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PET-CT surveillance versus neck dissection in advanced head and neck cancer

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Mehanna, Hisham, Wong, Wai-Lup, McConkey, Christopher C., Rahman, Joy K., Robinson, Max, Hartley, Andrew G.J., Nutting, Christopher, Powell, Ned, Al-Booz, Hoda, Robinson, Martin, Junor, Elizabeth, Rizwanullah, Mohammed, von Zeidler, Sandra L. V., Wieshmann, Hulya, Hulme, Claire, Smith, Alison F., Hall, Peter and Dunn, Janet A. (2016) PET-CT surveillance versus neck dissection in advanced head and neck cancer. New England Journal Of Medicine, 374 (15). pp. 1444-1454. doi:10.1056/NEJMoa1514493

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Official URL: http://dx.doi.org/10.1056/NEJMoa1514493

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Abstract

Background

The role of image-guided surveillance as compared with planned neck dissection in the treatment of patients with squamous-cell carcinoma of the head and neck who have advanced nodal disease (stage N2 or N3) and who have received chemoradiotherapy for primary treatment is a matter of debate.

Methods

In this prospective, randomized, controlled trial, we assessed the noninferiority of positron-emission tomography–computed tomography (PET-CT)–guided surveillance (performed 12 weeks after the end of chemoradiotherapy, with neck dissection performed only if PET-CT showed an incomplete or equivocal response) to planned neck dissection in patients with stage N2 or N3 disease. The primary end point was overall survival.

Results

From 2007 through 2012, we recruited 564 patients (282 patients in the planned-surgery group and 282 patients in the surveillance group) from 37 centers in the United Kingdom. Among these patients, 17% had nodal stage N2a disease and 61% had stage N2b disease. A total of 84% of the patients had oropharyngeal cancer, and 75% had tumor specimens that stained positive for the p16 protein, an indicator that human papillomavirus had a role in the causation of the cancer. The median follow-up was 36 months. PET-CT–guided surveillance resulted in fewer neck dissections than did planned dissection surgery (54 vs. 221); rates of surgical complications were similar in the two groups (42% and 38%, respectively). The 2-year overall survival rate was 84.9% (95% confidence interval [CI], 80.7 to 89.1) in the surveillance group and 81.5% (95% CI, 76.9 to 86.3) in the planned-surgery group. The hazard ratio for death slightly favored PET-CT–guided surveillance and indicated noninferiority (upper boundary of the 95% CI for the hazard ratio, <1.50; P=0.004). There was no significant difference between the groups with respect to p16 expression. Quality of life was similar in the two groups. PET-CT–guided surveillance, as compared with neck dissection, resulted in savings of £1,492 (approximately $2,190 in U.S. dollars) per person over the duration of the trial.

Conclusions

Survival was similar among patients who underwent PET-CT–guided surveillance and those who underwent planned neck dissection, but surveillance resulted in considerably fewer operations and it was more cost-effective. (Funded by the National Institute for Health Research Health Technology Assessment Programme and Cancer Research UK; PET-NECK Current Controlled Trials number, ISRCTN13735240.)

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit
Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Head -- Cancer -- Treatment, Neck -- Cancer -- Treatment, Tomography, Emission, Surgery
Journal or Publication Title: New England Journal Of Medicine
Publisher: Massachusetts Medical Society
ISSN: 1533-4406
Official Date: 23 March 2016
Dates:
DateEvent
23 March 2016Published
2015Accepted
Volume: 374
Number: 15
Page Range: pp. 1444-1454
DOI: 10.1056/NEJMoa1514493
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
06/302/129[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
C19677/A9674Cancer Research UKhttp://dx.doi.org/10.13039/501100000289

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