TY - JOUR
T1 - 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
T2 - NRG Oncology Radiation Therapy Oncology Group 0522
AU - Truong, Minh Tam
AU - Zhang, Qiang
AU - Rosenthal, David I.
AU - List, Marcie
AU - Axelrod, Rita
AU - Sherman, Eric
AU - Weber, Randal
AU - Nguyen-Tân, Phuc Felix
AU - El-Naggar, Adel
AU - Konski, André
AU - Galvin, James
AU - Schwartz, David
AU - Trotti, Andy
AU - Silverman, Craig
AU - Singh, Anurag
AU - Godette, Karen
AU - Bonner, James A.
AU - Jones, Christopher U.
AU - Garden, Adam S.
AU - Shenouda, George
AU - Matthiesen, Chance
AU - Le, Quynh Thu
AU - Bruner, Deborah
N1 - Funding Information:
Supported by grants U10CA21661, U10CA180868, U10CA180822, from the National Cancer Institute and Eli Lilly and Company. Supported in part under a grant (grant number: 4100054841) with the Pennsylvania Department of Health, which specifically disclaims responsibility for any analyses, interpretations, or conclusions.
Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2017/3/15
Y1 - 2017/3/15
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84992360718&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84992360718&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2016.08.003
DO - 10.1016/j.ijrobp.2016.08.003
M3 - Article
C2 - 27727066
AN - SCOPUS:84992360718
SN - 0360-3016
VL - 97
SP - 687
EP - 699
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 4
ER -