CHICAGO–In patients with sentinel node biopsy (SLNB)-positive melanoma, no survival benefit was achieved by complete lymph node dissection (CLND), according to an early study analysis presented at the 2015 American Society of Clinical Oncology annual meeting in Chicago, IL.
The phase 3 trial evaluated 1,258 patients with cutaneous melanoma of the trunk and extremities after positive SLNB. Of those, 483 were randomly assigned 1:1 to receive observation only or CLND.
“It was a difficult recruitment. Only every third patients with positive SLNB agreed to randomization,” said Ulrike Leiter, MD, from University Hospital Tuebingen in Germany.
The treatment arms did not differ significantly in age, gender, localization, number of positive nodes, tumor burden in the SN, tumor thickness, or ulceration and both groups received 3 years of follow up.
Results showed that during a mean follow up of 34 months, no significant treatment-related difference was observed in 5-year recurrence-free survival (P=0.52), distant metastases-free survival (P=0.92), and melanoma-specific survival (P=0.98) in the overall study population.
Researchers also found no statistically significant difference in cumulative incidence of recurrence between the two arms (P=0.51).
In addition, subgroup analyses demonstrated no significant difference in distant metastases-free survival between the two arms in patients with 1 mm or smaller tumor loads in the SLNB group (P=0.91), as well as patients with greater than 1 mm tumor loads (P=0.91).
RELATED: Pembrolizumab Plus Low-Dose Ipilimumab Safe in Melanoma, Renal Cell Carcinoma
Dr. Leiter noted during her discussion, “A substantially higher number of patients was needed for screening than planned…Reduction of the sample size from the planned 556 patients to the recruited 483 patients is associated with a reduction of the power from 80% to 75%.”
“Based on our findings, complete lymphadenectomy cannot be recommended in melanoma patients with micrometastases,” Dr. Leiter concluded.
A subsequent analysis is currently planned for 3 years after inclusion of the last patient.
- Leiter U, Stadler R, Mauch C, et al. Survival of SLNB-positive melanoma patients with and without complete lymph node dissection: A multicenter, randomized DECOG trial. J Clin Oncol. 2015;33:(suppl; abstr LBA9002).