Phase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer

David S. Ettinger, Robert Jotte, Paul Lorigan, Vicram Gupta, Lawrence Garbo, Carlos Alemany, Paul Conkling, David R. Spigel, Arkadiusz Z. Dudek, Chirag Shah, Ravi Salgia, Richard McNally, Markus F. Renschler, Jennifer W. Oliver

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112 Scopus citations


Purpose: Amrubicin is a synthetic anthracycline with potent topoisomerase II inhibition. This phase II study was conducted to confirm safety and activity of amrubicin in the treatment of refractory small-cell lung cancer (SCLC). Patients and Methods: Patients with refractory SCLC (either with progressive disease as best response or progression within 90 days of first-line therapy) received amrubicin (40 mg/m2/d for 3 every 21 days). The primary end point was overall response rate (ORR); secondary end points included progressionfree survival (PFS), overall survival (OS), and change in left ventricular ejection fraction (LVEF). Results: Seventy-five patients with a median progression-free interval after first-line therapy of 38 days were enrolled; 69 patients received a median of four amrubicin cycles (range, one to 12 cycles). The ORR was 21.3% (95% CI, 12.7% to 32.3%), with one complete response (1.3%) and 15 partial responses (20%). Median PFS and OS were 3.2 months (95% CI, 2.4 to 4.0 months) and 6.0 months (95% CI, 4.8 to 7.1 months), respectively. The ORR in 43 patients who never responded to first-line therapy was 16.3% (95% CI, 6.8% to 30.7%). Most commonly reported grade 3 or 4 adverse events included neutropenia (67%), thrombocytopenia (41%), and anemia (30%), with febrile neutropenia in 12%. There was no decrease in mean LVEF with cumulative amrubicin doses exceeding 750 mg/m2. Conclusion: Single-agent amrubicin showed promising activity with a 21.3% ORR and an acceptable safety profile when used as second-line therapy patients with platinum-refractory SCLC. Amrubicin did not induce early cardiotoxicity, but its long-term effects are unknown.

Original languageEnglish (US)
Pages (from-to)2598-2603
Number of pages6
JournalJournal of Clinical Oncology
Issue number15
StatePublished - May 20 2010


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