Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck

M J Awan; L Nedzi; D Wang; V Tumati; B Sumer; X -J Xie; I Smith; J Truelson; R Hughes; L L Myers; P Lavertu; S Wong; M Yao

doi:10.1093/annonc/mdy018

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Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck

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Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck

M J Awan, L Nedzi, D Wang, V Tumati, B Sumer, X -J Xie, I Smith, J Truelson, R Hughes, L L Myers, …

Annals of oncology, Vol.29(4), pp.998-1003

04/01/2018

DOI: 10.1093/annonc/mdy018

PMID: 29346519

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Abstract

Abstract Background The optimal regimen of chemotherapy and reirradiation (re-XRT) for recurrent head and neck squamous cell carcinoma (HNSCC) is controversial. We report the final outcomes of a multicenter phase II trial evaluating cetuximab and cisplatin-based chemotherapy concurrent with re-XRT for patients with recurrent HNSCC. Materials and methods Patients with unresectable recurrent disease or positive margins after salvage surgery arising within a previously irradiated field with KPS ≥ 70 were eligible for this trial. Cetuximab 400 mg/m2 was delivered as a loading dose in week 1 followed by weekly cetuximab 250 mg/m2 and cisplatin 30 mg/m2 concurrent with 6 weeks of intensity-modulated radiotherapy to a dose of 60-66 Gy in 30 daily fractions. Patients who previously received both concurrent cetuximab and cisplatin with radiation or who received radiotherapy less than 6 months prior were ineligible. Results From 2009 to 2013, 48 patients enrolled on this trial, 2 did not receive any protocol treatment. Of the remaining 46 patients, 34 were male and 12 female, with a median age of 62 years (range 36-85). Treatment was feasible and only 1 patient did not complete the treatment course. Common grade 3 or higher acute toxicities were lymphopenia (46%), pain (22%), dysphagia (13%), radiation dermatitis (13%), mucositis (11%) and anorexia (11%). There were no grade 5 acute toxicities. Eight grade 3 late toxicities were observed, four of which were swallowing related. With a median follow-up of 1.38 years, the 1-year overall survival (OS) was 60.4% and 1-year recurrence-free survival was 34.1%. On univariate analysis, OS was significantly improved with young age (P = 0.01). OS was not associated with radiation dose, surgery before re-XRT or interval from prior XRT. Conclusions Concurrent cisplatin and cetuximab with re-XRT is feasible and offers good treatment outcomes for patients with high-risk features. Younger patients had significantly improved OS. ClinicalTrials.Gov Identifier NCT00833261

reirradiation

cetuximab

head and neck cancer

cisplatin

Details

Title: Subtitle: Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck
Creators: M J Awan - Case Western Reserve University
L Nedzi - The University of Texas Southwestern Medical Center
D Wang - Rush University Medical Center
V Tumati - The University of Texas Southwestern Medical Center
B Sumer - Department of Otolaryngology Head and Neck Surgery, USA
X -J Xie - Department of Clinical Sciences, University of Texas Southwestern, Dallas, USA
I Smith - The University of Texas Southwestern Medical Center
J Truelson - Department of Otolaryngology Head and Neck Surgery, USA
R Hughes - The University of Texas Southwestern Medical Center
L L Myers - Department of Otolaryngology Head and Neck Surgery, USA
P Lavertu - University Hospitals of Cleveland
S Wong - Medical College of Wisconsin
M Yao - University Hospitals of Cleveland
Resource Type: Journal article
Publication Details: Annals of oncology, Vol.29(4), pp.998-1003
DOI: 10.1093/annonc/mdy018
PMID: 29346519
NLM abbreviation: Ann Oncol
ISSN: 0923-7534
eISSN: 1569-8041
Publisher: Oxford University Press
Grant note: CA225314 / Bristol-Myers Squibb (10.13039/100002491)
Language: English
Date published: 04/01/2018
Academic Unit: Preventive and Community Dentistry; Biostatistics; Dental Research
Record Identifier: 9984367738702771

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