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Complete lymph node dissection does not improve survival after positive SLNB in melanoma
CHICAGO — The surgical removal of the lymph nodes after a positive sentinel lymph node biopsy did not improve survival for patients with melanoma, according to findings from a randomized phase 3 trial presented at the ASCO Annual Meeting.
Complete lymph node dissection (CLND) is standard of practice in patients with a positive sentinel lymph node biopsy (SLNB) worldwide, according to the researchers.
However, the findings of the current study could change that practice and prevent unnecessary surgeries. The procedure carries the risk for adverse events including infection, nerve damage and lymphedema, — which can occur in more than 20% of patients and be a long-term adverse event in 5% to 10% of patients — according to study background.
“I think that our study is the beginning of the end of a general recommendation of complete lymph node dissection for patients with positive sentinel lymph nodes,” Claus Garbe, MD, a professor of dermatology and head of the division of dermato-oncology and the interdisciplinary skin tumor center at Eberhard Karls University, Tübingen in Germany, said in a press release. “However, it is possible that this surgery may provide a smaller survival advantage than this study could detect. So, doctors may want to discuss this finding with their patients to help them decide whether this procedure is right for them.”
Garbe and colleagues evaluated data from 483 patients with cutaneous melanoma of the trunk and extremities who had positive SLNB. The randomized trial only included patients with micrometastases, and the researchers still recommend CLND for patients with macrometastases.
Researchers randomly assigned patients 1:1 to observation (n = 241) — which included a lymph node ultrasound exam every 3 months and CT/MRI or PET scans every 6 months — CLND (n = 242). The groups were comparable with regard to age, gender, localization, ulceration, tumor thickness (median, 2.4 mm in each cohort), number of positive nodes and tumor burden in the sentinel node.
Researchers conducted 3-year follow-up in both groups.
Primary endpoints included RFS, distant metastases-free survival and melanoma-specific survival.
Mean follow-up was 35 months. More patients in the observation cohort developed lymph node regional metastases compared with patients in the CLND cohort (14.6% vs. 8.3%). However, there was no significant treatment-related difference in 5-year RFS, distant metastases-free survival and melanoma-specific survival.
Garbe added that another analysis of this study is planned in 3 years; however, the findings are unlikely to change as approximately 80% of melanoma recurrences happen in the first 3 years of diagnosis.
“We addressed the question whether complete lymphadenectomy in patients with melanoma and a positive node is a benefit for the patient,” Garbe said at a press briefing. “While we cannot yet confirm this recommendation, we expect that the surgical practice will change.” – by Anthony SanFilippo
Reference:
Leiter U, et al. Abstract LBA9002. Presented at: ASCO Annual Meeting; May 29-June 2, 2015; Chicago.
Disclosure: The study was funded by German Cancer Aid. Garbe reported honoraria, travel expenses and research funding from and consultant/advisory roles with Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Novartis and Roche. See the abstract for a list of all other researchers’ relevant financial disclosures.
Perspective
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Perspective
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What do I mean by that? We are looking for patients who have had an adequate sentinel node biopsy procedure where we are comfortable that all of the sentinel nodes that might have contained cancer have been removed, and where the tumor in the sentinel node itself is relatively limited and contained. For example, if patients had extranodal spread, they were excluded from this trial. We like to see only very small amounts of tumor in the lymph node, and we like to see a relatively favorable overall risk profile of the primary tumor. A thinner melanoma without ulceration might indicate a more favorable candidate for considering lymph node observation; however, that still needs to be further defined through ongoing studies. Appropriately selected patients — at least in a short run over the first 3 or 4 years — do have the option of having observation of their lymph nodes. These patients only have surgery if the lymph nodes become abnormal.
In this study, about 15% of the patients who were randomly assigned to observation already within that 3-year period had their lymph nodes become abnormal and had to have surgery. Many others over the years will need to have surgery, as well. So, going forward, it will be important to hone in on which patients are the ones whose tumors come back relatively quickly and probably should have surgery from the outset.
In addition to this study, there is the much larger international study called MSLT-II. In the MSLT-II trial, the same question is being asked: Are there some patients who can safely omit the complete lymph node dissection after a positive sentinel lymph node biopsy? However, MSLT-II has more than 1,900 patients randomly assigned, and it will have many more years of follow-up when we get some results from that within the next 2 or 3 years.
In the meantime, this particular study gives us reassurance that properly selected patients are not being disadvantaged if they choose, after an informed discussion, to delay their complete lymph node dissection.
One final message: This is only for people with a sentinel node biopsy. Patients with an enlarged lymph node that is seen on an X-ray, that is found on a CT scan or that is felt on palpation need a complete lymph node dissection. They were not on this study and that is not really a source of debate, but it is important to point that out so there is no confusion on that important point.