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Randomized phase III trial of single-agent pemetrexed versus carboplatin and pemetrexed in patients with advanced non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status of 2

Zukin, Mauro, Barrios, Carlos H., Rodrigues Pereira, Jose, De Albuquerque Ribeiro, Ronaldo, de Mendonça Beato, Carlos Augusto, do Nascimento, Yeni Neron, Murad, Andre, Franke, Fabio A., Precivale, Maristela, de Lima Araujo, Luiz Henrique, Da Rocha Baldotto, Clarissa Serodio, Vieira, Fernando Meton, Small, Isabele A., Ferreira, Carlos G., Lilenbaum, Rogerio C.·2013·Journal of Clinical Oncology

DOI 10.1200/jco.2012.48.1911

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Abstract

PURPOSE: To compare single-agent pemetrexed (P) versus the combination of carboplatin and pemetrexed (CP) in first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. PATIENTS AND METHODS: In a multicenter phase III randomized trial, patients with advanced NSCLC, ECOG PS of 2, any histology at first and later amended to nonsquamous only, no prior chemotherapy, and adequate organ function were randomly assigned to P alone (500 mg/m(2)) or CP (area under the curve of 5 and 500 mg/m(2), respectively) administered every 3 weeks for a total of four cycles. The primary end point was overall survival (OS). RESULTS: A total of 205 eligible patients were enrolled from eight centers in Brazil and one in the United States from April 2008 to July 2011. The response rates were 10.3% for P and 23.8% for CP (P = .032). In the intent-to-treat population, the median PFS was 2.8 months for P and 5.8 months for CP (hazard ratio [HR], 0.46; 95% CI, 0.35 to 0.63; P < .001), and the median OS was 5.3 months for P and 9.3 months for CP (HR, 0.62; 95% CI, 0.46 to 0.83; P = .001). One-year survival rates were 21.9% and 40.1%, respectively. Similar results were seen when patients with squamous disease were excluded from the analysis. Anemia (grade 3, 3.9%; grade 4, 11.7%) and neutropenia (grade 3, 1%; grade 4, 6.8%) were more frequent with CP. There were four treatment-related deaths in the CP arm. CONCLUSION: Combination chemotherapy with CP significantly improves survival in patients with advanced NSCLC and ECOG PS of 2.

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Authors: Zukin, M., Barrios, C. H., Rodrigues Pereira, J., De Albuquerque Ribeiro, R., de Mendonça Beato, C. A., do Nascimento, Y. N., Murad, A., Franke, F. A., Precivale, M., de Lima Araujo, L. H., Da Rocha Baldotto, C. S., Vieira, F. M., Small, I. A., Ferreira, C. G., & Lilenbaum, R. C.
Affiliations: Hospital Haroldo Juaçaba (BR)
Mauro Zukin, Luiz Henrique de Lima Araujo, Clarissa Serodio Da Rocha Baldotto, Fernando Meton Vieira, Isabele A. Small, and Carlos G. Ferreira, Instituto Nacional do Cancer, Rio de Janeiro; Carlos H. Barrios, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre; Jose Rodrigues Pereira, Instituto do Cancer Arnaldo Vieira Carvalho; Maristela Precivale, PGS Medical Statistics, Sao Paulo; Ronaldo De Albuquerque Ribeiro, Instituto do Cancer do Ceara, Fortaleza; Carlos Augusto de Mendonça Beato,...
ORCID: Zukin, Mauro
Barrios, Carlos H.
Franke, Fabio A.
Small, Isabele A.
Ferreira, Carlos G.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2013-08-10
Volume: 31
Issue: 23
Pages: 2849-2853
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2012.48.1911
OpenAlex: W2097268198
Cited by: 235
References: 7
Citations by year: 2026: 2 · 2025: 11 · 2024: 8 · 2023: 12 · 2022: 16 · 2021: 14 · 2020: 20 · 2019: 20 · 2018: 26 · 2017: 17 · 2016: 25 · 2015: 26 · 2014: 28 · 2013: 9
FWCI: 23.87
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords: non-small cell lung cancer, pemetrexed, carboplatin, combination chemotherapy, first-line therapy, overall survival, progression-free survival, anemia, neutropenia, non-relapse mortality
MeSH terms: Pemetrexed, Adult, Aged, Aged, 80 and over, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Glutamates, Guanine, Humans, Lung Neoplasms, Male, Middle Aged, Prospective Studies, Survival Rate, Carboplatin, Disease-Free Survival

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Randomized phase III trial of single-agent pemetrexed versus carboplatin and pemetrexed in patients with advanced non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status of 2

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