Quality of life and performance status from a sub-study conducted within a prospective phase III randomized trial of concurrent accelerated radiation plus cisplatin with or without cetuximab for locally advanced head and neck carcinoma: NRG Oncology RTOG 0522

Publication date: Available online 12 August 2016
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Minh Tam Truong, Qiang Zhang, David I. Rosenthal, Marcie List, Rita Axelrod, Eric Sherman, Randal Weber, Phuc Felix Nguyen-Tân, Adel El-Naggar, André Konski, James Galvin, David Schwartz, Andy Trotti, Craig Silverman, Anurag Singh, Karen Godette, James A. Bonner, Christopher U. Jones, Adam S. Garden, George Shenouda, Chance Matthiesen, Quynh-Thu Le, Deborah Bruner
PurposeTo analyze the quality of life (QOL) and performance status (PS) (secondary outcome) of stage III-IV head and neck cancer (HNC) patients enrolled on a prospective randomized phase III trial, comparing radiation-cisplatin without (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in FACT-H&N-Total score of ≥ 10% of the instrument range from baseline to 1-year.Methods and MaterialsPatients with QOL/PS study consent completed the Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN), Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5-years. Pretreatment QOL/PS scores were correlated with outcome and p16-status in oropharyngeal cancer (OPC) patients.ResultsOf 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=0.016), representing a 3.2% between-arm change of FACT-HN-Total score. Mean EQ-5D-index and PSS-HN scores were not significantly different between arms. P16-positive OPC patients had significantly higher baseline and 1-year scores for PSS-HN, FACT-HN-Total, physical, functional subscales, and 2-years for EQ-5D-index compared to p16-negative OPC patients. Higher pretreatment PSS-HN-diet, PSS-HN-eating, FACT-HN and EQ-5D-index scores were associated with better overall (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, PFS in p16-positive OPC, but not for p16-negative and non-OPC patients.ConclusionThere was no clinically meaningful difference in QOL/PS between arms. P16-positive OPC patients have significantly higher QOL/PS than p16-negative patients. Pretreatment QOL/PS is a significant independent predictor of outcome in locally advanced HNC.

Teaser

In this prospective randomized study, no differences in quality of life (QOL) and performance status (PS) were found between concurrent accelerated concomitant cisplatin with or without cetuximab. Distinct QOL/PS profiles were found between p16-positive and negative OPC patients. P16-positive OPC patients demonstrated higher baseline and 1-year QOL/PS scores using FACT-HN and PSS-HN, and greater acute PS decline at the end of treatment, compared to p16-negative patients. Pretreatment QOL/PS was independently correlated with survival.


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