We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
A Randomized Phase III Study of Single-Agent Amrubicin Vs. Carboplatin/Etoposide in Elderly Patients With Extensive-Disease Small-Cell Lung Cancer.
- Authors
Ikuo Sekine; Hiroaki Okamoto; Takeshi Horai; Kazuhiko Nakagawa; Hironobu Ohmatsu; Akira Yokoyama; Nobuyuki Katakami; Masahiko Shibuya; Nagahiro Saijo; Masahiro Fukuoka
- Abstract
This study compared amrubicin monotherapy with carboplatin/etoposide combination therapy in elderly Japanese patients with extensive-disease small-cell lung cancer (ED-SCLC). The trial was prematurely closed owing to 3 treatment-related deaths in the amrubicin arm. Overall survival in the amrubicin and carboplatin/ etoposide arms was 10.9 months and 11.3 months, respectively. Amrubicin monotherapy at 40 to 45 mg/m² was toxic and intolerable in elderly Japanese patients with ED-SCLC. Introduction: The efficacy and safety of amrubicin, a third-generation synthetic anthracycline, were evaluated by comparison with carboplatin/etoposide combination therapy in elderly Japanese patients with extensive-disease small-cell lung cancer (ED-SCLC). Patients and Methods: Eligibility included histologically or cytologically proven SCLC, no previous systemic chemotherapy, performance status of 0 to 2, and age ≥ 70 years. Patients received amrubicin (70-74 years old, 40-45 mg/m²; ≥ 75 years old, 40 mg/m² intravenously on days 1 to 3 every 3 weeks for 4 to 6 cycles or carboplatin (area under the curve of 5 intravenously on day 1) and etoposide (80 mg/m² intravenously on days 1 to 3) every 3 weeks for 4 to 6 cycles. Results: The target number of patients was 130 with 65 in each arm. However, the study was terminated early owing to 3 treatment-related deaths in the amrubicin arm, and only 62 patients (median age, 76 years; range, 70-88 years) were enrolled. The characteristics of the patients in the amrubicin and carboplatin/etoposide arms did not differ significantly. Overall survival, time to progression, and objective response rate were 10.9 vs. 11.3 months (P = .7353), 4.7 vs. 4.4 months, and 74.2% (23 of 31) vs. 60.0% (18 of 30), respectively, and quality of life showed no significant difference between the 2 arms. Higher incidences of febrile neutropenia and interstitial lung disease of grade 3 or worse occurred with amrubicin (34.4% vs. 3.3% and 12.5% vs. 0%, respectively). Conclusion: These results indicate that amrubicin monotherapy at 40 to 45 mg/m² is toxic and intolerable in elderly Japanese patients with ED-SCLC.
- Publication
Clinical Lung Cancer, 2014, Vol 15, Issue 2, p96
- ISSN
1525-7304
- Publication type
Article
- DOI
10.1016/j.cllc.2013.11.006