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.
Author(s): Zukin M(1), Barrios CH, Pereira JR, Ribeiro Rde A, Beato CA, do Nascimento YN,
Murad A, Franke FA, Precivale M, Araujo LH, Baldotto CS, Vieira FM, Small IA,
Ferreira CG, Lilenbaum RC.
Affiliation(s): Author information:
(1)Instituto Nacional do Cancer, Rio deJaneiro.
Publication date & source: 2013, J Clin Oncol. , 31(23):2849-53
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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