Norihito Okumura1, Makoto Sonobe2, Kazunori Okabe3, Hiroshige Nakamura4, Masafumi Kataoka5, Motohiro Yamashita6, Masao Nakata7, Kazuhiko Kataoka8, Yoshinori Yamashita9, Junichi Soh10, Hiroshige Yoshioka11, Katsuyuki Hotta12, Keitaro Matsuo13, Junichi Sakamoto14, Shinichi Toyooka10,15, Hiroshi Date2. 1. Department of Thoracic Surgery, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan. no7869@kchnet.or.jp. 2. Department of Thoracic Surgery, Kyoto University Graduate School of Medicine, 54 Shogoinkawara-cho, Sakyo-ku, Kyoto, Japan. 3. Division of Thoracic Surgery, Yamaguchi Ube Medical Center, 685 Higashikiwa, Ube, Japan. 4. Division of General Thoracic Surgery, Department of Surgery, Faculty of Medicine, Tottori University, 36-1 Nishi-cho, Yonago, Japan. 5. Department of Surgery, Okayama Saiseikai General Hospital, 1-17-18 Ifuku-cho, Kita-ku, Okayama, Japan. 6. Department of Thoracic Surgery, Shikoku Cancer Center, 160 Minamiumemoto, Matsuyama, Japan. 7. Department of General Thoracic Surgery, Kawasaki Medical School, 577 Matsushima, Kurashiki, Japan. 8. Department of Thoracic Surgery, Iwakuni Clinical Center, 1-1-1 Atagomachi, Iwakuni, Japan. 9. Department of Thoracic Surgery, Kure Medical Center/Chugoku Cancer Center, 3-1 Aoyamacho, Kure, Japan. 10. Department of Thoracic, Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine and Dentistry, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan. 11. Department of Respiratory Medicine, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Japan. 12. Department of Hematology and Oncology, Okayama University Graduate School of Medicine and Dentistry, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan. 13. Division of Molecular Medicine, Aichi Cancer Center Research Institute, 1-1 Kanokoden, Chikusa-ku, Nagoya, Japan. 14. Tokai Central Hospital, 4-6-2 Soharahigashijima, Kakamigahara, Japan. 15. Department of Clinical Genomic Medicine, Okayama University Graduate School of Medicine and Dentistry, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan.
Abstract
BACKGROUND: This multicenter study evaluated the feasibility of novel adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent, long-term maintenance with S-1 in patients with completely resected stage II-IIIA non-small-cell lung cancer (NSCLC). METHODS: Patients received four cycles of S-1 (80 mg/m2/day for 2 weeks, followed by 2 weeks rest) plus carboplatin (area under the curve 5, day 1) followed by S-1 (80 mg/m2/day for 2 weeks, followed by a 1-week rest). Patients unable to continue S-1 plus carboplatin because of severe toxicity converted to single-agent S-1 maintenance. The duration of adjuvant chemotherapy was 10 months in both situations. The primary endpoint was feasibility, defined as the proportion of patients who completed four cycles of S-1 plus carboplatin and single-agent S-1 maintenance for 10 months. The treatment completion rate was determined; treatment was considered feasible if the lower 90% confidence interval (CI) was ≥50%. RESULTS: Eighty-nine patients were enrolled, of whom 87 were eligible and assessable. Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment completion rate was 63.2% (90% CI, 54.4-71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%). The 2-year relapse-free survival rate was 59.8%. CONCLUSIONS: We concluded that adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 is feasible and tolerable in patients with completely resected NSCLC. CLINICAL REGISTRATION NUMBER: UMIN000005041.
BACKGROUND: This multicenter study evaluated the feasibility of novel adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent, long-term maintenance with S-1 in patients with completely resected stage II-IIIA non-small-cell lung cancer (NSCLC). METHODS: Patients received four cycles of S-1 (80 mg/m2/day for 2 weeks, followed by 2 weeks rest) plus carboplatin (area under the curve 5, day 1) followed by S-1 (80 mg/m2/day for 2 weeks, followed by a 1-week rest). Patients unable to continue S-1 plus carboplatin because of severe toxicity converted to single-agent S-1 maintenance. The duration of adjuvant chemotherapy was 10 months in both situations. The primary endpoint was feasibility, defined as the proportion of patients who completed four cycles of S-1 plus carboplatin and single-agent S-1 maintenance for 10 months. The treatment completion rate was determined; treatment was considered feasible if the lower 90% confidence interval (CI) was ≥50%. RESULTS: Eighty-nine patients were enrolled, of whom 87 were eligible and assessable. Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment completion rate was 63.2% (90% CI, 54.4-71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%). The 2-year relapse-free survival rate was 59.8%. CONCLUSIONS: We concluded that adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 is feasible and tolerable in patients with completely resected NSCLC. CLINICAL REGISTRATION NUMBER: UMIN000005041.
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Authors: S Niho; N Ikeda; H Michimae; K Suzuki; H Sakai; T Kaburagi; K Minato; T Kato; H Okamoto; T Seto; Y Hosomi; K Shimizu; F Oshita; H Kunitoh; M Tsuboi; M Takeuchi; K Watanabe Journal: Br J Cancer Date: 2013-07-18 Impact factor: 7.640