Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer
| Autor: | Axel Grothey, Sara Lonardi, Victor Sandor, Neeltje Steeghs, Rona Yaeger, Elena Elez, Yong Sang Hong, Harpreet Wasan, Christina Guo, Jan H.M. Schellens, Tae Won Kim, Eric Van Cutsem, Ashwin Gollerkeri, Tormod Kyrre Guren, Fotios Loupakis, Line Schmidt Tarpgaard, Kati Maharry, Jayesh Desai, Lisa Anderson, Sergey Orlov, Aitana Calvo Ferrándiz, Jeroen Dekervel, Michael Braun, Per Pfeiffer, Asha Krishnan, Pilar García-Alfonso, Michael D Pickard, Scott Kopetz, Janna Christy-Bittel, Hendrik Tobias Arkenau, Takayuki Yoshino, Fortunato Ciardiello, Christopher Hunt Keir, Van Morris, Josep Tabernero |
|---|---|
| Přispěvatelé: | Kopetz, Scott, Grothey, Axel, Yaeger, Rona, Van Cutsem, Eric, Desai, Jayesh, Yoshino, Takayuki, Wasan, Harpreet, Ciardiello, Fortunato, Loupakis, Fotio, Hong, Yong Sang, Steeghs, Neeltje, Guren, Tormod K, Arkenau, Hendrik-Tobia, Garcia-Alfonso, Pilar, Pfeiffer, Per, Orlov, Sergey, Lonardi, Sara, Elez, Elena, Kim, Tae-Won, Schellens, Jan H M, Guo, Christina, Krishnan, Asha, Dekervel, Jeroen, Morris, Van, Calvo Ferrandiz, Aitana, Tarpgaard, L S, Braun, Michael, Gollerkeri, Ashwin, Keir, Christopher, Maharry, Kati, Pickard, Michael, Christy-Bittel, Janna, Anderson, Lisa, Sandor, Victor, Tabernero, Josep |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Oncology medicine.medical_specialty Irinotecan/therapeutic use Colorectal cancer Kaplan-Meier Estimate 030204 cardiovascular system & hematology 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Carbamates/administration & dosage Internal medicine Encorafenib Proto-Oncogene Proteins B-raf/genetics medicine Humans 030212 general & internal medicine Benzimidazoles/administration & dosage Survival analysis Aged Cetuximab/administration & dosage Aged 80 and over Sulfonamides/administration & dosage Cetuximab business.industry Antineoplastic Combined Chemotherapy Protocols/adverse effects Colorectal Neoplasms/drug therapy Binimetinib General Medicine Middle Aged medicine.disease Survival Analysis digestive system diseases Intention to Treat Analysis BRAF V600E Irinotecan Clinical trial chemistry Mutation Disease Progression Female Electrocorticography business medicine.drug |
| Zdroj: | Kopetz, S, Grothey, A, Yaeger, R, Van Cutsem, E, Desai, J, Yoshino, T, Wasan, H, Ciardiello, F, Loupakis, F, Hong, Y S, Steeghs, N, Guren, T K, Arkenau, H T, Garcia-Alfonso, P, Pfeiffer, P, Orlov, S, Lonardi, S, Elez, E, Kim, T W, Schellens, J H M, Guo, C, Krishnan, A, Dekervel, J, Morris, V, Ferrandiz, A C, Tarpgaard, L S, Braun, M, Gollerkeri, A, Keir, C, Maharry, K, Pickard, M, Christy-Bittel, J, Anderson, L, Sandor, V & Tabernero, J 2019, ' Encorafenib, binimetinib, and cetuximab in BRAF V600E–mutated colorectal cancer ', New England Journal of Medicine, vol. 381, no. 17, pp. 1632-1643 . https://doi.org/10.1056/NEJMoa1908075 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1908075 |
| Popis: | BACKGROUND: Patients with metastatic colorectal cancer with the BRAF V600E mutation have a poor prognosis, with a median overall survival of 4 to 6 months after failure of initial therapy. Inhibition of BRAF alone has limited activity because of pathway reactivation through epidermal growth factor receptor signaling. METHODS: In this open-label, phase 3 trial, we enrolled 665 patients with BRAF V600E-mutated metastatic colorectal cancer who had had disease progression after one or two previous regimens. Patients were randomly assigned in a 1:1:1 ratio to receive encorafenib, binimetinib, and cetuximab (triplet-therapy group); encorafenib and cetuximab (doublet-therapy group); or the investigators' choice of either cetuximab and irinotecan or cetuximab and FOLFIRI (folinic acid, fluorouracil, and irinotecan) (control group). The primary end points were overall survival and objective response rate in the triplet-therapy group as compared with the control group. A secondary end point was overall survival in the doublet-therapy group as compared with the control group. We report here the results of a prespecified interim analysis. RESULTS: The median overall survival was 9.0 months in the triplet-therapy group and 5.4 months in the control group (hazard ratio for death, 0.52; 95% confidence interval [CI], 0.39 to 0.70; P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|