Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor–Positive, ERBB2-Negative Advanced Breast Cancer

帕博西利布 富维斯特朗 来曲唑 医学 肿瘤科 乳腺癌 内科学 阿那曲唑 抗雌激素 临床终点 转移性乳腺癌 人口 癌症 妇科 随机对照试验 三苯氧胺 环境卫生
作者
Antonio Llombart‐Cussac,José Manuel Pérez-García,Meritxell Bellet,Florence Dalenc,Miguel Gil‐Gil,Manuel Ruíz‐Borrego,Joaquín Gavilá,Miguel Sampayo-Cordero,Elena Aguirre,Thomas Powles,Frederik Marmé,Serena Di Cosimo,Joseph Gligorov,Andreas Schneeweiß,Joan Albanell,Pilar Zamora,Duncan Wheatley,Eduardo Martínez-De Dueñas,Kepa Amillano,Andrea Malfettone,Javier Cortés,Antonio Antón,Vladimir Moiseyenko,Paul Cottu,Gemma Viñas,Thierry Petit,Petra Tesařová,Vladimir Vladimirov,Joseph Banuelos,Marco Colleoni,Gianfilippo Bertelli,Purificación Martínez,R. Andrés,Tatiana Barannikova,Sònia Servitja,Jacques Médioni,Saverio Cinieri,Juan Bayo,Santiago González,Bohuslav Melichar,Vicente Caranyana,Francesco Atzori,Mark Beresford,Steven T. F. Chan,Maria Luque-Cabal,Juan de la Haba-Rodríguez,Joachim Bischoff,Guzel Mukhametsina,Marina Elena Cazzaniga,Daniele Generali,Andrew Wardley,Laura Cortesi,Luigi Cavanna,Mario Airoldi
出处
期刊:JAMA Oncology [American Medical Association]
卷期号:7 (12): 1791-1791 被引量:65
标识
DOI:10.1001/jamaoncol.2021.4301
摘要

The cyclin-dependent kinase 4 and 6 inhibitor palbociclib in combination with letrozole has become a standard first-line treatment for patients with endocrine-sensitive, hormone receptor-positive, ERBB2-negative advanced breast cancer. Meanwhile, the antiestrogen fulvestrant was shown to be superior to anastrozole in the absence of cyclin-dependent kinase 4 and 6 inhibition for this patient population.To assess whether fulvestrant is superior to letrozole when combined with palbociclib in the first-line scenario.In this international, randomized, open-label, phase 2 clinical study conducted from July 30, 2015, to January 8, 2018, patients with hormone receptor-positive, ERBB2-negative advanced breast cancer with no prior therapy in the metastatic setting and endocrine-sensitive criteria were recruited from 47 centers in 7 countries. Data were analyzed from February 11 to May 15, 2020.Patients were randomly assigned (1:1 ratio) to receive palbociclib with either fulvestrant or letrozole. Stratification factors were type of disease presentation (de novo vs recurrent) and the presence of visceral involvement (yes vs no).The primary end point was investigator-assessed progression-free survival determined by Response Evaluation Criteria in Solid Tumors, version 1.1.A total of 486 women (median age, 63 years [range, 25-90 years]; 3 Asian women [0.6%]; 4 Black women [0.8%]; 461 White women [94.9%]; 18 women of unknown race [3.7%]) were randomized (243 to fulvestrant-palbociclib and 243 to letrozole-palbociclib). Median investigator-assessed progression-free survival was 27.9 months (95% CI, 24.2-33.1 months) in the fulvestrant-palbociclib group vs 32.8 months (95% CI, 25.8-35.9 months) in the letrozole-palbociclib group (hazard ratio, 1.13; 95% CI, 0.89-1.45; P = .32). This result was consistent across the stratification factors. No significant differences were observed in objective response rate (46.5% vs 50.2%) and 3-year overall survival rate (79.4% vs 77.1%) for fulvestrant-palbociclib and letrozole-palbociclib, respectively. Grade 3-4 adverse events were comparable among treatment groups, and no new safety signals were identified. No treatment-related deaths were reported.Although fulvestrant-palbociclib demonstrated significant antitumor activity, this randomized clinical trial failed to identify an improvement in progression-free survival with this regimen over letrozole-palbociclib in patients with endocrine-sensitive, hormone receptor-positive, ERBB2-negative advanced breast cancer.ClinicalTrials.gov Identifier: NCT02491983.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
ChenXinde发布了新的文献求助10
刚刚
研究生发布了新的文献求助10
刚刚
Yangzx完成签到,获得积分10
刚刚
刚刚
萝卜沾不沾完成签到,获得积分20
刚刚
1秒前
清风明月完成签到,获得积分10
1秒前
倾卿如玉完成签到 ,获得积分10
1秒前
等到放晴的那天完成签到,获得积分10
2秒前
Damia完成签到,获得积分10
3秒前
KD完成签到,获得积分10
3秒前
3秒前
科目三应助向上采纳,获得10
3秒前
情怀应助库洛洛采纳,获得10
3秒前
英子爱阿亮完成签到,获得积分10
3秒前
3秒前
WXT完成签到,获得积分10
3秒前
4秒前
zckkk完成签到,获得积分10
4秒前
lemon完成签到,获得积分10
4秒前
臭臭完成签到,获得积分10
5秒前
林伯格完成签到,获得积分10
6秒前
无语的冬易完成签到,获得积分10
7秒前
fbh1完成签到,获得积分10
7秒前
肉哥完成签到,获得积分10
7秒前
7秒前
罗百事完成签到 ,获得积分10
8秒前
wanci应助多情怜蕾采纳,获得10
9秒前
Dannerys完成签到 ,获得积分10
9秒前
TCR完成签到,获得积分10
10秒前
10秒前
YuZhichao发布了新的文献求助10
10秒前
斯文败类应助科研通管家采纳,获得10
10秒前
Accepted应助科研通管家采纳,获得10
10秒前
10秒前
Accepted应助科研通管家采纳,获得10
10秒前
Akim应助科研通管家采纳,获得10
10秒前
kai完成签到 ,获得积分10
11秒前
BJ_whc完成签到,获得积分10
11秒前
cherylizan完成签到,获得积分10
11秒前
高分求助中
Evolution 10000
Sustainability in Tides Chemistry 2800
The Young builders of New china : the visit of the delegation of the WFDY to the Chinese People's Republic 1000
юрские динозавры восточного забайкалья 800
English Wealden Fossils 700
Foreign Policy of the French Second Empire: A Bibliography 500
Chen Hansheng: China’s Last Romantic Revolutionary 500
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3147162
求助须知:如何正确求助?哪些是违规求助? 2798435
关于积分的说明 7829030
捐赠科研通 2455138
什么是DOI,文献DOI怎么找? 1306576
科研通“疑难数据库(出版商)”最低求助积分说明 627838
版权声明 601567