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Amrubicin produced superior overall response rate compared with topotecan
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Results from North Japan Lung Cancer Study Group Trial 0402 showed that patients with small cell lung cancer had a better response rate with amrubicin than with topotecan.
The researchers evaluated 60 patients with SCLC who previously had been treated with platinum chemotherapy; 59 were evaluable for safety and efficacy. Patients were randomly assigned to 40 mg/m2 amrubicin (Amrubicin, Celgene) on days one through three of a three-week cycle or 1 mg/m2 topotecan (Hycamtin, GlaxoSmithKline) on days one through five of a three-week cycle.
Overall response rate for patients in the amrubicin arm was 38% (95% CI, 21%-58%) and disease control rate was 79% (95% CI, 60%-92%) compared with an overall response rate of 13% (95% CI, 1%-25%) in the topotecan group and a disease control rate of 47% (95% CI, 28%-66%).
The researchers wrote that overall response rate and disease control rate were better for patients assigned to amrubicin regardless of age, sex or prior chemotherapy treatment.
The median PFS for patients assigned to amrubicin was 3.5 months compared with 2.2 months in the topotecan arm. Median survival time in the amrubicin arm was 8.1 months compared with 8.4 months for patients assigned to topotecan.
The researchers noted that amrubicin was associated with better survival even among patients who underwent subsequent chemotherapy (P<.0001).
Neutropenia was severe in the amrubicin arm; 79% of patients developed grade 4 neutropenia and 14% developed febrile neutropenia. Only 43% of patients assigned to topotecan developed grade-4 neutropenia and 3% developed febrile neutropenia. The researchers observed one treatment-related death in the amrubicin arm. – by Jason Harris
J Clin Oncol. 2008:26:5401-5406.
The primary endpoint of this study was response rate, which was significantly better for amrubicin. There was, however, no difference for PFS or OS. In this trial, crossover was allowed but not mandated. In a post-hoc analysis, OS was statistically significantly better for patients who received amrubicin either on study or after completion of study vs. patients who never received amrubicin. However, that is a post hoc subset analysis and is therefore hypothesis-generating, but not conclusive evidence of the superior efficacy of amrubicin. Nevertheless, the data supports the further evaluation of amrubicin in a definitive phase-3 study. This future phase-3 study should pay particular emphasis to abrogation of toxicities seen with amrubicin in this study, particularly the high incidence of grade-4 neutropenia.
– George Simon, MD
Director of Thoracic Oncology, Fox Chase Cancer Center