A randomized phase II study of pemetrexed (PEM) with or without sorafenib (S) as second-line therapy in advanced non-small cell lung cancer (NSCLC) of nonsquamous histology: NCCTG N0626 study
| Autor: | Araba A. Adjei, Nathan R. Foster, K. L. Allen Ziegler, G. K. Dy, A. A. Adjei, S.E. Schild, Patrick J. Flynn, Marie-Christine Aubry, Kendrith M. Rowland, Sumithra J. Mandrekar, Julian R. Molina |
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| Rok vydání: | 2011 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 29:7513-7513 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2011.29.15_suppl.7513 |
| Popis: | 7513 Background: Based on preclinical data of additive cytotoxicity with sorafenib (S) and pemetrexed (PEM), this randomized phase II study was done to evaluate the safety and efficacy of the combination of S plus PEM vs PEM alone, as second line treatment of non-squamous NSCLC (determined by central pathology review). Methods: A lead-in phase to determine the tolerability of S plus PEM was followed by a 1:1 randomization of either PEM 500 mg/m2 q21 days plus S 400 mg p.o. BID for 21 days (arm A) or PEM 500 mg/m2 q21 days (arm B). The primary endpoint was progression-free survival (PFS). 47 patients (pts) per arm provided 82% power to detect an increase in the median PFS from 3.0 to 5.5 months (mos), with a 1-sided alpha of 0.05. Polymorphisms in VEGFA, VEGFR1-3, FPGS, GGH, SLC19A1 and TYMS were evaluated in germline DNA and correlated with outcomes. Results: One-hundred evaluable pts were randomized (49-A, 51-B). Baseline age, gender, and ECOG performance status were balanced between arms (p > 0.24). Pri... |
| Databáze: | OpenAIRE |
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