Minh Tam Truong1, Qiang Zhang2, David I Rosenthal3, Marcie List4, Rita Axelrod5, Eric Sherman6, Randal Weber3, Phuc Felix Nguyen-Tân7, Adel El-Naggar3, André Konski8, James Galvin5, David Schwartz9, Andy Trotti10, Craig Silverman11, Anurag Singh12, Karen Godette13, James A Bonner14, Christopher U Jones15, Adam S Garden3, George Shenouda16, Chance Matthiesen17, Quynh-Thu Le18, Deborah Bruner19. 1. Boston Medical Center Minority-Based Community Clinical Oncology Program (MBCCOP), Boston, MA. Electronic address: mitruong@bu.edu. 2. NRG Oncology Statistics and Data Management Center, Philadelphia, PA. 3. University of Texas-MD Anderson Cancer Center, Houston, TX. 4. The University of Chicago, Chicago, IL. 5. Thomas Jefferson University Hospital, Philadelphia, PA. 6. Memorial Sloan-Kettering Cancer Center, New York City, NY. 7. Centre Hospitalier de l'Université de Montréal-Notre Dame, Montréal, QC. 8. Penn Radiation Oncology, Pennsylvania Hospital, Philadelphia, PA. 9. University of Texas Southwestern Medical Center, Dallas, TX. 10. Moffitt Cancer Center, Tampa, FL. 11. University of Louisville James Graham Brown Cancer Center, Louisville, KY. 12. Roswell Park Cancer Institute, Buffalo, NY. 13. Boston Medical Center Minority-Based Community Clinical Oncology Program (MBCCOP), Boston, MA. 14. University of Alabama at Birmingham Medical Center, Birmingham, AL. 15. Sutter General Hospital, Formerly, Radiological Associates of Sacramento, Sacramento, CA. 16. McGill University, Montréal, QC. 17. University of Oklahoma Health Sciences Center, Oklahoma City, OK. 18. Stanford University Medical Center, Stanford, CA. 19. Emory University, Atlanta, GA.
Abstract
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.
RCT Entities:
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.
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