H Yoshioka1, N Katakami2, H Okamoto3, Y Iwamoto4, T Seto5, T Takahashi6, N Sunaga7, S Kudoh8, K Chikamori9, M Harada10, H Tanaka11, H Saito12, H Saka13, K Takeda14, N Nogami15, N Masuda16, T Harada17, H Kitagawa18, H Horio18, T Yamanaka19, M Fukuoka20, N Yamamoto21, K Nakagawa22. 1. Department of Respiratory Medicine, Kurashiki Central Hospital, Okayama. 2. Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Hyogo. 3. Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Kanagawa. 4. Department of Medical Oncology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima. 5. Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka. 6. Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka. 7. Department of Medicine and Molecular Science, Gunma University School of Medicine, Gunma. 8. Department of Respiratory Medicine, Osaka City University Hospital, Osaka. 9. Department of Respiratory Medicine, National Hospital Organization Yamaguchi-Ube Medical Center, Yamaguchi. 10. Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapporo. 11. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata. 12. Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Aichi. 13. Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center, Aichi. 14. Department of Medical Oncology, Osaka City General Hospital, Osaka. 15. Department of Respiratory Medicine, National Hospital Organization Shikoku Cancer Center, Ehime. 16. Department of Respiratory Medicine, Kitasato University Hospital, Kanagawa. 17. Center of Respiratory Disease, Japan Community Health Care Organization Hokkaido Hospital, Sapporo. 18. Drug Development Division, Sumitomo Dainippon Pharma. Co, Ltd, Tokyo. 19. Department of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, Kanagawa. 20. Medical Oncology, Izumi Municipal Hospital, Osaka. 21. Third Department of Internal Medicine, Wakayama Medical University Hospital, Wakayama. 22. Department of Medical Oncology, Faculty of Medicine, Kinki University Hospital, Osaka, Japan.
Abstract
Background: Amrubicin is approved for treating non-small-cell lung cancer (NSCLC) and small-cell lung cancer. However, no direct comparisons between amrubicin and docetaxel, a standard treatment for NSCLC, have been reported. Patients and methods: We conducted a randomized phase III trial of Japanese NSCLC patients after one or two chemotherapy regimens. Patients were randomized to amrubicin (35 mg/m2 on days 1-3 every 3 weeks) or docetaxel (60 mg/m2 on day 1 every 3 weeks). Outcomes included progression-free survival, overall survival, tumor responses, and safety. Results: Between October 2010 and June 2012, 202 patients were enrolled across 32 institutions. Median progression-free survival (3.6 versus 3.0 months; P = 0.54) and overall survival (14.6 versus 13.5 months; P = 0.86) were comparable in the amrubicin and docetaxel groups, respectively. The overall response rate was 14.4% (14/97) and 19.6% (19/97) in the amrubicin and docetaxel groups, respectively (P = 0.45). The disease control rate was 55.7% in both groups. Adverse events occurred in all patients, and included grade ≥3 neutropenia occurred in 82.7% and 78.8% of patients in the amrubicin and docetaxel groups, respectively, grade ≥3 leukopenia occurred in 63.3% and 70.7%, and grade ≥3 febrile neutropenia occurred in 13.3% and 18.2% of patients in the amrubicin and docetaxel groups, respectively. Of eight cardiac-related events in the amrubicin group, three were considered related to amrubicin and resolved without treatment discontinuation. Conclusions: This was the first phase III study to compare amrubicin and docetaxel in patients with pretreated NSCLC. Amrubicin did not significantly improve the primary endpoint of PFS compared with docetaxel. Clinical trial registration: NCT01207011 (ClinicalTrials.gov).
RCT Entities:
Background: Amrubicin is approved for treating non-small-cell lung cancer (NSCLC) and small-cell lung cancer. However, no direct comparisons between amrubicin and docetaxel, a standard treatment for NSCLC, have been reported. Patients and methods: We conducted a randomized phase III trial of Japanese NSCLCpatients after one or two chemotherapy regimens. Patients were randomized to amrubicin (35 mg/m2 on days 1-3 every 3 weeks) or docetaxel (60 mg/m2 on day 1 every 3 weeks). Outcomes included progression-free survival, overall survival, tumor responses, and safety. Results: Between October 2010 and June 2012, 202 patients were enrolled across 32 institutions. Median progression-free survival (3.6 versus 3.0 months; P = 0.54) and overall survival (14.6 versus 13.5 months; P = 0.86) were comparable in the amrubicin and docetaxel groups, respectively. The overall response rate was 14.4% (14/97) and 19.6% (19/97) in the amrubicin and docetaxel groups, respectively (P = 0.45). The disease control rate was 55.7% in both groups. Adverse events occurred in all patients, and included grade ≥3 neutropenia occurred in 82.7% and 78.8% of patients in the amrubicin and docetaxel groups, respectively, grade ≥3 leukopenia occurred in 63.3% and 70.7%, and grade ≥3 febrile neutropenia occurred in 13.3% and 18.2% of patients in the amrubicin and docetaxel groups, respectively. Of eight cardiac-related events in the amrubicin group, three were considered related to amrubicin and resolved without treatment discontinuation. Conclusions: This was the first phase III study to compare amrubicin and docetaxel in patients with pretreated NSCLC. Amrubicin did not significantly improve the primary endpoint of PFS compared with docetaxel. Clinical trial registration: NCT01207011 (ClinicalTrials.gov).