Issue: July 10, 2015
Perspective from Lynn M. Schuchter, MD, FASCO
Perspective from Vernon K. Sondak, MD
May 31, 2015
5 min read
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Complete lymph node dissection does not improve survival after positive SLNB in melanoma

Issue: July 10, 2015
Perspective from Lynn M. Schuchter, MD, FASCO
Perspective from Vernon K. Sondak, MD
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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.