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Sorafenib in patients with platinum (plat) treated extensive stage small cell lung cancer (E-SCLC): A SWOG (S0435) phase II trial
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2008
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Phase Ii TrialMedicineTumor Response RatePharmacologyClinical TrialsPathologyPlat RefractorySorafenib 400MgBronchial NeoplasmMetronomic TherapyPharmacotherapyCancer TreatmentOncologyRadiation OncologyCancer ResearchLung CancerMolecular OncologyHealth Sciences
8039 Background: Sorafenib is a multikinase inhibitor affecting pathways involved in tumor progression and angiogenesis. We conducted a phase II trial of Sorafenib in plat-treated E-SCLC patients (pts) to determine the tumor response rate, toxicity and overall survival. Methods: Pts with histologically confirmed SCLC, measurable disease, Zubrod performance status 0–1 and no more than 1 prior plat- based treatment were eligible. Pts were stratified by platinum-sensitivity status: sensitive (progression >90 days after plat) or refractory (progression during or ≤90 days after plat). Pts were treated with sorafenib 400mg PO BID continuously on a 28 day cycle. Results: Of 89 pts registered; 81 are evaluable for toxicity assessment and 79 were evaluable for response. Across all pts, there were 3 (4%) partial responses (PR) and 25 (32%) with stable disease (SD). There were no complete responses. Two of the PR’s (5%) were in the plat-sensitive group, while 1 PR (2%) was in the plat-refractory group. Both groups had similar SD rates (12 [32%] and 13 [31%]) in the plat- sensitive and plat-refractory groups, respectively. Median survival: 7 mo (plat sensitive) and 5 mo (plat refractory). Median progression free survival estimates are the same for both strata: 2 months. Major toxicities included: Twenty pts (25%) with grade (gr) 3 dermatologic; Eleven (14%) with gr 3/4 flu-like and nine (11%) with gr 3/4 metabolic. Eighteen pts discontinued treatment due to adverse events or side effects from therapy. Conclusions: Sorafenib induced response and SD in 35% of plat treated E-SCLC. Median survival in this study was comparable to historic controls receiving salvage chemotherapy. Further study is warranted in combination with chemotherapy. (Supported by SWOG grant CA 30102) Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bayer