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

Autor: Álamo MDC; Oncology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain., Ochenduszko S; Oncology Department, Hospital Universitario Dr. Peset, Valencia, Spain., Crespo G; Oncology Department, Hospital Universitario de Burgos, Burgos, Spain., Corral M; Oncology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain., Oramas J; Oncology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain., Sancho P; Oncology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain., Medina J; Oncology Department, Hospital Universitario Virgen de la Salud, Toledo, Spain., Garicano F; Oncology Department, Hospital de Galdakao, Bizkaia, Spain., López P; Oncology Department, Complejo Hospitalario General de Jaén, Jaén, Spain., Campos Balea B; Oncology Department, Hospital Lucus Augusti, Lugo, Spain., Rodríguez Garzotto A; Medical Department and Strategy, Roche S.A, Madrid, Spain., Muñoz-Couselo E; Oncology Department, Hospital Universitario Vall d´Hebron, Barcelona, Spain.; VHIO Vall d'Hebron Institute on Oncology, Barcelona, Spain.
Jazyk: angličtina
Zdroj: OncoTargets and therapy [Onco Targets Ther] 2021 Nov 27; Vol. 14, pp. 5345-5352. Date of Electronic Publication: 2021 Nov 27 (Print Publication: 2021).
DOI: 10.2147/OTT.S325208
Abstrakt: Background: 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 BRAF V600 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.
Competing Interests: BCB declares that has received consulting honoraria from Boehringer and Sanofi and is on the speaker’s bureau of Roche, Novartis, Merck Sharp & Dohme, Bristol-Myers Squibb, Rovi, Leopharma, Astra Zeneca, Leo-Pharma, and Sanofi. EMC declares that has received consulting honoraria, including travel and accommodation paid, and is on the speaker’s bureau of Novartis, Bristol-Myers Squibb, Merck Sharp & Dohme, Sanofi, Roche and Pierre Fabre. FG declares that has received consulting honoraria from Amgen, Merck Sharp & Dohme, Bristol-Myers Squibb and Roche. GC declares that has received consulting honoraria, including travel and accommodation paid, from Janssen, IPSEN, Novartis, Roche, Pierre Fabre, Bristol-Myers Squibb, Sanofi, and EISAI, and is on the speaker’s bureau of Roche, Merck, EVSA Pharma, EISAI, and Merck Sharp & Dohme. JM declares that has received consulting honoraria, including travel and accommodation paid, from Roche, Bristol-Myers Squibb, and Novartis, and is on the speaker’s bureau of Roche, Bristol-Myers Squibb, Novartis, Merck Sharp & Dohme, and Pierre Fabre. MC declares that received consulting honoraria, including travel and accommodation paid, from Novartis, Roche, Pierre Fabre, and Merck Sharp & Dohme. SO declares that has received consulting honoraria from Roche, Novartis, Merck Sharp & Dohme, and Bristol-Myers Squibb. The authors report no other conflicts of interest in this work.
(© 2021 Álamo et al.)
Databáze: MEDLINE
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