Patients with advanced head and neck cancer who have already received chemoradiotherapy can be followed with PET-CT-guided surveillance instead of undergoing surgery, concludes a new study from the United Kingdom.
The study was published online March 23 in the New England Journal of Medicine.
The results show a similar survival rate for the two options.
The 2-year overall survival rate was 84.9% in the group and 81.5% in the planned-surgery group
The surveillance option was more cost-effective. During the 2-year minimum follow-up period, the cost saving was about $2190 per person, compared with surgery.
"We believe now that there is very compelling evidence to support surveillance with PET-CT scanning," said lead author Hisham Mehanna, PhD, BMedSc (hons), MBChB (hons), chair of head and neck surgery at the University of Birmingham in the United Kingdom.
"This is level I evidence from a randomized controlled trial," he told Medscape Medical News.
Dr Mehanna pointed out that in the United Kingdom, guidelines for head and neck cancer have been changed to recommend surveillance. The new amended guidelines "are due to come out in next month," he said.
For select patients, surveillance does have advantages, as it spares the patient from undergoing unnecessary surgery and lowers the cost of care.
"The best patients for surveillance are those with advanced nodal disease and who are being treated with primary chemoradiotherapy, such as those with laryngeal or oropharyngeal cancers," Dr Mehanna explained.
Already in American Guidelines
However, in the United States, functional imaging is already widely used in this patient population and is already included in treatment guidelines.
Chemoradiation has become a primary treatment in patients with head and neck squamous cell carcinoma. At the same time, functional imaging "was coming of age," explained Gregory T. Wolf, MD, professor emeritus in the Department of Otolaryngology-Head and Neck Surgery at the University of Michigan Health System in Ann Arbor
"The combination of those two events led investigators to look at using functional imaging to decide whether a patient who was treated nonsurgically initially needed to have neck dissection," he told Medscape Medical News.
Dr Wolf explained that he is on the National Comprehensive Cancer Network (NCCN) guidelines committee for head and neck cancer, and around 2009, the NCCN developed guidelines for post-treatment functional imaging. This was adopted in the 2010 guidelines.
"That was a decision supported by consensus of committee members in terms of using scanning to avoid neck dissection," Dr Wolf said. "But the evidence was based on single-institution retrospective cohort studies."
This study "adds level I evidence to the use of functional imaging as a surveillance mechanism for patients who have definitive treatment with radiation and chemotherapy," he emphasised.
When the NCCN guidelines for the United States are revised, this new evidence will be included and the guideline algorithm will be changed to level I.
Although "this isn't particularly new to investigators in this country, as it is already routine practice, this is an important study because it has a large number of patients and contributes to firming up the evidence," Dr Wolf said.
The shortcomings of the study are that almost all of the patients had oropharyngeal cancer and were human papillomavirus (HPV)-positive. "That is biologically a different disease than the smoking-related head and neck cancers that we've treated over the past decades," he added. "Therefore, extrapolating these findings to all patients with head and neck cancer might still be questioned."
Similar Survival and Control
For their study, Dr Mehanna and colleagues conducted a prospective randomized controlled trial that assessed the noninferiority of PET-CT-guided surveillance (performed 12 weeks after the end of chemoradiotherapy) in patients with nodal stage N2 or N3, metastasis stage M0 disease.
Neck dissection performed only if PET-CT showed an incomplete or equivocal response.
The cohort consisted of 564 patients (282 patients in the planned-surgery group and 282 patients in the surveillance group) from 37 centers in the United Kingdom.
In this group, 17% had stage N2a disease, 61% had stage N2b disease, and 84% had oropharyngeal cancer. In addition, 75% had tumors that stained positive for the p16 protein, which is an indicator that HPV played a role in the cancer's development.
The median follow-up was 36 months.
The results show that patients in the PET-CT-guided surveillance had fewer neck dissections than did planned dissection surgery (54 vs 221), but rates of surgical complications were similar in the two groups (42% vs 38%).
The hazard ratio for death slightly favored PET-CT-guided surveillance and indicated noninferiority (upper boundary of the 95% confidence interval for the hazard ratio, <1 .50="" em="" nbsp="">P1>
The 2-year rate of locoregional control was 91.9% in the surveillance group and 91.4% in the planned-surgery group.
In the planned-surgery group, the 2-year rate of locoregional control was 90.4% among patients who underwent neck dissection after chemoradiotherapy and 94.8% for those patients who underwent neck dissection before chemoradiotherapy.
There was no significant difference between the groups as far as p16 expression.
Quality of life was also similar in the two groups.
The study was supported by academic grants from the National Institute for Health Research Health Technology Assessment Programme and Cancer Research UK. Dr Mehanna reports receiving grant support from GlaxoSmithKline and Silence Therapeutics; grant and nonfinancial support from Sanofi Pasteur and Merck Sharpe & Dohme; personal fees from AstraZeneca; personal fees and other support from Warwickshire Head and Neck Clinic LTD; and nonfinancial support from Merck outside the submitted work. Several of the coauthors report financial relationship, as noted in the publication.
N Engl J Med. Published online March 23, 2016.