Safety and efficacy study of oral metronomic capecitabine combined with pyrotinib in HER2-positive metastatic breast cancer : A phase II trial
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved..
PURPOSE: To analyze the safety and efficacy of orally administered metronomic capecitabine plus pyrotinib in HER2 positive metastatic breast cancer (MBC) patients, we conducted a prospective phase II study with a single-arm design.
METHODS: HER2 positive patients received oral metronomic capecitabine 500 mg three times a day and pyrotinib 400 mg per day. The primary endpoint was progression-free survival (PFS). Other endpoints included objective response rate (ORR), overall survival (OS), clinical benefit rate (CBR) and safety.
RESULTS: The study included 50 patients with MBC that was HER2-positive, while 1 patient was excluded due to nonstandard medication. The median PFS and OS was 11.9 months (95%CI 8.8-14.6) and 29.3 months (95%CI 24.4-34.8) respectively. ORR was 34.7%, and CBR was 81.6% with 2 CR (4.1%), 15 PR (30.6%) and 23 SD (46.9%). The mPFS in first- or second-line treatment was 12.2 months. The most frequent treatment-related adverse events included hand-foot syndrome, diarrhea, vomiting and nausea. Grade 3 adverse events occurred in 15(30.6%) patients, including hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%). 1 grade 4 adverse event of diarrhea (2.0%) was observed.
CONCLUSION: The combination of metronomic capecitabine and pyrotinib is a promising regimen with competitive efficacy and improved tolerability in HER2 positive metastatic breast cancer patients.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:72 |
|---|---|
| Enthalten in: |
Breast (Edinburgh, Scotland) - 72(2023) vom: 12. Dez., Seite 103581 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
He, Maiyue [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
6804DJ8Z9U |
|---|
| Anmerkungen: |
Date Completed 06.12.2023 Date Revised 06.12.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.breast.2023.103581 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM362389667 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM362389667 | ||
| 003 | DE-627 | ||
| 005 | 20231226091134.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.breast.2023.103581 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1207.xml |
| 035 | |a (DE-627)NLM362389667 | ||
| 035 | |a (NLM)37742492 | ||
| 035 | |a (PII)S0960-9776(23)00557-X | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a He, Maiyue |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety and efficacy study of oral metronomic capecitabine combined with pyrotinib in HER2-positive metastatic breast cancer |b A 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 06.12.2023 | ||
| 500 | |a Date Revised 06.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a PURPOSE: To analyze the safety and efficacy of orally administered metronomic capecitabine plus pyrotinib in HER2 positive metastatic breast cancer (MBC) patients, we conducted a prospective phase II study with a single-arm design | ||
| 520 | |a METHODS: HER2 positive patients received oral metronomic capecitabine 500 mg three times a day and pyrotinib 400 mg per day. The primary endpoint was progression-free survival (PFS). Other endpoints included objective response rate (ORR), overall survival (OS), clinical benefit rate (CBR) and safety | ||
| 520 | |a RESULTS: The study included 50 patients with MBC that was HER2-positive, while 1 patient was excluded due to nonstandard medication. The median PFS and OS was 11.9 months (95%CI 8.8-14.6) and 29.3 months (95%CI 24.4-34.8) respectively. ORR was 34.7%, and CBR was 81.6% with 2 CR (4.1%), 15 PR (30.6%) and 23 SD (46.9%). The mPFS in first- or second-line treatment was 12.2 months. The most frequent treatment-related adverse events included hand-foot syndrome, diarrhea, vomiting and nausea. Grade 3 adverse events occurred in 15(30.6%) patients, including hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%). 1 grade 4 adverse event of diarrhea (2.0%) was observed | ||
| 520 | |a CONCLUSION: The combination of metronomic capecitabine and pyrotinib is a promising regimen with competitive efficacy and improved tolerability in HER2 positive metastatic breast cancer patients | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a HER2-Positive | |
| 650 | 4 | |a Metastatic breast cancer | |
| 650 | 4 | |a Phase II study | |
| 650 | 4 | |a capecitabine | |
| 650 | 4 | |a metronomic chemotherapy | |
| 650 | 4 | |a pyrotinib | |
| 650 | 7 | |a Capecitabine |2 NLM | |
| 650 | 7 | |a 6804DJ8Z9U |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 Liu, Jiaxuan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Zijing |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Fei |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jiayu |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Pin |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Qing |e verfasserin |4 aut | |
| 700 | 1 | |a Yuan, Peng |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Yang |e verfasserin |4 aut | |
| 700 | 1 | |a Fan, Ying |e verfasserin |4 aut | |
| 700 | 1 | |a Mo, Hongnan |e verfasserin |4 aut | |
| 700 | 1 | |a Lan, Bo |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Qiao |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Binghe |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Breast (Edinburgh, Scotland) |d 1997 |g 72(2023) vom: 12. Dez., Seite 103581 |w (DE-627)NLM091676371 |x 1532-3080 |7 nnns |
| 773 | 1 | 8 | |g volume:72 |g year:2023 |g day:12 |g month:12 |g pages:103581 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.breast.2023.103581 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 72 |j 2023 |b 12 |c 12 |h 103581 | ||