A Phase II study of S-1 and irinotecan combination therapy in previously treated patients with advanced non-small cell lung cancer

Autor: Keiko Ohgino, Daisuke Arai, Hiroyuki Yasuda, Hideki Terai, Shinnosuke Ikemura, Tomoko Betsuyaku, Katsuhiko Naoki, Jun Miyata, Satoshi Yoda, Ichiro Kawada, Hiroki Kabata, Hirofumi Kamata, Kenzo Soejima, Kota Ishioka, Takashi Sato
Rok vydání: 2015
Předmět:
Zdroj: Japanese Journal of Clinical Oncology. 45:356-361
ISSN: 1465-3621
0368-2811
Popis: This Phase II study was conducted to evaluate the efficacy and safety of S-1 and irinotecan combination therapy as a second-line treatment in patients with advanced non-small cell lung cancer.Irinotecan was administered at 60 mg/m(2) on Days 1 and 8. Oral S-1 was administered on Days 1-14 every 3 weeks at 80 mg/day for patients with a body surface area of1.25 m(2), 100 mg/day for patients with a body surface area of 1.25-1.5 m(2) and 120 mg/day for patients with a body surface area of1.5 m(2). The primary endpoint was response rate, while the secondary endpoints were progression-free survival, overall survival and safety.Thirty-one patients were enrolled in this study. The response and disease control rates were 6.5 and 58.1%, respectively. Progression-free survival and median survival time were 2.8 and 12.6 months, respectively. Grade 3-4 adverse events were reported for 29.0% of the patients. Hematological toxicities of Grade 3 or 4 included leukopenia (9.7%), neutropenia (9.7%), febrile neutropenia (3.2%), thrombopenia (3.2%) and anemia (6.5%). Non-hematological toxicities of Grade 3 or 4 included pneumonitis (6.5%), diarrhea, colitis, dyspnea, rash, oral mucositis, anorexia and pulmonary thromboembolism/deep vein thrombosis (3.2% each).S-1 and irinotecan combination therapy at the present dose and schedule exhibited only modest efficacy with mild toxicities in previously treated patients with non-small cell lung cancer. No further clinical investigation with current dose and schedules is warranted for patients with non-small cell lung cancer who failed first-line platinum-based doublet chemotherapy.
Databáze: OpenAIRE