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

2.50
Hdl Handle:
http://hdl.handle.net/10541/109048
Title:
Phase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer.
Authors:
Ettinger, David S; Jotte, Robert; Lorigan, Paul C ( 0000-0002-8875-2164 ) ; Gupta, Vicram; Garbo, Lawrence; Alemany, Carlos; Conkling, Paul; Spigel, David R; Dudek, Arkadiusz Z; Shah, Chirag; Salgia, Ravi; McNally, Richard J Q; Renschler, Markus F; Oliver, Jennifer W
Abstract:
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/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.
Affiliation:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA. ettinda@jhmi.edu
Citation:
Phase 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
Journal:
Journal of Clinical Oncology
Issue Date:
20-May-2010
URI:
http://hdl.handle.net/10541/109048
DOI:
10.1200/JCO.2009.26.7682
PubMed ID:
20385980
Type:
Article
Language:
en
ISSN:
1527-7755
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorEttinger, David Sen
dc.contributor.authorJotte, Roberten
dc.contributor.authorLorigan, Paul Cen
dc.contributor.authorGupta, Vicramen
dc.contributor.authorGarbo, Lawrenceen
dc.contributor.authorAlemany, Carlosen
dc.contributor.authorConkling, Paulen
dc.contributor.authorSpigel, David Ren
dc.contributor.authorDudek, Arkadiusz Zen
dc.contributor.authorShah, Chiragen
dc.contributor.authorSalgia, Ravien
dc.contributor.authorMcNally, Richard J Qen
dc.contributor.authorRenschler, Markus Fen
dc.contributor.authorOliver, Jennifer Wen
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.en
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

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