Bibliographic Details
| Title: |
Phase II trial of humanized anti-Lewis Y monoclonal antibody for advanced hormone receptor-positive breast cancer that progressed following endocrine therapy |
| Authors: |
Testa, Laura, Mano, Max, Arai, Roberto Jun, Bonadio, Renata Colombo, Serrano, Sergio V., Zorzetto, Marina M Costa, Crocamo, Susanne, Smaletz, Oren, Freitas-Junior, Ruffo, Hoff, Paulo M. |
| Source: |
Clinics. January 2021 76 |
| Publisher Information: |
Faculdade de Medicina / USP, 2021. |
| Publication Year: |
2021 |
| Subject Terms: |
Breast Cancer, Metastatic, Anti-Lewis Y, Monoclonal Antibody, Targeted Therapy |
| More Details: |
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. |
| Document Type: |
article |
| File Description: |
text/html |
| Language: |
English |
| ISSN: |
1807-5932 |
| DOI: |
10.6061/clinics/2021/e3146 |
| Access URL: |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322021000100316 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edssci.S1807.59322021000100316 |
| Database: |
SciELO |
