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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.). 

Collaborators (59)

Robinson M, Rolles M, Fisher S, Jose J, Lee L, Hwang D, Sharp J, Tierney P, Evans M, Whitaker S, Hartley A, Brammer C, Paleri V, Purohit O, Booz H, Nutting C, Homer J, Christian J, Sanghera B, Jones T, Ahmed I, Griffiths H, Jeannon JP, Junor E, Ramachandra P, Fresco L, Ahmed I, Hurman D, Sanghera P, Jones J, Pracy P, Jennings C, Martin T, Parmar S, Moor J, Thompson A, Goodchild K, Loo V, Kim D, Primrose W, Balfour A, Wight R, Balfour A, Cook A, Roy A, Biswas A, Sutton D, Cogill G, Horner J, Goodchild K, Junor E, Ahmed I, Davies J, Forster M, Sivaramalingham M, De Winton E, Rizwanullah M, Thompson A, Biswas A.

Author information

Mehanna H1, Wong WL1, McConkey CC1, Rahman JK1, Robinson M1, Hartley AG1, Nutting C1, Powell N1, Al-Booz H1, Robinson M1, Junor E1, Rizwanullah M1, von Zeidler SV1, Wieshmann H1, Hulme C1, Smith AF1, Hall P1, Dunn J1; PET-NECK Trial Management Group.​

1From the Institute of Head and Neck Studies and Education, University of Birmingham (H.M.), and University Hospitals Birmingham (A.G.J.H.), Birmingham, Paul Strickland Scanner Centre, Mount Vernon Hospital, Northwood (W.-L.W.), Warwick Clinical Trials Unit, University of Warwick, Coventry (C.C.M., J.K.R., J.D.), Newcastle University, Newcastle upon Tyne (Max Robinson), Royal Marsden Hospital, London (C.N.), Cardiff University, Cardiff (N.P.), Bristol Haematology and Oncology Centre, Bristol (H.A.-B.), Weston Park Hospital, Sheffield (Martin Robinson), Western General Hospital, Edinburgh (E.J.), Beatson West of Scotland Cancer Centre, Glasgow (M. Rizwanullah), University of Liverpool, Liverpool (H.W.), and the Academic Unit of Health Economics, University of Leeds, Leeds (C.H., A.F.S., P.H.) - all in the United Kingdom; and the Pathology Department, Universidade Federal do Espírito Santo, Vitória, Brazil (S.V.Z.).