A randomized phase III study of single-agent amrubicin vs. carboplatin/etoposide in elderly patients with extensive-disease small-cell lung cancer.

Abstract

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/m(2); ≥ 75 years old, 40 mg/m(2)) 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/m(2) 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/m(2) is toxic and intolerable in elderly Japanese patients with ED-SCLC.

• Authors: Ikuo Sekine, Hiroaki Okamoto, Takeshi Horai, Kazuhiko Nakagawa, Hironobu Ohmatsu, Akira Yokoyama, Nobuyuki Katakami, Masahiko Shibuya, Nagahiro Saijo, Masahiro Fukuoka
• Journal: Clinical lung cancer (Clin Lung Cancer) Vol. 15 Issue 2 Pg. 96-102 (Mar 2014) ISSN: 1938-0690 [Electronic] United States
• PMID: 24361248 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Anthracyclines
• Etoposide
• amrubicin
• Carboplatin

Topics

• Aged
• Anthracyclines (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Brain Neoplasms (drug therapy, mortality, secondary)
• Carboplatin (administration & dosage)
• Etoposide (administration & dosage)
• Female
• Follow-Up Studies
• Humans
• Lung Neoplasms (drug therapy, mortality, pathology)
• Male
• Neoplasm Staging
• Prognosis
• Quality of Life
• Small Cell Lung Carcinoma (drug therapy, mortality, pathology)
• Survival Rate