Scholarlink

Background <p>Recently, we reported the real-world effectiveness of palbociclib plus endocrine therapy (ET) in HR+/HER2– advanced breast cancer (ABC) in Japan (NCT05399329). However, median overall survival (OS) was not reached because of limited follow-up (36&#xa0;months). Here, we present follow-up data from this study, including real-world clinical outcomes and treatment patterns.</p> Methods <p>The P-BRIDGE study was a multi-center, observational study evaluating the real-world effectiveness and treatment patterns of patients diagnosed with HR+/HER2– ABC who received palbociclib plus ET in first (1L) or second line (2L) in Japan. The primary endpoint was real-world progression-free survival (rwPFS); secondary endpoints included OS and chemotherapy-free survival (CFS).</p> Results <p>Of the 693 eligible patients, 426 and 267 patients received palbociclib with ET as 1L and 2L treatment, respectively. After a median follow-up of 48.1&#xa0;months, the median rwPFS (95% CI) was 26.2 months (21.4-30.4) for 1L and 14.9 months (11.7-18.3) for 2L, respectively. Median OS (95% CI) was 68.2 months (60.8-NE) for 1L and 50.7 months (42.2-57.2) for 2L, respectively. OS analysis was also performed in the following subgroups: TFI &lt; 12 months/TFI ≥ 12months/de novo metastatic median OS was 56.3 months (43.9-68.2), NR (NE-NE), NR (56.3-NE), visceral metastasis was 65.0&#xa0;months (56.3-NE), liver metastasis was 46.4 months (37.2-NE), and bone only metastasis was NR (57.8-NE) in 1L, respectively.</p> Conclusions <p>The updated results from this study further confirm the real-world effectiveness of palbociclib plus ET in routine clinical practice in Japan. More than 5 years of median OS in 1L was observed, supporting the use of palbociclib plus ET as 1L standard of care for HR+/HER2– ABC.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Overall survival of palbociclib plus endocrine therapy in Japanese patients with HR+/HER2– advanced breast cancer in the first-or second-line setting: a multicenter observational study (P-BRIDGE study)

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年4月5日

查看全文
  • Shigenori E. Nagai,
  • Masaya Hattori,
  • Tetsuhiro Yoshinami,
  • Hiroko Masuda,
  • Takuho Okamura,
  • Kenichi Watanabe,
  • Takahiro Nakayama,
  • Michiko Tsuneizumi,
  • Daisuke Takabatake,
  • Michiko Harao,
  • Hiroshi Yoshino,
  • Natsuko Mori,
  • Hiroyuki Yasojima,
  • Chiya Oshiro,
  • Madoka Iwase,
  • Miki Yamaguchi,
  • Takafumi Sangai,
  • Shinsuke Sasada,
  • Takanori Ishida,
  • Manabu Futamura,
  • Yasuaki Muramatsu,
  • Nobuyoshi Kosaka,
  • Norikazu Masuda

摘要

Background

Recently, we reported the real-world effectiveness of palbociclib plus endocrine therapy (ET) in HR+/HER2– advanced breast cancer (ABC) in Japan (NCT05399329). However, median overall survival (OS) was not reached because of limited follow-up (36 months). Here, we present follow-up data from this study, including real-world clinical outcomes and treatment patterns.

Methods

The P-BRIDGE study was a multi-center, observational study evaluating the real-world effectiveness and treatment patterns of patients diagnosed with HR+/HER2– ABC who received palbociclib plus ET in first (1L) or second line (2L) in Japan. The primary endpoint was real-world progression-free survival (rwPFS); secondary endpoints included OS and chemotherapy-free survival (CFS).

Results

Of the 693 eligible patients, 426 and 267 patients received palbociclib with ET as 1L and 2L treatment, respectively. After a median follow-up of 48.1 months, the median rwPFS (95% CI) was 26.2 months (21.4-30.4) for 1L and 14.9 months (11.7-18.3) for 2L, respectively. Median OS (95% CI) was 68.2 months (60.8-NE) for 1L and 50.7 months (42.2-57.2) for 2L, respectively. OS analysis was also performed in the following subgroups: TFI < 12 months/TFI ≥ 12months/de novo metastatic median OS was 56.3 months (43.9-68.2), NR (NE-NE), NR (56.3-NE), visceral metastasis was 65.0 months (56.3-NE), liver metastasis was 46.4 months (37.2-NE), and bone only metastasis was NR (57.8-NE) in 1L, respectively.

Conclusions

The updated results from this study further confirm the real-world effectiveness of palbociclib plus ET in routine clinical practice in Japan. More than 5 years of median OS in 1L was observed, supporting the use of palbociclib plus ET as 1L standard of care for HR+/HER2– ABC.