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A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer
De-escalating adjuvant therapy following pathologic complete response (pCR) to an abbreviated neoadjuvant regimen in human epidermal growth factor receptor 2-positive (HER2+) breast cancer is the focus of international research efforts. However, the feasibility of this approach and its appeal to pat...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9091255/ https://www.ncbi.nlm.nih.gov/pubmed/35538105 http://dx.doi.org/10.1038/s41523-022-00429-7 |
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author | Waks, Adrienne G. Desai, Neelam V. Li, Tianyu Poorvu, Philip D. Partridge, Ann H. Sinclair, Natalie Spring, Laura M. Faggen, Meredith Constantine, Michael Metzger, Otto Alberti, Jillian Deane, Julia Rosenberg, Shoshana M. Frank, Elizabeth Tolaney, Sara M. Krop, Ian E. Tung, Nadine M. Tayob, Nabihah King, Tari A. Mittendorf, Elizabeth A. Winer, Eric P. |
author_facet | Waks, Adrienne G. Desai, Neelam V. Li, Tianyu Poorvu, Philip D. Partridge, Ann H. Sinclair, Natalie Spring, Laura M. Faggen, Meredith Constantine, Michael Metzger, Otto Alberti, Jillian Deane, Julia Rosenberg, Shoshana M. Frank, Elizabeth Tolaney, Sara M. Krop, Ian E. Tung, Nadine M. Tayob, Nabihah King, Tari A. Mittendorf, Elizabeth A. Winer, Eric P. |
author_sort | Waks, Adrienne G. |
collection | PubMed |
description | De-escalating adjuvant therapy following pathologic complete response (pCR) to an abbreviated neoadjuvant regimen in human epidermal growth factor receptor 2-positive (HER2+) breast cancer is the focus of international research efforts. However, the feasibility of this approach and its appeal to patients and providers had not been formally investigated. We aimed to assess adherence to de-escalated adjuvant antibody doublet therapy (trastuzumab and pertuzumab [HP], without chemotherapy) among patients with pCR following neoadjuvant paclitaxel/HP (THP). In this single-arm prospective trial, patients with treatment-naïve stage II-III HER2+ breast cancer received neoadjuvant weekly paclitaxel ×12 and HP every 3 weeks ×4. The primary endpoint was receipt of adjuvant non-HER2-directed cytotoxic chemotherapy. Ninety-eight patients received ≥1 dose of THP on study. Patients had median age of 50 years, 86% had stage II tumors, and 34% were hormone receptor-negative. Five patients had incomplete clinical response following THP and received doxorubicin and cyclophosphamide before surgery; they were classified as non-pCR and censored from further analyses. The overall pCR rate was 56.7%. Among patients with pCR, the adherence rate to de-escalated antibody-only therapy (HP) was 98.2% (95% CI 90.3–100.0%), and the primary feasibility endpoint was reached. The majority of patients felt positive or neutral about their adjuvant treatment plans. With brief follow-up (median 19.1 months), there were no breast cancer recurrences. De-escalation of adjuvant chemotherapy among patients who experience pCR in early-stage HER2+ breast cancer is a practicable approach for both patients and physicians. Planned and ongoing prospective trials will determine the long-term efficacy of this approach. Trial registration clinicaltrials.gov, NCT03716180, https://clinicaltrials.gov/ct2/show/NCT03716180. |
format | Online Article Text |
id | pubmed-9091255 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-90912552022-05-12 A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer Waks, Adrienne G. Desai, Neelam V. Li, Tianyu Poorvu, Philip D. Partridge, Ann H. Sinclair, Natalie Spring, Laura M. Faggen, Meredith Constantine, Michael Metzger, Otto Alberti, Jillian Deane, Julia Rosenberg, Shoshana M. Frank, Elizabeth Tolaney, Sara M. Krop, Ian E. Tung, Nadine M. Tayob, Nabihah King, Tari A. Mittendorf, Elizabeth A. Winer, Eric P. NPJ Breast Cancer Article De-escalating adjuvant therapy following pathologic complete response (pCR) to an abbreviated neoadjuvant regimen in human epidermal growth factor receptor 2-positive (HER2+) breast cancer is the focus of international research efforts. However, the feasibility of this approach and its appeal to patients and providers had not been formally investigated. We aimed to assess adherence to de-escalated adjuvant antibody doublet therapy (trastuzumab and pertuzumab [HP], without chemotherapy) among patients with pCR following neoadjuvant paclitaxel/HP (THP). In this single-arm prospective trial, patients with treatment-naïve stage II-III HER2+ breast cancer received neoadjuvant weekly paclitaxel ×12 and HP every 3 weeks ×4. The primary endpoint was receipt of adjuvant non-HER2-directed cytotoxic chemotherapy. Ninety-eight patients received ≥1 dose of THP on study. Patients had median age of 50 years, 86% had stage II tumors, and 34% were hormone receptor-negative. Five patients had incomplete clinical response following THP and received doxorubicin and cyclophosphamide before surgery; they were classified as non-pCR and censored from further analyses. The overall pCR rate was 56.7%. Among patients with pCR, the adherence rate to de-escalated antibody-only therapy (HP) was 98.2% (95% CI 90.3–100.0%), and the primary feasibility endpoint was reached. The majority of patients felt positive or neutral about their adjuvant treatment plans. With brief follow-up (median 19.1 months), there were no breast cancer recurrences. De-escalation of adjuvant chemotherapy among patients who experience pCR in early-stage HER2+ breast cancer is a practicable approach for both patients and physicians. Planned and ongoing prospective trials will determine the long-term efficacy of this approach. Trial registration clinicaltrials.gov, NCT03716180, https://clinicaltrials.gov/ct2/show/NCT03716180. Nature Publishing Group UK 2022-05-10 /pmc/articles/PMC9091255/ /pubmed/35538105 http://dx.doi.org/10.1038/s41523-022-00429-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Waks, Adrienne G. Desai, Neelam V. Li, Tianyu Poorvu, Philip D. Partridge, Ann H. Sinclair, Natalie Spring, Laura M. Faggen, Meredith Constantine, Michael Metzger, Otto Alberti, Jillian Deane, Julia Rosenberg, Shoshana M. Frank, Elizabeth Tolaney, Sara M. Krop, Ian E. Tung, Nadine M. Tayob, Nabihah King, Tari A. Mittendorf, Elizabeth A. Winer, Eric P. A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer |
title | A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer |
title_full | A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer |
title_fullStr | A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer |
title_full_unstemmed | A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer |
title_short | A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer |
title_sort | prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in her2-positive breast cancer |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9091255/ https://www.ncbi.nlm.nih.gov/pubmed/35538105 http://dx.doi.org/10.1038/s41523-022-00429-7 |
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