Huge honor for Dr. Anil D' Cruz presenting results of a randomized clinical trial of elective versus therapeutic neck lymph node dissection in newly diagnosed patients with non metastatic oral cancer at the plenary session of the 2015 American Society of Clinical Oncology meeting in Chicago in from of over 30,000 people. His study has defined the practice changing standard of care for these patients.
Congratulations Anil! Proud day for him, St. John's, Tata's and India!
Dr Leo Mascarenhas
Details of the study below
Elective neck dissection performed at the same time patients have surgery for early-stage, node-negative, oral squamous cell cancer significantly improved overall survival and reduced the risk of death and recurrence when compared with a watchful waiting approach, according to findings of a phase III randomized trial.
These findings should be practice changing, said lead study author Anil D’Cruz, MBBS, MS, FRCS, who presented them during a press briefing at the 2015 ASCO Annual Meeting.
“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.
That debate has centered on whether it is best to remove surrounding lymph nodes when the primary oral cancer surgery is performed or to wait to perform therapeutic neck dissection when the patient relapses. Clinical practice in this setting varies widely.
Oral cancer is 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% 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 I/II oral squamous cell carcinoma (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).
Both trial arms were balanced based on tumor site and stage: 427 of the cases involved the tongue, 68 affected the buccal mucosa, and 5 were tumors at the floor of the mouth; 221 patients had stage I tumors, and 279 were stage II. Overall survival (OS) was the study’s primary endpoint.
After a median follow-up of 39 months, 146 recurrences were reported in the TND arm versus 81 in patients who had END. Three-year OS also was significantly better in the END cohort compared with the TND group: 80.0% vs 67.5%, respectively (HR = 0.63; 95% CI, 0.44-0.89; P = .01).
The study’s secondary endpoint, disease-free survival (DFS), also favored the END arm of the trial, with the procedure reducing the risk of recurrence by about 55%. Three-year DFS was 69.5% in the END cohort versus 45.9% in patients assigned to TND (HR = 0.44; CI 95%, 0.34-0.58; P <.001).
Overall, D’Cruz reported that performing END in patients with early oral SCC reduced mortality by 36%, preventing 1 death in every 8 patients and 1 recurrence in every 4 patients who undergo the procedure.
Study authors acknowledged in an ASCO statement that the only drawback to neck dissection is that the procedure can be linked to shoulder problems, which affect 5% to 40% of patients because the nerve that supplies the large muscles associated with shoulder movement crosses the surgical dissection field. Future research should focus on techniques that could minimize this complication, they said.
Jyoti D. Patel, ASCO spokesperson and moderator of the press briefing where the results were reported, said the findings were particularly important in countries and in populations where there are multiple barriers to healthcare:
“This one and done approach we know now definitively improves survival.”
“Armed with the results of this study,” said D’Cruz, “doctors will be able to confidently counsel patients that adding neck surgery to their initial treatment is worthwhile.”