Phase II study of oral S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer

Autor: Jun-ichi Saitoh, Yosuke Kamide, Katsuyuki Shirai, Masaki Nishioka, Yasuhiko Koga, Yoshio Tomizawa, Noriaki Sunaga, Akihiro Ono, Masana Matsuura, Akihiro Yoshii, Kyoichi Kaira, Takashi Nakano, Takeshi Ebara, Takeshi Hisada, Reiko Yoshino, Tamotsu Ishizuka, Yasuki Iwasaki
Rok vydání: 2013
Předmět:
Zdroj: Lung Cancer. 82:449-454
ISSN: 0169-5002
Popis: Purpose To determine the efficacy and safety of oral S-1 in combination with cisplatin and thoracic radiotherapy in patients with unresectable stage III non-small-cell lung cancer (NSCLC). Methods and materials S-1 (50 mg/m 2 ) was administered orally twice daily for 14 days, with cisplatin (40 mg/m 2 ) on days 1 and 8 of each cycle every 3 weeks, for 2–4 cycles. Thoracic radiation therapy was administered in 2 Gy fractions five times weekly for a total dose of 60 Gy. The primary endpoint was the response rate, and secondary endpoints included progression-free survival, overall survival and safety. Results Forty-one patients were enrolled in this study. The objective response rate was 87.8% (98% CI: 77.8–97.8%). The median progression-free survival was 467 days (15.4 months), and the median survival time was 904 days (29.7 months). The overall survival rates at 1- and 2-years were 85.7% and 52.9%, respectively. Hematological toxicities included grade 3/4 neutropenia (17%) and grade 3/4 leukopenia (27%). No grade 3 febrile neutropenia was detected, and grade 3/4 non-hematological toxicities were also mild. A grade 3 gastrointestinal hemorrhage was observed in one patient. Conclusions The combination of oral S-1 plus cisplatin with concurrent radiotherapy is a promising treatment with a high efficacy and lower toxicity in patients with locally advanced NSCLC.
Databáze: OpenAIRE