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

Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):687-699. doi: 10.1016/j.ijrobp.2016.08.003. Epub 2016 Aug 12.


Purpose: 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.

Methods and materials: 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).

Results: 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.

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT00265941.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Cetuximab / administration & dosage
  • Chemoradiotherapy / mortality*
  • Chemoradiotherapy / psychology*
  • Chemoradiotherapy / statistics & numerical data
  • Cisplatin / administration & dosage
  • Dose Fractionation, Radiation
  • Female
  • Head and Neck Neoplasms / mortality*
  • Head and Neck Neoplasms / psychology
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / mortality
  • Neoplasm Recurrence, Local / prevention & control*
  • Neoplasm Recurrence, Local / psychology
  • Prevalence
  • Quality of Life / psychology*
  • Risk Factors
  • Survival Rate
  • Treatment Outcome
  • United States / epidemiology


  • Antineoplastic Agents
  • Cetuximab
  • Cisplatin

Associated data

  • ClinicalTrials.gov/NCT00265941