Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice

Mª del Carmen Álamo,1 Sebastian Ochenduszko,2 Guillermo Crespo,3 Mónica Corral,4 Juana Oramas,5 Pilar Sancho,6 Javier Medina,7 Fernando Garicano,8 Pedro López,9 Begoña Campos Balea,10 Analia Rodríguez Garzotto,11 Eva Muñoz-Couselo12,13 1Oncology Department, Hospital Universitario Virgen Macarena, Se...

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Autores principales: Álamo MC, Ochenduszko S, Crespo G, Corral M, Oramas J, Sancho P, Medina J, Garicano F, López P, Campos Balea B, Rodríguez Garzotto A, Muñoz-Couselo E
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Publicado: Dove Medical Press 2021
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spelling oai:doaj.org-article:c4c4575b8a5f4a8b85e34e1b4211b4692021-11-28T19:13:10ZDurable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice1178-6930https://doaj.org/article/c4c4575b8a5f4a8b85e34e1b4211b4692021-11-01T00:00:00Zhttps://www.dovepress.com/durable-response-to-vemurafenib-and-cobimetinib-for-the-treatment-of-b-peer-reviewed-fulltext-article-OTThttps://doaj.org/toc/1178-6930Mª del Carmen Álamo,1 Sebastian Ochenduszko,2 Guillermo Crespo,3 Mónica Corral,4 Juana Oramas,5 Pilar Sancho,6 Javier Medina,7 Fernando Garicano,8 Pedro López,9 Begoña Campos Balea,10 Analia Rodríguez Garzotto,11 Eva Muñoz-Couselo12,13 1Oncology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain; 2Oncology Department, Hospital Universitario Dr. Peset, Valencia, Spain; 3Oncology Department, Hospital Universitario de Burgos, Burgos, Spain; 4Oncology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain; 5Oncology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain; 6Oncology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain; 7Oncology Department, Hospital Universitario Virgen de la Salud, Toledo, Spain; 8Oncology Department, Hospital de Galdakao, Bizkaia, Spain; 9Oncology Department, Complejo Hospitalario General de Jaén, Jaén, Spain; 10Oncology Department, Hospital Lucus Augusti, Lugo, Spain; 11Medical Department and Strategy, Roche S.A, Madrid, Spain; 12Oncology Department, Hospital Universitario Vall d´Hebron, Barcelona, Spain; 13VHIO Vall d’Hebron Institute on Oncology, Barcelona, SpainCorrespondence: Eva Muñoz-CouseloOncology Department, Hospital Universitario Vall d´Hebron, Passeig de la Vall d’Hebron, 119, Barcelona, 08035, SpainEmail emunoz@vhio.netBackground: The combination of BRAF and MEK inhibitors delays the onset of resistance and provides more sustained and dramatic responses in comparison with a BRAF inhibitor in monotherapy. The objective of the study was to evaluate the effectiveness of the combination therapy with vemurafenib/cobimetinib in terms of durability, and to describe differential characteristics in patients associated to durable responses in real-world settings.Patients and Methods: Retrospective, observational, cross-sectional, multicenter study involving 41 patients with advanced melanoma harboring a BRAFV600 mutation who initiated a combination therapy with vemurafenib/cobimetinib between May 2018 and March 2019. Participants were differentiated regarding the durability of the response: durable (complete response, CR, or a partial response, PR, for at least 12 months) and non-durable (stable disease, SD, progressive disease, PD, or CR/PR < 12 months). Secondary endpoints included treatment adherence, labor productivity, anxiety/depression, and safety profile.Results: During the combination therapy, 12 patients (29.3%) had a CR, 19 a PR (46.3%), 5 showed SD (12.2%), and 5 had PD. A total of 12 patients (29.3%) were considered as achieving a durable response and 29 (70.7%) as a non-durable one. Practically all sociodemographic and clinical characteristics were similar between patients. Body mass index was the only differential factor (with higher body mass index achieving a non-durable response). The treatment adherence was 100% in patients with durable response and 66.7% in those with non-durable.Conclusion: The combination treatment with vemurafenib/cobimetinib results in an important impact on long-term survival, leading to a steady CR in one-third of the patients.Keywords: vemurafenib, cobimetinib, BRAF, metastatic melanoma, durable response, clinical practiceÁlamo MCOchenduszko SCrespo GCorral MOramas JSancho PMedina JGaricano FLópez PCampos Balea BRodríguez Garzotto AMuñoz-Couselo EDove Medical Pressarticlevemurafenibcobimetinibbrafmetastatic melanomadurable responseclinical practiceNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENOncoTargets and Therapy, Vol Volume 14, Pp 5345-5352 (2021)
institution DOAJ
collection DOAJ
language EN
topic vemurafenib
cobimetinib
braf
metastatic melanoma
durable response
clinical practice
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
spellingShingle vemurafenib
cobimetinib
braf
metastatic melanoma
durable response
clinical practice
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
Álamo MC
Ochenduszko S
Crespo G
Corral M
Oramas J
Sancho P
Medina J
Garicano F
López P
Campos Balea B
Rodríguez Garzotto A
Muñoz-Couselo E
Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice
description Mª del Carmen Álamo,1 Sebastian Ochenduszko,2 Guillermo Crespo,3 Mónica Corral,4 Juana Oramas,5 Pilar Sancho,6 Javier Medina,7 Fernando Garicano,8 Pedro López,9 Begoña Campos Balea,10 Analia Rodríguez Garzotto,11 Eva Muñoz-Couselo12,13 1Oncology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain; 2Oncology Department, Hospital Universitario Dr. Peset, Valencia, Spain; 3Oncology Department, Hospital Universitario de Burgos, Burgos, Spain; 4Oncology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain; 5Oncology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain; 6Oncology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain; 7Oncology Department, Hospital Universitario Virgen de la Salud, Toledo, Spain; 8Oncology Department, Hospital de Galdakao, Bizkaia, Spain; 9Oncology Department, Complejo Hospitalario General de Jaén, Jaén, Spain; 10Oncology Department, Hospital Lucus Augusti, Lugo, Spain; 11Medical Department and Strategy, Roche S.A, Madrid, Spain; 12Oncology Department, Hospital Universitario Vall d´Hebron, Barcelona, Spain; 13VHIO Vall d’Hebron Institute on Oncology, Barcelona, SpainCorrespondence: Eva Muñoz-CouseloOncology Department, Hospital Universitario Vall d´Hebron, Passeig de la Vall d’Hebron, 119, Barcelona, 08035, SpainEmail emunoz@vhio.netBackground: The combination of BRAF and MEK inhibitors delays the onset of resistance and provides more sustained and dramatic responses in comparison with a BRAF inhibitor in monotherapy. The objective of the study was to evaluate the effectiveness of the combination therapy with vemurafenib/cobimetinib in terms of durability, and to describe differential characteristics in patients associated to durable responses in real-world settings.Patients and Methods: Retrospective, observational, cross-sectional, multicenter study involving 41 patients with advanced melanoma harboring a BRAFV600 mutation who initiated a combination therapy with vemurafenib/cobimetinib between May 2018 and March 2019. Participants were differentiated regarding the durability of the response: durable (complete response, CR, or a partial response, PR, for at least 12 months) and non-durable (stable disease, SD, progressive disease, PD, or CR/PR < 12 months). Secondary endpoints included treatment adherence, labor productivity, anxiety/depression, and safety profile.Results: During the combination therapy, 12 patients (29.3%) had a CR, 19 a PR (46.3%), 5 showed SD (12.2%), and 5 had PD. A total of 12 patients (29.3%) were considered as achieving a durable response and 29 (70.7%) as a non-durable one. Practically all sociodemographic and clinical characteristics were similar between patients. Body mass index was the only differential factor (with higher body mass index achieving a non-durable response). The treatment adherence was 100% in patients with durable response and 66.7% in those with non-durable.Conclusion: The combination treatment with vemurafenib/cobimetinib results in an important impact on long-term survival, leading to a steady CR in one-third of the patients.Keywords: vemurafenib, cobimetinib, BRAF, metastatic melanoma, durable response, clinical practice
format article
author Álamo MC
Ochenduszko S
Crespo G
Corral M
Oramas J
Sancho P
Medina J
Garicano F
López P
Campos Balea B
Rodríguez Garzotto A
Muñoz-Couselo E
author_facet Álamo MC
Ochenduszko S
Crespo G
Corral M
Oramas J
Sancho P
Medina J
Garicano F
López P
Campos Balea B
Rodríguez Garzotto A
Muñoz-Couselo E
author_sort Álamo MC
title Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice
title_short Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice
title_full Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice
title_fullStr Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice
title_full_unstemmed Durable Response to Vemurafenib and Cobimetinib for the Treatment of BRAF-Mutated Metastatic Melanoma in Routine Clinical Practice
title_sort durable response to vemurafenib and cobimetinib for the treatment of braf-mutated metastatic melanoma in routine clinical practice
publisher Dove Medical Press
publishDate 2021
url https://doaj.org/article/c4c4575b8a5f4a8b85e34e1b4211b469
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