Effects of dose modifications on the safety and efficacy of dacomitinib for EGFR mutation-positive non-small-cell lung cancer

Aim: We evaluated reasons for dacomitinib dose reduction (DR) and examined adverse event (AE) incidence, key efficacy end points (progression-free survival [PFS]/overall survival [OS]), and pharmacokinetics in dose-reducing patients in the ARCHER 1050 trial. Patients & methods: Newly diagnosed p...

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Autores: Corral-Jaime, J. (Jesús)|||/items/aba4503e-6970-43e0-9219-238766ac8852, Mok, T.S. (Tony S.)|||/items/e91edeb3-d511-44a4-a72c-338e96ade778, Nakagawa, K. (Kazuhiko)|||/items/04e7db33-fd42-4c2b-a989-0d6a89ae878a, Rosell, R. (Rafael)|||/items/771e36b5-84e0-4ac6-9009-324f454c04b0, Lee, K.H. (Ki Hyeong)|||/items/494d4428-b76a-475d-a658-c74ee1ade123, Migliorino, M.R. (Maria Rita)|||/items/9abafe36-e406-4036-b7f4-de06f44c197f, Pluzanski, A. (Adam)|||/items/60793365-1e98-4ea9-8e43-b3df9623206c, Linke, R. (Rolf)|||/items/07873284-7c5d-4745-b966-cff39ed3b29d, Devgan, G. (Geeta)|||/items/fb3e0082-1314-470f-91f3-6e2b9787a62d, Tan, W. (Weiwei)|||/items/55ef5622-8ca9-4887-a576-36b6711f47dc, Quinn, S. (Susan)|||/items/1e0851a9-c13a-4765-97f3-d086cb24a7cc, Wang, T. (Tao)|||/items/6e6bf742-59a8-45e8-a19a-07e87e41dea3, Wu, Y.L. (Yi-Long)|||/items/7a103463-4dcc-4ad4-87d3-0c0081a787df
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universidad de Navarra
Repositorio:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:inglés
OAI Identifier:oai:dadun.unav.edu:10171/62028
Acceso en línea:https://hdl.handle.net/10171/62028
Access Level:acceso abierto
Palabra clave:Materias Investigacion::Ciencias de la Salud::Oncología
EGFR
NSCLC
Dacomitinib
Dose
First-line
Descripción
Sumario:Aim: We evaluated reasons for dacomitinib dose reduction (DR) and examined adverse event (AE) incidence, key efficacy end points (progression-free survival [PFS]/overall survival [OS]), and pharmacokinetics in dose-reducing patients in the ARCHER 1050 trial. Patients & methods: Newly diagnosed patients with EGFR mutation-positive, advanced non-small-cell lung cancer received oral dacomitinib (45 mg once-daily [QD]), with stepwise toxicity-managing DR (30 and 15 mg QD) permitted. Results: Skin toxicities (62.7%) were the most common DR-leading AEs. The AE incidence and severity decreased following DRs. Initial plasma dacomitinib exposure (45 mg QD) was generally lower in patients remaining at 45 mg QD compared with dose-reducing patients. Median PFS and OS were similar in all dacomitinib-treated patients and dose-reducing patients. Conclusion: Tolerability-guided dose modifications enabled patients to continue with dacomitinib and benefit from PFS/OS improvement.

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