Randomized, double-blind, placebo-controlled phase II study of carboplatin and paclitaxel with or without vorinostat, a histone deacetylase inhibitor (HDAC), for first-line therapy of advanced non-small cell lung cancer (NCI 7863)
Carolyn Vachani, RN, MSN, AOCN
Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 3, 2009
Title: Randomized, double-blind, placebo-controlled phase II study of carboplatin and paclitaxel with or without vorinostat, a histone deacetylase inhibitor (HDAC), for first-line therapy of advanced non-small cell lung cancer (NCI 7863)
Reviewer: Arpi Thukral, MD
Presenter: Suresh. S. Ramalingam, MD
Affiliation: Emory University
This presentation is a review of a phase II study of vorinostat (or placebo), given with paclitaxel and carboplatin for non-small cell lung cancer (NSCLC). Vorinostat is an oral agent currently approved by the FDA for cutananeous T cell lymphoma therapy. The primary objective of this study was to compare response rate (RR) associated with patients receiving paclitaxel and carboplatin (PC) with either vorinostat or placebo.
The secondary objective was to examine and compare progression-free-survival (PFS), overall survival (OS), and toxicity data in the two groups.
The study included 94 participants with stage IIIB or IV NSCLC who had not previously received chemotherapy. While the response rate was better in the vorinostat arm, there was no statistically significant (SS) difference in PFS or OS, but the study was not large enough to detect SS differences in PFS or OS. The only SS in side effects was an increase in thrombocytopenia in the vorinostat group. There were two treatment related deaths in the vorinostat group.
This agent will require further larger studies to determine if it affects PFS or OS, as well as quality of life. The agent has some effectiveness and may increase the effectiveness of the paclitaxel / carboplatin regimen.
Also see Interpreting a Cancer Research Study