PET-CT Surveillance versus Neck Dissection in Advanced Head and Neck Cancer

PET-CT Surveillance versus Neck Dissection in Advanced Head and Neck Cancer

Hisham Mehanna, Ph.D., Wai-Lup Wong, F.R.C.R., Christopher C. McConkey, Ph.D., Joy K. Rahman, M.Sc., Max Robinson, Ph.D., Andrew G.J. Hartley, F.R.C.R., Christopher Nutting, Ph.D., Ned Powell, Ph.D., Hoda Al-Booz, F.R.C.R., Martin Robinson, F.R.C.R., Elizabeth Junor, F.R.C.R., Mohammed Rizwanullah, F.R.C.R., Sandra V. von Zeidler, Ph.D., Hulya Wieshmann, F.R.C.R., Claire Hulme, Ph.D., Alison F. Smith, M.Sc., Peter Hall, Ph.D., and Janet Dunn, Ph.D., for the PET-NECK Trial Management Group

N Engl J Med 2016; 374:1444-1454April 14, 2016DOI: 10.1056/NEJMoa1514493

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.)

Presented in part at the Annual Meeting of the American Society of Clinical Oncology, Chicago, May 29–June 2, 2015.

Supported by academic grants from the National Institute for Health Research Health Technology Assessment Programme (06/302/129) and Cancer Research UK (C19677/A9674, for tissue-sample collection).

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on March 23, 2016, at NEJM.org.

Address reprint requests to Dr. Mehanna at the Institute of Head and Neck Studies and Education, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom, or at h.mehanna@bham.ac.uk.

A complete list of investigators in the PET-NECK Trial Management Group is provided in the Supplementary Appendix, available at NEJM.org.