Rie Kondo1, Satoshi Watanabe1, Satoshi Shoji1, Kosuke Ichikawa1, Tetsuya Abe1, Junko Baba2, Junta Tanaka1, Hiroki Tsukada3, Masaki Terada4, Kazuhiro Sato5, Yoshie Maruyama6, Masato Makino7, Akira Hirata8, Hiroshi Tanaka9, Toshiyuki Koya1, Hirohisa Yoshizawa10, Toshiaki Kikuchi1. 1. Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. 2. Department of Respiratory Medicine, Nishi-Niigata Chuo National Hospital, Niigata, Japan. 3. Department of Respiratory Medicine, Niigata City General Hospital, Niigata, Japan. 4. Department of Respiratory Medicine, Saiseikai Niigata Daini Hospital, Niigata, Japan. 5. Department of Respiratory Medicine, Nagaoka Red Cross Hospital, Nagaoka, Japan. 6. Department of Internal Medicine, Tsubame Rosai Hospital, Tsubame, Japan. 7. Department of Internal Medicine, Niigata Prefectural Shibata Hospital, Shibata, Japan. 8. Department of Respiratory Medicine, Tsuruoka Municipal Shonai Hospital, Tsuruoka, Japan. 9. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan. 10. Department of Respiratory Medicine, Niigata Medical Center, Niigata, Japan.
Abstract
OBJECTIVE: Chemotherapy with irinotecan plus cisplatin has shown promise in chemo-naïve small-cell lung cancer (SCLC) patients. However, irinotecan treatment for relapsed or refractory SCLC has not been adequately evaluated. This phase II study evaluated the appropriate treatment schedule of irinotecan as a single agent. This study was designed to determine the antitumor activity, toxicity, and survival in previously treated SCLC patients. METHODS: Previously treated SCLC patients with at least one platinum-based regimen received irinotecan (100 mg/m2) on days 1 and 8, every 3 weeks, until disease progression. The assessment of the response rate was the primary endpoint. RESULTS: Thirty patients were enrolled, with an objective response rate of 41.3% (95% confidence interval [CI] 25.5-59.3), and a disease control rate of 69%. Median progression-free and overall survival was 4.1 months (95% CI, 2.2-5.4) and 10.4 months (95% CI, 8.1-14), respectively. The grade 3/4 hematological toxicities were neutropenia (36.7%), thrombocytopenia (3.3%), anemia (13.3%), and febrile neutropenia (6.6%). There were no grade 4 nonhematological toxicities. Frequent grade 3 nonhematological toxicities included diarrhea (10%), anorexia (6.6%), and hyponatremia (6.6%). CONCLUSIONS: This phase II study showed a high objective response rate and long survival. Irinotecan monotherapy schedule used was well tolerated, and could be an active treatment option for these patients.
OBJECTIVE: Chemotherapy with irinotecan plus cisplatin has shown promise in chemo-naïve small-cell lung cancer (SCLC) patients. However, irinotecan treatment for relapsed or refractory SCLC has not been adequately evaluated. This phase II study evaluated the appropriate treatment schedule of irinotecan as a single agent. This study was designed to determine the antitumor activity, toxicity, and survival in previously treated SCLCpatients. METHODS: Previously treated SCLCpatients with at least one platinum-based regimen received irinotecan (100 mg/m2) on days 1 and 8, every 3 weeks, until disease progression. The assessment of the response rate was the primary endpoint. RESULTS: Thirty patients were enrolled, with an objective response rate of 41.3% (95% confidence interval [CI] 25.5-59.3), and a disease control rate of 69%. Median progression-free and overall survival was 4.1 months (95% CI, 2.2-5.4) and 10.4 months (95% CI, 8.1-14), respectively. The grade 3/4 hematological toxicities were neutropenia (36.7%), thrombocytopenia (3.3%), anemia (13.3%), and febrile neutropenia (6.6%). There were no grade 4 nonhematological toxicities. Frequent grade 3 nonhematological toxicities included diarrhea (10%), anorexia (6.6%), and hyponatremia (6.6%). CONCLUSIONS: This phase II study showed a high objective response rate and long survival. Irinotecan monotherapy schedule used was well tolerated, and could be an active treatment option for these patients.
Authors: Thomas J Semrad; Edward J Kim; I-Yeh Gong; Tianhong Li; Scott Christensen; Mili Arora; Jonathan W Riess; David R Gandara; Karen Kelly Journal: Cancer Chemother Pharmacol Date: 2021-05-15 Impact factor: 3.288