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

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 & 3 others Chance Matthiesen, Quynh Thu Le, Deborah Bruner

Research output: Contribution to journalArticle

15 Citations (Scopus)

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.

Original languageEnglish (US)
JournalInternational Journal of Radiation Oncology Biology Physics
DOIs
StateAccepted/In press - Jan 4 2016

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Radiation Oncology
Head and Neck Neoplasms
Cisplatin
radiation therapy
Neck
Radiotherapy
cancer
Head
Quality of Life
Radiation
Oropharyngeal Neoplasms
Carcinoma
radiation
Arm
therapy
Commonwealth of Independent States
Therapeutics
pretreatment
Cetuximab
Survival

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

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. / Truong, Minh Tam; Zhang, Qiang; Rosenthal, David I.; List, Marcie; Axelrod, Rita; Sherman, Eric; Weber, Randal; Nguyen-Tân, Phuc Felix; El-Naggar, Adel; Konski, André; Galvin, James; Schwartz, David; Trotti, Andy; Silverman, Craig; Singh, Anurag; Godette, Karen; Bonner, James A.; Jones, Christopher U.; Garden, Adam S.; Shenouda, George; Matthiesen, Chance; Le, Quynh Thu; Bruner, Deborah.

In: International Journal of Radiation Oncology Biology Physics, 04.01.2016.

Research output: Contribution to journalArticle

Truong, MT, Zhang, Q, Rosenthal, DI, List, M, Axelrod, R, Sherman, E, Weber, R, Nguyen-Tân, PF, El-Naggar, A, Konski, A, Galvin, J, Schwartz, D, Trotti, A, Silverman, C, Singh, A, Godette, K, Bonner, JA, Jones, CU, Garden, AS, Shenouda, G, Matthiesen, C, Le, QT & Bruner, D 2016, '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', International Journal of Radiation Oncology Biology Physics. https://doi.org/10.1016/j.ijrobp.2016.08.003
Truong, Minh Tam ; Zhang, Qiang ; Rosenthal, David I. ; List, Marcie ; Axelrod, Rita ; Sherman, Eric ; Weber, Randal ; Nguyen-Tân, Phuc Felix ; El-Naggar, Adel ; Konski, André ; Galvin, James ; Schwartz, David ; Trotti, Andy ; Silverman, Craig ; Singh, Anurag ; Godette, Karen ; Bonner, James A. ; Jones, Christopher U. ; Garden, Adam S. ; Shenouda, George ; Matthiesen, Chance ; Le, Quynh Thu ; Bruner, Deborah. / 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. In: International Journal of Radiation Oncology Biology Physics. 2016.
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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 = "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.",
author = "Truong, {Minh Tam} and Qiang Zhang and Rosenthal, {David I.} and Marcie List and Rita Axelrod and Eric Sherman and Randal Weber and Nguyen-T{\^a}n, {Phuc Felix} and Adel El-Naggar and Andr{\'e} Konski and James Galvin and David Schwartz and Andy Trotti and Craig Silverman and Anurag Singh and Karen Godette and Bonner, {James A.} and Jones, {Christopher U.} and Garden, {Adam S.} and George Shenouda and Chance Matthiesen and Le, {Quynh Thu} and Deborah Bruner",
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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

PY - 2016/1/4

Y1 - 2016/1/4

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.

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