Phase II trial of humanized anti-Lewis Y monoclonal antibody for advanced hormone receptor-positive breast cancer that progressed following endocrine therapy
Clinics
;
76: e3146, 2021. tab, graf
Article
in English
| LILACS
| ID: biblio-1339696
ABSTRACT
OBJECTIVES:
The Lewis-Y antigen is expressed in 44%-90% of breast cancers (BCs). The expression of the antigen in carcinoma tissue differs from that in normal tissues. This study aimed to evaluate the clinical benefit of the humanized anti-Lewis Y monoclonal antibody, hu3S193, in advanced hormone receptor-positive and Lewis Y-positive BC after administration of endocrine therapy (ET).METHODS:
A single-arm phase II study was conducted in seven centers. Patients with advanced hormone receptor-positive BC who failed first-line ET were included. The inclusion criterion was the observation of tumoral expression of the Lewis Y antigen during immunohistochemistry. The treatment comprised hu3S193 antibody administration at weekly intravenous doses of 20 mg/m2 for 8-week cycles. The primary endpoint was the clinical benefit rate. ClinicalTrials.gov NCT01370239.RESULTS:
The study stopped accrual following an unplanned interim analysis as the hu3S193 antibody lacked sufficient activity to justify continuation of the study. Twenty-two patients were enrolled, of whom 21 were included in the efficacy analysis. The clinical benefit rate was 19%, with four patients presenting with stable disease after 24 weeks. One patient with prolonged stable disease received medication for over 2 years. No partial or complete responses were observed. The median time to progression and overall survival was 5.4 and 37.5 months, respectively.CONCLUSIONS:
The humanized anti-Lewis Y monoclonal antibody, hu3S193, exhibited insufficient activity in this cohort. However, the possibility of activity in a more strictly selected subgroup of patients with higher levels of Lewis Y tumoral expression cannot be overlooked.
Full text:
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Index:
LILACS (Americas)
Main subject:
Breast Neoplasms
/
Carcinoma
Limits:
Female
/
Humans
Language:
English
Journal:
Clinics
Journal subject:
Medicine
Year:
2021
Type:
Article
Affiliation country:
Brazil
Institution/Affiliation country:
Hospital de Cancer de Barretos, Fundaçao Pio XII/BR
/
Instituto Nacional do Cancer - INCA/BR
/
Recepta Biopharma e Hospital Israelita Albert Einstein/BR
/
Universidade Federal de Goias/BR
/
Universidade de Sao Paulo/BR
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