February 12, 2014
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Biopsy-based management improved outcomes in melanoma

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Patients with primary cutaneous melanomas who underwent sentinel-node biopsy after wide excision experienced significantly longer DFS than patients who underwent nodal observation, according to long-term, phase 3 study results.

Biopsy-based management also was associated with prolonged distant DFS and melanoma-specific survival among patients who developed nodal metastases from intermediate-thickness melanomas, the researchers wrote.

The analysis included 2,001 patients. Of them, 340 had thin melanomas (˂1.2 mm), 1,347 had melanomas of intermediate thickness (1.2-3.5 mm), and 314 had thick melanomas (˃3.5 mm).

 

Donald L. Morton

Donald L. Morton, MD, of the department of surgical oncology at Saint John’s Health Center’s John Wayne Cancer Institute, and colleagues randomly assigned 60% of patients who undergo wide excision followed by sentinel-node biopsy. The other 40% underwent wide excision followed by nodal observation.

Patients in the biopsy arm underwent immediate complete lymphadenectomy for biopsy-detected nodal metastases. Those in the observation arm underwent lymphadenectomy after nodal relapse.

Researchers reported no significant treatment-related difference in 10-year melanoma-specific survival among patients with intermediate-thickness melanomas, regardless of metastases development (81.4 ± 1.5% for biopsy vs. 78.3 ± 2% for observation). The finding translated to an HR for death of 0.84 (95% CI, 0.64-1.09) in the biopsy arm.

The results also showed similar 10-year melanoma-specific survival among patients with thick melanomas, regardless of whether they underwent biopsy or observation.

Overall, 20.8% of patients developed nodal metastases. The development of nodal metastases was associated with considerably shorter 10-year melanoma-specific survival among patients with intermediate-thickness melanomas (HR for death=3.09; P<.001) and thick melanomas (HR=1.75; P=.03).

Sentinel-node biopsy was associated with significantly improved 10-year DFS among patients with intermediate-thickness melanomas (71.3 ± 1.8% vs. 64.7 ± 2.3%; HR for recurrence or metastasis=0.76; P=.01) and thick melanomas (50.7 ± 4% vs. 40.5 ± 4.7%; HR=0.70; P=.03).

Among patients with intermediate-thickness melanomas and nodal metastases, biopsy-based management also was associated with improved 10-year distant DFS (HR=0.62; P=.02) and 10-year melanoma-specific survival (HR=0.56; P=.006).

“These long-term results clearly validate the use of sentinel-node biopsy in patients with intermediate-thickness or thick primary melanomas,” Morton and colleagues wrote. “The procedure provides accurate and important staging information, enhances regional disease control and, among patients with nodal metastases, appears to improve melanoma-specific survival substantially.”

Disclosure: The researchers report advisory board roles with; travel support, grant support or honoraria from; stock ownership in; and holdings on patents licensed to GlaxoSmithKline, Melanoma Diagnostics, Merck, Myriad Genetics, Provectus Pharmaceuticals and Roche.