Sorafenib in Platinum-Treated Patients with Extensive Stage Small Cell Lung Cancer: A Southwest Oncology Group (SWOG 0435) Phase II Trial

Abstract

Introduction Sorafenib is a multi-kinase inhibitor affecting pathways involved in tumor progression and angiogenesis. We conducted a phase II trial of Sorafenib in platinum-treated extensive stage small cell lung cancer (SCLC) patients to determine the tumor response rate, toxicity and overall survival. Methods Patients with histologically confirmed, measurable disease, Zubrod performance status 0–1 and no more than 1 prior platinum based treatment were eligible. Patients were stratified by platinum-sensitivity status: sensitive (progression >90 days after platinum) or refractory (progression during or ≤90 days after platinum). Pts were treated with sorafenib 400mg PO BID continuously on a 28 day cycle. Results Of 89 pts registered; 82 were evaluable for toxicity assessment and 83 were evaluable for response There were 4 partial responses seen among the 38 patients in the platinum sensitive stratum, for an estimated response rate of 11% (95% confidence interval: 3% – 25%); and one partial response among the 45 patients in the platinum refractory stratum for an estimated response rate of 2% (95% confidence interval: 0% – 12%). The median overall survival estimates were 5.3 months (95% confidence interval: 3.3–7.5 months) and 6.7 months (95% confidence interval: 6.1–9.1 months) for the platinum-refractory and platinum-sensitive strata respectively. Nineteen patients discontinued treatment due to adverse events or side effects from therapy. Conclusions Based on the lack of disease control seen in our trial, further investigation of single-agent sorafenib in the SCLC population is not recommended. Combination trials of Sorafenib and chemotherapy are ongoing.

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