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.
{"title":"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.","authors":"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","doi":"10.1007/s12282-025-01760-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, NCT04735367.</p>","PeriodicalId":520574,"journal":{"name":"Breast cancer (Tokyo, Japan)","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast cancer (Tokyo, Japan)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s12282-025-01760-0","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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Abstract
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.
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