Randomized phase II trial of All-trans-retinoic acid with chemotherapy based on paclitaxel and cisplatin as first-line treatment in patients with advanced non-small-cell lung cancer
| Autor: | Carlos Enrique Rojas-Marín, T. Ceron-Lizarraga, Oscar Arrieta, Elena Aréchaga-Ocampo, Norma Hernández-Pedro, Claudia H. Gonzalez-De la Rosa, Luis Manuel Martínez-Barrera, María E. Vázquez-Manríquez, Miguel Á. Álvarez-Avitia, Miguel Angel Rios-Trejo, Jaime de la Garza, Geraldine Villanueva-Rodríguez |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Male
Cancer Research Pathology medicine.medical_specialty Lung Neoplasms Paclitaxel Receptors Retinoic Acid medicine.medical_treatment Tretinoin Gastroenterology chemistry.chemical_compound Double-Blind Method Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Carcinoma Medicine Humans Lung cancer Aged Cisplatin Chemotherapy business.industry Respiratory disease Cancer Middle Aged medicine.disease Oncology chemistry Female business medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 28(21) |
| ISSN: | 1527-7755 |
| Popis: | Purpose This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel (PC) 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-β2) as a response biomarker. Patients and Methods Patients with stages IIIB with pleural effusion and IV NSCLC were included to receive PC, and randomly assigned to receive ATRA 20 mg/m2/d (RA/PC) or placebo (P/PC) 1 week before treatment until two cycles were completed. RAR-β2 expression was analyzed in tumor and adjacent lung tissue. Results One hundred seven patients were included, 55 in the P/PC group and 52 in the RA/PC group. RR for RA/PC was 55.8% (95% CI, 46.6% to 64.9%) and for P/PC, 25.4% (95% CI, 21.3 to 29.5%; P = .001). The RA/PC group had a longer median PFS (8.9 v 6.0 months; P = .008). Multivariate analysis of PFS showed significant differences for the RA/PC group (hazard ratio, 0.62; 95% CI, 0.4 to 0.95). No significant differences in toxicity grade 3/4 were found between groups, except for hypertriglyceridemia (10% v 0%) in RA/PC (P = .05). Immunohistochemistry and reverse-transcriptase polymerase chain reaction assays showed expression of RAR-β2 in normal tissues of all tumor samples, but only 10% of samples in the tumor tissue. Conclusion Adding ATRA to chemotherapy could increase RR and PFS in patients with advanced NSCLC with an acceptable toxicity profile. A phase III clinical trial is warranted to confirm these findings. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|