Randomized Phase II Trial: Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel
plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free
survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an
acceptable toxicity profile and its association with the expression of Retinoic acid
receptor beta 2 (RAR-beta2 ) as a response biomarker.
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin
(PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week
prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by
Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The primary end-point was Response rate (RR) and Progression-free survival (PFS), as well as identifying whether expression of RAR-beta2 is a response biomarker.
Oscar Arrieta, M.D.
National Institute of Cancerología
Mexico: National Council of Science and Technology