The real-world impact of modern treatments on the survival of patients with metastatic melanoma

Real-world evidence to guide healthcare policies in oncology

“…Importantly, we were able to discern a sub-group of real-world patients who had very similar baseline characteristics to patients enrolled in pivotal clinical-trials (“trial-like”), from a subgroup of patients that was not represented in such trials because they failed to meet one or more key criteria for enrolment (“trial-excluded”). As reported in our recent study [9], both groups had an improved outcome in 2016 versus 2014 or 2012. Hence, the introduction of novel treatments in 2016 led to a better survival outcome of the broad population of patients diagnosed with metastatic melanoma in the real-world.…”

“…We have recently analyzed the differences in real-world outcome of all patients with metastatic melanoma diagnosed across Denmark in the pre-modern era (calendar year 2012, when BRAF-inhibitors but not first line immune checkpoint inhibitors where available), early-modern era (2014, first-line anti-CTLA-4 available) and modern era (2016, first line anti-PD-1 and MEK-inhibitors available) [9]. Despite similar baseline characteristics (data not shown), the survival outcome of the global metastatic melanoma population was significantly improved in 2016 versus 2014 (hazard ratio, HR for death 0.73, 95% CI 0.60–0.88; p = 0.0013) or 2012 (HR 0.61, 95% CI 0.50–0.75; p > 0.0001), with no major differences in 2014 versus 2012 (HR 0.85, 95% CI 0.70–1.03; p = 0.0935) (Figure 1).…”

Real-world data on PD-1 inhibitor therapy in metastatic melanoma

“…These findings imply that results from phase III trials are not necessarily generalizable to patients treated in clinical routine, and stress the importance of real-world validation of the efficacy and safety of novel therapies. Registry studies do, however, suggest that the survival of patients with MM has improved since the introduction of ICI and BRAF plus MEK inhibitors [9]. This study was conducted to evaluate the OS and AEs among patients with metastatic MM treated with PD-1 inhibitors in clinical routine at the Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.…”

The real‐world outcome of metastatic melanoma: Unknown primary vs. known cutaneous

“…A total of 576 cases with metastatic MKP ( n = 496) or MUP ( n = 80) with adequate records were retrieved from DAMMED. We applied the same methods that we recently used in another real‐world study to identify what proportion of diagnosed patients met seven key eligibility criteria for phase III immunotherapy clinical trials (including but not limited to World Health Organization performance status (PS) = 0–1 and absence of active central nervous system metastases) at baseline, and therefore had a better prognosis. A similar proportion of patients with MKP (41%, n = 202) or MUP (36%, n = 29; p = 0.46) met all the predefined eligibility criteria, and could thus be classified as “trial‐like” (or good‐prognosis) according to our previous study .…”

“…We applied the same methods that we recently used in another real‐world study to identify what proportion of diagnosed patients met seven key eligibility criteria for phase III immunotherapy clinical trials (including but not limited to World Health Organization performance status (PS) = 0–1 and absence of active central nervous system metastases) at baseline, and therefore had a better prognosis. A similar proportion of patients with MKP (41%, n = 202) or MUP (36%, n = 29; p = 0.46) met all the predefined eligibility criteria, and could thus be classified as “trial‐like” (or good‐prognosis) according to our previous study . Other baseline characteristics such as the proportion of men, BRAF mutant disease, PS = 0 and normal lactate dehydrogenase (LDH) were similar, except for the proportion of patients with AJCC 7th edition stage IV M1c disease (68%, n = 336 in MKP vs .…”