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
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...
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Published in | Journal of clinical oncology Vol. 28; no. 21; pp. 3463 - 3471 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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United States
American Society of Clinical Oncology
20.07.2010
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Abstract | 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-beta2) as a response biomarker.
Patients with stages IIIB with pleural effusion and IV NSCLC were included to receive PC, and randomly assigned to receive ATRA 20 mg/m(2)/d (RA/PC) or placebo (P/PC) 1 week before treatment until two cycles were completed. RAR-beta2 expression was analyzed in tumor and adjacent lung tissue.
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-beta2 in normal tissues of all tumor samples, but only 10% of samples in the tumor tissue.
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. |
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AbstractList | 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-beta2) as a response biomarker.
Patients with stages IIIB with pleural effusion and IV NSCLC were included to receive PC, and randomly assigned to receive ATRA 20 mg/m(2)/d (RA/PC) or placebo (P/PC) 1 week before treatment until two cycles were completed. RAR-beta2 expression was analyzed in tumor and adjacent lung tissue.
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-beta2 in normal tissues of all tumor samples, but only 10% of samples in the tumor tissue.
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. 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/m 2 /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. |
Author | Elena Aréchaga-Ocampo María E. Vázquez-Manríquez Carlos Rojas-Marín Geraldine Villanueva-Rodríguez Miguel Á. Álvarez-Avitia Miguel Ángel Ríos-Trejo Tania L. Cerón-Lizárraga Jaime De la Garza Norma Hernández-Pedro Claudia H. González-De la Rosa Luis Martínez-Barrera Oscar Arrieta |
Author_xml | – sequence: 1 givenname: Oscar surname: Arrieta fullname: Arrieta, Oscar email: ogar@servidor.unam.mx organization: Instituto Nacional de Cancerología, Universidad Autónoma Metropolitana, Mexico City, Mexico. ogar@servidor.unam.mx – sequence: 2 givenname: Claudia H surname: González-De la Rosa fullname: González-De la Rosa, Claudia H – sequence: 3 givenname: Elena surname: Aréchaga-Ocampo fullname: Aréchaga-Ocampo, Elena – sequence: 4 givenname: Geraldine surname: Villanueva-Rodríguez fullname: Villanueva-Rodríguez, Geraldine – sequence: 5 givenname: Tania L surname: Cerón-Lizárraga fullname: Cerón-Lizárraga, Tania L – sequence: 6 givenname: Luis surname: Martínez-Barrera fullname: Martínez-Barrera, Luis – sequence: 7 givenname: María E surname: Vázquez-Manríquez fullname: Vázquez-Manríquez, María E – sequence: 8 givenname: Miguel Angel surname: Ríos-Trejo fullname: Ríos-Trejo, Miguel Angel – sequence: 9 givenname: Miguel A surname: Alvarez-Avitia fullname: Alvarez-Avitia, Miguel A – sequence: 10 givenname: Norma surname: Hernández-Pedro fullname: Hernández-Pedro, Norma – sequence: 11 givenname: Carlos surname: Rojas-Marín fullname: Rojas-Marín, Carlos – sequence: 12 givenname: Jaime surname: De la Garza fullname: De la Garza, Jaime |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20547984$$D View this record in MEDLINE/PubMed |
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Snippet | This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel (PC) plus all-trans retinoic acid (ATRA) increases response rate... Purpose This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel (PC) plus all-trans retinoic acid (ATRA) increases... |
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SubjectTerms | Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - mortality Cisplatin - administration & dosage Double-Blind Method Female Humans Lung Neoplasms - drug therapy Lung Neoplasms - mortality Male Middle Aged Paclitaxel - administration & dosage Receptors, Retinoic Acid - analysis Tretinoin - administration & dosage |
Title | 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 |
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