Reduced-intensity Therapy for Advanced Oropharyngeal Cancer in Non-smoking Human Papilloma Virus (HPV)-16 Positive Patients

Fecha de inicio: 1 de enero de 2011

Inclusion Criteria: Patients must have pathologically-confirmed, previously untreated,stage III-IV(excluding N3 or T4) squamous cell carcinoma of the oropharynx, without evidence of distant metastasis Pretreatment tumor biopsy with sufficient tumor for HPV or p16 analysis is required. The tumor must be HPV(+) or p16(+) Smoking history <10 pack-year or equivalent (including cigarettes, cigars, pipes, chewing tobacco, and/or marijuana). One cannabis joint is equivalent to 5 cigarettes. (Aldington etal, Thorax 2007; 62:1058-1063). Smoking status definitions (National Health Interview Survey and Behavioral Risk Factor Surveillance System (Nelson DE etal al, Am J Pub Health 2003;93:1335): Smokers: smoking now every day or some days in past month Quitters: at least 100 cigarettes/lifetime and not smoking in the past 1-12 months Former smoker: at least 100 cigarettes/lifetime and not smoking >12 months Never smokers: <100 cigarettes (or equivalent)/lifetime KPS > 80 (see Appendix A) Patients must undergo pre-treatment endoscopic tumor staging and PET-CT scanning Laboratory criteria: WBC > 3500/ul granulocyte > 1500/ul Platelet count > 100,000/ul Total Bilirubin < 1.5 X ULN AST and ALT < 2.5 X ULN Creatinine clearance >30 cc/min Patients must sign study specific informed consent Patients must have, in the opinion of a treating physician, tumor that is accessible to biopsy in the clinic. Exclusion Criteria: Prior head and neck malignancy or history of other prior non-head and neck malignancy (excluding skin cancer and early stage treated prostate cancer) within the past 3 years Prior head and neck radiation or chemotherapy Any medical or psychiatric illness, which in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment or limit compliance with study requirements Patients residing in prison Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule)