Lead Time to Recurrence After Posttreatment Plasma and Saliva HPV DNA Testing in Patients With Low-Risk HPV Oropharynx Cancer

Joseph Califano; Andrew Yousef; Heba Mostafa; Alexandra Valsamakis; Xinlian Zhang; Nikolaos Batis; Christy Varghese; Joanna Parish; Michael Forman; Junko Jarrett; Karen Messer; Hisham Mehanna

doi:10.1001/jamaoto.2023.1730

Lead Time to Recurrence After Posttreatment Plasma and Saliva HPV DNA Testing in Patients With Low-Risk HPV Oropharynx Cancer

Joseph Califano^*, Andrew Yousef, Heba Mostafa, Alexandra Valsamakis, Xinlian Zhang, Nikolaos Batis, Christy Varghese, Joanna Parish, Michael Forman, Junko Jarrett, Karen Messer, Hisham Mehanna^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

IMPORTANCE: Head and neck squamous cell carcinoma is a highly lethal cancer that is often associated with human papillomavirus (HPV). Recent studies have shown promise in the use of HPV DNA detection in salivary rinses and plasma as a factor associated with a future diagnosis of HPV-positive oropharynx cancer (HPVOPC). However, the use of plasma and salivary HPV DNA detection in defining risk for recurrence in the context of a prospective, phase 3, clinical trial coupled with standardized clinical surveillance has not been reported.

OBJECTIVE: To identify patients with low-risk HPVOPC at risk for recurrence by detection of HPV16 DNA in plasma and salivary rinses.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, 233 low-risk patients were recruited from 32 head and neck treatment centers in Ireland (1 [3.1%]), the Netherlands (1 [3.1%]), and the UK (30 [93.8%]) as part of the DE-ESCALATE HPV trial, an open-label, phase 3 randomized clinical trial examining treatment with cetuximab vs cisplatin for HPVOPC. Patients were assayed for the presence of HPV16 DNA in plasma and salivary rinse via a quantitative polymerase chain reaction-based assay.

MAIN OUTCOMES AND MEASURES: Assay results were associated with risk of recurrence and lead time from HPV16 DNA detection to recurrence.

RESULTS: Of 233 patients, 45 (19.3%) were women, and the mean (SD) age was 57.01 (8.45) years. A total 1040 salivary or blood samples were collected during the course of the study. With a median follow-up of 760 days, the sensitivity and specificity of combined plasma and salivary rinse HPV DNA assays for detecting recurrence were 65% and 87%, respectively. There was a median lead time of positive test to event/recurrence date of 19 days (range, 0-536 days) and mean (SD) of 122 (169.8) days.

CONCLUSION AND RELEVANCE: The results of this cohort study suggest that in the setting of a randomized, prospective, phase 3 trial for low-risk patients with HPVOPC, posttreatment presence of HPV DNA in plasma and salivary rinses is associated with recurrence; a lead time between test positivity and clinical recurrence offers a potential opportunity for earlier detection of recurrence.

Original language	English
Pages (from-to)	812-819
Number of pages	8
Journal	JAMA Otolaryngology - Head and Neck Surgery
Volume	149
Issue number	9
Early online date	27 Jul 2023
DOIs	https://doi.org/10.1001/jamaoto.2023.1730
Publication status	Published - 1 Sept 2023

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Cite this

Califano, J., Yousef, A., Mostafa, H., Valsamakis, A., Zhang, X., Batis, N., Varghese, C., Parish, J., Forman, M., Jarrett, J., Messer, K., & Mehanna, H. (2023). Lead Time to Recurrence After Posttreatment Plasma and Saliva HPV DNA Testing in Patients With Low-Risk HPV Oropharynx Cancer. JAMA Otolaryngology - Head and Neck Surgery, 149(9), 812-819. https://doi.org/10.1001/jamaoto.2023.1730

@article{aefddf6132c64d439a45d28f0e424564,

title = "Lead Time to Recurrence After Posttreatment Plasma and Saliva HPV DNA Testing in Patients With Low-Risk HPV Oropharynx Cancer",

abstract = "IMPORTANCE: Head and neck squamous cell carcinoma is a highly lethal cancer that is often associated with human papillomavirus (HPV). Recent studies have shown promise in the use of HPV DNA detection in salivary rinses and plasma as a factor associated with a future diagnosis of HPV-positive oropharynx cancer (HPVOPC). However, the use of plasma and salivary HPV DNA detection in defining risk for recurrence in the context of a prospective, phase 3, clinical trial coupled with standardized clinical surveillance has not been reported.OBJECTIVE: To identify patients with low-risk HPVOPC at risk for recurrence by detection of HPV16 DNA in plasma and salivary rinses.DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, 233 low-risk patients were recruited from 32 head and neck treatment centers in Ireland (1 [3.1%]), the Netherlands (1 [3.1%]), and the UK (30 [93.8%]) as part of the DE-ESCALATE HPV trial, an open-label, phase 3 randomized clinical trial examining treatment with cetuximab vs cisplatin for HPVOPC. Patients were assayed for the presence of HPV16 DNA in plasma and salivary rinse via a quantitative polymerase chain reaction-based assay.MAIN OUTCOMES AND MEASURES: Assay results were associated with risk of recurrence and lead time from HPV16 DNA detection to recurrence.RESULTS: Of 233 patients, 45 (19.3%) were women, and the mean (SD) age was 57.01 (8.45) years. A total 1040 salivary or blood samples were collected during the course of the study. With a median follow-up of 760 days, the sensitivity and specificity of combined plasma and salivary rinse HPV DNA assays for detecting recurrence were 65% and 87%, respectively. There was a median lead time of positive test to event/recurrence date of 19 days (range, 0-536 days) and mean (SD) of 122 (169.8) days.CONCLUSION AND RELEVANCE: The results of this cohort study suggest that in the setting of a randomized, prospective, phase 3 trial for low-risk patients with HPVOPC, posttreatment presence of HPV DNA in plasma and salivary rinses is associated with recurrence; a lead time between test positivity and clinical recurrence offers a potential opportunity for earlier detection of recurrence.",

author = "Joseph Califano and Andrew Yousef and Heba Mostafa and Alexandra Valsamakis and Xinlian Zhang and Nikolaos Batis and Christy Varghese and Joanna Parish and Michael Forman and Junko Jarrett and Karen Messer and Hisham Mehanna",

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doi = "10.1001/jamaoto.2023.1730",

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volume = "149",

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Califano, J, Yousef, A, Mostafa, H, Valsamakis, A, Zhang, X, Batis, N , Varghese, C , Parish, J, Forman, M, Jarrett, J, Messer, K & Mehanna, H 2023, 'Lead Time to Recurrence After Posttreatment Plasma and Saliva HPV DNA Testing in Patients With Low-Risk HPV Oropharynx Cancer', JAMA Otolaryngology - Head and Neck Surgery, vol. 149, no. 9, pp. 812-819. https://doi.org/10.1001/jamaoto.2023.1730

TY - JOUR

T1 - Lead Time to Recurrence After Posttreatment Plasma and Saliva HPV DNA Testing in Patients With Low-Risk HPV Oropharynx Cancer

AU - Califano, Joseph

AU - Yousef, Andrew

AU - Mostafa, Heba

AU - Valsamakis, Alexandra

AU - Zhang, Xinlian

AU - Batis, Nikolaos

AU - Varghese, Christy

AU - Parish, Joanna

AU - Forman, Michael

AU - Jarrett, Junko

AU - Messer, Karen

AU - Mehanna, Hisham

PY - 2023/9/1

Y1 - 2023/9/1

N2 - IMPORTANCE: Head and neck squamous cell carcinoma is a highly lethal cancer that is often associated with human papillomavirus (HPV). Recent studies have shown promise in the use of HPV DNA detection in salivary rinses and plasma as a factor associated with a future diagnosis of HPV-positive oropharynx cancer (HPVOPC). However, the use of plasma and salivary HPV DNA detection in defining risk for recurrence in the context of a prospective, phase 3, clinical trial coupled with standardized clinical surveillance has not been reported.OBJECTIVE: To identify patients with low-risk HPVOPC at risk for recurrence by detection of HPV16 DNA in plasma and salivary rinses.DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, 233 low-risk patients were recruited from 32 head and neck treatment centers in Ireland (1 [3.1%]), the Netherlands (1 [3.1%]), and the UK (30 [93.8%]) as part of the DE-ESCALATE HPV trial, an open-label, phase 3 randomized clinical trial examining treatment with cetuximab vs cisplatin for HPVOPC. Patients were assayed for the presence of HPV16 DNA in plasma and salivary rinse via a quantitative polymerase chain reaction-based assay.MAIN OUTCOMES AND MEASURES: Assay results were associated with risk of recurrence and lead time from HPV16 DNA detection to recurrence.RESULTS: Of 233 patients, 45 (19.3%) were women, and the mean (SD) age was 57.01 (8.45) years. A total 1040 salivary or blood samples were collected during the course of the study. With a median follow-up of 760 days, the sensitivity and specificity of combined plasma and salivary rinse HPV DNA assays for detecting recurrence were 65% and 87%, respectively. There was a median lead time of positive test to event/recurrence date of 19 days (range, 0-536 days) and mean (SD) of 122 (169.8) days.CONCLUSION AND RELEVANCE: The results of this cohort study suggest that in the setting of a randomized, prospective, phase 3 trial for low-risk patients with HPVOPC, posttreatment presence of HPV DNA in plasma and salivary rinses is associated with recurrence; a lead time between test positivity and clinical recurrence offers a potential opportunity for earlier detection of recurrence.

AB - IMPORTANCE: Head and neck squamous cell carcinoma is a highly lethal cancer that is often associated with human papillomavirus (HPV). Recent studies have shown promise in the use of HPV DNA detection in salivary rinses and plasma as a factor associated with a future diagnosis of HPV-positive oropharynx cancer (HPVOPC). However, the use of plasma and salivary HPV DNA detection in defining risk for recurrence in the context of a prospective, phase 3, clinical trial coupled with standardized clinical surveillance has not been reported.OBJECTIVE: To identify patients with low-risk HPVOPC at risk for recurrence by detection of HPV16 DNA in plasma and salivary rinses.DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, 233 low-risk patients were recruited from 32 head and neck treatment centers in Ireland (1 [3.1%]), the Netherlands (1 [3.1%]), and the UK (30 [93.8%]) as part of the DE-ESCALATE HPV trial, an open-label, phase 3 randomized clinical trial examining treatment with cetuximab vs cisplatin for HPVOPC. Patients were assayed for the presence of HPV16 DNA in plasma and salivary rinse via a quantitative polymerase chain reaction-based assay.MAIN OUTCOMES AND MEASURES: Assay results were associated with risk of recurrence and lead time from HPV16 DNA detection to recurrence.RESULTS: Of 233 patients, 45 (19.3%) were women, and the mean (SD) age was 57.01 (8.45) years. A total 1040 salivary or blood samples were collected during the course of the study. With a median follow-up of 760 days, the sensitivity and specificity of combined plasma and salivary rinse HPV DNA assays for detecting recurrence were 65% and 87%, respectively. There was a median lead time of positive test to event/recurrence date of 19 days (range, 0-536 days) and mean (SD) of 122 (169.8) days.CONCLUSION AND RELEVANCE: The results of this cohort study suggest that in the setting of a randomized, prospective, phase 3 trial for low-risk patients with HPVOPC, posttreatment presence of HPV DNA in plasma and salivary rinses is associated with recurrence; a lead time between test positivity and clinical recurrence offers a potential opportunity for earlier detection of recurrence.

U2 - 10.1001/jamaoto.2023.1730

DO - 10.1001/jamaoto.2023.1730

M3 - Article

C2 - 37498566

SN - 2168-6181

VL - 149

SP - 812

EP - 819

JO - JAMA Otolaryngology - Head and Neck Surgery

JF - JAMA Otolaryngology - Head and Neck Surgery

IS - 9

ER -

Lead Time to Recurrence After Posttreatment Plasma and Saliva HPV DNA Testing in Patients With Low-Risk HPV Oropharynx Cancer

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