Wednesday, January 5, 2011 (Last Updated: 01/06/2011)
WEDNESDAY, Jan. 5 (HealthDay News) -- The addition of iniparib, a poly(adenosine diphosphate-ribose) polymerase inhibitor, to chemotherapy appears to increase survival and improve clinical benefit in patients with metastatic triple-negative breast cancer, according to research published online Jan. 5 in the New England Journal of Medicine.
Joyce O'Shaughnessy, M.D., of the Baylor Charles A. Sammons Cancer Center in Dallas, and colleagues randomly assigned 123 patients to receive gemcitabine and carboplatin with or without iniparib to assess the safety and efficacy of the two treatments.
The researchers found that the rate of clinical benefit increased from 34 to 56 percent in patients whose treatment included iniparib; median progression-free survival in these patients also increased from 3.6 to 5.9 months, and median overall survival increased from 7.7 to 12.3 months. The two groups experienced grade 3 or 4 adverse events at the same rate.
"The addition of iniparib to chemotherapy improved the clinical benefit and survival of patients with metastatic triple-negative breast cancer without significantly increased toxic effects. On the basis of these results, a phase 3 trial adequately powered to evaluate overall survival and progression-free survival is being conducted," the authors write.
The study was supported by BiPar Sciences, now owned by Sanofi-Aventis; several authors disclosed financial ties to both companies.
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