Paired phase II trials evaluating cetuximab and radiotherapy for low risk HPV associated oropharyngeal cancer and locoregionally advanced squamous cell carcinoma of the head and neck in patients not eligible for cisplatin.


Journal

Head & neck
ISSN: 1097-0347
Titre abrégé: Head Neck
Pays: United States
ID NLM: 8902541

Informations de publication

Date de publication:
08 2020
Historique:
received: 18 10 2019
revised: 13 12 2019
accepted: 10 01 2020
pubmed: 29 1 2020
medline: 22 6 2021
entrez: 29 1 2020
Statut: ppublish

Résumé

Alternative therapeutic strategies are needed for localized oropharyngeal carcinoma. Cetuximab represents a potential option for those ineligible for cisplatin or, until recently, an agent for de-escalation in low risk HPV+ oropharyngeal carcinoma (OPSCC). Our objective was to define the toxicity and efficacy of cetuximab-radiotherapy. We conducted paired phase II trials evaluating cetuximab-radiotherapy in two cohorts (a) low risk HPV+ OPSCC and (b) cisplatin ineligible. The mean follow-up was 48 months. Forty-two patients were enrolled in cohort A with a 2-year disease free survival (DFS) of 81%. Twenty-one patients were enrolled in cohort B prior to closure due to adverse outcomes with a 2-year DFS of 37%. Severe toxicities were seen in 60% of patients, 30% required enteral nutrition. Among cisplatin ineligible patients, cetuximab treatment engendered poor outcomes. Rates of severe toxicities were on par with platinum-based regimens suggesting that cetuximab is not a benign treatment.

Sections du résumé

BACKGROUND
Alternative therapeutic strategies are needed for localized oropharyngeal carcinoma. Cetuximab represents a potential option for those ineligible for cisplatin or, until recently, an agent for de-escalation in low risk HPV+ oropharyngeal carcinoma (OPSCC). Our objective was to define the toxicity and efficacy of cetuximab-radiotherapy.
METHODS
We conducted paired phase II trials evaluating cetuximab-radiotherapy in two cohorts (a) low risk HPV+ OPSCC and (b) cisplatin ineligible. The mean follow-up was 48 months.
RESULTS
Forty-two patients were enrolled in cohort A with a 2-year disease free survival (DFS) of 81%. Twenty-one patients were enrolled in cohort B prior to closure due to adverse outcomes with a 2-year DFS of 37%. Severe toxicities were seen in 60% of patients, 30% required enteral nutrition.
CONCLUSION
Among cisplatin ineligible patients, cetuximab treatment engendered poor outcomes. Rates of severe toxicities were on par with platinum-based regimens suggesting that cetuximab is not a benign treatment.

Identifiants

pubmed: 31989702
doi: 10.1002/hed.26085
pmc: PMC7404812
mid: NIHMS1612096
doi:

Substances chimiques

Cetuximab PQX0D8J21J
Cisplatin Q20Q21Q62J

Types de publication

Clinical Trial, Phase II Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

1728-1737

Subventions

Organisme : NCI NIH HHS
ID : P50 CA097248
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA046592
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA131290
Pays : United States
Organisme : NIDCD NIH HHS
ID : T32 DC005356
Pays : United States

Informations de copyright

© 2020 Wiley Periodicals, Inc.

Références

Head Neck. 2019 Apr;41(4):857-864
pubmed: 30775826
JAMA Oncol. 2017 Apr 1;3(4):483-491
pubmed: 28006059
N Engl J Med. 2010 Jul 1;363(1):24-35
pubmed: 20530316
Radiother Oncol. 2009 Jul;92(1):4-14
pubmed: 19446902
Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):915-22
pubmed: 20947269
Lancet Oncol. 2016 Apr;17(4):440-451
pubmed: 26936027
J Clin Oncol. 2013 Feb 10;31(5):543-50
pubmed: 23295795
Oral Oncol. 2019 Apr;91:69-78
pubmed: 30926065
J Clin Oncol. 2019 Jun 20;37(18):1578-1589
pubmed: 31021656
Lancet. 2019 Jan 5;393(10166):40-50
pubmed: 30449625
Lancet Oncol. 2010 Jan;11(1):21-8
pubmed: 19897418
J Natl Cancer Inst. 2008 Feb 20;100(4):261-9
pubmed: 18270337
J Clin Oncol. 2016 Feb 10;34(5):427-35
pubmed: 26644536
J Clin Oncol. 2010 Jun 1;28(16):2732-8
pubmed: 20421546
J Clin Oncol. 2016 Apr 20;34(12):1300-8
pubmed: 26712222
Cancer. 2007 Oct 1;110(7):1429-35
pubmed: 17724670
Am J Surg Pathol. 2012 Jul;36(7):945-54
pubmed: 22743284
CA Cancer J Clin. 2015 Mar;65(2):87-108
pubmed: 25651787
Clin Cancer Res. 2016 Nov 1;22(21):5229-5237
pubmed: 27217441
Lancet. 2000 Mar 18;355(9208):949-55
pubmed: 10768432
N Engl J Med. 2006 Feb 9;354(6):567-78
pubmed: 16467544

Auteurs

Paul L Swiecicki (PL)

Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
Department of Internal Medicine, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan.

Pin Li (P)

Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan.

Emily Bellile (E)

Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan.

Chaz Stucken (C)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Kelly Malloy (K)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Andrew Shuman (A)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Department of Otolaryngology, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan.

Matthew E Spector (ME)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Steven Chinn (S)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Keith Casper (K)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Scott McLean (S)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Jeffery Moyer (J)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Department of Otolaryngology, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan.

Douglas Chepeha (D)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Gregory T Wolf (GT)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Mark Prince (M)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Department of Otolaryngology, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan.

Carol Bradford (C)

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

Mukesh Nyati (M)

Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.

Avraham Eisbruch (A)

Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.

Francis P Worden (FP)

Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.

Shruti Jolly (S)

Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.

Michelle Mierzwa (M)

Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Department of Radiation Oncology, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan.

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