Ribociclib或Palbociclib联合Fulvestrant治疗激素受体阳性/ her2阴性转移性 乳腺癌的实际疗效:土耳其肿瘤组(TOG)研究。

IF 2.9 3区 医学 Q2 ONCOLOGY
Seda Kahraman, Enes Erul, Ozge Gumusay, Deniz Can Guven, Sercan Aksoy, Gul Basaran, Mustafa Seyyar, Elif Sahin, Devrim Cabuk, Ertugrul Bayram, Semra Paydas, Burcin Cakan Demirel, Arzu Yaren, Burcu Gulbagci, Ilhan Hacibekiroglu, Naziyet Kose Baytemur, Umut Demirci, Sena Ece Davarci, Hacer Demir, Eda Eylemer Mocan, Ozlem Dogan, Ebru Cilbir, Alper Yasar, Ibrahim Vedat Bayoglu, Mutlu Hizal, Erkan Kayikcioglu, Bulent Cetin, Omer Acar, Atike Pinar Erdogan, Merve Keskinkilic, Tugba Yavuzsen, Olcun Umit Unal, Funda Yilmaz, Mutlu Dogan, Sibel Oyucu Orhan, Erdem Cubukcu, Cihan Erol, Teoman Sakalar, Ozgecan Dulgar, Yusuf Karakas, Gulhan Ozkanli, Berna Bozkurt Duman, Deniz Isik, Muge Karaoglanoglu, Sadi Kerem Okutur, Nilgun Yildirim, Esra Aydin, Basak Oyan Uluc, Murat Keser, Burak Bilgin, Asude Aksoy, Onder Eren, Nurhan Onal Kalkan, Muhammed Muhiddin Er, Hakan Yucel, Veli Sunar, Nail Paksoy, Dincer Aydin, Nazim Serdar Turhal, Serkan Menekse, Engin Kut, Musa Baris Aykan, Ozlem Ozdemir, Melike Ozcelik, Yakup Iriagac, Fatih Selcukbiricik, Ali Inal, Nuri Karadurmus, Muhammed Bulent Akinci, Mehmet Ali Nahit Sendur
{"title":"Ribociclib或Palbociclib联合Fulvestrant治疗激素受体阳性/ her2阴性转移性 乳腺癌的实际疗效:土耳其肿瘤组(TOG)研究。","authors":"Seda Kahraman, Enes Erul, Ozge Gumusay, Deniz Can Guven, Sercan Aksoy, Gul Basaran, Mustafa Seyyar, Elif Sahin, Devrim Cabuk, Ertugrul Bayram, Semra Paydas, Burcin Cakan Demirel, Arzu Yaren, Burcu Gulbagci, Ilhan Hacibekiroglu, Naziyet Kose Baytemur, Umut Demirci, Sena Ece Davarci, Hacer Demir, Eda Eylemer Mocan, Ozlem Dogan, Ebru Cilbir, Alper Yasar, Ibrahim Vedat Bayoglu, Mutlu Hizal, Erkan Kayikcioglu, Bulent Cetin, Omer Acar, Atike Pinar Erdogan, Merve Keskinkilic, Tugba Yavuzsen, Olcun Umit Unal, Funda Yilmaz, Mutlu Dogan, Sibel Oyucu Orhan, Erdem Cubukcu, Cihan Erol, Teoman Sakalar, Ozgecan Dulgar, Yusuf Karakas, Gulhan Ozkanli, Berna Bozkurt Duman, Deniz Isik, Muge Karaoglanoglu, Sadi Kerem Okutur, Nilgun Yildirim, Esra Aydin, Basak Oyan Uluc, Murat Keser, Burak Bilgin, Asude Aksoy, Onder Eren, Nurhan Onal Kalkan, Muhammed Muhiddin Er, Hakan Yucel, Veli Sunar, Nail Paksoy, Dincer Aydin, Nazim Serdar Turhal, Serkan Menekse, Engin Kut, Musa Baris Aykan, Ozlem Ozdemir, Melike Ozcelik, Yakup Iriagac, Fatih Selcukbiricik, Ali Inal, Nuri Karadurmus, Muhammed Bulent Akinci, Mehmet Ali Nahit Sendur","doi":"10.1016/j.clbc.2025.03.003","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Real-world (RW) data provide valuable information about the effectiveness and safety of treatment modalities in the general population that is not limited by selection criteria in clinical studies. The aim of this study was to evaluate the effectiveness of palbociclib or ribociclib plus fulvestrant in hormone receptor-positive and human epidermal factor 2-negative metastatic breast cancer (HR+/HER2-MBC).</p><p><strong>Materials and methods: </strong>We conducted a multicenter, retrospective cohort study that included 522 patients with HR+/HER2-MBC treated with ribociclib or palbociclib in combination with fulvestrant.</p><p><strong>Results: </strong>Median real-world progression-free survival (mPFS) was 12.9 months (95% CI, 11.16-14.65) for the entire cohort, and no statistically significant difference was present between the palbociclib and ribociclib groups (P = .70). Real-world median overall survival (mOS) was estimated to be 43.3 months (95% CI, 20-66.6) for the palbociclib group and 48.5 months (95% CI, NA-NA) for the ribociclib group and similar between the 2 groups (P = .56). When evaluated for the entire group, there was a significant difference in mPFS between patients with primary and secondary endocrine resistance (8.6 and 13.5 months, P = .002), and this difference was more pronounced in the palbociclib arm (6.6 and 14.4 months, P = .006) than in the ribociclib arm (11.6 and 13.3 months, P = .064).</p><p><strong>Conclusion: </strong>Although the 3 CDK4/6 inhibitors did not seem to differ significantly from each other in terms of effectiveness in a real-world context, they may vary depending primarily on the specific characteristics of the patient population being treated.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Treatment Efficacy of Ribociclib or Palbociclib Plus Fulvestrant in Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer: Turkish Oncology Group (TOG) Study.\",\"authors\":\"Seda Kahraman, Enes Erul, Ozge Gumusay, Deniz Can Guven, Sercan Aksoy, Gul Basaran, Mustafa Seyyar, Elif Sahin, Devrim Cabuk, Ertugrul Bayram, Semra Paydas, Burcin Cakan Demirel, Arzu Yaren, Burcu Gulbagci, Ilhan Hacibekiroglu, Naziyet Kose Baytemur, Umut Demirci, Sena Ece Davarci, Hacer Demir, Eda Eylemer Mocan, Ozlem Dogan, Ebru Cilbir, Alper Yasar, Ibrahim Vedat Bayoglu, Mutlu Hizal, Erkan Kayikcioglu, Bulent Cetin, Omer Acar, Atike Pinar Erdogan, Merve Keskinkilic, Tugba Yavuzsen, Olcun Umit Unal, Funda Yilmaz, Mutlu Dogan, Sibel Oyucu Orhan, Erdem Cubukcu, Cihan Erol, Teoman Sakalar, Ozgecan Dulgar, Yusuf Karakas, Gulhan Ozkanli, Berna Bozkurt Duman, Deniz Isik, Muge Karaoglanoglu, Sadi Kerem Okutur, Nilgun Yildirim, Esra Aydin, Basak Oyan Uluc, Murat Keser, Burak Bilgin, Asude Aksoy, Onder Eren, Nurhan Onal Kalkan, Muhammed Muhiddin Er, Hakan Yucel, Veli Sunar, Nail Paksoy, Dincer Aydin, Nazim Serdar Turhal, Serkan Menekse, Engin Kut, Musa Baris Aykan, Ozlem Ozdemir, Melike Ozcelik, Yakup Iriagac, Fatih Selcukbiricik, Ali Inal, Nuri Karadurmus, Muhammed Bulent Akinci, Mehmet Ali Nahit Sendur\",\"doi\":\"10.1016/j.clbc.2025.03.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Real-world (RW) data provide valuable information about the effectiveness and safety of treatment modalities in the general population that is not limited by selection criteria in clinical studies. The aim of this study was to evaluate the effectiveness of palbociclib or ribociclib plus fulvestrant in hormone receptor-positive and human epidermal factor 2-negative metastatic breast cancer (HR+/HER2-MBC).</p><p><strong>Materials and methods: </strong>We conducted a multicenter, retrospective cohort study that included 522 patients with HR+/HER2-MBC treated with ribociclib or palbociclib in combination with fulvestrant.</p><p><strong>Results: </strong>Median real-world progression-free survival (mPFS) was 12.9 months (95% CI, 11.16-14.65) for the entire cohort, and no statistically significant difference was present between the palbociclib and ribociclib groups (P = .70). Real-world median overall survival (mOS) was estimated to be 43.3 months (95% CI, 20-66.6) for the palbociclib group and 48.5 months (95% CI, NA-NA) for the ribociclib group and similar between the 2 groups (P = .56). When evaluated for the entire group, there was a significant difference in mPFS between patients with primary and secondary endocrine resistance (8.6 and 13.5 months, P = .002), and this difference was more pronounced in the palbociclib arm (6.6 and 14.4 months, P = .006) than in the ribociclib arm (11.6 and 13.3 months, P = .064).</p><p><strong>Conclusion: </strong>Although the 3 CDK4/6 inhibitors did not seem to differ significantly from each other in terms of effectiveness in a real-world context, they may vary depending primarily on the specific characteristics of the patient population being treated.</p>\",\"PeriodicalId\":10197,\"journal\":{\"name\":\"Clinical breast cancer\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-03-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical breast cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.clbc.2025.03.003\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical breast cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.clbc.2025.03.003","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

背景:真实世界(RW)数据提供了关于治疗方式在普通人群中的有效性和安全性的有价值的信息,这些信息不受临床研究选择标准的限制。本研究的目的是评估帕博西尼或核博西尼联合氟维司汀治疗激素受体阳性和人表皮因子2阴性转移性乳腺癌(HR+/HER2-MBC)的有效性。材料和方法:我们进行了一项多中心、回顾性队列研究,纳入了522例HR+/HER2-MBC患者,这些患者接受了核波西尼或帕博西尼联合氟维司汀治疗。结果:整个队列的中位真实无进展生存期(mPFS)为12.9个月(95% CI, 11.16-14.65),帕博西尼组和核博西尼组之间没有统计学上的显著差异(P = 0.70)。帕博西尼组的实际中位总生存期(mOS)估计为43.3个月(95% CI, 20-66.6),核博西尼组为48.5个月(95% CI, NA-NA),两组之间相似(P = 0.56)。当对整个组进行评估时,原发性和继发性内分泌抵抗患者的mPFS有显著差异(8.6和13.5个月,P = 0.002),帕博西尼组(6.6和14.4个月,P = 0.006)比核素西尼组(11.6和13.3个月,P = 0.064)的差异更明显。结论:尽管这3种CDK4/6抑制剂在现实环境中的有效性似乎没有显著差异,但它们可能主要取决于所治疗患者群体的具体特征。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World Treatment Efficacy of Ribociclib or Palbociclib Plus Fulvestrant in Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer: Turkish Oncology Group (TOG) Study.

Background: Real-world (RW) data provide valuable information about the effectiveness and safety of treatment modalities in the general population that is not limited by selection criteria in clinical studies. The aim of this study was to evaluate the effectiveness of palbociclib or ribociclib plus fulvestrant in hormone receptor-positive and human epidermal factor 2-negative metastatic breast cancer (HR+/HER2-MBC).

Materials and methods: We conducted a multicenter, retrospective cohort study that included 522 patients with HR+/HER2-MBC treated with ribociclib or palbociclib in combination with fulvestrant.

Results: Median real-world progression-free survival (mPFS) was 12.9 months (95% CI, 11.16-14.65) for the entire cohort, and no statistically significant difference was present between the palbociclib and ribociclib groups (P = .70). Real-world median overall survival (mOS) was estimated to be 43.3 months (95% CI, 20-66.6) for the palbociclib group and 48.5 months (95% CI, NA-NA) for the ribociclib group and similar between the 2 groups (P = .56). When evaluated for the entire group, there was a significant difference in mPFS between patients with primary and secondary endocrine resistance (8.6 and 13.5 months, P = .002), and this difference was more pronounced in the palbociclib arm (6.6 and 14.4 months, P = .006) than in the ribociclib arm (11.6 and 13.3 months, P = .064).

Conclusion: Although the 3 CDK4/6 inhibitors did not seem to differ significantly from each other in terms of effectiveness in a real-world context, they may vary depending primarily on the specific characteristics of the patient population being treated.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Clinical breast cancer
Clinical breast cancer 医学-肿瘤学
CiteScore
5.40
自引率
3.20%
发文量
174
审稿时长
48 days
期刊介绍: Clinical Breast Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of breast cancer. Clinical Breast Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of breast cancer. The main emphasis is on recent scientific developments in all areas related to breast cancer. Specific areas of interest include clinical research reports from various therapeutic modalities, cancer genetics, drug sensitivity and resistance, novel imaging, tumor genomics, biomarkers, and chemoprevention strategies.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信