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Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung
Joachim von Pawel1, Robert Jotte2, David R Spigel2
1Joachim von Pawel, Asklepios Fachkliniken München-Gauting, Gauting; Jörg Mezger, St Vincentius-Kliniken Karlsruhe, Karlsruhe; Martin Steins, Thoraxklinik am Universitätsklinikum, Heidelberg; Wolfgang Schütte, Krankenhaus Martha-Maria Halle-Dölau, Halle; Martin Reck, Krankenhaus Großhansdorf, Großhansdorf, Germany; Robert Jotte, Rocky Mountain Cancer Center, Denver, CO, and US Oncology, Houston, TX; David R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Mary E.R. O'Brien, Royal Marsden National Health Service (NHS) Foundation Trust, Surrey; Paul Lorigan, Christie NHS Foundation Trust, Manchester, United Kingdom; Mark A. Socinski, University of Pittsburgh Medical Center, Pittsburgh, PA; Léon Bosquée, Centre Hospitalier Universitaire Sart-Tilman, Liège; Kristiaan Nackaerts, Universitair Ziekenhuis Gasthuisberg, Leuven, Belgium; Jeffrey Bubis, Cancer Specialists of North Florida, Jacksonville, FL; José M. Trigo, Hospital Universitario Virgen de la Victoria, Malaga; Manuel Domine, Fundación Jiménez Diaz, Universidad Autónoma de Madrid, Madrid, Spain; Philip Clingan, Southern Medical Day Care Centre, Wollongong, New South Wales, Australia; Frances A. Shepherd, University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Shaoyi Li and Markus F. Renschler, Celgene, Summit, NJ. j.pawel@asklepios.com.
Purpose:
Amrubicin, a third-generation anthracycline and potent topoisomerase II inhibitor, showed promising activity in small-cell lung cancer (SCLC) in phase II trials. This phase III trial compared the safety and efficacy of amrubicin versus topotecan as second-line treatment for SCLC.
Patients And Methods:
A total of 637 patients with refractory or sensitive SCLC were randomly assigned at a ratio of 2:1 to 21-day cycles of amrubicin 40 mg/m(2) intravenously (IV) on days 1 to 3 or topotecan 1.5 mg/m(2) IV on days 1 to 5. Primary end point was overall survival (OS); secondary end points included overall response rate (ORR), progression-free survival (PFS), and safety.
Results:
Median OS was 7.5 months with amrubicin versus 7.8 months with topotecan (hazard ratio [HR], 0.880; P = .170); in refractory patients, median OS was 6.2 and 5.7 months, respectively (HR, 0.77; P = .047). Median PFS was 4.1 months with amrubicin and 3.5 months with topotecan (HR, 0.802; P = .018). ORR was 31.1% with amrubicin and 16.9% with topotecan (odds ratio, 2.223; P < .001). Grade ≥ 3 treatment-emergent adverse events in the amrubicin and topotecan arms were: neutropenia (41% v 54%; P = .004), thrombocytopenia (21% v 54%; P < .001), anemia (16% v 31%; P < .001), infections (16% v 10%; P = .043), febrile neutropenia (10% v 3%; P = .003), and cardiac disorders (5% v 5%; P = .759); transfusion rates were 32% and 53% (P < .001), respectively. NQO1 polymorphisms did not influence safety outcomes.
Conclusion:
Amrubicin did not improve survival when compared with topotecan in the second-line treatment of patients with SCLC. OS did not differ significantly between treatment groups, although an improvement in OS was noted in patients with refractory disease treated with amrubicin.
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