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- Title
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.
- 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
- Abstract
<bold>Background: </bold>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).<bold>Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusion: </bold>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.<bold>Trial Registration: </bold>Trial registration number: UMIN000011994 . Date of registration: 10/8/2013.
- Subjects
NON-small-cell lung carcinoma; ADJUVANT chemotherapy; LUNG cancer; RESEARCH; COMBINATION drug therapy; HETEROCYCLIC compounds; RESEARCH methodology; LUNG tumors; MEDICAL cooperation; EVALUATION research; FLUOROURACIL; DRUG administration; TUMOR classification; COMPARATIVE studies; RANDOMIZED controlled trials; COMBINED modality therapy
- Publication
BMC Cancer, 2021, Vol 21, Issue 1, p1
- ISSN
1471-2407
- Publication type
journal article
- DOI
10.1186/s12885-021-08232-6