TY - JOUR
T1 - Vemurafenib in BRAF-mutant metastatic melanoma patients in real-world clinical practice
T2 - Prognostic factors associated with clinical outcomes
AU - Schouwenburg, Maartje G.
AU - Jochems, Anouk
AU - Leeneman, Brenda
AU - Franken, Margreet G.
AU - Van Den Eertwegh, Alfons J.M.
AU - Haanen, John B.A.G.
AU - Van Zeijl, Michiel C.T.
AU - Aarts, Maureen J.
AU - Van Akkooi, Alexander C.J.
AU - Van Den Berkmortel, Franchette W.P.J.
AU - Blokx, Willeke A.M.
AU - De Groot, Jan Willem B.
AU - Hospers, Geke A.P.
AU - Kapiteijn, Ellen
AU - Koornstra, Rutger H.
AU - Kruit, Wim H.
AU - Louwman, Marieke W.J.
AU - Piersma, Djura
AU - Van Rijn, Rozemarijn S.
AU - Suijkerbuijk, Karijn P.M.
AU - Ten Tije, Albert J.
AU - Vreugdenhil, Gerard
AU - Wouters, Michel W.J.M.
AU - Van Der Hoeven, Jacobus J.M.
N1 - Publisher Copyright:
© Copyright 2018 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2018/8/1
Y1 - 2018/8/1
N2 - The aim of this population-based study was to identify the factors associated with clinical outcomes in vemurafenib-Treated patients and to evaluate outcomes across subgroups of patients with different risk profiles. Data were retrieved from the Dutch Melanoma Treatment Registry. Time to next treatment (TTNT) and overall survival (OS) of all metastatic melanoma patients who received vemurafenib between 2012 and 2015 were assessed using Kaplan-Meier estimates. A risk score was developed on the basis of all prognostic factors associated with TTNT and OS derived from multivariable Cox regression analyses. Patients were stratified according to the presence of prognostic risk factors by counting the number of factors, ranging from 0 to 6. A total of 626 patients received vemurafenib with a median follow-up of 35.8 months. The median TTNT and OS were 4.7 months [95% confidence intervals (CI): 4.4-5.1] and 7.3 months (95% CI: 6.6-8.0). The strongest prognostic factors were serum lactate dehydrogenase (LDH) level, Eastern Cooperative Oncology Group performance score, number of organ sites involved and brain metastases. Patients with a favourable risk profile (no risk factors) had a median TTNT and OS of 7.1 (95% CI: 5.8-8.5) and 15.4 months (95% CI: 10.0-20.9). The median OS more than halved for patients with greater than or equal to 2 risk factors compared with patients with no risk factors. The clinical outcomes of vemurafenib in metastatic melanoma patients with a favourable risk profile are comparable with the results of the trials. Combining prognostic factors into a risk score could be valuable to stratify patients into favourable and poor-prognosis groups.
AB - The aim of this population-based study was to identify the factors associated with clinical outcomes in vemurafenib-Treated patients and to evaluate outcomes across subgroups of patients with different risk profiles. Data were retrieved from the Dutch Melanoma Treatment Registry. Time to next treatment (TTNT) and overall survival (OS) of all metastatic melanoma patients who received vemurafenib between 2012 and 2015 were assessed using Kaplan-Meier estimates. A risk score was developed on the basis of all prognostic factors associated with TTNT and OS derived from multivariable Cox regression analyses. Patients were stratified according to the presence of prognostic risk factors by counting the number of factors, ranging from 0 to 6. A total of 626 patients received vemurafenib with a median follow-up of 35.8 months. The median TTNT and OS were 4.7 months [95% confidence intervals (CI): 4.4-5.1] and 7.3 months (95% CI: 6.6-8.0). The strongest prognostic factors were serum lactate dehydrogenase (LDH) level, Eastern Cooperative Oncology Group performance score, number of organ sites involved and brain metastases. Patients with a favourable risk profile (no risk factors) had a median TTNT and OS of 7.1 (95% CI: 5.8-8.5) and 15.4 months (95% CI: 10.0-20.9). The median OS more than halved for patients with greater than or equal to 2 risk factors compared with patients with no risk factors. The clinical outcomes of vemurafenib in metastatic melanoma patients with a favourable risk profile are comparable with the results of the trials. Combining prognostic factors into a risk score could be valuable to stratify patients into favourable and poor-prognosis groups.
KW - clinical practice
KW - metastatic melanoma
KW - prognostic factors
KW - risk score
KW - vemurafenib
UR - http://www.scopus.com/inward/record.url?scp=85049615120&partnerID=8YFLogxK
U2 - 10.1097/CMR.0000000000000453
DO - 10.1097/CMR.0000000000000453
M3 - Article
C2 - 29750749
SN - 0960-8931
VL - 28
SP - 326
EP - 332
JO - Melanoma Research
JF - Melanoma Research
IS - 4
ER -