Haruyasu Murakami1, Nobuyuki Yamamoto2, Taro Shibata3, Koji Takeda4, Yukito Ichinose5, Yuichiro Ohe6, Noboru Yamamoto7, Yuichiro Takeda8, Shinzoh Kudoh9, Shinji Atagi10, Miyako Satouchi11, Katsuyuki Kiura12, Naoyuki Nogami13, Masahiro Endo14, Hirokazu Watanabe15, Tomohide Tamura7. 1. Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan. Electronic address: ha.murakami@scchr.jp. 2. Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan; Third Department of Internal Medicine, Wakayama Medical University, Wakayama 641-8509, Japan. 3. Japan Clinical Oncology Group Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo 104-0045, Japan. 4. Department of Clinical Oncology, Osaka City General Hospital, Osaka 534-0021, Japan. 5. Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka 811-1395, Japan. 6. Division of Thoracic Oncology, National Cancer Center Hospital East, Chiba 277-8577, Japan. 7. Division of Thoracic Oncology, National Cancer Center Hospital, Tokyo 104-0045, Japan. 8. Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo 162-8655, Japan. 9. Department of Respiratory Medicine, Osaka City University Hospital, Osaka 545-8586, Japan. 10. Department of Thoracic Oncology, Kinki-Chuo Chest Medical Center, Osaka 591-8555, Japan. 11. Department of Thoracic Oncology, Hyogo Cancer Center, Hyogo 673-8558, Japan. 12. Department of Respiratory Medicine, Okayama University Hospital, Okayama 700-8558, Japan. 13. Department of Thoracic Oncology, Shikoku Cancer Center, Ehime 791-0280, Japan. 14. Division of Diagnostic Radiology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan. 15. Division of Diagnostic Radiology, National Cancer Center Hospital, Tokyo 104-0045, Japan.
Abstract
OBJECTIVES: We conducted an open-label, multicenter, single-arm study to confirm the efficacy and safety of amrubicin (AMR), a topoisomerase II inhibitor, for treating refractory small-cell lung cancer (SCLC). PATIENTS AND METHODS: Patients with chemotherapy-refractory SCLC received 40 mg/m(2) AMR for 3 consecutive days, every 21 days. The primary endpoint was the overall response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Between November 2009 and February 2011, 82 patients were enrolled. Each patient received a median of four treatment cycles (range, 1-22 cycles). ORR was 32.9% [P<0.0001 by the exact binomial test for the null hypothesis that ORR ≤ 10%; 95% confidence interval (CI), 22.9-44.2%]. The median PFS and OS periods were 3.5 months (95% CI, 3.0-4.3 months) and 8.9 months (95% CI, 7.6-11.3 months), respectively. Significant differences in ORR (21.4% v 45.0%; P=0.034), PFS (median, 2.9 v 5.1 months; P=0.0009), and OS (median, 7.9 v 13.1 months; P=0.0128) were observed between patients previously treated with etoposide and others. Neutropenia was the most common grade 3 or 4 adverse events (93.9%), and febrile neutropenia developed in 26.8% patients. No treatment-related death occurred. CONCLUSIONS: AMR monotherapy can be considered an effective and safe treatment option for refractory SCLC. Previous chemotherapy with etoposide may influence AMR efficacy.
OBJECTIVES: We conducted an open-label, multicenter, single-arm study to confirm the efficacy and safety of amrubicin (AMR), a topoisomerase II inhibitor, for treating refractory small-cell lung cancer (SCLC). PATIENTS AND METHODS: Patients with chemotherapy-refractory SCLC received 40 mg/m(2) AMR for 3 consecutive days, every 21 days. The primary endpoint was the overall response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Between November 2009 and February 2011, 82 patients were enrolled. Each patient received a median of four treatment cycles (range, 1-22 cycles). ORR was 32.9% [P<0.0001 by the exact binomial test for the null hypothesis that ORR ≤ 10%; 95% confidence interval (CI), 22.9-44.2%]. The median PFS and OS periods were 3.5 months (95% CI, 3.0-4.3 months) and 8.9 months (95% CI, 7.6-11.3 months), respectively. Significant differences in ORR (21.4% v 45.0%; P=0.034), PFS (median, 2.9 v 5.1 months; P=0.0009), and OS (median, 7.9 v 13.1 months; P=0.0128) were observed between patients previously treated with etoposide and others. Neutropenia was the most common grade 3 or 4 adverse events (93.9%), and febrile neutropenia developed in 26.8% patients. No treatment-related death occurred. CONCLUSIONS: AMR monotherapy can be considered an effective and safe treatment option for refractory SCLC. Previous chemotherapy with etoposide may influence AMR efficacy.
Authors: Sang Ok Jung; Sun Young Kim; Ju-Ock Kim; Sung Soo Jung; Hee Sun Park; Jae Young Moon; Sung Min Kim; Jeong Eun Lee Journal: Thorac Cancer Date: 2015-01-27 Impact factor: 3.500