B Leeneman

Dutch Melanoma Treatment Registry: Quality assurance in the care of patients with metastatic melanoma in the Netherlands

BACKGROUND In recent years, the treatment of metastatic melanoma has changed dramatically due to the development of immune checkpoint and mitogen-activated protein (MAP) kinase inhibitors. A population-based registry, the Dutch Melanoma Treatment Registry (DMTR), was set up in July 2013 to assure the safety and quality of melanoma care in the Netherlands. This article describes the design and objectives of the DMTR and presents some results of the first 2 years of registration. METHODS The DMTR documents detailed information on all Dutch patients with unresectable stage IIIc or IV melanoma. This includes tumour and patient characteristics, treatment patterns, clinical outcomes, quality of life, healthcare utilisation, informal care and productivity losses. These data are used for clinical auditing, increasing the transparency of melanoma care, providing insights into real-world cost-effectiveness and creating a platform for research. RESULTS Within 1 year, all melanoma centres were participating in the DMTR. The quality performance indicators demonstrated that the BRAF inhibitors and ipilimumab have been safely introduced in the Netherlands with toxicity rates that were consistent with the phase III trials conducted. The median overall survival of patients treated with systemic therapy was 10.1 months (95% confidence interval [CI] 9.1-11.1) in the first registration year and 12.7 months (95% CI 11.6-13.7) in the second year. CONCLUSION The DMTR is the first comprehensive multipurpose nationwide registry and its collaboration with all stakeholders involved in melanoma care reflects an integrative view of cancer management. In future, the DMTR will provide insights into challenging questions regarding the definition of possible subsets of patients who benefit most from the new drugs.

Improved Survival In Patients With Advanced Melanoma In Real-World Clinical Practice: First Results Of The Dutch Melanoma Treatment Registry.

PCN62 ImProved SurvIval WIth IPIlImumab IN PatIeNtS WIth advaNCed melaNoma IN real-World ClINICal PraCtICe: FIrSt reSultS oF the dutCh melaNoma treatmeNt regIStry Leeneman B1, Franken MG2, Jochems A3, Schouwenburg MG4, Wouters MW5, Van den Eertwegh AJ6, Haanen JB5, Van der Hoeven KJ3, Uyl de Groot CA2 1Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands, 2Erasmus University, Rotterdam, The Netherlands, 3Leiden University Medical Center, Leiden, The Netherlands, 4Dutch Institute for Clinical Auditing, Deventer, The Netherlands, 5Netherlands Cancer Institute, Amsterdam, The Netherlands, 6VU University Medical Center, Amsterdam, The Netherlands Objectives: Ipilimumab improved the survival of advanced melanoma patients in phase III trials (MDX010-20 [previously treated patients] and CA184-024 [treatment naïve patients]). Uncertainty exists, however, whether this benefit can be translated to real-world clinical practice. We investigated the use and survival outcomes of ipilimumab in The Netherlands. MethOds: We retrieved data from the populationbased Dutch Melanoma Treatment Registry (DMTR). The DMTR includes all Dutch patients with unresectable stage IIIc/IV melanoma. Detailed data were prospectively collected from start of diagnosis until death or loss to follow-up. Survival outcomes (overall survival [OS] and one-year survival) in patients receiving ipilimumab in clinical practice were assessed using Kaplan-Meier estimates, and were compared with outcomes of pivotal trials and outcomes of real-world patients diagnosed before the introduction of ipilimumab (2003-2011; stage IV only) using data from the Dutch Comprehensive Cancer Centres. Results: From 2012-2015, 545 patients received at least one dose of ipilimumab in real-world practice (65% received four dosages; median follow-up 4.6 months; data cut-off March 9, 2015). Ipilimumab was most frequently prescribed in the second line (60%), followed by the first (31%), third (8%), and fourth line (2%), respectively. Median OS was 7.7 months (IQR:3.6-NR) and one-year survival was 40%. This is somewhat lower than in the pivotal trials, which may be due to differences in baseline characteristics and time of follow-up (MDX010-20: median follow-up 27.8 months, median OS 10.1 months, one-year survival 46%; CA184-024: median follow-up 11.0 months, median OS 11.2 months, one-year survival 48%). However, the survival was higher compared to the survival in the period before the introduction of ipilimumab (2003-2011: median OS 6.8 months [IQR:3.3-18.5], one-year survival 33%). cOnclusiOns: Melanoma survival has improved since the introduction of ipilimumab. Although survival was somewhat lower in real-world compared to pivotal trials, a survival benefit was observed in Dutch real-world clinical practice.

Improved Survival With Ipilimumab In Patients With Advanced Melanoma In Real-World Clinical Practice: First Results Of The Dutch Melanoma Treatment Registry.

PCN62 ImProved SurvIval WIth IPIlImumab IN PatIeNtS WIth advaNCed melaNoma IN real-World ClINICal PraCtICe: FIrSt reSultS oF the dutCh melaNoma treatmeNt regIStry Leeneman B1, Franken MG2, Jochems A3, Schouwenburg MG4, Wouters MW5, Van den Eertwegh AJ6, Haanen JB5, Van der Hoeven KJ3, Uyl de Groot CA2 1Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands, 2Erasmus University, Rotterdam, The Netherlands, 3Leiden University Medical Center, Leiden, The Netherlands, 4Dutch Institute for Clinical Auditing, Deventer, The Netherlands, 5Netherlands Cancer Institute, Amsterdam, The Netherlands, 6VU University Medical Center, Amsterdam, The Netherlands Objectives: Ipilimumab improved the survival of advanced melanoma patients in phase III trials (MDX010-20 [previously treated patients] and CA184-024 [treatment naïve patients]). Uncertainty exists, however, whether this benefit can be translated to real-world clinical practice. We investigated the use and survival outcomes of ipilimumab in The Netherlands. MethOds: We retrieved data from the populationbased Dutch Melanoma Treatment Registry (DMTR). The DMTR includes all Dutch patients with unresectable stage IIIc/IV melanoma. Detailed data were prospectively collected from start of diagnosis until death or loss to follow-up. Survival outcomes (overall survival [OS] and one-year survival) in patients receiving ipilimumab in clinical practice were assessed using Kaplan-Meier estimates, and were compared with outcomes of pivotal trials and outcomes of real-world patients diagnosed before the introduction of ipilimumab (2003-2011; stage IV only) using data from the Dutch Comprehensive Cancer Centres. Results: From 2012-2015, 545 patients received at least one dose of ipilimumab in real-world practice (65% received four dosages; median follow-up 4.6 months; data cut-off March 9, 2015). Ipilimumab was most frequently prescribed in the second line (60%), followed by the first (31%), third (8%), and fourth line (2%), respectively. Median OS was 7.7 months (IQR:3.6-NR) and one-year survival was 40%. This is somewhat lower than in the pivotal trials, which may be due to differences in baseline characteristics and time of follow-up (MDX010-20: median follow-up 27.8 months, median OS 10.1 months, one-year survival 46%; CA184-024: median follow-up 11.0 months, median OS 11.2 months, one-year survival 48%). However, the survival was higher compared to the survival in the period before the introduction of ipilimumab (2003-2011: median OS 6.8 months [IQR:3.3-18.5], one-year survival 33%). cOnclusiOns: Melanoma survival has improved since the introduction of ipilimumab. Although survival was somewhat lower in real-world compared to pivotal trials, a survival benefit was observed in Dutch real-world clinical practice.