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Background <p>Palbociclib (PAL), a cyclin-dependent kinase 4/6 inhibitor, plus endocrine therapy (ET) is recommended as first-line (1L) treatment for hormone receptor-positive (HR+)/ human epidermal growth factor 2 negative (HER2-) advanced breast cancer (ABC). Despite broad use in real-world clinical settings, few studies have evaluated its effectiveness in elderly patients in Japan.</p> Methods <p>The multicenter, observational P-BRIDGE study included HR+/HER2- ABC patients (<i>N</i> = 693) who initiated PAL + ET as 1L or second-line treatment during 2017–2020 in Japan. Treatment outcomes and patterns were evaluated by age category (&lt; 65; ≥ 65 to &lt; 75; ≥ 75 years).</p> Results <p>Among patients treated with 1L PAL + ET (<i>N</i> = 426), 266, 118, and 42 patients were aged &lt; 65, ≥ 65 to &lt; 75, and ≥ 75 years, respectively. Patients aged ≥ 75 years were less likely to initiate PAL at 125&#xa0;mg (64.3%) than patients aged &lt; 65 (95.5%) and ≥ 65 to &lt; 75 (88.1%) years. More patients aged ≥ 75 years discontinued PAL due to adverse events than other age groups. Median real-world progression-free survival (95% CI) was 24.5 months (18.2–30,4), 25.7 months (16.8–36.7), and 45.4 months (20.4–52.4), in the &lt; 65, ≥ 65 to &lt; 75, and ≥ 75-year age groups, respectively. Corresponding median overall survival was 68.2 months (65.0-not reached [NR]), NR (56.3-NR), and 68.0 months (45.8-NR), respectively.</p> Conclusions <p>The effectiveness of PAL + ET in elderly patients in the real-world setting in Japan appears comparable to other age groups. These findings support PAL + ET as a viable treatment option for all patients, including the elderly, while highlighting the need for close monitoring and individualized treatment strategies, especially in older patients.</p>

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Real-world outcomes of palbociclib plus endocrine therapy in elderly patients with HR+/HER2- advanced breast cancer in Japan: a subgroup analysis of the P-BRIDGE study by age group

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  • 发表日期：

    2026年2月11日

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  • Hiroko Masuda,
  • Shigenori E. Nagai,
  • Masaya Hattori,
  • Tetsuhiro Yoshinami,
  • 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,
  • Hirotaka Oda,
  • Yasuaki Muramatsu,
  • Norikazu Masuda

摘要

Background

Palbociclib (PAL), a cyclin-dependent kinase 4/6 inhibitor, plus endocrine therapy (ET) is recommended as first-line (1L) treatment for hormone receptor-positive (HR+)/ human epidermal growth factor 2 negative (HER2-) advanced breast cancer (ABC). Despite broad use in real-world clinical settings, few studies have evaluated its effectiveness in elderly patients in Japan.

Methods

The multicenter, observational P-BRIDGE study included HR+/HER2- ABC patients (N = 693) who initiated PAL + ET as 1L or second-line treatment during 2017–2020 in Japan. Treatment outcomes and patterns were evaluated by age category (< 65; ≥ 65 to < 75; ≥ 75 years).

Results

Among patients treated with 1L PAL + ET (N = 426), 266, 118, and 42 patients were aged < 65, ≥ 65 to < 75, and ≥ 75 years, respectively. Patients aged ≥ 75 years were less likely to initiate PAL at 125 mg (64.3%) than patients aged < 65 (95.5%) and ≥ 65 to < 75 (88.1%) years. More patients aged ≥ 75 years discontinued PAL due to adverse events than other age groups. Median real-world progression-free survival (95% CI) was 24.5 months (18.2–30,4), 25.7 months (16.8–36.7), and 45.4 months (20.4–52.4), in the < 65, ≥ 65 to < 75, and ≥ 75-year age groups, respectively. Corresponding median overall survival was 68.2 months (65.0-not reached [NR]), NR (56.3-NR), and 68.0 months (45.8-NR), respectively.

Conclusions

The effectiveness of PAL + ET in elderly patients in the real-world setting in Japan appears comparable to other age groups. These findings support PAL + ET as a viable treatment option for all patients, including the elderly, while highlighting the need for close monitoring and individualized treatment strategies, especially in older patients.