Pyrotinib in combination with letrozole for hormone receptor-positive, human epidermal growth factor receptor 2-positive metastatic breast cancer (PLEHERM) : a multicenter, single-arm, phase II trial
© 2023. The Author(s)..
BACKGROUND: Human epidermal growth factor receptor 2 (HER2) targeted therapy combined with endocrine therapy has been recommended as an alternative treatment strategy for patients with hormone receptor (HR)-positive, HER2-positive metastatic breast cancer (MBC). This study aimed to evaluate the role of pyrotinib, an oral pan-HER irreversible tyrosine kinase inhibitor, in combination with letrozole for patients with HR-positive, HER2-positive MBC.
METHODS: In this multi-center, phase II trial, HR-positive and HER2-positive MBC patients who were not previously treated for metastasis disease were enrolled. Patients received daily oral pyrotinib 400 mg and letrozole 2.5 mg until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the clinical benefit rate (CBR) assessed by an investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1.
RESULTS: From November 2019 to December 2021, 53 patients were enrolled and received pyrotinib plus letrozole. As of August 2022, the median follow-up duration was 11.6 months (95% confidence interval [CI], 8.7-14.0 months). The CBR was 71.7% (95% CI, 57.7-83.2%), and the objective response rate was 64.2% (95% CI, 49.8-76.9%). The median progression-free survival was 13.7 months (95% CI, 10.7-18.7 months). The most common treatment-related adverse event of grade 3 or higher was diarrhea (18.9%). No treatment-related deaths were reported, and one patient experienced treatment discontinuation due to adverse event.
CONCLUSIONS: Our preliminary results suggested that pyrotinib plus letrozole is feasible for the first-line treatment of patients with HR-positive and HER2-positive MBC, with manageable toxicities.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT04407988.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
|---|---|
| Enthalten in: |
BMC medicine - 21(2023), 1 vom: 26. Juni, Seite 226 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Hu, Zhe-Yu [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 05.07.2023 Date Revised 05.07.2023 published: Electronic ClinicalTrials.gov: NCT04407988 Citation Status MEDLINE |
|---|
| doi: |
10.1186/s12916-023-02943-2 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM358669499 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM358669499 | ||
| 003 | DE-627 | ||
| 005 | 20231226075234.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1186/s12916-023-02943-2 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1195.xml |
| 035 | |a (DE-627)NLM358669499 | ||
| 035 | |a (NLM)37365596 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Hu, Zhe-Yu |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Pyrotinib in combination with letrozole for hormone receptor-positive, human epidermal growth factor receptor 2-positive metastatic breast cancer (PLEHERM) |b a multicenter, single-arm, phase II trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 05.07.2023 | ||
| 500 | |a Date Revised 05.07.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04407988 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a BACKGROUND: Human epidermal growth factor receptor 2 (HER2) targeted therapy combined with endocrine therapy has been recommended as an alternative treatment strategy for patients with hormone receptor (HR)-positive, HER2-positive metastatic breast cancer (MBC). This study aimed to evaluate the role of pyrotinib, an oral pan-HER irreversible tyrosine kinase inhibitor, in combination with letrozole for patients with HR-positive, HER2-positive MBC | ||
| 520 | |a METHODS: In this multi-center, phase II trial, HR-positive and HER2-positive MBC patients who were not previously treated for metastasis disease were enrolled. Patients received daily oral pyrotinib 400 mg and letrozole 2.5 mg until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the clinical benefit rate (CBR) assessed by an investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 | ||
| 520 | |a RESULTS: From November 2019 to December 2021, 53 patients were enrolled and received pyrotinib plus letrozole. As of August 2022, the median follow-up duration was 11.6 months (95% confidence interval [CI], 8.7-14.0 months). The CBR was 71.7% (95% CI, 57.7-83.2%), and the objective response rate was 64.2% (95% CI, 49.8-76.9%). The median progression-free survival was 13.7 months (95% CI, 10.7-18.7 months). The most common treatment-related adverse event of grade 3 or higher was diarrhea (18.9%). No treatment-related deaths were reported, and one patient experienced treatment discontinuation due to adverse event | ||
| 520 | |a CONCLUSIONS: Our preliminary results suggested that pyrotinib plus letrozole is feasible for the first-line treatment of patients with HR-positive and HER2-positive MBC, with manageable toxicities | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov, NCT04407988 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a HER2-positive | |
| 650 | 4 | |a Hormone receptor-positive | |
| 650 | 4 | |a Letrozole | |
| 650 | 4 | |a Metastatic breast cancer | |
| 650 | 4 | |a Pyrotinib | |
| 650 | 7 | |a ERBB2 protein, human |2 NLM | |
| 650 | 7 | |a EC 2.7.10.1 |2 NLM | |
| 650 | 7 | |a Letrozole |2 NLM | |
| 650 | 7 | |a 7LKK855W8I |2 NLM | |
| 650 | 7 | |a pyrotinib |2 NLM | |
| 650 | 7 | |a Receptor, ErbB-2 |2 NLM | |
| 650 | 7 | |a EC 2.7.10.1 |2 NLM | |
| 700 | 1 | |a Yan, Min |e verfasserin |4 aut | |
| 700 | 1 | |a Xiong, Huihua |e verfasserin |4 aut | |
| 700 | 1 | |a Ran, Li |e verfasserin |4 aut | |
| 700 | 1 | |a Zhong, Jincai |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Ting |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Tao |e verfasserin |4 aut | |
| 700 | 1 | |a Xie, Ning |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Liping |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Xiaohong |e verfasserin |4 aut | |
| 700 | 1 | |a Xiao, Huawu |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Jing |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Binliang |e verfasserin |4 aut | |
| 700 | 1 | |a Ouyang, Quchang |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMC medicine |d 2003 |g 21(2023), 1 vom: 26. Juni, Seite 226 |w (DE-627)NLM143503421 |x 1741-7015 |7 nnns |
| 773 | 1 | 8 | |g volume:21 |g year:2023 |g number:1 |g day:26 |g month:06 |g pages:226 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1186/s12916-023-02943-2 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 21 |j 2023 |e 1 |b 26 |c 06 |h 226 | ||