Pemetrexed (P) and bevacizumab (B) in patients (pts) with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): Final results and correlation with TS, MTHFR, and VEGF gene polymorphisms.

5533 Background: We hypothesized that B, a monoclonal antibody against VEGF, will potentiate the activity of P, a multi- targeted antifolate, in R/M SCCHN. Methods: Eligible pts had R/M SCCHN with measurable disease, good performance status (PS), no history of gross hemoptysis, and no prior systemic therapy for R/M SCCHN. Treatment consisted of P 500 mg/m2 and B 15 mg/Kg, given intravenously every 21 days, with folic acid and B12, until progression. Primary endpoint was time-to-progression (TTP). DNA was isolated from whole blood samples for the detection of polymorphisms in thymidylate synthase (TS), methylenetetrahydrofolate reductase (MTHFR), and VEGF. Results: 40 pts were enrolled. Median age 59 (36-85); male/female, 32/8; PS 0/1, 16/24; prior chemotherapy as part of curative treatment: 29; primary site: oropharynx (21), oral cavity (7), larynx (4). Median number of cycles 5.5 (1-15). In 37 evaluable pts, the overall response rate was 30% (95% CI, 19-51%) (CR: 2; PR:11; SD: 21) and disease control rat...