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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.
- Source :
-
European Journal of Cancer . May2021, Vol. 148, p382-394. 13p. - Publication Year :
- 2021
-
Abstract
- 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. 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. 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. 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. • Pembrolizumab + eribulin showed clinical benefit in luminal metastatic breast cancer (BC). • Objective responses were achieved regardless of programmed death ligand 1 status. • Its safety profile is similar to eribulin or pembrolizumab monotherapy. • New predictive biomarkers are required in endocrine-resistant BC. [ABSTRACT FROM AUTHOR]
- Subjects :
- *THERAPEUTIC use of monoclonal antibodies
*THERAPEUTIC use of antineoplastic agents
*BALDNESS
*RESEARCH
*COMBINATION drug therapy
*CLINICAL trials
*INTRAVENOUS therapy
*CONFIDENCE intervals
*DIARRHEA
*PERIPHERAL neuropathy
*CANCER chemotherapy
*METASTASIS
*CANCER relapse
*MONOCLONAL antibodies
*ANTINEOPLASTIC agents
*NEUTROPENIA
*MEDICAL cooperation
*TREATMENT effectiveness
*ASTHENIA
*ERIBULIN
*DESCRIPTIVE statistics
*ANEMIA
*FATIGUE (Physiology)
*BREAST tumors
Subjects
Details
- Language :
- English
- ISSN :
- 09598049
- Volume :
- 148
- Database :
- Academic Search Index
- Journal :
- European Journal of Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 150021587
- Full Text :
- https://doi.org/10.1016/j.ejca.2021.02.028