Publication:
Pembrolizumab plus eribulin in hormone-receptor–positive, HER2-negative, locally recurrent or metastatic breast cancer (KELLY): An open-label, multicentre, single-arm, phase Ⅱ trial

Simple item page
dc.contributor.authorPérezGarcía, José M.
dc.contributor.authorLlombart-Cussac, Antonio
dc.contributor.authorGion, María
dc.contributor.authorCurigliano, Giuseppe
dc.contributor.authorLópez Miranda, Elena
dc.contributor.authorAlonso Romero, José Luis
dc.contributor.authorBermejo, Begoña
dc.contributor.authorCalvo, Lourdes
dc.contributor.authorCarañana, Vicente
dc.contributor.authorCruz Sánchez, Susana de la
dc.contributor.authorMárquez Vázquez, Raúl
dc.contributor.authorPrat, Aleix
dc.contributor.authorRuiz Borrego, Manuel
dc.contributor.authorSampayo Cordero, Miguel
dc.contributor.authorSeguí-Palmer, Miguel Á.
dc.contributor.authorSoberino, Jesús
dc.contributor.authorMalfettone, Andrea
dc.contributor.authorSchmid, Peter
dc.contributor.authorCortés, Javier
dc.contributor.departmentMedicina
dc.date.accessioned2024-11-05T11:44:26Z
dc.date.available2024-11-05T11:44:26Z
dc.date.issued2021-05
dc.description© 2021 Elsevier Ltd. This document is the Published version of a Published Work that appeared in final form in European Journal of Cancer (EJC). To access the final edited and published work see https://doi.org/10.1016/j.ejca.2021.02.028
dc.description.abstractBackground Pembrolizumab has modest activity if used in patients with hormone-receptor–positive (HR+), HER2-negative, previously treated metastatic breast cancer (BC). Our study investigated whether there would be any clinical benefit in combining chemotherapy with pembrolizumab in a similar patient population. Methods This single-arm, phase Ⅱ trial enrolled women aged ≥18 years with HR+, HER2-negative, inoperable, locally recurrent or metastatic BC. Patients were previously treated with hormonal therapy and 1–2 chemotherapy regimens for locally recurrent and/or metastatic BC. On each 21-day cycle, patients received intravenous pembrolizumab 200 mg on day 1 and eribulin 1∙23 mg/m2 on days 1 and 8. The primary endpoint was the clinical benefit rate. Analysis of safety and activity was carried out in all patients who met the screening criteria and received at least 1 dose of study treatment. The trial is registered at ClinicalTrials.gov, NCT03222856. Results Of the 44 patients enrolled between January 29 and October 17, 2018, clinical benefit was achieved in 25 (56∙8%, 95% confidence interval [CI]: 41∙0–71∙7), objective response in 18 (40∙9%, 95% CI: 26∙3–56∙8), median progression-free survival was 6∙0 months (95% CI: 3∙7–8∙4), and 1-year overall survival was 59∙1% (95% CI: 45∙8–76∙2). The most common treatment-emergent adverse events (AEs) of any grade were neutropenia (20 [45∙5%]), anaemia (17 [38∙6%]), alopecia (19 [43∙2%]), asthenia (19 [43∙2%]), diarrhoea (14 [31∙8%]), fatigue (14 [31∙8%]), and peripheral neuropathy (12 [27∙3%]). Serious AEs occurred in 14 (31∙8%) patients including febrile neutropenia (3 [6∙8%]), neutropenia (2 [4∙5%]), fever (2 [4∙5%]) and peripheral neuropathy (2 [4∙5%]). Immune-related AEs occurred in 11 (25∙0%) patients. One (2∙3%) patient died of cardiac arrest unrelated to study treatment. Conclusion Pembrolizumab plus eribulin demonstrates encouraging antitumour activity in patients with heavily pre-treated, HR+, HER2-negative, locally recurrent or metastatic BC. The safety and tolerability of the combination is similar to eribulin or pembrolizumab monotherapy.es
dc.formatapplication/pdfes
dc.format.extent13es
dc.identifier.citationEuropean Journal of Cancer, 2021, Vol. 148, pp. 382-394
dc.identifier.doihttps://doi.org/10.1016/j.ejca.2021.02.028
dc.identifier.issnPrint: 0959-8049
dc.identifier.issnElectronic: 1879-0852
dc.identifier.urihttp://hdl.handle.net/10201/146004
dc.languageenges
dc.publisherElsevier
dc.relationMSD Spaines
dc.relation.publisherversionhttps://www.sciencedirect.com/science/article/pii/S0959804921001258?via%3Dihub
dc.rights.accessRightsinfo:eu-repo/semantics/restrictedAccess
dc.subjectPembrolizumabes
dc.subjectEribulines
dc.subjectHR-positive / HER2-negative metastatic breast canceres
dc.subjectPD-L1es
dc.titlePembrolizumab plus eribulin in hormone-receptor–positive, HER2-negative, locally recurrent or metastatic breast cancer (KELLY): An open-label, multicentre, single-arm, phase Ⅱ triales
dc.typeinfo:eu-repo/semantics/articlees
dspace.entity.typePublicationes
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
1-s2.0-S0959804921001258-main.pdf
Size:
1015.92 KB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
2.26 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Artículos