Pyrotinib plus docetaxel as first-line treatment for HER2-positive metastatic breast cancer: the PANDORA phase II trial

Yabing Zheng, Wen-Ming Cao, Xiying Shao, Yanxia Shi, Li Cai, Wenyan Chen, Jian Liu, Peng Shen, Yiding Chen, Xian Wang, Huiping Li, Man Li, Zhanhong Chen () and Xiaojia Wang ()
Additional contact information
Yabing Zheng: Zhejiang Cancer Hospital
Wen-Ming Cao: Zhejiang Cancer Hospital
Xiying Shao: Zhejiang Cancer Hospital
Yanxia Shi: Sun Yat-sen University Cancer Center
Li Cai: Harbin Medical University Cancer Hospital
Wenyan Chen: Nanchang People’s Hospital
Jian Liu: Fujian Cancer Hospital, Fuzhou
Peng Shen: Zhejiang University School of Medicine
Yiding Chen: Zhejiang University School of Medicine
Xian Wang: Zhejiang University School of Medicine
Huiping Li: Beijing Cancer Hospital
Man Li: The Second Affiliated Hospital of Dalian Medical University
Zhanhong Chen: Zhejiang Cancer Hospital
Xiaojia Wang: Zhejiang Cancer Hospital

Nature Communications, 2023, vol. 14, issue 1, 1-9

Abstract: Abstract The role of pyrotinib in the treatment of HER2-positive metastatic breast cancer (MBC) has been well-established. This multicenter, single-arm phase II trial (NCT03876587) aimed to assess the benefit of pyrotinib plus docetaxel as a first-line treatment for HER2-positive MBC. Women with HER2-positive MBC who had not undergone HER2 blockade or chemotherapy for metastatic disease were enrolled in the study and received daily oral pyrotinib 400 mg plus intravenous docetaxel 75 mg/m2 every 3 weeks. The primary endpoint was the objective response rate (ORR), secondary endpoints included progression-free survival (PFS), duration of response (DoR), clinical benefit rate (CBR), overall survival (OS) and safety. From June 2019 to June 2021, 79 patients were enrolled. The confirmed ORR was 79.7% (95% confidence interval [CI], 70.8-88.6), and the CBR was 87.3% (95%CI, 80.0-94.6) in the intention-to-treat population. The pre-specified primary endpoint was met. The median DoR was 15.9 months (interquartile range, 8.3-19.5); the median PFS was 16.0 months (95% CI, 11.2-20.8), and the median OS was not reached. The most common grade ≥3 treatment-related adverse events observed were leukopenia (29.1%), neutropenia (27.8%), and diarrhea (21.5%). This study demonstrates that pyrotinib plus docetaxel show an acceptable safety profile and promising antitumor activity as a first-line treatment option for patients with HER2-positive MBC.

Date: 2023
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
https://www.nature.com/articles/s41467-023-44140-y Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-44140-y

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-023-44140-y

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().