日本激素受体阳性/人类表皮生长因子受体2阴性晚期乳腺癌一线或二线治疗患者帕博西尼（palbociclib）联合内分泌治疗（ET）的实际无进展生存期和总生存期：一项观察性研究

IF 4 3区医学 Q1 OBSTETRICS & GYNECOLOGY Breast Cancer Pub Date : 2024-04-20 DOI:10.1007/s12282-024-01575-5

Tetsuhiro Yoshinami, Shigenori E. Nagai, Masaya Hattori, Takuho Okamura, Kenichi Watanabe, Takahiro Nakayama, Hiroko Masuda, Michiko Tsuneizumi, Daisuke Takabatake, Michiko Harao, Hiroshi Yoshino, Natsuko Mori, Hiroyuki Yasojima, Chiya Oshiro, Madoka Iwase, Miki Yamaguchi, Takafumi Sangai, Nobuyoshi Kosaka, Kentaro Tajima, Norikazu Masuda

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引用次数: 0

摘要

背景最近一项在美国进行的大型真实世界研究报告了帕博西尼（palbociclib）联合芳香化酶抑制剂对HR+/HER2-晚期乳腺癌（ABC）的疗效。然而，日本和西方国家的当地临床实践和可用的医疗方法可能有所不同。因此，调查日本的实际数据非常重要。这项多中心观察性研究（NCT05399329）通过估算日本常规临床实践中的实际无进展生存期（rwPFS）和总生存期（OS），报告了palbociclib联合ET作为HR+/HER2-ABC一线或二线治疗的有效性中期分析。方法通过对日本20个研究机构诊断为HR+/HER2- ABC并接受过palbociclib plus ET一线或二线治疗的患者进行病历回顾，了解palbociclib plus ET的实际临床结果和治疗模式。主要终点为rwPFS；次要终点为OS、真实世界总反应率、真实世界临床获益率和无化疗生存期。结果在677名符合条件的患者中，分别有420名和257名患者在一线和二线治疗中接受了palbociclib联合ET治疗。一线治疗组和二线治疗组的中位rwPFS（95%置信区间）分别为24.5个月（19.9-29.4）和14.5个月（10.2-19.0）。一线组未达到中位OS，二线组为46.7个月（38.8个月，未估算）。新发转移、无治疗间隔（TFI）≥12个月和TFI < 12个月的36个月OS率分别为80.2%（69.1-87.7）、82.0%（70.7-89.3）和66.0%（57.9-72.9）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Real-world progression-free survival and overall survival of palbociclib plus endocrine therapy (ET) in Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in the first-line or second-line setting: an observational study

Background

A recent large real-world study conducted in the United States reported the effectiveness of palbociclib plus aromatase inhibitor in HR+/HER2− advanced breast cancer (ABC). However, local clinical practice and available medical treatment can vary between Japan and Western countries. Thus, it is important to investigate Japanese real-world data. This observational, multicenter study (NCT05399329) reports the interim analysis of effectiveness of palbociclib plus ET as first-line or second-line treatment for HR+/HER2− ABC by estimating real-world progression-free survival (rwPFS) and overall survival (OS) in Japanese routine clinical practice.

Methods

Real-world clinical outcomes and treatment patterns of palbociclib plus ET were captured using a medical record review of patients diagnosed with HR+/HER2− ABC who had received palbociclib plus ET in the first-line or second-line treatment across 20 sites in Japan. The primary endpoint was rwPFS; secondary endpoints were OS, real-world overall response rate, real-world clinical benefit rate, and chemotherapy-free survival.

Results

Of the 677 eligible patients, 420 and 257 patients, respectively, had received palbociclib with ET as first-line and second-line treatments. Median rwPFS (95% confidence interval) was 24.5 months (19.9–29.4) for first-line and 14.5 months (10.2–19.0) for second-line treatment groups. Median OS was not reached in the first-line group and was 46.7 months (38.8-not estimated) for the second-line group. The 36-month OS rates for de novo metastasis, treatment-free interval (TFI) ≥ 12 months, and TFI < 12 months were 80.2% (69.1–87.7), 82.0% (70.7–89.3), and 66.0% (57.9–72.9), respectively.

Conclusion

The addition of palbociclib to ET was effective for treating HR+/HER2− ABC in Japanese routine clinical practice.

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来源期刊

Breast Cancer ONCOLOGY-OBSTETRICS & GYNECOLOGY

CiteScore

6.70

自引率

2.50%

发文量

105

审稿时长

6-12 weeks

期刊介绍： Breast Cancer, the official journal of the Japanese Breast Cancer Society, publishes articles that contribute to progress in the field, in basic or translational research and also in clinical research, seeking to develop a new focus and new perspectives for all who are concerned with breast cancer. The journal welcomes all original articles describing clinical and epidemiological studies and laboratory investigations regarding breast cancer and related diseases. The journal will consider five types of articles: editorials, review articles, original articles, case reports, and rapid communications. Although editorials and review articles will principally be solicited by the editors, they can also be submitted for peer review, as in the case of original articles. The journal provides the best of up-to-date information on breast cancer, presenting readers with high-impact, original work focusing on pivotal issues.