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Phase II trial of pemetrexed plus bevacizumab for second-line therapy of patients with advanced non-small-cell lung cancer: CCTGcctg and SWOG study N0426
Journal of Clinical Oncology, 10/26/09

Adjei AA et al. – The purpose of this study was to evaluate the efficacy and toxicity of pemetrexed combined with bevacizumab as second-line therapy for patients with advanced non–small-cell lung cancer (NSCLC) and to correlate allelic variants in pemetrexed-metabolizing genes with clinical outcome. The study did not meet it's primary end point. However, the median PFS time of 4 months is promising. Pharmacogenetic studies in larger cohorts are needed to definitively identify polymorphisms that predict for survival and toxicity of pemetrexed.

Methods

Patients with previously treated NSCLC received pemetrexed (500 mg/m2 intravenous) combined with bevacizumab (15 mg/kg intravenous) every 3 weeks
Primary end point, evaluated using one-stage Fleming design for detecting true success rate of at least 70%, was the proportion of patients who were progression free and on treatment at 3 months
Polymorphisms in genes responsible for pemetrexed transport (reduced folate carrier [SLC19A1]) and metabolism (folylpolyglutamate synthase [FPGS] and gamma-glutamyl hydrolase [GGH]) evaluated in germline DNA (blood) correlated with treatment outcome

Results

48 evaluable patients (14 females and 34 males) received a median of 4 cycles (range, one to 20 cycles)
Most common grade 3 or 4 nonhematologic adverse events (AEs) were fatigue (13%), dyspnea (10%), and thrombosis (10%)
Grade 3 or 4 hematologic AEs were neutropenia (19%) and lymphopenia (13%)
24 of the first 42 patients met success criteria
Median overall survival (OS) and progression-free survival (PFS) times 8.6 and 4.0 months, respectively
Exon 6 (2522)CT polymorphism in SLC19A1 correlated with 3-month progression-free status and with PFS
IVS1(1307)CT polymorphism in GGH correlated with OS

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