CHICAGO – Elective neck dissection at the time of primary surgery for early oral cancers increased overall survival by 12.5% compared with a watch-and-wait approach.
The risk of death was reduced by 36% among patients randomized in a phase III trial to neck lymph node dissection at the time of primary surgery, and the risk of recurrences was reduced by 55%, reported Dr. Anil K. D’Cruz from the head and neck service of the Tata Memorial Centre in Mumbai, India.
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Dr. Anil K. D'Cruz
“Elective neck dissection should be the standard of care for early oral, node-negative squamous cell cancers, based on the findings of our study. For every eight patients undergoing elective neck dissection, one death is prevented, and for every four patients who undergo elective neck dissection, one recurrence is prevented,” he said at a briefing prior to his presentation of the data in a plenary session at the annual meeting of the American Society of Clinical Oncology.
“Dr. D’Cruz should be congratulated on such a robust study that will impact the lives of potentially over 300,000 people with oral cancer globally. This is particularly important in countries and in populations where there are multiple barriers to health care. This ‘one and done’ approach we know now definitively improves survival,” commented ASCO Expert Dr. Jyoti D. Patel from the Feinberg School of Medicine at Northwestern University, Chicago.
Dr. Patel moderated the briefing, but was not involved in the study.
Results of the study are also published online in the New England Journal of Medicine.
Cancers of the lips and oral cavity are especially prevalent in countries where tobacco use and excessive alcohol consumption are common, with these two risk factors alone accounting for an estimated 90% of oral cancer diagnoses.
Neil Osterweil/Frontline Medical News
Dr. Jyoti D. Patel
Until now, management of neck lymph nodes at the time of primary surgery for oral cancers has been controversial, due to a lack of clear evidence of a survival disadvantage to waiting until recurrence before performing a neck dissection, and to concerns about additional surgical procedures with their associated morbidities, including nerve injury and shoulder dysfunction, Dr. D’Cruz said in an interview.
In an attempt to settle the question, Dr. D’Cruz and colleagues conducted a randomized trial in which patients with early stage oral squamous cell carcinomas (stage T1-T2,N0) underwent perioral excision of the primary tumor and were then assigned to either elective neck dissection, or an observation (watch and wait) strategy to be followed by therapeutic neck dissection for nodal relapses.
The trial was terminated early because of evident benefit after 596 patients had been recruited. Dr. D’Cruz presented data from the second interim analysis of 500 patients with a least 9 months of follow-up, 245 of whom had been randomized to upfront neck dissection, and 255 of whom were assigned to watch-and-wait. There were 427 cancers of the tongue, 68 of the buccal mucosa, and 5 of the floor of the mouth.
At a median follow-up of 39 months, 50 patients treated with elective neck dissection had died, compared with 79 patients treated with observation, translating into a 12.5% improvement in overall survival for the elective strategy.
The upfront neck dissection strategy was associated with a 23.6% absolute increase in 3-year overall survival (80% vs. 67.5%, hazard ratio [HR] 0.63, P = .01). The benefits of elective dissection on both overall survival and disease-free survival remained after adjustment for stratification factors, Dr. D’Cruz said.
For the secondary endpoint of disease-free survival, there were 81 recurrences among patients treated with elective dissection, compared with 146 for those assigned to watch and wait. This translated into respective DFS rates of 69.5% and 45.9% (HR 0.45 P < .001).
The rates of adverse events were 6.6% for patients treated with elective dissection, compared with 3.6% for patients who underwent therapeutic dissection.
Dr. Hisham Mehanna, from the Institute of Head and Neck Studies and Eduation at the University of Birmingham, United Kingdom, the invited discussant, commented in the plenary that sentinel node biopsy might be an effective method for monitoring patients for recurrence, thus sparing the possible need for upfront dissection with its attendant morbidities. Surveillance by clinical follow-up alone, however, is not adequate, and in settings where only clinical follow-up is available (such as in low resource settings), elective neck dissection should become the standard of care, he recommended.
The study was sponsored by India’s Department of Atomic Energy Clinical Trial Center. Dr. D’Cruz and Dr. Patel reported having no disclosures relevant to the study.