A record number of new agents have been approved in the treatment of melanoma in the past 5 years, and the subsequent significant changes were included in the 2016 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Melanoma.1

The updates included more options for adjuvant therapy, such as biochemotherapy and high-dose ipilimumab, and for in-transit disease, such as intralesional injection with the immunotherapy talimogene laherparepvec (T-VEC).

These guidelines came at a time when an estimated 76 380 patients in the United States will be diagnosed with melanoma this year alone and approximately 10 130 of these patients will die of their disease. And these numbers have been rising: the incidence of melanoma in the United States increased at a rate of 33% for men and 23% for women between 2002 and 2006.


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Guidelines coauthor Marc Ernstoff, MD, professor and chair of the department of medicine and the senior vice president for clinical investigation at Roswell Park Cancer Institute in Buffalo, NY, said that these new therapeutic approaches reflect the dramatic changes in melanoma across the past 5 years and the increasing knowledge of driver pathways, cancer immunobiology, and disease behavior.

“These new approaches have significantly increased survival and decreased disease-associated morbidity,” Dr Ernstoff told Cancer Therapy Advisor. “The guidelines are a careful review of the studies and literature by a panel of expert surgical, radiation, and medical oncologists, dermatologists and dermatopathologists, along with patient advocates. This careful review distills the current therapeutic options that impact patient care decisions, based on published evidence, and also provides considerations of care that are not well addressed by other literature to date.”

The 2016 guidelines for melanoma were designed to simplify an enormous body of knowledge and experience into fairly simple management algorithms. Not surprisingly, the treatment recommendations for primary tumors were based on a stronger body of scientific data than were the recommendations for treating recurrent disease.

The authors of the 2016 guidelines stated that all clinical decisions about individual patient management must be tempered by the clinician’s judgment and other factors, including local resources and expertise, as well as the individual patient’s needs, wishes, and expectations.

Similarly, Jason Luke, MD, assistant professor of medicine at the Melanoma and Developmental Therapeutics Clinics at The University of Chicago in Chicago, IL, said the 2016 NCCN guidelines are important because they highlight the specific approaches that should be considered the baseline standard in melanoma treatment.

“Having a consensus statement about the current state of the field is enormously helpful to practitioners who do not commonly come in contact with a disease like melanoma,” Dr Luke told Cancer Therapy Advisor.

“These guidelines absolutely have morbidity and mortality implications as improper use of the drugs—either outside of their indication or without the appropriate knowledge base—has the potential to deprive patients of maximally efficacious therapy and can rarely expose the patient to life-threatening side effects.”

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He said standard treatment for melanoma is changing faster than any other area of cancer treatment, and it is extremely important that guideline statements attempt to capture this for the practitioner who has little familiarity or experience in this field. Despite tremendous advancement in melanoma, Dr Luke said we are only at the beginning of the journey to maximize the effectiveness of therapy and personalize it for each patient.