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