title: Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiation Therapy Oncology Group 0522.
abstract: To analyze the quality of life (QOL) and performance status (PS) (secondary outcome) in patients with stage III to IV head and neck cancer (HNC) enrolled on a prospective randomized phase 3 trial comparing radiation-cisplatin without cetuximab (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) total score of ≥10% of the instrument range from baseline to 1 year.
  
  
  
  Patients who gave consent to the QOL/PS study completed the FACT-HN, Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5 years. The pretreatment QOL/PS scores were correlated with outcome and p16 status in patients with oropharyngeal cancer (OPC).
  
  
  
  Of 818 analyzable patients, the 1-year change from baseline score for FACT-HN total was -0.41 (CIS arm) and -5.11 (CET/CIS arm) (P=.016), representing a 3.2% between-arm change of the FACT-HN total score. The mean EQ-5D index and PSS-HN scores were not significantly different between arms. The p16-positive OPC patients had significantly higher baseline and 1-year scores for PSS-HN, FACT-HN total, physical and functional subscales, and 2-years for the EQ-5D index compared with p16-negative OPC patients. Higher pretreatment PSS-HN diet, PSS-HN eating, FACT-HN, and EQ-5D index scores were associated with better overall survival (OS) and progression-free (PFS) survival on multivariate analysis. Higher baseline FACT-HN total, functional, physical subscale, and EQ-5D index scores were associated with improved OS and PFS in p16-positive OPC patients but not in p16-negative and non-OPC patients.
  
  
  
  There was no clinically meaningful difference in QOL/PS between arms. The p16-positive OPC patients had significantly higher QOL/PS than did p16-negative patients. Pretreatment QOL/PS is a significant independent predictor of outcome in locally advanced HNC.
authors.affiliation: Boston Medical Center Minority-Based Community Clinical Oncology Program (MBCCOP), Boston, MA. Electronic address: mitruong@bu.edu.
authors.forename: Minh Tam
authors.initials: MT
authors.lastname: Truong
authors.affiliation: NRG Oncology Statistics and Data Management Center, Philadelphia, PA.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: University of Texas-MD Anderson Cancer Center, Houston, TX.
authors.forename: David I
authors.initials: DI
authors.lastname: Rosenthal
authors.affiliation: The University of Chicago, Chicago, IL.
authors.forename: Marcie
authors.initials: M
authors.lastname: List
authors.affiliation: Thomas Jefferson University Hospital, Philadelphia, PA.
authors.forename: Rita
authors.initials: R
authors.lastname: Axelrod
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York City, NY.
authors.forename: Eric
authors.initials: E
authors.lastname: Sherman
authors.affiliation: University of Texas-MD Anderson Cancer Center, Houston, TX.
authors.forename: Randal
authors.initials: R
authors.lastname: Weber
authors.affiliation: Centre Hospitalier de l'Université de Montréal-Notre Dame, Montréal, QC.
authors.forename: Phuc Felix
authors.initials: PF
authors.lastname: Nguyen-Tân
authors.affiliation: University of Texas-MD Anderson Cancer Center, Houston, TX.
authors.forename: Adel
authors.initials: A
authors.lastname: El-Naggar
authors.affiliation: Penn Radiation Oncology, Pennsylvania Hospital, Philadelphia, PA.
authors.forename: André
authors.initials: A
authors.lastname: Konski
authors.affiliation: Thomas Jefferson University Hospital, Philadelphia, PA.
authors.forename: James
authors.initials: J
authors.lastname: Galvin
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, TX.
authors.forename: David
authors.initials: D
authors.lastname: Schwartz
authors.affiliation: Moffitt Cancer Center, Tampa, FL.
authors.forename: Andy
authors.initials: A
authors.lastname: Trotti
authors.affiliation: University of Louisville James Graham Brown Cancer Center, Louisville, KY.
authors.forename: Craig
authors.initials: C
authors.lastname: Silverman
authors.affiliation: Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Anurag
authors.initials: A
authors.lastname: Singh
authors.affiliation: Boston Medical Center Minority-Based Community Clinical Oncology Program (MBCCOP), Boston, MA.
authors.forename: Karen
authors.initials: K
authors.lastname: Godette
authors.affiliation: University of Alabama at Birmingham Medical Center, Birmingham, AL.
authors.forename: James A
authors.initials: JA
authors.lastname: Bonner
authors.affiliation: Sutter General Hospital, Formerly, Radiological Associates of Sacramento, Sacramento, CA.
authors.forename: Christopher U
authors.initials: CU
authors.lastname: Jones
authors.affiliation: University of Texas-MD Anderson Cancer Center, Houston, TX.
authors.forename: Adam S
authors.initials: AS
authors.lastname: Garden
authors.affiliation: McGill University, Montréal, QC.
authors.forename: George
authors.initials: G
authors.lastname: Shenouda
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK.
authors.forename: Chance
authors.initials: C
authors.lastname: Matthiesen
authors.affiliation: Stanford University Medical Center, Stanford, CA.
authors.forename: Quynh-Thu
authors.initials: QT
authors.lastname: Le
authors.affiliation: Emory University, Atlanta, GA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Bruner
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000068818:Cetuximab / Q000008:administration & dosage; D059248:Chemoradiotherapy / Q000401:mortality* / Q000523:psychology* / Q000706:statistics & numerical data; D002945:Cisplatin / Q000008:administration & dosage; D019583:Dose Fractionation, Radiation; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality* / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000517:prevention & control* / Q000523:psychology; D015995:Prevalence; D011788:Quality of Life / Q000523:psychology*; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D000970:Antineoplastic Agents; D000068818:Cetuximab; D002945:Cisplatin