Researchers involved in a multicenter U.S. clinical trial have reported that the addition of Zolinza® (varinostat) to Paraplatin® (carboplatin) and Taxol® (paclitaxel) improves responses in patients with previously untreated Stage IIIB-IV non–small cell lung cancer (NSCLC). The details of this study were published early online on November 23, 2009 in the Journal of Clinical Oncology.[1]

Zolinza™ is a small molecule inhibitor of histone deacetylase that is approved by the U.S. Food and Drug Administration for the treatment of cutaneous T-cell lymphoma. A Phase II study of Zolinza alone in patients with relapsed NSCLC did not result in any objective responses; however, prolongation of time to tumor progression was observed.[2] This observation prompted studies of Zolinza in combination with known active chemotherapy drugs for treatment of NSCLC.

The current study was a Phase II randomized, double-blind, placebo-controlled trial that evaluated Zolinza in combination with Taxol and Paraplatin in 94 patients with previously untreated advanced NSCLC. The response rate was 34% for patients treated with Zolinza and 12.5% for patients treated with placebo. Median progression-free survival was 6.0 months for the Zolinza group and 4.1 months for the placebo group (p=0.48). Overall survival was 13.0 months for patients receiving Zolinza and 9.7 months for patients receiving placebo (P=0.17).

Comments: Zolinza appears to enhance the efficacy of a regimen of Taxol and Paraplatin without significant increase in toxicity.

References:

[1] Ramalingam SS, Maitland ML, Frankel P, et al. Carboplatin and paclitaxel in combination with either vorinostat or placebo for first-line therapy of advanced non-small-cell lung cancer. Journal of Clinical Oncology [early online publication]. November 23, 2009.