PMID- 29750749 OWN - NLM STAT- MEDLINE DCOM- 20190201 LR - 20190201 IS - 1473-5636 (Electronic) IS - 0960-8931 (Linking) VI - 28 IP - 4 DP - 2018 Aug TI - Vemurafenib in BRAF-mutant metastatic melanoma patients in real-world clinical practice: prognostic factors associated with clinical outcomes. PG - 326-332 LID - 10.1097/CMR.0000000000000453 [doi] 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. FAU - Schouwenburg, Maartje G AU - Schouwenburg MG AD - Department of Medical Oncology, Leiden University Medical Centre. AD - Dutch Institute for Clinical Auditing, Leiden. FAU - Jochems, Anouk AU - Jochems A AD - Department of Medical Oncology, Leiden University Medical Centre. AD - Dutch Institute for Clinical Auditing, Leiden. FAU - Leeneman, Brenda AU - Leeneman B AD - Department of Health Technology Assessment, Erasmus School of Health Policy and Management. FAU - Franken, Margreet G AU - Franken MG AD - Institute for Medical Technology Assessment, Erasmus University. FAU - van den Eertwegh, Alfons J M AU - van den Eertwegh AJM AD - Department of Medical Oncology, VU University Medical Centre. FAU - Haanen, John B A G AU - Haanen JBAG AD - Departments of Medical Oncology. FAU - van Zeijl, Michiel C T AU - van Zeijl MCT AD - Department of Medical Oncology, Leiden University Medical Centre. AD - Dutch Institute for Clinical Auditing, Leiden. FAU - Aarts, Maureen J AU - Aarts MJ AD - Department of Medical Oncology, Maastricht University Medical Centre, Maastricht. FAU - van Akkooi, Alexander C J AU - van Akkooi ACJ AD - Surgical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam. FAU - van den Berkmortel, Franchette W P J AU - van den Berkmortel FWPJ AD - Department of Internal Medicine, Zuyderland Medical Centre Geleen-Heerlen, Sittard-Geleen. FAU - Blokx, Willeke A M AU - Blokx WAM AD - Departments of Pathology. FAU - de Groot, Jan Willem B AU - de Groot JWB AD - Department of Medical Oncology, Isala, Zwolle. FAU - Hospers, Geke A P AU - Hospers GAP AD - Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen. FAU - Kapiteijn, Ellen AU - Kapiteijn E AD - Department of Medical Oncology, Leiden University Medical Centre. FAU - Koornstra, Rutger H AU - Koornstra RH AD - Medical Oncology, Radboud University Medical Centre, Nijmegen. FAU - Kruit, Wim H AU - Kruit WH AD - Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam. FAU - Louwman, Marieke W J AU - Louwman MWJ AD - Netherlands Comprehensive Cancer Organisation, Utrecht. FAU - Piersma, Djura AU - Piersma D AD - Department of Internal Medicine, Medisch Spectrum Twente, Enschede. FAU - van Rijn, Rozemarijn S AU - van Rijn RS AD - Department of Internal Medicine, Medical Centre Leeuwarden, Leeuwarden. FAU - Suijkerbuijk, Karijn P M AU - Suijkerbuijk KPM AD - Department of Medical Oncology, University Medical Centre Utrecht Cancer Center, Utrecht. FAU - Ten Tije, Albert J AU - Ten Tije AJ AD - Departments of Medical Oncology. AD - Department of Internal Medicine, Amphia Hospital, Breda. FAU - Vreugdenhil, Gerard AU - Vreugdenhil G AD - Department of Internal Medicine, Maxima Medical Center, Veldhoven, The Netherlands. FAU - Wouters, Michel W J M AU - Wouters MWJM AD - Dutch Institute for Clinical Auditing, Leiden. AD - Surgical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam. FAU - van der Hoeven, Jacobus J M AU - van der Hoeven JJM AD - Department of Medical Oncology, Leiden University Medical Centre. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - Melanoma Res JT - Melanoma research JID - 9109623 RN - 0 (Antineoplastic Agents) RN - 207SMY3FQT (Vemurafenib) RN - EC 2.7.11.1 (Proto-Oncogene Proteins B-raf) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/pharmacology/*therapeutic use MH - Female MH - Humans MH - Male MH - Melanoma/*drug therapy/pathology MH - Middle Aged MH - Neoplasm Metastasis MH - Prognosis MH - Proto-Oncogene Proteins B-raf/*genetics MH - Risk Factors MH - Skin Neoplasms/*drug therapy/pathology MH - Vemurafenib/pharmacology/*therapeutic use MH - Young Adult EDAT- 2018/05/12 06:00 MHDA- 2019/02/02 06:00 CRDT- 2018/05/12 06:00 PHST- 2018/05/12 06:00 [pubmed] PHST- 2019/02/02 06:00 [medline] PHST- 2018/05/12 06:00 [entrez] AID - 10.1097/CMR.0000000000000453 [doi] PST - ppublish SO - Melanoma Res. 2018 Aug;28(4):326-332. doi: 10.1097/CMR.0000000000000453.