Thursday, March 11, 2010 (Last Updated: 03/16/2010)
THURSDAY, March 11 (HealthDay News) -- The addition of sorafenib to carboplatin and paclitaxel chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) does not show a clinical benefit supporting use as first-line therapy, according to research published online March 8 in the Journal of Clinical Oncology.
Giorgio Scagliotti, M.D., of the University of Turin in Torino, Italy, and colleagues analyzed data from 926 chemotherapy-naïve adults with unresectable stage IIIB or IV cancer. Patients received up to six 21-day cycles of carboplatin and paclitaxel, with either sorafenib or placebo on days two through 19. The primary end point was overall survival.
The researches found that median overall survival was 10.7 months in the sorafenib group and 10.6 months in the placebo group. The study was terminated after an interim analysis. Patients with squamous cell carcinoma in the treatment group had shorter median overall survival than patients in the placebo group (8.9 versus 13.6 months). Grade 3 or 4 toxicities related to sorafenib included rash, hand-foot skin reaction, and diarrhea.
"Despite the disappointing results reported here, there is evidence supporting the activity of sorafenib monotherapy in second- and late-line NSCLC from a single-arm, second-line, phase II study and a randomized, placebo-controlled, third-line discontinuation phase II study. Sorafenib monotherapy continues to be evaluated as a third- and fourth-line treatment in patients with advanced NSCLC in a large phase III study," the authors conclude.
The study was supported by Bayer HealthCare and Onyx Pharmaceuticals. Several co-authors reported financial relationships with pharmaceutical companies.
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