Removing lymph nodes in the neck before they are affected by oral squamous cell cancer is a life-saving measure and should be adopted as a new standard in treating the disease, according to the results of a phase 3 study.
The randomized phase 3 study showed an improvement in overall survival and a reduction in the risk of death and recurrence when the nodes were removed during patients’ initial surgery for early-stage, node-negative, oral squamous cell cancer (SCC), rather than in a separate operation after a recurrence of the disease.
The findings were presented by lead author Anil D’Cruz during a press briefing May 31 during the 2015 annual meeting of the American Society of Clinical Oncology (ASCO), a gathering of nearly 30,000 oncology professionals in Chicago.
“Our study is the first to conclusively prove that more lives can be saved with elective neck dissection,” said D’Cruz, adding that the results resolve a question doctors have been asking for more than five decades. There is currently wide variation in this setting regarding whether nodes are removed before or after a relapse.
Oral cancer is a global problem affecting more than 300,000 individuals in both developed and developing countries, D’Cruz stressed. “It is seen anywhere where there is an excessive consumption of alcohol and tobacco,” which is responsible for 90 percent of oral cancer diagnoses, according to ASCO.
D’Cruz is a professor and chief of the Department of Head and Neck Surgery at Tata Memorial Centre in Mumbai, where the trial was carried out between 2004 and 2014. The trial recruited 596 patients with stage 1 or 2 oral SCC and no lymph node involvement.
The findings reported at ASCO are drawn from an interim analysis involving 500 patients who, after excision of their primary tumors, were randomly assigned to therapeutic neck dissection (TND; n = 255), also known as “watch and wait,” or elective neck dissection (END; n = 245).
The trial arms were balanced based on tumor site and stage: 427 of the cases involved the tongue, 68 affected the buccal mucosa, and five were tumors at the floor of the mouth; 221 patients had stage 1 tumors and 279 were stage 2. Overall survival (OS) was the study’s primary endpoint.
Three-year OS was significantly better in the END cohort compared with the TND group: 80.0 percent vs 67.5 percent, respectively (hazard ratio [HR] = 0.63; 95 percent confidence interval [CI], 0.44-0.89; P =.01).
The study’s secondary endpoint was disease-free survival. After a median follow-up of 39 months, 146 recurrences were reported in the TND arm versus 81 in patients who had END. The procedure reduced the risk of recurrence by about 55 percent; three-year DFS was 69.5 percent in the END cohort versus 45.9 percent in patients assigned to TND (HR = 0.44; CI 95 percent, 0.34-0.58; P < .001).
Overall, D’Cruz reported that performing END in patients with early oral SCC reduced mortality by 36 percent, preventing one death in every eight patients and one recurrence in every four patients who undergo the procedure.