"DICA heeft een meer gestandaardiseerde manier om grote aantallen observationele data te verzamelen"
De kans op verantwoord onderzoek, Oncologieuptodate vol 9, nr3Bekijk artikel
Het blad Anti-Cancer Drugs heeft 2 artikelen gepubliceerd waarin data uit de DMTR (Dutch Melanoma Treatment Registry) is gebruikt:
Real-world healthcare costs of ipilimumab in patients with advanced cutaneous melanoma in The Netherlands.
Auteurs: Franken, M.G., Leeneman, B., Jochems, A., Schouwenburg, M.G., Aarts, M.J., van Akkooi, A.C., van den Berkmortel, F.W.P.J., van den Eertwegh, A.J.M., de Groot, J.W.B., van der Hoeven, K.J.M., Hospers, G.A.P., Kapiteijn, E., Koornstra, R., Kruit, W.H.J., Louwman, M.W.J., Piersma, D., van Rijn, R.S., Suijkerbuijk, K.P.M., ten Tije, A.J., Vreugdenhil, G., Wouters, M.W.J.M., van Zeijl, M, Haanen, J.B.A.G. en Uyl-de Groot, C.A.
Lees hier het volledige artikel.
Real-world use, safety, and survival of ipilimumab in metastatic cutaneous melanoma in The Netherlands.
Auteurs: Jochems, A., Leeneman, B., Franken, M.G., Schouwenburg, M.G., Aarts, M.J., van Akkooi, A.C., van den Berkmortel, F.W.P.J., van den Eertwegh, A.J.M., Groenewegen, G., de Groot, J.W.B., Haanen, J.B.A.G., Hospers, G.A.P., Kapiteijn, E., Koornstra, R., Kruit, W.H.J., Louwman, M.W.J., Piersma, D., van Rijn, R.S., ten Tije, A.J., Vreugdenhil, G., Wouters, M.W.J.M., Uyl-de Groot, C.A. en van der Hoeven, K.J.M.
Lees hier het volledige artikel.
Samenvatting 'Real-world healthcare costs of ipilimumab in patients with advanced cutaneous melanoma in The Netherlands':
There is limited evidence on the costs associated with ipilimumab. We investigated healthcare costs of all Dutch patients with advanced cutaneous melanoma who were treated with ipilimumab. Data were retrieved from the nation-wide Dutch Melanoma Treatment Registry. Costs were determined by applying unit costs to individual patient resource use. A total of 807 patients who were diagnosed between July 2012 and July 2015 received ipilimumab in Dutch practice. The mean (median) episode duration was 6.27 (4.61) months (computed from the start of ipilimumab until the start of a next treatment, death, or the last date of follow-up). The average total healthcare costs amounted to €81 484, but varied widely (range: €18 131–€160 002). Ipilimumab was by far the most important cost driver (€73 739). Other costs were related to hospital admissions (€3323), hospital visits (€1791), diagnostics and imaging (€1505), radiotherapy (€828), and surgery (€297). Monthly costs for resource use other than ipilimumab were €1997 (SD: €2629). Treatment-naive patients (n=344) had higher total costs compared with previously-treated patients (n=463; €85 081 vs. €78 811). Although patients with colitis (n=106) had higher costs for resource use other than ipilimumab (€11 426) compared with patients with other types of immune-related adverse events (n=90; €9850) and patients with no immune-related adverse event (n=611; €6796), they had lower total costs (€76 075 vs. €87 882 and €81 480, respectively). In conclusion, this nation-wide study provides valuable insights into the healthcare costs of advanced cutaneous melanoma patients who were treated with ipilimumab in clinical practice. Most of the costs were attributable to ipilimumab, but the costs and its distribution varied considerably across subgroups.
Samenvatting 'Real-world use, safety, and survival of ipilimumab in metastatic cutaneous melanoma in The Netherlands':
Phase III trials with ipilimumab showed an improved survival in patients with metastatic melanoma. We evaluated the use and safety of ipilimumab, and the survival of all patients with metastatic cutaneous melanoma (N=807) receiving ipilimumab in real-world clinical practice in The Netherlands using data from the Dutch Melanoma Treatment Registry. Patients who were registered between July 2012 and July 2015 were included and analyzed according to their treatment status: treatment-naive (N=344) versus previously-treated (N=463). Overall, 70% of treatment-naive patients and 62% of previously-treated patients received all four planned doses of ipilimumab. Grade 3 and 4 immune-related adverse events occurred in 29% of treatment-naive patients and 21% of previously-treated patients. No treatment-related deaths occurred. Median time to first event was 5.4 months [95% confidence interval (CI): 4.7–6.5 months] in treatment-naive patients and 4.4 months (95% CI: 4.0–4.7 months) in previously-treated patients. Median overall survival was 14.3 months (95% CI: 11.6–16.7 months) in treatment-naive patients and 8.7 months (95% CI: 7.6–9.6 months) in previously-treated patients. In both patient groups, an elevated lactate dehydrogenase level (hazard ratio: 2.25 and 1.70 in treatment-naive and previously-treated patients, respectively) and American Joint Committee on Cancer M1c-stage disease (hazard ratio: 1.81 and 1.83, respectively) were negatively associated with overall survival. These real-world outcomes of ipilimumab slightly differed from outcomes in phase III trials. Although phase III trials are crucial for establishing efficacy, real-world data are of great added value enhancing the generalizability of outcomes of ipilimumab in clinical practice.