New Guidelines for Early-Stage Melanoma Treatment

The American Academy of Dermatology has published new clinical practice guidelines with recommendations for the treatment of patients with primary cutaneous melanoma. The guidelines include best practice recommendations based on the latest evidence and addresses new areas such as melanoma in pregnancy and testing for hereditary risk.

The guidelines, published in the Journal of the American Academy of Dermatology, include recommendations for patients with primary cutaneous melanoma defined as American Joint Committee on Cancer stages 0-IIC and pathologic stage III by virtue of positive sentinel lymph node biopsy (SLNB). The guidelines were developed by a multidisciplinary work group made up of specialists in medical and surgical oncology, dermatopathology, Mohs micrographic surgery, and others. For this update, the group reviewed evidence published since 2011.

“There was an urgent need for the update of these guidelines because in 2011 something remarkable happened: the FDA approved the first drug that ever showed a survival advantage for patients with metastatic disease,” Anthony J. Olszanski, MD, RPh, co-director of the melanoma and skin cancer program at Fox Chase Cancer Center. “These guidelines don’t speak about that because they are aimed at the dermatologic sector and their treatment of earlier disease, but it is critical that dermatologists understand what is out there for patients because they are the first people that typically see these patients and are able to give them that message of hope.”

Other important updates for dermatologists include the results of two major surgical trials in melanoma - The Multicenter Selective Lymphadenectomy Trial (MSLT) I and MSLT-II trials - which have also been published since 2011, according to Olszanski. MSLT-I established that a positive or negative SLNB was significantly prognostic for disease recurrence and death. SLNB was significantly associated with disease-free survival among patients with intermediate thickness melanoma and thick melanomas. MSLT-II assessed complete lymph node dissection (CLND) vs active nodal observation with ultrasound in patients with positive SLNB and showed that immediate CLND increased the rate of regional disease control and improved staging among patients with a positive sentinel lymph node.

Among the new areas addressed in the guidelines was the use of genetic testing. The group recommended that patients with a family history of melanoma receive education and counseling about genetic risk, but that formal genetic testing may not be appropriate and should be considered on an individual basis after counseling takes place.

Those who should undergo genetic counseling include patients with cutaneous melanoma who have:

• A family history of invasive cutaneous melanoma or pancreatic cancer (three or more affected members on one side of the family)

• Multiple primary invasive melanomas

• One or more melanocytic BRCA1 association protein 1 mutated atypical intradermal tumor (MBAIT) and a family history of mesothelioma, meningioma, and/or uveal melanoma

• Two or more MBAITS

Olszanski said that the field of genetic testing does not affect many dermatologists when treating melanoma, but that some do try to test when they recognize that results could influence the treatment of patients.

“That is often inappropriately done because there are no treatments given to stage II disease that would be influenced by genetic testing,” Olszanski said. “However, there are a number of genetic risk factors that clearly put some patients and their family members at a predisposition for a higher rate of developing melanoma and other cancers. The paper did an adequate job of explaining familial risk factors.”

The group also reviewed evidence on melanoma in pregnancy. Some studies have reported that melanoma is the most common malignancy reported during pregnancy. However, according to the guidelines, evidence is lacking that pregnancy increases a woman’s risk of melanoma or affects prognosis of the disease. Any decision regarding the management of melanoma in pregnant women should be based on patient health and disease stage.

According to the guidelines, biopsy with surgical excision remains the standard of care for melanoma treatment with Mohs surgery or other forms of staged excision used only for certain subtypes of melanoma found on certain parts of the body. Topical therapy or radiation can be considered as second-line therapy in limited cases when surgery is not possible.

“We hope these guidelines will help dermatologists and other physicians enhance their delivery of life-saving treatment to patients,” Susan M. Swetter, MD, FAAD, of Stanford University Medical Center and Cancer Institute and chair of the work group that developed the guidelines, said in a press release.