Online citations, reference lists, and bibliographies.

Phase 2 Trial Of De-intensified Chemoradiation Therapy For Favorable-Risk Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma.

Bhishamjit S. Chera, Robert J Amdur, Joel E Tepper, Bahjat F. Qaqish, Rebecca L. Green, Shannon L. Aumer, Neil D. Hayes, Jared M Weiss, Juneko E Grilley-Olson, Adam Mikial Zanation, Trevor Hackman, William K. Funkhouser, Nathan Christopher Sheets, Mark Christian Weissler, William M Mendenhall
Published 2015 · Medicine
Cite This
Download PDF
Analyze on Scholarcy
Share
PURPOSE To perform a prospective, multi-institutional, phase 2 study of a substantial decrease in concurrent chemoradiation therapy (CRT) intensity as primary treatment for favorable-risk, human papillomavirus-associated oropharyngeal squamous cell carcinoma. METHODS AND MATERIALS The major inclusion criteria were: (1) T0 to T3, N0 to N2c, M0; (2) human papillomavirus or p16 positive; and (3) minimal/remote smoking history. Treatment was limited to 60 Gy intensity modulated radiation therapy with concurrent weekly intravenous cisplatinum (30 mg/m(2)). The primary study endpoint was pathologic complete response (pCR) rate based on required biopsy of the primary site and dissection of pretreatment positive lymph node regions, regardless of radiographic response. Power computations were performed for the null hypothesis that the pCR rate is 87% and n=40, resulting in a type 1 error of 14.2%. Secondary endpoint measures included physician-reported toxicity (Common Toxicity Terminology for Adverse Events, CTCAE), patient-reported symptoms (PRO-CTCAE), and modified barium swallow studies. RESULTS The study population was 43 patients. The pCR rate was 86% (37 of 43). The incidence of CTCAE grade 3/4 toxicity and PRO-CTCAE severe/very severe symptoms was as follows: mucositis 34%/45%, general pain 5%/48%, nausea 18%/52%, vomiting 5%/34%, dysphagia 39%/55%, and xerostomia 2%/75%. Grade 3/4 hematologic toxicities were 11%. Thirty-nine percent of patients required a feeding tube for a median of 15 weeks (range, 5-22 weeks). There were no significant differences in modified barium swallow studies before and after CRT. CONCLUSIONS The pCR rate with decreased intensity of therapy with 60 Gy of IMRT and weekly low-dose cisplatinum is very high in favorable-risk oropharyngeal squamous cell carcinoma, with evidence of decreased toxicity compared with standard therapies. ClinicalTrials.gov ID: NCT01530997.
This paper references
10.1002/cncr.20069
Is concurrent chemoradiation the treatment of choice for all patients with Stage III or IV head and neck carcinoma?
Adam S Garden (2004)
10.1093/annonc/mdq219
Concomitant chemoradiation versus radical radiotherapy in advanced squamous cell carcinoma of oropharynx and nasopharynx using weekly cisplatin: a phase II randomized trial.
Alpana Sharma (2010)
10.1200/jco.2014.32.18_suppl.lba6006
E1308: Reduced-dose IMRT in human papilloma virus (HPV)-associated resectable oropharyngeal squamous carcinomas (OPSCC) after clinical complete response (cCR) to induction chemotherapy (IC).
Shuli Li (2014)
10.1093/jnci/djh183
Genetic patterns in head and neck cancers that contain or lack transcriptionally active human papillomavirus.
Boudewijn J. M. Braakhuis (2004)
10.1002/cncr.23279
Lymph node-positive head and neck cancer treated with definitive radiotherapy: can treatment response determine the extent of neck dissection?
Anamaria Reyna Yeung (2008)
10.1200/JCO.1999.17.3.1008
Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35.
Kristin Bjordal (1999)
10.1093/jnci/djn011
Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial.
Carole Fakhry (2008)
10.1097/00005537-199911000-00010
Management implications of evaluating the N2 and N3 neck after organ preservation therapy.
Mark Strasser (1999)
10.1001/archotol.128.1.44
Development and validation of the neck dissection impairment index: a quality of life measure.
Rodney J. Taylor (2002)
10.1016/0360-3016(93)90167-T
Evaluation of the dose for postoperative radiation therapy of head and neck cancer: first report of a prospective randomized trial.
Lester J. Peters (1993)
10.1159/000355194
Cisplatin versus Cetuximab Given Concurrently with Definitive Radiation Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Jessica Ley (2013)
10.1158/1078-0432.CCR-07-1402
Inverse Relationship between Human Papillomavirus-16 Infection and Disruptive p53 Gene Mutations in Squamous Cell Carcinoma of the Head and Neck
William H Westra (2008)
10.1016/j.ijrobp.2013.12.027
Final results of local-regional control and late toxicity of RTOG 9003: a randomized trial of altered fractionation radiation for locally advanced head and neck cancer.
Jonathan J. Beitler (2014)
10.1002/hed.21669
Transoral laser microsurgery as primary treatment for advanced-stage oropharyngeal cancer: a United States multicenter study.
Bruce H. Haughey (2011)
10.1200/JCO.2003.01.008
An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer.
David Adelstein (2003)
10.1016/j.radonc.2006.03.010
A phase II study of concomitant boost radiation plus concurrent weekly cisplatin for locally advanced unresectable head and neck carcinomas.
José Antonio Valero Medina (2006)
10.1002/hed.21224
Comprehensive IMRT plus weekly cisplatin for advanced head and neck cancer: the University of Wisconsin experience.
Anne M. Traynor (2010)
10.1016/S1470-2045(13)70011-1
Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial.
Robert I. Haddad (2013)
10.1016/j.ejca.2010.04.016
Relationships between epidermal growth factor receptor expression and human papillomavirus status as markers of prognosis in oropharyngeal cancer.
Angela M. Hong (2010)
10.1093/jnci/dju244
Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).
Ethan M. Basch (2014)
10.1200/JCO.2011.36.4596
Human papillomavirus and rising oropharyngeal cancer incidence in the United States.
Anil K Chaturvedi (2011)
10.1002/cncr.25189
Concomitant weekly cisplatin and altered fractionation radiotherapy in locally advanced head and neck cancer.
Heather E. Newlin (2010)
10.1093/jnci/85.5.365
The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.
Neil K Aaronson (1993)
10.1200/JCO.2008.20.2853
Effect of HPV-associated p16INK4A expression on response to radiotherapy and survival in squamous cell carcinoma of the head and neck.
Pernille Lassen (2009)
10.1016/S1470-2045(09)70311-0
Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival.
James A. Bonner (2010)
10.1016/J.IJROBP.2015.07.1377
On the Feasibility of the Dosimetric Compliance Criteria of NRG-HN002: A Randomized Phase 2 Trial for Patients With p16-Positive, Nonsmoking-Associated, Locoregionally Advanced Oropharyngeal Cancer
Tawfik Giaddui (2015)
10.1007/BF00417897
A penetration-aspiration scale
John C. Rosenbek (2004)
10.1016/S1470-2045(06)70910-X
Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study.
Ethan M. Basch (2006)
10.1056/NEJMoa0912217
Human papillomavirus and survival of patients with oropharyngeal cancer.
K Kian Ang (2010)
10.1056/NEJMoa053422
Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck.
James A. Bonner (2006)
10.1093/jnci/dju127
Recommended patient-reported core set of symptoms to measure in head and neck cancer treatment trials.
Bhishamjit S. Chera (2014)
10.1016/j.ijrobp.2009.02.015
The relationship between human papillomavirus status and other molecular prognostic markers in head and neck squamous cell carcinomas.
Christina S. Kong (2009)
10.1056/NEJM200104123441503
Human papillomavirus infection as a risk factor for squamous-cell carcinoma of the head and neck.
Jon Mork (2001)
10.1001/archotol.1991.01870180037007
Standardizing neck dissection terminology. Official report of the Academy's Committee for Head and Neck Surgery and Oncology.
Kevin Thomas Robbins (1991)
10.1016/j.ijrobp.2010.07.008
Concurrent cisplatin and radiation versus cetuximab and radiation for locally advanced head-and-neck cancer.
Lawrence Koutcher (2011)
10.1177/000348940811701210
Validity and Reliability of the Eating Assessment Tool (EAT-10)
Peter C Belafsky (2008)
10.1056/NEJMoa065497
Case-control study of human papillomavirus and oropharyngeal cancer.
Gypsyamber D’souza (2007)
10.1200/JCO.2007.14.8841
Factors associated with severe late toxicity after concurrent chemoradiation for locally advanced head and neck cancer: an RTOG analysis.
Mitchell Machtay (2008)
10.1200/JCO.2012.44.0164
Deintensification candidate subgroups in human papillomavirus-related oropharyngeal cancer according to minimal risk of distant metastasis.
B O'Sullivan (2013)



This paper is referenced by
10.1016/j.ijrobp.2016.06.2456
Methods for Reducing Normal Tissue Complication Probabilities in Oropharyngeal Cancer: Dose Reduction or Planning Target Volume Elimination.
Stuart E. Samuels (2016)
10.1016/j.ijrobp.2017.02.022
The Older Adult With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma: Knowledge Gaps and Future Direction in Assessment and Treatment.
Ronald J Maggiore (2017)
10.1016/j.oraloncology.2018.09.020
The interplay of IMRT and transoral surgery in HPV-mediated oropharyngeal cancer: Getting the balance right.
Shao Hui Huang (2018)
10.1016/j.ijrobp.2017.03.034
Dosimetric Predictors of Patient-Reported Xerostomia and Dysphagia With Deintensified Chemoradiation Therapy for HPV-Associated Oropharyngeal Squamous Cell Carcinoma.
Bhishamjit S. Chera (2017)
10.1016/j.prro.2016.12.004
Beware of deintensification of radiation therapy in patients with p16-positive oropharynx cancer and rheumatological diseases.
Bhishamjit S. Chera (2017)
10.1007/s11912-016-0541-x
The Role of Transoral Robotic Surgery in the Management of HPV Negative Oropharyngeal Squamous Cell Carcinoma
Ryan Sload (2016)
10.1002/hed.25535
Shoulder symptoms and quality of life impact of limited neck dissection after de‐intensified chemoradiotherapy: Secondary analysis of two prospective trials
Kyle Wang (2019)
10.1016/j.otc.2017.03.008
Through the Glass Brightly: Pathology Review in the Multidisciplinary Setting.
Margaret Brandwein-Weber (2017)
10.1007/s10147-016-1009-6
Clinical features and treatment strategy for HPV-related oropharyngeal cancer
Kenji Okami (2016)
10.1002/lary.27351
Radiographic muscle invasion not a recurrence predictor in HPV-associated oropharyngeal squamous cell carcinoma.
Zainab Farzal (2019)
10.1016/j.radonc.2017.06.020
Dose-volume toxicity modeling for de-intensified chemo-radiation therapy for HPV-positive oropharynx cancer.
Panayiotis Mavroidis (2017)
10.1002/hed.25337
Pretreatment metabolic tumor volume as a prognostic factor in HPV‐associated oropharyngeal cancer in the context of AJCC 8th edition staging
John M Floberg (2018)
10.1002/lary.26460
Radiotherapy alone or combined with chemotherapy for base of tongue squamous cell carcinoma.
Kaitlin M. Christopherson (2017)
10.1200/JCO.19.02444
Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer
Bhishamjit S. Chera (2020)
10.1016/j.semradonc.2016.05.004
Successes and Failures of Combined Modality Therapies in Head and Neck Cancer.
Daniel W. Bowles (2016)
10.1016/j.prro.2018.03.009
Incidence of radiographically occult nodal metastases in HPV+ oropharyngeal carcinoma: Implications for reducing elective nodal coverage.
Gokoulakrichenane Loganadane (2018)
10.1016/j.hoc.2019.08.019
The Evolving Role of Radiotherapy for Head and Neck Cancer.
David L. Schwartz (2020)
10.1016/J.CTRO.2019.06.005
Chronic radiation-associated dysphagia in oropharyngeal cancer survivors: Towards age-adjusted dose constraints for deglutitive muscles.
Anderson Head (2019)
10.1016/j.jgo.2016.01.010
Concurrent chemoradiotherapy in older adults with squamous cell head & neck cancer: Evidence and management.
Vivek Verma (2016)
10.1016/j.ijrobp.2016.06.002
The Challenges of Treatment Adaptation and De-intensification in Human Papillomavirus-Positive Oropharyngeal Cancer: The Difficult Journey Back.
John N. Waldron (2016)
10.1016/j.oraloncology.2020.104609
Factors associated with HPV testing in oropharyngeal cancer in the National Cancer Data Base from 2013 to 2015.
Angela L Mazul (2020)
10.3390/cancers8080075
HPV Associated Head and Neck Cancer
Tara Spence (2016)
10.1017/S1460396919000189
Dosimetric changes achieved and changes in target and parotid volumes in patients undergoing adaptive planning during chemoradiation therapy with helical delivery of treatment
Michael A Cummings (2019)
10.1016/j.canrad.2019.12.003
[Treatment de-intensification strategies for HPV-driven oropharyngeal cancer: A short review].
Chaimaa Lahmamssi (2020)
10.1016/j.oraloncology.2016.04.015
Impact of post-chemoradiotherapy superselective/selective neck dissection on patient reported quality of life.
Kyle Wang (2016)
10.1001/jamaoto.2018.0602
RNA Oncoimmune Phenotyping of HPV-Positive p16-Positive Oropharyngeal Squamous Cell Carcinomas by Nodal Status
Wesley H. Stepp (2018)
10.1007/s10555-017-9686-9
The role of human papillomavirus on the prognosis and treatment of oropharyngeal carcinoma
Nicholas Fung (2017)
10.1155/2019/9173729
Advances in the Management of HPV-Related Oropharyngeal Cancer
Francesca De Felice (2019)
10.25670/OI2019-010ON
Možnosti deintenzifikacije zdravljenja HPV pozitivnih ploščatoceličnih karcinomov orofarinksa
Gaber Plavc (2019)
10.1016/j.ejca.2018.08.015
Human papillomavirus-associated oropharyngeal cancer among patients aged 70 and older: Dramatically increased prevalence and clinical implications.
Diana J Lu (2018)
10.1055/S-0043-121596
HPV – Das andere Kopf-Hals-Karzinom
Claus Wittekindt (2018)
10.1016/j.semradonc.2017.08.005
Therapeutic Implications of the Genetic Landscape of Head and Neck Cancer.
Janice Cho (2018)
See more
Semantic Scholar Logo Some data provided by SemanticScholar