title: Phase II trial of bevacizumab + cetuximab + cisplatin with concurrent intensity-modulated radiation therapy for patients with stage III/IVB head and neck squamous cell carcinoma.
abstract: The purpose of this study was to evaluate the efficacy and tolerability of the addition of 2 monoclonal antibodies, bevacizumab and cetuximab, to 2 cycles of high-dose cisplatin administered concurrently with intensity-modulated radiation therapy (IMRT) for head and neck squamous cell carcinoma (HNSCC).
  
  
  
  Patients with newly diagnosed stage III/IVB (M0) HNSCC received cetuximab (400 mg/m(2) loading dose, followed by 250 mg/m(2) weekly), bevacizumab (15 mg/kg, days 1 and 22), and cisplatin (50 mg/m(2) , days 1, 2, 22, and 23) concurrently with IMRT (70 Gy). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and safety and tolerability.
  
  
  
  Among 30 patients enrolled in this study, the primary tumor site was the oropharynx in 24 patients (p16 immunohistochemistry was positive in 17, negative in 1, and not done in 6 of the oropharyngeal tumors). Median age was 57 years (range, 38-77 years) and 27 patients had clinical stage IVA disease. All patients completed the full planned dose of radiation therapy. The most common ≥ grade 3 adverse events were lymphopenia, mucositis (functional), and dysphagia. With a median follow-up of 33.8 months, 2-year PFS was 88.5% (95% confidence interval [CI] = 68.1-96.1) and 2-year OS was 92.8% (95% CI = 74.2-98.1).
  
  
  
  The addition of bevacizumab and cetuximab to 2 cycles of cisplatin, given concurrently with IMRT, was well-tolerated and was associated with favorable efficacy outcomes in this patient population. © 2015 Wiley Periodicals, Inc. Head Neck 38: E566-E570, 2016.
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Matthew G
authors.initials: MG
authors.lastname: Fury
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center Regional Network Site, Basking Ridge, New Jersey.
authors.forename: Han
authors.initials: H
authors.lastname: Xiao
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Sherman
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Shrujal
authors.initials: S
authors.lastname: Baxi
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center Regional Network Site, Sleepy Hollow, New York.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Smith-Marrone
authors.affiliation: Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Basking Ridge, New Jersey.
authors.forename: Karen
authors.initials: K
authors.lastname: Schupak
authors.affiliation: Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Commack, New York.
authors.forename: Richard
authors.initials: R
authors.lastname: Gewanter
authors.affiliation: Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Commack, New York.|Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center Regional Network Site, Rockville Center, New York.
authors.forename: Daphna
authors.initials: D
authors.lastname: Gelblum
authors.affiliation: Head and Neck Medical Oncology Service, Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Sofia
authors.initials: S
authors.lastname: Haque
authors.affiliation: Head and Neck Medical Oncology Service, Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Heiko
authors.initials: H
authors.lastname: Schoder
authors.affiliation: Head and Neck Medical Oncology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Jatin P
authors.initials: JP
authors.lastname: Shah
authors.affiliation: Head and Neck Medical Oncology Service, Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Nora
authors.initials: N
authors.lastname: Katabi
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Rachel
authors.initials: R
authors.lastname: Kurtzman
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Brynna
authors.initials: B
authors.lastname: Lipson
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Lisa
authors.initials: L
authors.lastname: Cox
authors.affiliation: Head and Neck Medical Oncology Service, Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Nancy Y
authors.initials: NY
authors.lastname: Lee
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: David G
authors.initials: DG
authors.lastname: Pfister
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D000068258:Bevacizumab / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D000068818:Cetuximab / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000627:therapeutic use*; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D050397:Radiotherapy, Intensity-Modulated
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D000068818:Cetuximab; D002945:Cisplatin
keywords: bevacizumab; human papillomavirus; intensity-modulated radiation therapy (IMRT); neck; squamous