2017 ASCO Annual Meeting!
Session: Head and Neck Cancer
Type: Oral Abstract Session
Time: Monday June 5, 8:00 AM to 11:00 AM
Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial.
Head and Neck Cancer
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr 6000)
Author(s): Athanassios Argiris, Shuli Li, Panayiotis Savvides, James Ohr, Jill Gilbert, Marshall A. Levine, Missak Haigentz, Nabil F. Saba, Arnab Chakravarti, Chukwuemeka Ikpeazu, Charles Schneider, Harlan Pinto, Arlene A. Forastiere, Barbara Burtness; Thomas Jefferson University, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA; Dignity Health St. Joseph's Hospital, Phoenix, AZ; University of Pittsburgh Medical Center Cancer Center Pavilion, Pittsburgh, PA; Vanderbilt University School of Medicine, Nashville, TN; Greater Baltimore Medical Center, Towson, MD; Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY; Winship Cancer Institute, Atlanta, GA; Ohio State University, Columbus, OH; University of Miami Sylvester Comprehensive Cancer Center, Plantation, FL; Helen F. Graham Cancer Center, Christiana Care Health System, Newark, DE; Stanford University Medical Center and VA Palo Alto, Palo Alto, CA; Johns Hopkins University School of Medicine, Baltimore, MD; Yale School of Medicine, New Haven, CT
Background: The addition of B, an anti-VEGF monoclonal antibody, to chemotherapy has improved outcomes in several solid tumors. Pemetrexed plus B showed promising efficacy in R/M SCCHN (Argiris et al. JCO 2011). E1305 was designed to evaluate the addition of B to a platinum doublet in R/M SCCHN. Methods: B-eligible pts with performance status 0-1, not having received chemotherapy for R/M SCCHN (prior chemotherapy for locally advanced disease allowed ≥ 4 months) and without factors predisposing to bleeding (history of bleeding due to SCCHN, anticoagulation, central cavitary lung metastasis, carotid invasion) were randomized to: A) one of 4 regimens (investigator's choice) given every 3 weeks: 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, or B) the same regimen (B1, B2, B3, B4) plus B 15 mg/Kg IV, every 3 weeks, until progression. Chemotherapy could be stopped after 6 cycles after maximum response. All pts received prophylactic antibiotics. The primary endpoint was overall survival (OS). Control median OS of 8.5 months (mo) was projected; the addition of B was hypothesized to increase median OS to 11.5 mo with a hazard ratio (HR) of 0.74. Results: 403 pts were randomized (200 in arm A; 203 in arm B). Baseline characteristics were well balanced. 38% in arm A/42% in arm B had an oropharyngeal primary; 87% received C or Cb plus D. With a median follow-up of 23.1 mo, median OS was 11 mo in arm A and 12.6 mo in arm B; HR 0.84 (95% CI 0.67-1.05), p = 0.13. The 1-, 2-, 3-, and 4-year OS were 46% vs 51%, 18% vs 26%, 8% vs 16%, 6% vs 13%, in arm A vs B, respectively. Median PFS was 4.4 mo in arm A and 6.1 mo in arm B (HR 0.71, 95% CI 0.58-0.87; p = 0.0012). Objective response rate was 25% in arm A vs 36% in arm B (p = 0.013). Grade 3-5 bleeding occurred in 3.5% in arm A vs 7.7% in arm B (p = 0.08). Conclusions: B added to a standard platinum doublet improved response rate and PFS but not OS in first-line treatment of R/M SCCHN. The control arm in this study performed better than expected. Clinical trial information: NCT00588770