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

• Published in: BMC cancer Vol. 21; no. 1; pp. 506 - 10
• Main Authors: Okumura, Norihito, Soh, Junichi, Suzuki, Hiroyuki, Nakata, Masao, Fujiwara, Toshiya, Nakamura, Hiroshige, Sonobe, Makoto, Fujinaga, Takuji, Kataoka, Kazuhiko, Gemba, Kenichi, Kataoka, Masafumi, Hotta, Katsuyuki, Yoshioka, Hiroshige, Matsuo, Keitaro, Sakamoto, Junichi, Date, Hiroshi, Toyooka, Shinichi
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 06.05.2021; BioMed Central; BMC
• Subjects: Adjuvant chemotherapy; Adjuvant treatment; Adult; Adverse events; Aged; Alternate-day administration; Antimitotic agents; Antineoplastic agents; Cancer; Cancer therapies; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - pathology; Chemotherapy; Chemotherapy, Adjuvant; Dosage; Dosage and administration; Drug Administration Schedule; Drug Combinations; Drug dosages; Drug therapy; Feasibility studies; Female; Head & neck cancer; Histology; Humans; Internet resources; Lung cancer; Lung cancer, Non-small cell; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Male; Middle Aged; Neoplasm Staging; Non-small cell lung cancer; Non-small cell lung carcinoma; Oral administration; Oxonic Acid - administration & dosage; Oxonic Acid - adverse effects; S-1; Small cell lung carcinoma; Tegafur - administration & dosage; Tegafur - adverse effects; Testing; Toxicity; Japan; Adjuvant chemotherapy; Alternate-day administration; S-1; Non-small cell lung cancer
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-021-08232-6

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). Patients were randomly assigned to receive adjuvant chemotherapy for 1 year comprising either alternate-day oral administration of S-1 (80 mg/m /day) for 4 days a week (Group A) or a 2-week oral administration of S-1 (80 mg/m /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. 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). 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 number: UMIN000011994 . Date of registration: 10/8/2013.