Long-Term Outcomes Support Sentinel-Node Biopsy for Staging Melanoma
Published Online: Tuesday, April 22, 2014
Vernon K. Sondak, MD
Chair, Department of Cutaneous Oncology
Director, Surgical Education
Moffitt Cancer Center
Christopher Puleo, PA-C
Certified Physician Assistant
Moffitt Cancer Center
The final results of the Multicenter Selective Lymphadenectomy Trial (MSLT-1), which began in 1994 and enrolled patients through 2002, also showed that biopsy-based staging provides important prognostic information, according to updated findings published in The New England Journal of Medicine.1 During the phase III trial, 2001 patients with primary cutaneous melanomas were randomly assigned to undergo wide excision and nodal observation, with lymphadenectomy for nodal relapse (40%) or wide excision and sentinel-node biopsy with intermediate lymphadenectomy for nodal metastases detected on biopsy (60%).
In the MSLT-1 trial, researchers sought to determine whether the minimally invasive sentinel-node biopsy could be used after primary surgery to identify patients with clinically occult nodal metastases, instead of waiting for nodal recurrence. In the past, elective complete lymphadenectomy was recommended, despite its potential complications.
The study results support the benefits of sentinel- node biopsies, a procedure that was introduced in 1992, noted Vernon K. Sondak, MD, chair of the Department of Cutaneous Oncology at Moffitt Cancer Center in Tampa, Florida, in a press release announcing the findings. Sondak said Moffitt played a pioneering role in helping to develop the biopsy procedure, which he said has now become a “worldwide standard.”
Moffitt was among more than a dozen cancer centers and research institutions that participated in the multinational MSLT-1 study, which was initiated at the John Wayne Cancer Institute at Saint John’s Health Center in Santa Monica, California.
DFSR Outcomes SuperiorOf the 2001 patients initially involved in the study, 1661 underwent randomization and 1638 were included in the 10-year follow-up. Of the initial patient population, 1347 had intermediate-thickness primary melanomas and 314 had thick primary melanomas.
Mean (± standard error [SE]) 10-year DFSRs, the primary endpoint of the study, were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3±1.8% vs 64.7±2.3%) and among those with thick melanomas, defined as >3.50 mm (50.7±4.0% vs 40.5±4.7%). (Table).
The study found that in the biopsy group, patients with sentinel-node metastases had poorer outcomes than patients with tumor-free sentinel nodes. Patients with intermediate-thickness melanomas who had sentinel-node metastases had a 10-year melanoma-specific survival rate of 62.1±4.8%, compared with 85.1±5% of patients with tumor-free sentinel, for a hazard ratio for death from melanoma of 3.09 (P = .001). For participants with thick melanomas, the survival rates were 48.0±7.0% without metastasis versus 64.6±2.9% with metastasis (HR = 1.75; P = .03). According to a multivariate analysis, sentinel-node status was the strongest predictor of disease recurrence or death from melanoma. Although sentinel-node biopsies resulted in better DFSRs, there was no significant treatment-related difference in the 10-year melanoma-specific survival rates among those in the biopsy group (81.4±1.5%) and those in the observation group (78.3±2.0%) among patients with intermediate-thickness melanomas. Similarly, there was no difference among patients with thick melanomas (Table).
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