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

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

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

Purpose: 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.

Purpose: 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.

Patients were assigned to receive placebo (P/PC) 1 week prior to treatment until completing two cycles

Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two cycles

Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin

Patients were randomized to receive or placebo (P/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin

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.

Evaluate the efficiency and safety of low doses of ATRA in patients with advanced NSCLC who receive first-line CT.

Inclusion Criteria: Stage III B and IV NSCLC Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 No prior cytotoxic chemotherapy for NSCLC Age ≥18 years, adequate laboratory measurements Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Life expectancy of >12 weeks. Exclusion Criteria: Patients who had received prior chemotherapy Patients with other comorbid conditions