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A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer

PURPOSE: Neoadjuvant combination immune checkpoint blockade and intralesional oncolytic virotherapy have the potential to activate antitumor responses in patients with breast cancer. EXPERIMENTAL DESIGN: Eligibility for this pilot phase I trial included patients with localized HER2-negative breast c...

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Autores principales: Nguyen, Vina P., Campbell, Katie M., Nowicki, Theodore S., Elumalai, Nila, Medina, Egmidio, Baselga-Carretero, Ignacio, DiNome, Maggie L., Chang, Helena R., Oseguera, Denise K., Ribas, Antoni, Glaspy, John A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Association for Cancer Research 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10445661/
https://www.ncbi.nlm.nih.gov/pubmed/37621406
http://dx.doi.org/10.1158/2767-9764.CRC-23-0145
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author Nguyen, Vina P.
Campbell, Katie M.
Nowicki, Theodore S.
Elumalai, Nila
Medina, Egmidio
Baselga-Carretero, Ignacio
DiNome, Maggie L.
Chang, Helena R.
Oseguera, Denise K.
Ribas, Antoni
Glaspy, John A.
author_facet Nguyen, Vina P.
Campbell, Katie M.
Nowicki, Theodore S.
Elumalai, Nila
Medina, Egmidio
Baselga-Carretero, Ignacio
DiNome, Maggie L.
Chang, Helena R.
Oseguera, Denise K.
Ribas, Antoni
Glaspy, John A.
author_sort Nguyen, Vina P.
collection PubMed
description PURPOSE: Neoadjuvant combination immune checkpoint blockade and intralesional oncolytic virotherapy have the potential to activate antitumor responses in patients with breast cancer. EXPERIMENTAL DESIGN: Eligibility for this pilot phase I trial included patients with localized HER2-negative breast cancer who received systemic nivolumab and ipilimumab and intratumor talimogene laherparepvec (T-VEC; NCT04185311). The primary objective was to evaluate the safety and adverse event profile of immunotherapy combined with T-VEC in patients with localized, HER2-negative breast cancer. RESULTS: Six patients were enrolled, 4 having relapses after prior neoadjuvant chemotherapy and 2 who were previously untreated. Toxicities included 1 patient having grade 3 hypotension and type 1 diabetes mellitus, 3 patients with hypothyroidism, and all patients having constitutional symptoms known to be associated with the administration of T-VEC. One patient had a pathologic complete response, 3 patients had pathologic partial responses, 1 showed no significant response, and 1 had disease progression. Biopsies demonstrated increased immune cell infiltration in samples from patients who responded to therapy. CONCLUSIONS: This triple immunotherapy regimen provided responses in patients with advanced or relapsed HER2-negative breast cancer, at the expense of long-term toxicities. SIGNIFICANCE: Systemic immune checkpoint blockade with a programmed death receptor 1 and a CTL antigen-4 blocking antibody, combined with intralesional oncolytic virotherapy, is a chemotherapy-free combination aimed at inducing an antitumor immune response locally and systemic immunity.
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spelling pubmed-104456612023-08-24 A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer Nguyen, Vina P. Campbell, Katie M. Nowicki, Theodore S. Elumalai, Nila Medina, Egmidio Baselga-Carretero, Ignacio DiNome, Maggie L. Chang, Helena R. Oseguera, Denise K. Ribas, Antoni Glaspy, John A. Cancer Res Commun Research Article PURPOSE: Neoadjuvant combination immune checkpoint blockade and intralesional oncolytic virotherapy have the potential to activate antitumor responses in patients with breast cancer. EXPERIMENTAL DESIGN: Eligibility for this pilot phase I trial included patients with localized HER2-negative breast cancer who received systemic nivolumab and ipilimumab and intratumor talimogene laherparepvec (T-VEC; NCT04185311). The primary objective was to evaluate the safety and adverse event profile of immunotherapy combined with T-VEC in patients with localized, HER2-negative breast cancer. RESULTS: Six patients were enrolled, 4 having relapses after prior neoadjuvant chemotherapy and 2 who were previously untreated. Toxicities included 1 patient having grade 3 hypotension and type 1 diabetes mellitus, 3 patients with hypothyroidism, and all patients having constitutional symptoms known to be associated with the administration of T-VEC. One patient had a pathologic complete response, 3 patients had pathologic partial responses, 1 showed no significant response, and 1 had disease progression. Biopsies demonstrated increased immune cell infiltration in samples from patients who responded to therapy. CONCLUSIONS: This triple immunotherapy regimen provided responses in patients with advanced or relapsed HER2-negative breast cancer, at the expense of long-term toxicities. SIGNIFICANCE: Systemic immune checkpoint blockade with a programmed death receptor 1 and a CTL antigen-4 blocking antibody, combined with intralesional oncolytic virotherapy, is a chemotherapy-free combination aimed at inducing an antitumor immune response locally and systemic immunity. American Association for Cancer Research 2023-08-23 /pmc/articles/PMC10445661/ /pubmed/37621406 http://dx.doi.org/10.1158/2767-9764.CRC-23-0145 Text en © 2023 The Authors; Published by the American Association for Cancer Research https://creativecommons.org/licenses/by/4.0/This open access article is distributed under the Creative Commons Attribution 4.0 International (CC BY 4.0) license.
spellingShingle Research Article
Nguyen, Vina P.
Campbell, Katie M.
Nowicki, Theodore S.
Elumalai, Nila
Medina, Egmidio
Baselga-Carretero, Ignacio
DiNome, Maggie L.
Chang, Helena R.
Oseguera, Denise K.
Ribas, Antoni
Glaspy, John A.
A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer
title A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer
title_full A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer
title_fullStr A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer
title_full_unstemmed A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer
title_short A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer
title_sort pilot study of neoadjuvant nivolumab, ipilimumab, and intralesional oncolytic virotherapy for her2-negative breast cancer
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10445661/
https://www.ncbi.nlm.nih.gov/pubmed/37621406
http://dx.doi.org/10.1158/2767-9764.CRC-23-0145
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