Journal
LUNG CANCER
Volume 69, Issue 1, Pages 99-104Publisher
ELSEVIER IRELAND LTD
DOI: 10.1016/j.lungcan.2009.09.012
Keywords
Amrubicin; Relapse; Phase II trial; Non-small cell lung cancer; Small cell lung cancer; Previously treated lung cancer
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Purpose: This study was designed to confirm the efficacy and safety of amrubicin, a new anthracycline agent, in patients with previously treated non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Methods: Eligible patients were required to have recurrent or refractory NSCLC and SCLC after one or two previous chemotherapy regimens. All patients received intravenous amrubicin 35 mg/m(2) on days 1-3 every 3 weeks. Overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) were evaluated. Results: Sixty-six patients (37 NSCLC and 29 SCLC) were assessable for efficacy and safety evaluation. Grade 3 or 4 neutropenia was observed in 39.4% of all patients (NSCLC, 37.8%; SCLC, 41.4%). Nonhematological toxicities were mild. No treatment-related death was observed. The ORRs were 13.5% (95% CI, 4.5-28.8%) in NSCLC and 44.8% (95% CI, 26.4-64.3%) in SCLC. In SCLC, ORRs were 60.0% in the sensitive relapse and 36.8% in the refractory relapse (p = 0.2332). In NSCLC, the PFS, OS, and 1-year survival were 3.3 months, 12.0 months, and 35.3%, respectively. In SCLC, the PFS, OS, and 1-year survival were 4.0 months, 12.0 months, and 46.7%, respectively. Conclusions: Amrubicin is an active and well-tolerated regimen in patients with previously treated lung cancer. Amrubicin 35 mg/m2 seems to achieve similar efficacy with less toxicity than amrubicin 40 mg/m2 in this patient population. These results warrant further evaluation in previously treated lung cancer. (C) 2009 Elsevier Ireland Ltd. All rights reserved.
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