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dc.contributor.authorEttinger, David S
dc.contributor.authorJotte, Robert
dc.contributor.authorLorigan, Paul C
dc.contributor.authorGupta, Vicram
dc.contributor.authorGarbo, Lawrence
dc.contributor.authorAlemany, Carlos
dc.contributor.authorConkling, Paul
dc.contributor.authorSpigel, David R
dc.contributor.authorDudek, Arkadiusz Z
dc.contributor.authorShah, Chirag
dc.contributor.authorSalgia, Ravi
dc.contributor.authorMcNally, Richard J Q
dc.contributor.authorRenschler, Markus F
dc.contributor.authorOliver, Jennifer W
dc.date.accessioned2010-08-04T12:03:12Z
dc.date.available2010-08-04T12:03:12Z
dc.date.issued2010-05-20
dc.identifier.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 Oncolen
dc.identifier.issn1527-7755
dc.identifier.pmid20385980
dc.identifier.doi10.1200/JCO.2009.26.7682
dc.identifier.urihttp://hdl.handle.net/10541/109048
dc.description.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.
dc.language.isoenen
dc.subjectRefractory Small-Cell Lung Canceren
dc.subjectAmrubicinen
dc.subject.meshAnthracyclines
dc.subject.meshAntineoplastic Agents
dc.subject.meshLung Neoplasms
dc.subject.meshSmall Cell Lung Carcinoma
dc.titlePhase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer.en
dc.typeArticleen
dc.contributor.departmentSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA. ettinda@jhmi.eduen
dc.identifier.journalJournal of Clinical Oncologyen
html.description.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.


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