dc.contributor |
Universitat de Vic - Universitat Central de Catalunya. Facultat de Medicina |
|
dc.contributor.author |
Tabernero, Josep |
|
dc.contributor.author |
Grothey, Axel |
|
dc.contributor.author |
Van Cutsem, Eric |
|
dc.contributor.author |
Wasan, Harpreet |
|
dc.contributor.author |
Yoshino, Takayuki |
|
dc.contributor.author |
Desai, Jayesh |
|
dc.contributor.author |
Ciardiello, Fortunato |
|
dc.contributor.author |
Loupakis, Fotio |
|
dc.contributor.author |
Hong, Yong Sang |
|
dc.date.accessioned |
2024-01-31T14:22:07Z |
|
dc.date.available |
2024-01-31T14:22:07Z |
|
dc.date.created |
2021 |
|
dc.date.issued |
2021 |
|
dc.identifier.citation |
Tabernero, J., Grothey, A., Van Cutsem, E., Yaeger, R., Wasan, H., Yoshino, T., Kopetz, S. (2021). Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study. Journal of clinical oncology official journal of the American Society of Clinical Oncology, 39(4), 273-284. https://doi.org/10.1200/JCO.20.02088 |
es |
dc.identifier.issn |
1527-7755 |
|
dc.identifier.uri |
http://hdl.handle.net/10854/7720 |
|
dc.description.abstract |
PURPOSE BEACON CRC evaluated encorafenib plus cetuximab with or without binimetinib versus investigators' choice of irinotecan or FOLFIRI plus cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), after progression on 1-2 prior regimens. In the previously reported primary analysis, encorafenib, binimetinib plus cetuximab (ENCO/BINI/CETUX; triplet) and encorafenib plus cetuximab (ENCO/CETUX; doublet) regimens improved overall survival (OS) and objective response rate (ORR; by blinded central review) versus standard of care. The purpose of this analysis was to report updated efficacy and safety data.
METHODS In this open-label, phase III trial, 665 patients with BRAF V600E-mutant mCRC were randomly assigned 1:1:1 to receive triplet, doublet, or control. Primary end points were OS and independently reviewed ORR comparing triplet to control. OS for doublet versus control was a key secondary end point. Updated analyses include 6 months of additional follow-up and ORR for all randomized patients.
RESULTS Patients received triplet (n=224), doublet (n=220), or control (n=221). Median OS was 9.3 months (95% CI, 8.2 to 10.8) for triplet and 5.9 months (95% CI, 5.1 to 7.1) for control (hazard ratio [HR], 0.60 [95% CI, 0.47 to 0.75]). Median OS for doublet was 9.3 months (95% CI, 8.0 to 11.3) (HR v control, 0.61 [95% CI, 0.48 to 0.77]). Confirmed ORR was 26.8% (95% CI, 21.1% to 33.1%) for triplet, 19.5% (95% CI, 14.5% to 25.4%) for doublet, and 1.8% (95% CI, 0.5% to 4.6%) for control. Adverse events were consistent with the prior primary analysis, with grade >= 3 adverse events in 65.8%, 57.4%, and 64.2% for triplet, doublet, and control, respectively.
CONCLUSION In the BEACON CRC study, encorafenib plus cetuximab improved OS, ORR, and progression-free survival in previously treated patients in the metastatic setting compared with standard chemotherapy. Based on the primary and updated analyses, encorafenib plus cetuximab is a new standard care regimen for previously treated patients with BRAF V600E mCRC. (C) 2021 by American Society of Clinical Oncology |
es |
dc.description.sponsorship |
Supported by the Cancer Center Core Grant P30 CA 008748 to Memorial Sloan-Kettering Cancer Center. The BEACON trial was sponsored by Pfizer and was conducted with support from Merck KGaA Darmstadt, Germany (for sites outside of North America), ONO Pharmaceutical, and Pierre Fabre. |
EN |
dc.format |
application/pdf |
es |
dc.format.extent |
13 p. |
es |
dc.language.iso |
eng |
es |
dc.publisher |
American Society of Clinical Oncology |
es |
dc.rights |
Aquest document està subjecte a aquesta llicència Creative Commons |
es |
dc.rights.uri |
https://creativecommons.org/licenses/by-nc-nd/4.0/deed.ca |
es |
dc.subject.other |
Còlon -- Càncer |
es |
dc.subject.other |
Metàstasi |
es |
dc.title |
Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study |
es |
dc.type |
info:eu-repo/semantics/article |
es |
dc.identifier.doi |
https://doi.org/10.1200/JCO.20.02088 |
|
dc.rights.accessRights |
info:eu-repo/semantics/openAccess |
es |
dc.type.version |
info:eu-repo/publishedVersion |
es |
dc.indexacio |
Indexat a WOS/JCR |
es |
dc.indexacio |
Indexat a SCOPUS |
es |