Safety Analysis Of A Phase Iii Randomized Trial Of Chemotherapy With Or Without Bevacizumab (B) In Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck (R/M Scchn).

6022 Background: The addition of B, an anti-VEGF monoclonal antibody, to chemotherapy has improved outcomes in several solid tumors. Pemetrexed plus B in R/M SCCHN showed promising efficacy but significant incidence (15%) of grade 3-5 bleeding (Argiris et al. JCO 2011). Methods: Patients (pts) with performance status (PS) 0-1, adequate laboratory parameters, no history of bleeding, not receiving anticoagulation or having blood vessel invasion were randomized to: A) one of 4 regimens (investigator’s choice): A1, cisplatin (C) 100 mg/m2, 5-FU 1000 mg/m2/day x 4 days; A2, carboplatin (Cb) AUC 6, 5-FU 1000 mg/m2/day x 4 days; A3, C 75 mg/m2, docetaxel (D) 75 mg/m2; A4, Cb AUC 6, D 75 mg/m2, every 3 weeks, or B) the same regimen (B1, B2, B3, B4) plus B 15 mg/Kg IV, every 3 weeks, until progression. All pts received prophylactic antibiotics. Chemotherapy could be stopped after 6 cycles after maximum response. The primary endpoint was overall survival with a planned sample size of 400. Results: We report safety ...