According to a new study published online in the Journal of Clinical Oncology, researchers have found that maintenance sunitinib after chemotherapy was safe and improved progression-free survival in patients with extensive-stage small-cell lung cancer (SCLC).
For the placebo-controlled, phase II study, researchers sought to evaluate the efficacy of maintenance sunitinib, a tyrosine kinase inhibitor used to treat various cancers, after chemotherapy for SCLC.
Researchers enrolled 144 patients and 138 of whom received cisplatin 80mg/m2 or carboplatin AUC 5 on day 1 plus etoposide 100mg/m2/day on days 1 to 3 every 21 days for four to six cycles.
Then, 95 patients were randomly assigned to receive placebo or sunitinib 37.5mg daily until disease progression.
Results showed that for the 85 patients that received maintenance therapy, the median progression-free survival on maintenance was 2.1 months for placebo and 3.7 months for sunitinib (HR = 1.62; 70% CI: 1.27 – 2.08; 95% CI: 1.02 – 2.60; one-sided P = 0.02).
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The median overall survival from random assignment was 6.9 months and 9.0 months for placebo and sunitinib, respectively (HR = 1.28; 95% CI: 0.79 – 2.10; one-sided P = 0.16). In addition, three sunitinib patients achieved a complete response compared with zero placebo patients.
In regard to safety, the most common grade 3 adverse events with sunitinib were fatigue, neutropenia, leukopenia, and thrombocytopenia.