Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1784745790899486720 |
---|---|
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. |
format | Online Article Text |
id | pubmed-9276725 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT wangbiyun arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT suntao arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT zhaoyannan arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wangshusen arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT zhangjian arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wangzhonghua arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT tengyuee arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT caili arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT yanmin arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wangxiaojia arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT jiangzefei arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT panyueyin arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT luojianfeng arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT shaozhimin arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wujiong arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT guoxiaomao arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT huxichun arandomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wangbiyun randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT suntao randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT zhaoyannan randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wangshusen randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT zhangjian randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wangzhonghua randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT tengyuee randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT caili randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT yanmin randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wangxiaojia randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT jiangzefei randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT panyueyin randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT luojianfeng randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT shaozhimin randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT wujiong randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT guoxiaomao randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer AT huxichun randomizedphase3trialofgemcitabineornabpaclitaxelcombinedwithcisplatinasfirstlinetreatmentinpatientswithmetastatictriplenegativebreastcancer |