Phase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer.
AuthorsEttinger, David S
Lorigan, Paul C
Spigel, David R
Dudek, Arkadiusz Z
McNally, Richard J Q
Renschler, Markus F
Oliver, Jennifer W
AffiliationSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA. email@example.com
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AbstractPURPOSE: 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/m(2)/d for 3 every 21 days). The primary end point was overall response rate (ORR); secondary end points included progression-free 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/m(2). 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.
CitationPhase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer. 2010, 28 (15):2598-603 J Clin Oncol
JournalJournal of Clinical Oncology