According to a new study published in the Journal of Clinical Oncology, researchers have found that amrubicin did not improve survival when compared to topotecan for the second-line treatment of patients with small-cell lung cancer (SCLC).
For the phase 3 study, 637 patients with refractory or sensitive SCLC were randomly assigned 2:1 to receive amrubicin, a third-generation anthracycline and topoisomerase II inhibitor, 40mg/m2 IV on days 1 through 3 or topotecan 1.5mg/m2 IV on days 1 through 5 of 21-day cycles.
Researchers found that amrubicin group had a median overall survival of 7.5 months versus 7.8 months in the topotecan group (HR, 0.880; P = 0.170). In patients with refractory SCLC, median overall survival was 6.2 months in the amrubicin group and 5.7 months in the topotecan group (HR, 0.88; P = 0.047). Median progression-free survival was 4.1 months and 3.5 for patients who received amrubicin and topotecan, respectively (HR, 0.802; P = 0.018).
Overall response rates were 31.1% for the amrubicin group and 16.9% for the topotecan group (OR, 2.223; P < 0.001). Despite positive results with amrubicin in SCLC in phase 2 trials, amrubicin did not improve overall survival when compared to topotecan; however, it did improve overall survival in patients with refractory disease.
This phase III trial compared the safety and efficacy of amrubicin versus topotecan as second–line treatment for SCLC. Amrubicin did not improve survival when compared with topotecan in the second–line treatment of patients with SCLC.