni Clinical Center
Kenichi Gemba
Department of Respiratory Medicine, Chugoku Central Hospital
Masafumi Kataoka
Department of Surgery, Okayama Saiseikai General Hospital
Katsuyuki Hotta
Center for Innovative Clinical Medicine, Okayama University Hospital
Hiroshige Yoshioka
Department of Thoracic Oncology, Kansai Medical University Hospital
Keitaro Matsuo
Division of Cancer Epidemiology and Prevention, Aichi Cancer Center Research Institute
Junichi Sakamoto
Tokai Central Hospital
Hiroshi Date
Department of Thoracic Surgery, Kyoto University
Shinichi Toyooka
Department of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
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.
