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Background <p>An open-label, single-arm, multicenter Japanese phase 2 study (J-Ph2) found first-line palbociclib plus letrozole to be effective and tolerable in postmenopausal Japanese women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2–) advanced breast cancer (ABC), but overall survival (OS) data were immature. Here, we report the final analysis of a follow-up study of J-Ph2 evaluating OS and subsequent therapy.</p> Methods <p>Patients (<i>N</i> = 42) who participated in J-Ph2 were included in this follow-up study. Primary endpoint was OS; other endpoints included chemotherapy-free survival (CFS) and type and duration of subsequent therapy. Median OS, CFS, and duration of subsequent therapy were estimated using the Kaplan–Meier method; outcomes were stratified by baseline demographic, disease characteristics, and type of second-line therapies.</p> Results <p>At median follow up of 101.0&#xa0;months, median OS was 85.4&#xa0;months (95% CI, 64.3–not estimable) and median CFS was 69.1&#xa0;months (95% CI, 24.2–85.4). Eighty-one percent of patients (34/42) received a second-line therapy; of those, 85.3% (29/34) received endocrine-based therapy and 8.8% (3/34) received chemotherapy. Median duration of second-line therapy was 7.6&#xa0;months. Sixty-nine percent of patients (29/42) received a third-line therapy; of those, 58.6% (17/29) received endocrine-based therapy and 31.0% (9/29) received chemotherapy; median duration of third-line therapy was 6.0&#xa0;months.</p> Conclusion <p>This analysis showed a median OS of&#xa0; &gt; 7&#xa0;years with first-line palbociclib plus letrozole in Japanese patients with ER+/HER2– ABC. Patient demographics, disease characteristics, and subsequent therapy decisions may have contributed to the extended median OS observed in this study.</p> Clinical trial registration <p>ClinicalTrials.gov, NCT04735367.</p>

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Overall survival and subsequent therapy patterns in Japanese patients with ER+/HER2− advanced breast cancer treated with palbociclib plus letrozole in the first-line setting: a final analysis

  • 期刊论文

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  • 发表日期：

    2025年8月21日

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  • Masato Takahashi,
  • Hiroyuki Yasojima,
  • Tomofumi Osako,
  • Kenichi Inoue,
  • Masahiro Kawashima,
  • Hideki Maeda,
  • Mitsuya Ito,
  • Yasuaki Sagara,
  • Kan Yonemori,
  • Masaya Hattori,
  • Naohito Yamamoto,
  • Yasuaki Muramatsu,
  • Akiko Matsui,
  • Norikazu Masuda

摘要

Background

An open-label, single-arm, multicenter Japanese phase 2 study (J-Ph2) found first-line palbociclib plus letrozole to be effective and tolerable in postmenopausal Japanese women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2–) advanced breast cancer (ABC), but overall survival (OS) data were immature. Here, we report the final analysis of a follow-up study of J-Ph2 evaluating OS and subsequent therapy.

Methods

Patients (N = 42) who participated in J-Ph2 were included in this follow-up study. Primary endpoint was OS; other endpoints included chemotherapy-free survival (CFS) and type and duration of subsequent therapy. Median OS, CFS, and duration of subsequent therapy were estimated using the Kaplan–Meier method; outcomes were stratified by baseline demographic, disease characteristics, and type of second-line therapies.

Results

At median follow up of 101.0 months, median OS was 85.4 months (95% CI, 64.3–not estimable) and median CFS was 69.1 months (95% CI, 24.2–85.4). Eighty-one percent of patients (34/42) received a second-line therapy; of those, 85.3% (29/34) received endocrine-based therapy and 8.8% (3/34) received chemotherapy. Median duration of second-line therapy was 7.6 months. Sixty-nine percent of patients (29/42) received a third-line therapy; of those, 58.6% (17/29) received endocrine-based therapy and 31.0% (9/29) received chemotherapy; median duration of third-line therapy was 6.0 months.

Conclusion

This analysis showed a median OS of  > 7 years with first-line palbociclib plus letrozole in Japanese patients with ER+/HER2– ABC. Patient demographics, disease characteristics, and subsequent therapy decisions may have contributed to the extended median OS observed in this study.

Clinical trial registration

ClinicalTrials.gov, NCT04735367.