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在日本,接受帕博西利联合治疗的 HR+/HER2- 晚期/转移性乳腺癌患者的真实世界治疗模式和临床结局:来自 IRIS 研究的结果。

Real-world treatment patterns and clinical outcomes in patients receiving palbociclib combinations for HR+/HER2- advanced/metastatic breast cancer in Japan: Results from the IRIS study.

机构信息

Adelphi Real World, Adelphi Mill, Grimshaw Lane, Bollington, Macclesfield, Cheshire SK10 5JB, United Kingdom.

Pfizer, 235 East 42nd Street, New York, United States of America.

出版信息

Cancer Treat Res Commun. 2022;32:100573. doi: 10.1016/j.ctarc.2022.100573. Epub 2022 May 6.

Abstract

BACKGROUND

The incidence of breast cancer is rising in Japan, particularly in postmenopausal women. The CDK 4/6 inhibitor palbociclib has demonstrated efficacy in clinical studies in patients with hormone receptor-positive (HR+), human epidermal growth factor 2 (HER2)-negative advanced/metastatic breast cancer (ABC/MBC). The Ibrance Real World Insights (IRIS) study (NCT03159195) collected real-world data for palbociclib-treated patients in several countries including Japan, where such data are currently scarce.

METHODS

IRIS was a retrospective chart review study of patients with confirmed HR+/HER2- ABC/MBC receiving palbociclib according to approved indications in real-world clinical practice. In Japan, physicians each abstracted data from patient medical records for up to eight sequential patients treated with palbociclib plus an aromatase inhibitor (P+AI) or fulvestrant (P+F). Outcomes included progression-free rates (PFRs) and survival rates (SRs).

RESULTS

Fifty-eight physicians abstracted data for 170 patients receiving palbociclib in the first (64.1%) or second or later line (35.9%), in combination with AI (51.2%) or fulvestrant (48.8%). Median follow-up was 10.4 months. Most patients were initiated on palbociclib 125 mg/d (P+AI, 63.2%; P+F, 78.3%). PFRs at 12 and 24 months were 76.2% and 52.6%, respectively, for P+AI and 71.6% and 65.6%, respectively for P+F. PFRs at 12 and 24 months were 85.4% and 66.5%, respectively, for first-line palbociclib combinations and 56.4% and 50.7%, respectively, for second- or later-line palbociclib combinations.

CONCLUSIONS

In this analysis of the Japanese IRIS cohort, outcomes in terms of PFRs and SRs appear to be better with first- versus second or later-line palbociclib, regardless of the endocrine partner.

摘要

背景

乳腺癌在日本的发病率呈上升趋势,尤其是在绝经后妇女中。CDK4/6 抑制剂哌柏西利在激素受体阳性(HR+)、人表皮生长因子 2(HER2)阴性的晚期/转移性乳腺癌(ABC/MBC)患者的临床研究中显示出疗效。Ibrance 真实世界洞察(IRIS)研究(NCT03159195)在包括日本在内的多个国家收集了哌柏西利治疗患者的真实世界数据,而目前日本此类数据较为缺乏。

方法

IRIS 是一项回顾性病历审查研究,纳入了在真实世界临床实践中根据批准的适应证接受哌柏西利治疗的 HR+/HER2-ABC/MBC 患者。在日本,医生从每位患者的病历中提取了最多 8 例连续接受哌柏西利联合芳香化酶抑制剂(P+AI)或氟维司群(P+F)治疗的患者数据。主要结局包括无进展率(PFR)和生存率(SR)。

结果

58 位医生为 170 例接受哌柏西利治疗的患者提取了数据,其中 64.1%的患者在一线治疗中接受了哌柏西利,35.9%的患者在二线或更后线治疗中接受了哌柏西利,与 AI 联合应用的患者比例为 51.2%,与氟维司群联合应用的患者比例为 48.8%。中位随访时间为 10.4 个月。大多数患者起始哌柏西利剂量为 125mg/d(P+AI 组,63.2%;P+F 组,78.3%)。P+AI 组的 12 个月和 24 个月 PFR 分别为 76.2%和 52.6%,P+F 组的 12 个月和 24 个月 PFR 分别为 71.6%和 65.6%。一线哌柏西利联合治疗的 12 个月和 24 个月 PFR 分别为 85.4%和 66.5%,二线或更后线哌柏西利联合治疗的 12 个月和 24 个月 PFR 分别为 56.4%和 50.7%。

结论

在这项日本 IRIS 队列分析中,无论内分泌治疗伙伴如何,一线哌柏西利治疗的无进展率和生存率似乎优于二线或更后线哌柏西利治疗。

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