Mehanna, Hisham, Wong, Wai-Lup, McConkey, Christopher C., Rahman, Joy K., Robinson, Max, Hartley, Andrew G.J., Nutting, Christopher, Powell, Ned George, Al-Booz, Hoda, Robinson, Martin, Junor, Elizabeth, Rizwanullah, Mohammed, V. von Zeidler, Sandra, Wieshmann, Hulya, Hulme, Claire, Smith, Alison F., Hall, Peter and Dunn, Janet 2016. PET-CT Surveillance versus Neck Dissection in Advanced Head and Neck Cancer. New England Journal of Medicine 374 (15) , pp. 1444-1454. 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.
Item Type: | Article |
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Date Type: | Publication |
Status: | Published |
Schools: | Medicine |
Subjects: | R Medicine > R Medicine (General) |
Publisher: | Massachusetts Medical Society |
ISSN: | 0028-4793 |
Funders: | HTA/CRUK |
Date of First Compliant Deposit: | 14 November 2016 |
Date of Acceptance: | 23 March 2016 |
Last Modified: | 02 May 2023 23:57 |
URI: | https://orca.cardiff.ac.uk/id/eprint/96089 |
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