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A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer

Platinum is recommended in combination with gemcitabine in the treatment of metastatic triple-negative breast cancer (mTNBC). We conduct a randomized phase 3, controlled, open-label trial to compare nab-paclitaxel/cisplatin (AP) with gemcitabine/cisplatin (GP) in mTNBC patients (ClinicalTrials.gov N...

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Autores principales: Wang, Biyun, Sun, Tao, Zhao, Yannan, Wang, Shusen, Zhang, Jian, Wang, Zhonghua, Teng, Yue-E, Cai, Li, Yan, Min, Wang, Xiaojia, Jiang, Zefei, Pan, Yueyin, Luo, Jianfeng, Shao, Zhimin, Wu, Jiong, Guo, Xiaomao, Hu, Xichun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9276725/
https://www.ncbi.nlm.nih.gov/pubmed/35821019
http://dx.doi.org/10.1038/s41467-022-31704-7
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author Wang, Biyun
Sun, Tao
Zhao, Yannan
Wang, Shusen
Zhang, Jian
Wang, Zhonghua
Teng, Yue-E
Cai, Li
Yan, Min
Wang, Xiaojia
Jiang, Zefei
Pan, Yueyin
Luo, Jianfeng
Shao, Zhimin
Wu, Jiong
Guo, Xiaomao
Hu, Xichun
author_facet Wang, Biyun
Sun, Tao
Zhao, Yannan
Wang, Shusen
Zhang, Jian
Wang, Zhonghua
Teng, Yue-E
Cai, Li
Yan, Min
Wang, Xiaojia
Jiang, Zefei
Pan, Yueyin
Luo, Jianfeng
Shao, Zhimin
Wu, Jiong
Guo, Xiaomao
Hu, Xichun
author_sort Wang, Biyun
collection PubMed
description Platinum is recommended in combination with gemcitabine in the treatment of metastatic triple-negative breast cancer (mTNBC). We conduct a randomized phase 3, controlled, open-label trial to compare nab-paclitaxel/cisplatin (AP) with gemcitabine/cisplatin (GP) in mTNBC patients (ClinicalTrials.gov NCT02546934). 254 patients with untreated mTNBC randomly receive AP (nab-paclitaxel 125 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) or GP (gemcitabine 1250 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) intravenously every 3 weeks until progression disease, intolerable toxicity or withdrawal of consent. The primary endpoint is progression-free survival (PFS); secondary endpoints are objective response rate (ORR), safety and overall survival (OS). The trial has met pre-specified endpoints. The median PFS is 9.8 months with AP as compared to 7.4 months with GP (stratified HR, 0.67; 95% CI, 0.50–0.88; P = 0.004). AP significantly increases ORR (81.1% vs. 56.3%, P < 0.001) and prolongs OS (stratified HR, 0.62; 95% CI, 0.44–0.90; P = 0.010) to GP. Of grade 3 or 4 adverse events, a significantly higher incidence of neuropathy in AP and thrombocytopenia in GP is noted. These findings warrant further assessment of adding novel agents to the nab-paclitaxel/platinum backbone due to its high potency for patients with mTNBC.
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spelling pubmed-92767252022-07-14 A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer Wang, Biyun Sun, Tao Zhao, Yannan Wang, Shusen Zhang, Jian Wang, Zhonghua Teng, Yue-E Cai, Li Yan, Min Wang, Xiaojia Jiang, Zefei Pan, Yueyin Luo, Jianfeng Shao, Zhimin Wu, Jiong Guo, Xiaomao Hu, Xichun Nat Commun Article Platinum is recommended in combination with gemcitabine in the treatment of metastatic triple-negative breast cancer (mTNBC). We conduct a randomized phase 3, controlled, open-label trial to compare nab-paclitaxel/cisplatin (AP) with gemcitabine/cisplatin (GP) in mTNBC patients (ClinicalTrials.gov NCT02546934). 254 patients with untreated mTNBC randomly receive AP (nab-paclitaxel 125 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) or GP (gemcitabine 1250 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) intravenously every 3 weeks until progression disease, intolerable toxicity or withdrawal of consent. The primary endpoint is progression-free survival (PFS); secondary endpoints are objective response rate (ORR), safety and overall survival (OS). The trial has met pre-specified endpoints. The median PFS is 9.8 months with AP as compared to 7.4 months with GP (stratified HR, 0.67; 95% CI, 0.50–0.88; P = 0.004). AP significantly increases ORR (81.1% vs. 56.3%, P < 0.001) and prolongs OS (stratified HR, 0.62; 95% CI, 0.44–0.90; P = 0.010) to GP. Of grade 3 or 4 adverse events, a significantly higher incidence of neuropathy in AP and thrombocytopenia in GP is noted. These findings warrant further assessment of adding novel agents to the nab-paclitaxel/platinum backbone due to its high potency for patients with mTNBC. Nature Publishing Group UK 2022-07-12 /pmc/articles/PMC9276725/ /pubmed/35821019 http://dx.doi.org/10.1038/s41467-022-31704-7 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
Wang, Biyun
Sun, Tao
Zhao, Yannan
Wang, Shusen
Zhang, Jian
Wang, Zhonghua
Teng, Yue-E
Cai, Li
Yan, Min
Wang, Xiaojia
Jiang, Zefei
Pan, Yueyin
Luo, Jianfeng
Shao, Zhimin
Wu, Jiong
Guo, Xiaomao
Hu, Xichun
A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer
title A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer
title_full A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer
title_fullStr A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer
title_full_unstemmed A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer
title_short A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer
title_sort randomized phase 3 trial of gemcitabine or nab-paclitaxel combined with cisplatin as first-line treatment in patients with metastatic triple-negative breast cancer
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9276725/
https://www.ncbi.nlm.nih.gov/pubmed/35821019
http://dx.doi.org/10.1038/s41467-022-31704-7
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