Who Ultimately Benefits From New Therapies in Metastatic Melanoma?
Posted: Tuesday, March 19, 2019
Whether or not they would have qualified for enrollment in clinical trials, a large “real-world” cohort of patients with metastatic melanoma diagnosed in 2012, 2014, and 2016 experienced significant survival benefits from the latest immunotherapies, retrospective research showed. The group studied included 800 patients diagnosed with metastatic melanoma in Denmark in those years, except for those with ocular melanoma. These research findings were published in the European Journal of Cancer.
Of the 837 study patients (from the Danish Metastatic Melanoma database), 61% would not have qualified for clinical trials (“trial-excluded”), most (75%) because they had either brain metastases or an Eastern Cooperative Oncology Group/World Health Organization performance status of at least 2. However, reported Danish investigator Marco Donia, MD, PhD, of Herlev Hospital in Herlev, and colleagues, these patients experienced gains in median overall survival: from 4.2 months in 2012 to 5.2 months in 2014 to 6.9 months in 2016.
The 39% of patients in the “trial-like” group experienced median overall survival gains as well; in 2012, 2014, and 2016, respectively, the median overall survivals were 16.5 months, 18.8 months, and not reached. In addition, noted the researchers, “subgroup analysis of the BRAF wild-type population showed an improved 1-year survival rate in 2016 versus 2014 (35.9% vs. 18.8%; P = .0153).”
Dr. Donia and colleagues chose the years they did because 2012 saw the introduction of interleukin2 (IL-2) and BRAF inhibitors; CTLA-4 inhibitors came on the scene in 2014; and PD-1 and MEK inhibitors emerged in 2016. All have been major changes in the first-line treatment of metastatic melanoma.
“These data support the application of modern treatments to patient populations [who] are not represented in pivotal trials” as well as to patients who are, the team stated.
Disclosure: The study authors’ disclosure information may be found at ejcancer.com.