“The data from this trial should be discussed with patients,” Dr Ariyan said to Cancer Therapy Advisor. “Instead of offering a complete lymph node dissection to everyone, patients need to understand survival may not be affected, especially in patients with a low tumor burden.”

Dr Ariyan noted that the National Comprehensive Cancer Network (NCCN) changed its guideline for patients with positive sentinel lymph node biopsy from recommending complete lymph node dissection to discussing and dissection with the patient. She also cited the Multicenter Selective Lymphadenectomy Trial-II (MSLT-II), a larger, ongoing study comparing complete lymph node dissection with ultrasound surveillance after positive sentinel lymph node biopsy.


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“I believe that MSLT-II is likely to provide guidance,” she said. “In the meantime, the pros and cons [of complete lymph node dissection] need to be discussed with the patients.”

“This is a very strong effort,” Ken Tanabe, MD, chief of surgical oncology at Massachusetts General Hospital in Boston, said in an interview with Cancer Therapy Advisor. “Technically it’s underpowered relative to what they wanted to demonstrate statistically, but it seems that the likelihood of equivalence in distant-free survival is high.”

Dr Tanabe pointed out that treatment of melanoma patients with sentinel lymph node biopsy is rapidly changing, noting that this change should inform the discussion of whether to perform complete lymph node dissection.

“When this study started in 2006, the likelihood of doing well once diagnosed with stage IV disease was relatively low,” he said. “Now, a significantly higher percentage of patients enjoy a great response to immune checkpoint inhibitor therapy. I think it’s appropriate to look at distant disease-free survival as opposed to overall survival.

“I think that the conversation of whether to do a sentinel lymph node biopsy is an important discussion to have with the patient,” he said. “I think it’s a tenable pathway to go with observation rather than complete lymph node dissection. The patient should understand the pros and cons of it–especially a patient who has a greater burden of disease in the lymph node–where there are higher chances of additional non-sentinel nodes containing melanoma.”

Dr Tanabe noted that there have been numerous studies that investigated the efficacy of lymph node dissection, and the results have often been controversial, with different experts drawing different conclusions. “We acknowledge that the medical community is divided about how these data should be implemented in practice,” he said.

References

  1. Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, et al. Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial [published online head of print May 5, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)00141-8.
  2. Ariyan C. Complete lymph node dissection in melanoma [published online ahead of print May 5, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)30071-7