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. 2011 Mar;3(1):30–56. doi: 10.3978/j.issn.2072-1439.2010.12.03

Table 4. Phase II/III trials with histone deacetylase inhibitors and retinoids.

TREATMENT REFERENCE/ STUDY PHASE PATIENTS RESPONSES SURVIVAL
VORINOSTAT
Vorinostat + carboplatin and paclitaxel Ramalingam SS Phase II 2010 94 untreated stage IIIB or IV NSCLC RR 34% PFS 6.0 months OS 13.0 months
BEXAROTENE
SPIRIT I (cisplatin+vinorelbine+/- bexarotene) Ramlau R Phase III 2008 623 patients untreated stage IIIB or IV NSCLC ORR 16.7% vs 24.4%(control) SD 37% vs 35.3% (control) Subpopulation with grade 3/4 hypertriglyceridemia: longer median survival than control patients (12.3 v 9.9
SPIRIT II (carboplatin+ paclitaxel+/- bexarotene) Blumenschein GR Phase III 2008 602 patients with stage IIIB or stage IV NSCLC ORR 19.3% vs 23.5% (control) SD 40.2% and 37.6% (control) Subpopulation with grade 3/4 hypertriglyceridemia: significantly longer median survival than control patients (12.4 v 9.2 months)

ORR: overall response rate; SD: stable disease; PR: partial response; PFS: progression-free survival; OS: overall survival