Breast Cancer最新文献

{"title":"Prognostic impact of ER-staining patterns and heterogeneity of ER positive HER2 negative breast cancer.","authors":"Yumiko Akita, Ravi Velaga, Madoka Iwase, Satoko Shimada, Toyone Kikumori, Dai Takeuchi, Yuko Takano, Takahiro Ichikawa, Tomoki Ebata, Norikazu Masuda","doi":"10.1007/s12282-025-01716-4","DOIUrl":"10.1007/s12282-025-01716-4","url":null,"abstract":"<p><strong>Background: </strong>Estrogen receptor (ER) expression is critical in breast cancer treatment. While low ER (1-9%) resembles triple-negative cancer with chemotherapy efficacy, the significance of \"intermediate expression\" (≥ 10%) and the therapeutic efficacy remain unclear. This study explores the differences in staining patterns and molecular characteristics of ER-low to intermediate expression to guide treatment.</p><p><strong>Methods: </strong>A total of 104 breast cancer patients treated between January 2008 and July 2024 with an Allred Proportion Score (PS) of 2-4 were included. PS2 (n = 21) was classified as ER-low, while PS3 (n = 26) and PS4 (n = 57) as ER-intermediate (ER-int). ER-int was further divided by ER staining pattern: \"Island\" (heterogeneous) and \"Scatter,\" (uniform) subgroups. The prognosis, clinical factors, and gene expression profiles (n = 11) were analyzed.</p><p><strong>Results: </strong>The Island subgroup was associated with poorest prognosis (p = 0.0116), particularly among the patients treated with endocrine-only treatment patients (p < 0.0001). Elevated tumor-infiltrating lymphocyte (TIL) levels correlated with worse prognosis in endocrine-only treatment patients (p < 0.0043), with TIL levels highest in ER-low, followed by Island and Scatter subgroups. Island tumors were enriched in CD36, GZMB, and type I interferon genes; additionally, 23 \"ISLAND\" genes showed significant prognostic differences in the TCGA BRCA ER-int (10-69%) cohort.</p><p><strong>Conclusion: </strong>This study emphasizes the importance of recognizing heterogeneity within the ER-int subtype. Identifying distinct ER staining patterns and prognostic significance of TILs and transcriptome in ER-int tumors suggests the need for individualized treatment strategies for Island subtype.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"917-934"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12394359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144095940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of the COVID-19 pandemic on breast cancer diagnosis and treatment trends in Japan.","authors":"Minoru Miyashita, Hiraku Kumamaru, Naoki Hayashi, Fuyo Kimura, Hiroyuki Yamamoto, Naoki Niikura, Yasuaki Sagara, Hiromitsu Jinno, Masakazu Toi, Shigehira Saji","doi":"10.1007/s12282-025-01718-2","DOIUrl":"10.1007/s12282-025-01718-2","url":null,"abstract":"<p><strong>Background: </strong>There is no comprehensive report regarding which patient groups were disrupted by the COVID-19 pandemic in Japan having universal health insurance system. To provide the guidance regarding how to act in future pandemics, we investigated the changes in breast cancer (BC) diagnosis and treatment during the COVID-19 pandemic.</p><p><strong>Methods: </strong>The trends of monthly data were calculated in relation to the variables of a total of 291,018 primary BCs registered on the Japanese National Clinical Database between January 2018 and April 2021.</p><p><strong>Results: </strong>An analysis of the nationwide data during the pandemic showed 9% decrease of newly identified BC compared with before the pandemic. The impact was more relevant in the 40-50, 51-60 and 61-70-years age groups (13%, 8% and 9% decrease, respectively). The most substantial reduction was noted in patients identified through screenings without symptoms with a 17% decrease. These effects were also apparent in cT1, cN0, cStage 0, and cStage I (11%, 9%, 8% and 11% decrease, respectively). In breast surgery procedures, there was a notable decrease in breast-conserving surgery (13%) as well as post-operative radiation therapy (11%). During this period, strategies using neoadjuvant endocrine therapy or chemotherapy were implemented to avoid treatment delays for especially Stage I patients (1.5 folds increase).</p><p><strong>Conclusions: </strong>We have identified the patient groups that are more vulnerable to the effects of the pandemic. The changes during the pandemic might provide the guidance regarding how to act in future emergencies to minimize disadvantages for BC patients.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"947-959"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12394362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144053727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alcohol consumption and breast lesions: targets for risk-based screening in high-risk Italian women.","authors":"Sonia Cerrai, Alessio Lachi, Michela Franchini, Stefania Pieroni, Giada Anastasi, Marco Scalese, Anna Odone, Silvano Gallus, Luc Smits, Sabrina Molinaro","doi":"10.1007/s12282-025-01720-8","DOIUrl":"10.1007/s12282-025-01720-8","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Breast cancer in Italy is still the most frequent cancer among women, and alcohol consumption is recognized as a risk factor for its development. Overall, in 2020, approximately 10% of all breast cancer-related deaths were attributable to alcohol consumption. Despite advancements in diagnostics and therapeutic options reducing mortality trends, the incidence of breast cancer is projected to rise in Italy. This study aims to assess how alcohol consumption influences the timing of breast lesion diagnosis. Understanding these associations can enhance primary prevention strategies and support the adoption of a risk-based prevention approach, integrating lifestyle factors into personalized screening programs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;P.I.N.K. (Prevention, Imaging, Network and Knowledge) study collected data on a prospective dynamic cohort of women who voluntarily underwent breast cancer screening at breast centers throughout Italy, between 2018 and 2023, outside the free national screening program. The occurrence of breast lesion diagnosis and baseline information were collected through clinical visits and an auto-administered questionnaire, including data on absent, moderate or high alcohol consumption during the last 12 months and smoking. 3774 women (mean age 58.9 ± 10.0, range 40-98 years) were included in the present analysis, encompassing women with a suspected or confirmed diagnosis of benign or malignant tumor and healthy women that contributed at least 4 years to the study. An Event History Analysis was carried out to evaluate the effect of alcohol consumption on the timing to event. The event was represented by the transition of the health status, from not diagnosed to diagnosed with breast lesion. The Accelerated Failure Time parameterization was used to directly interpret how the covariates influence the time to the event. The model was adjusted by familiality of breast/ovarian cancer, marital status, level of education, and type of access to health care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;High alcohol consumption exhibited an accelerating effect on the transition to the diagnosed state, indicating a significantly shortened time to event: β coefficient - 0.33 (p-value 0.010) in the adjusted model, indicating an anticipation of about 4 months. The effect of moderate alcohol consumption did not reach statistical significance, neither in the unadjusted model nor in the adjusted model. Adjustment for smoking status led to a further increase of the β coefficient for high alcohol consumption (- 0.40; p value 0.003) and brought moderate alcohol consumption closer to statistical significance (β - 0.15; p-value 0.087). Familiality of breast or ovarian cancer showed a statistically non-significant accelerating effect, while marital status different from maiden, high education, and private access to health care showed decelerating effects.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;High alcohol consumption was confirmed a","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"970-978"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12394356/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A nomogram to predict the benefit of postmastectomy radiotherapy in breast cancer with nodal micrometastases.","authors":"Zhen-Zhen Lu, Lin-Feng Guo, Juan Zhou, San-Gang Wu","doi":"10.1007/s12282-025-01717-3","DOIUrl":"10.1007/s12282-025-01717-3","url":null,"abstract":"<p><strong>Background: </strong>The role of postmastectomy radiotherapy (PMRT) in breast cancer (BC) with nodal micrometastases (N1mic) remains unclear. This study aimed to evaluate the efficacy of PMRT in T1-2N1mic BC patients who have undergone mastectomy.</p><p><strong>Methods: </strong>Female patients with T1-2N1mic BC who underwent mastectomy and were registered in the Surveillance, Epidemiology, and End Results database between 2010 and 2017. The chi-square test, logistic regression analysis, Kaplan-Meier methods, and multivariate Cox proportional hazards analysis were used for statistical analyses. Nomograms for predicting breast cancer-specific survival (BCSS) and overall survival (OS) were created by integrating the independent prognostic factors.</p><p><strong>Results: </strong>A total of 5948 eligible patients were included in this study. A total of 1207 patients (20.3%) received PMRT, while 4741 patients (79.7%) did not. The use of PMRT increased over the study period, from 15.7% in 2010 to 23.8% in 2017 (P < 0.001). The multivariate Cox proportional hazards analysis showed that PMRT did not improve BCSS and OS. Nomograms were established based on the independent prognostic factors to predict the BCSS and CSS of patients. Regarding BCSS, there were 3627 patients (61.0%) classified as low-risk and 2321 patients (39.0%) classified as high-risk using a cutoff point of 125, PMRT did not improve BCSS in patients with low-risk (P = 0.697) and high-risk (P = 0.149) groups. Regarding OS, there were 4791 patients (80.5%) classified as low-risk and 1157 patients (19.5%) classified as high-risk using a cutoff point of 130, patients who received PMRT had significantly better 5-year OS than those who did not receive PMRT (P = 0.047), while similar outcomes were found between the treatment arms in the low-risk group (P = 0.575).</p><p><strong>Conclusions: </strong>While our findings suggest that PMRT does not enhance survival outcomes in T1-T2N1mic BC patients, it may offer a survival advantage in high-risk subgroups.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"935-946"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144054855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Why combine and why neoadjuvant? Tumor immunological perspectives on chemoimmunotherapy in triple-negative breast cancer.","authors":"Kazuhiro Kakimi, Tomoharu Sugie","doi":"10.1007/s12282-025-01707-5","DOIUrl":"10.1007/s12282-025-01707-5","url":null,"abstract":"<p><p>Triple-negative breast cancer (TNBC) is an aggressive subtype characterized by limited targeted therapies and high recurrence rates. While immune checkpoint inhibitors (ICIs) have shown promise, their efficacy as monotherapy is limited. Clinically, ICIs demonstrate significant benefit primarily when combined with chemotherapy, particularly in the neoadjuvant setting for early-stage TNBC, which yields superior outcomes compared to adjuvant therapy. This review elucidates the tumor immunological principles underlying these observations. We discussed how the suppressive tumor microenvironment (TME), progressive T cell exhaustion, and associated epigenetic scarring constrain ICI monotherapy effectiveness. Crucially, we highlight the immunological advantages of the neoadjuvant approach: the presence of the primary tumor provides abundant antigens, and intact tumor-draining lymph nodes (TDLNs) act as critical sites for ICI-mediated priming and expansion of naïve and precursor exhausted T cells. This robust activation within TDLNs enhances systemic anti-tumor immunity and expands the T cell repertoire, a process less effectively achieved in the adjuvant setting after tumor resection. These mechanisms provide a strong rationale for the improved pathological complete response (pCR) rates and event-free survival observed with neoadjuvant chemoimmunotherapy, as demonstrated in trials like KEYNOTE-522. We further explore the implications for adjuvant therapy decisions based on treatment response, the challenges of ICI resistance, the need for predictive biomarkers, management of immune-related adverse events (irAEs), and future therapeutic directions. Understanding the dynamic interplay between chemotherapy, ICIs, T cells, and the TME, particularly the role of TDLNs in the neoadjuvant context, is essential for optimizing immunotherapy strategies and improving outcomes for patients with TNBC.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"676-688"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144051133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world evidence of febrile neutropenia-related hospitalization on patients with perioperative chemotherapy for early breast cancer in Japan.","authors":"Tetsuhiro Yoshinami, Nobuhiro Shibata, Kentaro Tamaki, Kentaro Ishimaru, Satoru Ito, Tomoyuki Nukada, Shinji Ohno","doi":"10.1007/s12282-025-01714-6","DOIUrl":"10.1007/s12282-025-01714-6","url":null,"abstract":"<p><strong>Purpose: </strong>To clarify particularly how febrile neutropenia-related hospitalization (FNH) affects patients' daily lives, by analyzing real-world data on FNH among patients with early breast cancer (EBC) receiving perioperative chemotherapy in Japan.</p><p><strong>Methods: </strong>This retrospective nationwide large-scale database study was conducted using anonymized claims data from 2010 to 2020. The patients with EBC who had available surgical records were included. Men, those aged < 18 years, and those who had not available chemotherapy records were excluded. FNH was defined as hospitalization during perioperative chemotherapy for EBC, with administration of intravenous antibacterial drugs and a diagnosis of FN, sepsis, infection, or fever.</p><p><strong>Results: </strong>The analysis population included 33,310 EBC patients with a mean age of 56.9 years, who received a total of 267,535 perioperative chemotherapy cycles. FNH occurred in 1,910 patients (5.73%) and 2144 chemotherapy cycles (0.80%). Median duration of FNH was 6.0 days. Fourth-generation cephalosporins were the most used intravenous antibacterial drugs (50.42%). Median duration of intravenous antibacterial drugs administration was 4.0 days. Therapeutic granulocyte-colony stimulating factor (G-CSF) was used in 1285 patients (67.28%). Median cost for FNH was estimated to be 189 thousand yen in 1,474 chemotherapy cycles with FNH, in which patients received intravenous antibacterial drugs administration for 3-8 days.</p><p><strong>Conclusion: </strong>This nationwide real-world data analysis revealed the incidence, duration, treatment patterns, and medical cost of FNH in patients with EBC receiving perioperative chemotherapy in Japan. These findings indicate that FNH imposes a considerable burden on patients' daily lives, including time and financial impacts, contributing to the implementation of appropriate shared decision-making for primary G-CSF prophylaxis.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"857-866"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144095944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polymorphous adenocarcinoma-like tumor of the breast: the first case report from Japan.","authors":"Yuki Hara, Puay Hoon Tan, Maria Pia Foschini, Hiroshi Yano, Saki Sawada, Hiroko Hayashi, Ichiro Isomoto, Rin Yamaguchi","doi":"10.1007/s12282-025-01708-4","DOIUrl":"10.1007/s12282-025-01708-4","url":null,"abstract":"<p><p>Polymorphous adenocarcinoma-like (PmA-like) tumor of the breast is a rare salivary gland-like neoplasm, with few cases reported globally. We present the first case of a PmA-like tumor with a fibrous pseudocapsule from Japan, including radiological findings. A 40-year-old premenopausal woman presented with a painful mass in the right breast. Mammography revealed a high-density oval mass with predominantly circumscribed margins, while ultrasonography showed a hypoechoic oval mass with heterogeneous internal echoes and vascularity. Both imaging modalities suggested malignancy, prompting a vacuum-assisted biopsy. Histopathological evaluation demonstrated diverse growth patterns and positivity for cytokeratin (CK) 7 and Bcl-2. Initially diagnosed as an unusual ductal proliferation, malignancy could not be excluded, leading to lumpectomy. The resected tumor measured 26 mm, exhibited a fibrous pseudocapsule with focal disruption, and showed varied histological patterns, including solid, cribriform, glandular, and cord-like structures. Immunohistochemistry revealed expression of CK7, S100, vimentin, CK5/6, E-cadherin, Bcl-2, p63, and smooth muscle actin (SMA), with no expression of p40, estrogen receptor, progesterone receptor, HER2, c-Kit, or androgen receptor. These findings, including penetration beyond the capsule, supported the diagnosis of an invasive PmA-like tumor of the breast. Following surgery, the patient underwent additional resection and sentinel lymph node biopsy due to a positive margin. No residual tumor or nodal metastases were found. The patient declined adjuvant therapy and remains recurrence-free after 26 months of follow-up. PmA-like tumors of the breast present diagnostic challenges due to their rarity and diverse histopathological features. Further studies are necessary to characterize their clinical behavior and guide management strategies.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"867-873"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144059381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reevaluating HER2-null breast cancer using an enhanced HER2 immunohistochemistry protocol.","authors":"Takeshi Ushigusa, Nami Hirakawa, Naoki Kanomata","doi":"10.1007/s12282-025-01721-7","DOIUrl":"10.1007/s12282-025-01721-7","url":null,"abstract":"<p><p>Human epidermal growth factor receptor 2 (HER2) status is crucial for the classification of breast cancer and the selection of its treatment. Although HER2-low breast cancer is a recognized therapeutic subgroup, the classification of HER2 immunohistochemistry (IHC) 0 remains unclear. We reassessed 58 HER2-null breast cancer cases using an enhanced HER2 IHC protocol and the VENTANA OptiView detection system. HER2 expression was evaluated based on membrane positivity rate (%) and staining intensity. Microscopic assessment was performed to determine the percentage of HER2-positive tumor cells. Digital image analysis was used to quantify staining intensity. Detectable membrane HER2 positivity was observed in all tumors previously classified as HER2-null; the positivity rates ranged from 0.33% to 90% and the staining intensity indicated both inter- and intratumoral heterogeneity. These findings suggest that enhanced HER2 IHC protocols can improve detection sensitivity. This approach may help to refine HER2 classification and optimize patient selection for HER2-targeted therapies. Further research is needed to determine the clinical significance of HER2 expression detected using enhanced protocols.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"874-880"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144058963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Limitations in translating in vitro ADSC findings to clinical breast cancer risk.","authors":"Janhavi Venkataraman, Kefah Mokbel","doi":"10.1007/s12282-025-01710-w","DOIUrl":"10.1007/s12282-025-01710-w","url":null,"abstract":"","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"882-883"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144063470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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).","authors":"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","doi":"10.1007/s12282-025-01689-4","DOIUrl":"10.1007/s12282-025-01689-4","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"705-715"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}