Temidayo A Fadelu, Ashley Odai-Afotey, Alyssa Martin, Molly Skeffington, Melissa Hughes, Renee Fullem, Anna Revette, Brett Nava-Coulter, Adriana Perilla-Glen, Sandra Brown Rn, Ross Kusmick, Abigail Moore, Simone Buck, Kerry Sendrick, Sarah Sammons, Sara M Tolaney, Nancy U Lin, Rachel A Freedman
{"title":"The LIFT UP study: feasibility of systematically identifying and addressing resource needs in those with metastatic breast cancer.","authors":"Temidayo A Fadelu, Ashley Odai-Afotey, Alyssa Martin, Molly Skeffington, Melissa Hughes, Renee Fullem, Anna Revette, Brett Nava-Coulter, Adriana Perilla-Glen, Sandra Brown Rn, Ross Kusmick, Abigail Moore, Simone Buck, Kerry Sendrick, Sarah Sammons, Sara M Tolaney, Nancy U Lin, Rachel A Freedman","doi":"10.1007/s10549-026-07961-1","DOIUrl":"10.1007/s10549-026-07961-1","url":null,"abstract":"<p><strong>Purpose: </strong>Social determinants of health (SDOH) and health-related social needs (HRSN) impact cancer outcomes, yet few programs systematically address these needs. We examined the feasibility of routine assessment of SDOH/HRSN within a clinical metastatic breast cancer (MBC) program and subsequent linkage to support services.</p><p><strong>Methods: </strong>We approached patients with MBC seen at an NCI-designated center from January-October 2023 who were ≤ 6 months from MBC consultation or diagnosis. Enrolled participants were administered a baseline survey of SDOH/HRSN, referred to appropriate services, and surveyed again at 3-6 months. Outcomes included feasibility of SDOH/HRSN documentation (defined as ≥ 80% of participants completing baseline surveys); prevalence of needs; and use of and satisfaction with support services.</p><p><strong>Results: </strong>Among the 112 patients approached, 98 (87.5%) enrolled and 73 (74.5%) completed the baseline survey. Median age was 58 years (range 29-84), with 82.2%, 8.2%, and 1.4% identifying as White, Black, or Hispanic, respectively. Overall, 71.2% reported 1 + need; 28.8% had 3 + needs. Reported concerns included transportation costs (32.9%), medical costs (20.8%), medication payments (15.5%), and utility bills (19.2%); 13.7% and 6.9% reported food or housing insecurity, respectively. Although all participants needing resources were referred, 27.3% accessed referred services, and 59.1% of reported needs were partially or fully met on follow-up assessment. Patients and clinicians expressed positive feelings about the intervention.</p><p><strong>Conclusions: </strong>Our findings highlight the challenges and importance of systematically assessing SDOH/HRSN in a clinical setting, with a high degree of unmet needs reported among MBC patients. Future work will address utilization barriers and resource customization.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147627006","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}
Manuel Hörner, Lara M Tretschock, Nelson John, Philipp Ziegler, Lothar Häberle, Sabrina Uhrig, Chloë Goossens, Niklas Amann, Jan-Philipp Cieslik, Dominik Dannehl, Thomas M Deutsch, Moritz Dimpfl, Max Ehlert, Kathleen Eichstädt, Alexander Englisch, Melitta B Köpke, Annika Krückel, Theresa Link, Annika Müller, Kristin Reinhardt, Jonas Roth, Henning Schäffler, Lea Sych, Christian M Tegeler, Catharina Wichmann, Maggie Banys-Paluchowski, Henriette Princk, Achim Rody, Sara Y Brucker, Nina Ditsch, Johannes Ettl, Tanja Fehm, Carolin C Hack, Peyman Hadji, Alexander Hein, Wolfgang W Janni, Hans-Christian Kolberg, Diana Lüftner, Michael P Lux, Volkmar Müller, Andreas Schneeweiss, Florin-Andrei Taran, Hans Tesch, Diethelm Wallwiener, Frederik Marmé, Stephan Seitz, Erik Belleville, Andreas Hartkopf, Laura L Michel, Markus Wallwiener, Peter A Fasching, Nikolas Tauber
{"title":"Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial.","authors":"Manuel Hörner, Lara M Tretschock, Nelson John, Philipp Ziegler, Lothar Häberle, Sabrina Uhrig, Chloë Goossens, Niklas Amann, Jan-Philipp Cieslik, Dominik Dannehl, Thomas M Deutsch, Moritz Dimpfl, Max Ehlert, Kathleen Eichstädt, Alexander Englisch, Melitta B Köpke, Annika Krückel, Theresa Link, Annika Müller, Kristin Reinhardt, Jonas Roth, Henning Schäffler, Lea Sych, Christian M Tegeler, Catharina Wichmann, Maggie Banys-Paluchowski, Henriette Princk, Achim Rody, Sara Y Brucker, Nina Ditsch, Johannes Ettl, Tanja Fehm, Carolin C Hack, Peyman Hadji, Alexander Hein, Wolfgang W Janni, Hans-Christian Kolberg, Diana Lüftner, Michael P Lux, Volkmar Müller, Andreas Schneeweiss, Florin-Andrei Taran, Hans Tesch, Diethelm Wallwiener, Frederik Marmé, Stephan Seitz, Erik Belleville, Andreas Hartkopf, Laura L Michel, Markus Wallwiener, Peter A Fasching, Nikolas Tauber","doi":"10.1007/s10549-026-07939-z","DOIUrl":"10.1007/s10549-026-07939-z","url":null,"abstract":"<p><strong>Purpose: </strong>Mutations in PIK3CA are one of several actionable mutations for patients with hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Alpelisib in combination with fulvestrant was the first approved PI3K inhibitor and was introduced in clinical practice in 2019. A lack of evidence for the use of alpelisib in the context of current treatment options like cyclin-dependent 4/6 inhibitor (CDK4/6i), highlights the importance of this analysis. We provide a real-world analysis of the use of alpelisib with the prospective German PRAEGNANT registry (NCT02338167).</p><p><strong>Methods: </strong>57 patients with advanced breast cancer receiving alpelisib and fulvestrant were identified. 55 Patients had received prior CDK4/6i therapy. Progression-free survival (PFS) and overall survival (OS) were calculated for all patients, and stratified according CDK4/6i pre-treatment, using the Kaplan-Meier method. Subgroups (age, line of therapy, concomitant disease among others), somatic PIK3CA mutations, reasons for discontinuation and adverse events (AEs) were analyzed.</p><p><strong>Results: </strong>The median PFS was 5.0 (95% confidence interval [CI], 3.1-9.4) months, and the median OS was 20.1 (95% CI, 14.6-30.8) months. Line of therapy and concomitant diseases appeared to affect PFS, while the line of therapy and preexisting diabetes influenced OS. However, subgroups were too small for statistical testing. Discontinuation was mainly due to tumor progression (56.1%). Hyperglycemia, rash and diarrhea were the most documented AEs.</p><p><strong>Conclusion: </strong>This prospective real-world analysis shows slightly shorter median PFS and OS times compared with the pivotal trials. Patients in our analyses received alpelisib in later therapy lines, which may explain the poorer outcome.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13046609/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147589850","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}
Amber O Molnar, Eric McArthur, Sarah E Bota, Kathryn Stirling, Jaffa Romain, Darryl P Leong, Som D Mukherjee, Abhijat Kitchlu, Michael Walsh
{"title":"Kidney function changes associated with trastuzumab use in women with breast cancer: a retrospective cohort study.","authors":"Amber O Molnar, Eric McArthur, Sarah E Bota, Kathryn Stirling, Jaffa Romain, Darryl P Leong, Som D Mukherjee, Abhijat Kitchlu, Michael Walsh","doi":"10.1007/s10549-026-07953-1","DOIUrl":"10.1007/s10549-026-07953-1","url":null,"abstract":"<p><strong>Purpose: </strong>Higher concentrations of human epidermal growth receptor 2 (HER2) may cause chronic kidney disease. We sought to determine if trastuzumab (a HER2 inhibitor) may be kidney protective.</p><p><strong>Methods: </strong>Retrospective cohort study using administrative datasets. Women from Ontario, Canada with new stage 1-3 breast cancer between April 2009 and March 2019 were included. We matched trastuzumab users (n = 6,557) 1:1 with non-users on baseline eGFR, urine albumin-to-creatinine ratio (ACR), heart failure and propensity score. Change in eGFR was examined using linear mixed models. Secondary outcomes of ≥ 30 and ≥ 40% eGFR decline, incident eGFR < 60 mL/min/1.73 m<sup>2</sup> and heart failure were examined using Cox proportional hazards models. Follow-up was 3 years.</p><p><strong>Results: </strong>The linear mixed model showed no significant interaction between treatment with trastuzumab and time (estimate 0.11, 95% CI -0.01 to 0.23, ml/min/1.73 m<sup>2</sup>/year). There was an increased risk of ≥ 30% eGFR decline (HR 1.82, 95% CI 1.58 to 2.09), incident eGFR < 60 mL/min/1.73 m<sup>2</sup> (HR 2.09, 95% CI 1.52 to 2.88) and heart failure (HR 8.07, 95% CI 5.91 to 11.02) associated with trastuzumab use at ≤ 1.5 years but not > 1.5 years. There was an increased risk of ≥ 40% eGFR decline associated with trastuzumab use at 3 months (HR 3.06, 95% CI 1.85 to 5.08) but not beyond 3 months.</p><p><strong>Conclusion: </strong>Trastuzumab was not associated with change in eGFR over 3 years but was associated with increased risk of ≥ 30% and ≥ 40% eGFR decline and new eGFR < 60 mL/min/1.73 m<sup>2</sup> at earlier time points, potentially mediated by the increased heart failure risk observed with trastuzumab.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147589820","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}
José C Valentín López, Alice Ho, Kevin S Hughes, Aditya Bardia, Neelima Vidula
{"title":"Utilizing natural language processing (NLP) to identify breast cancer-associated lung metastases from pathology reports to delineate characteristics of this site of recurrence.","authors":"José C Valentín López, Alice Ho, Kevin S Hughes, Aditya Bardia, Neelima Vidula","doi":"10.1007/s10549-026-07956-y","DOIUrl":"10.1007/s10549-026-07956-y","url":null,"abstract":"<p><strong>Purpose: </strong>Natural language processing (NLP, artificial intelligence) can enable automated identification of records in large datasets. The purpose of this study was to evaluate the feasibility of NLP in identifying breast cancer-associated lung metastases and to understand the clinical characteristics and challenges of this common site of breast cancer recurrence.</p><p><strong>Methods: </strong>NLP was applied to a large dataset of institutional pathology reports at an academic center to identify patients with pathologically confirmed breast cancer-associated lung metastases seen between 3/2012 and 5/2019. Chart review was conducted to confirm breast cancer-associated lung metastases and ascertain clinical and pathological features.</p><p><strong>Results: </strong>Altogether, NLP identified 32 patients with pathology reports describing breast cancer-associated lung metastases from a pool of approximately 91,000 records. There was pathologic confirmation from lung biopsy tissue in the majority of cases (75%; n = 24) and from pleural fluid specimens (25% n = 8) on the remainder. After this dataset was defined using NLP, we were able to analyze clinical and pathologic features of the breast cancer-associated lung metastases.</p><p><strong>Conclusions: </strong>NLP can be applied to identify organ-specific metastases from pathology reports, such as breast cancer-associated lung metastases as done here, which can then facilitate observational, translational, and clinical research to characterize and address challenges posed by this common site of breast cancer recurrence. This cohort of patients highlights the potential application of NLP for disease characterization and clinical research in oncology.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147589860","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}
Kathleen M Decker, Allison Feely, Marshall Pitz, Pamela Hebbard, Julian O Kim, Piotr Czaykowski, Harminder Singh, Oliver Bucher, Grace Musto, Pascal Lambert
{"title":"The impact of the COVID-19 pandemic on breast cancer screening, treatment, and overall survival.","authors":"Kathleen M Decker, Allison Feely, Marshall Pitz, Pamela Hebbard, Julian O Kim, Piotr Czaykowski, Harminder Singh, Oliver Bucher, Grace Musto, Pascal Lambert","doi":"10.1007/s10549-026-07943-3","DOIUrl":"10.1007/s10549-026-07943-3","url":null,"abstract":"<p><strong>Purpose: </strong>We examined the association between the COVID-19 pandemic and screening, treatment, and overall survival for individuals diagnosed with breast cancer in Manitoba, Canada.</p><p><strong>Methods: </strong>We used population-based data and a quasi-experimental study with an interrupted time series analysis to examine the number of screening mammograms, first treatment rates, and 2-year overall survival prior to and after COVID-19 for individuals diagnosed with breast cancer.</p><p><strong>Results: </strong>There was a significant decrease in screening mammograms 2 years after the start of the pandemic (ratio = 0.73%, 95% Confidence Interval (CI) 0.58, 0.89). From April to June 2020, fewer individuals diagnosed with stage I-III breast cancer had surgery (ratio = 0.59, 95% CI 0.33, 1.07). Fewer individuals diagnosed with stage I-III breast cancer had radiotherapy (RT) (ratio = 0.69, 95% CI 0.53, 0.91). RT factions per person-year were lower (ratio = 0.81, 95% CI 0.71, 0.92, April to June 2020 and 0.60, 95% CI 0.56, 0.66, July 2020 to December 2022). The proportion of individuals with stage I-III ER+ /HER2- breast cancer who had hormone therapy (HT) was lower (ratio = 0.55, 95% CI 0.36, 0.84). The proportion of individuals with stage I-III HER2+ breast cancer who had neoadjuvant chemotherapy (ratio = 3.64, 95% CI 1.18, 11.16) or targeted therapy (ratio = 3.34, 95% CI 1.13, 9.84) was higher. The proportion of individuals who had adjuvant chemotherapy (ratio = 0.14, 95% CI 0.04, 0.47, April to June 2020 and ratio = 0.19, 95% CI 0.08, 0.48, January to December 2022), targeted therapy (ratio = 0.14, 95% CI 0.04, 0.45, April to June 2020 and ratio = 0.18, 95% CI 0.07, 0.45 January to December 2022), or HT (ratio = 0.43, 95% CI 0.22, 0.83) was lower. The proportion of individuals with stage I-III triple-negative breast cancer who had neoadjuvant chemotherapy was higher (ratio = 2.92, 95% CI 1.04, 8.17). There was no difference for any treatment for stage IV breast cancers. There was no difference in 2-year overall survival for stage I-III or stage IV breast cancers.</p><p><strong>Conclusion: </strong>In Manitoba, Canada, there was a significant decrease in the number of screening mammograms 2 years after the start of the pandemic. Breast cancer treatment changed in accordance with updated guidelines with no impact on 2-year overall survival.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13038738/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580484","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}
Weronika Kupis, Danuta Kłosowska, Marek Harhala, Michał Sekuła, Katarzyna Pogoda, Jan Borysowski
{"title":"The use of endpoints in phase 3 randomized controlled trials in metastatic breast cancer.","authors":"Weronika Kupis, Danuta Kłosowska, Marek Harhala, Michał Sekuła, Katarzyna Pogoda, Jan Borysowski","doi":"10.1007/s10549-026-07954-0","DOIUrl":"10.1007/s10549-026-07954-0","url":null,"abstract":"<p><strong>Purpose: </strong>To assess the use of endpoints in phase 3 randomized controlled trials (RCTs) in metastatic breast cancer (BC).</p><p><strong>Methods: </strong>Eligible RCTs were searched for in the WHO International Clinical Trials Registry Platform. The impact of selected variables on the use of the primary endpoints was determined with multivariable logistic regression.</p><p><strong>Results: </strong>The study included 267 phase 3 RCTs of systemic treatments, started between 2008 and 2025. The most common primary endpoint was progression-free survival (PFS; n = 228; 85.4%). It was less likely in trials of chemotherapy relative to conjugates (adjusted odds ratio [aOR], 0.10; 95% CI 0.01-0.61; p = 0.01). Among the PFS-based trials with available results (n = 107), median improvement in PFS was 2.8 months (interquartile [IQ] range, 1.35-5.75). 185/228 (81.1%) trials with PFS as the primary endpoint utilized overall survival (OS) as a secondary endpoint and 108/228 (47.4%) had quality of life (QoL) as a secondary endpoint. OS was used as the primary endpoint in only 35 trials (13.1%). It was more likely in trials enrolling patients with triple-negative BC (TNBC) relative to HER2+ BC (aOR, 5.54; 95% CI 1.57-21.93; p = 0.01). However, line of treatment did not have any statistically significant impact on the odds of OS (p > 0.05) CONCLUSION: OS as the primary endpoint has been almost completely replaced by PFS. Improvements in PFS are often modest. OS should be used as the primary endpoint more frequently, especially in TNBC and trials of later-line treatments. Moreover more trials should include QoL as a secondary endpoint.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580480","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}
Grazielle Morais Tavares, Susana Oliveira Botelho Ramalho, Leonardo Roberto da Silva, Guilherme Defante Telles, Geisilene Russano de Paiva Silva, Renato Zocchio Torresan, Sophie Françoise Mauricette Derchain
{"title":"Adjuvant capecitabine in women with triple-negative breast cancer with residual disease after carboplatin-containing neoadjuvant chemotherapy.","authors":"Grazielle Morais Tavares, Susana Oliveira Botelho Ramalho, Leonardo Roberto da Silva, Guilherme Defante Telles, Geisilene Russano de Paiva Silva, Renato Zocchio Torresan, Sophie Françoise Mauricette Derchain","doi":"10.1007/s10549-026-07949-x","DOIUrl":"10.1007/s10549-026-07949-x","url":null,"abstract":"<p><strong>Background: </strong>Triple-negative breast cancer (TNBC) is an aggressive subtype characterized by early relapse and limited therapeutic options. Carboplatin added to anthracycline/taxane neoadjuvant chemotherapy (NACT) raises pathologic complete response (pCR) rates. The role of adjuvant capecitabine following NACT containing carboplatin remains unclear, particularly in real-world settings.</p><p><strong>Methods: </strong>Data of patients who were diagnosed with TNBC and received NACT at CAISM/UNICAMP (2017-2023), followed up until June 2025 were analyzed retrospectively. The cohort study included 184 women with TNBC treated with anthracycline, taxane, and carboplatin-based NACT. Clinical, pathological, and treatment data were collected from institutional databases and the CAISM Biobank. Survival outcomes were analyzed according to pCR and use of adjuvant capecitabine among patients with non-pCR. Median follow-up was estimated using the reverse Kaplan-Meier method. Additional exploratory analyses included stratification by Residual Cancer Burden (RCB-I vs RCB-II/III), multivariable Cox models including capecitabine as the exposure variable, and administrative censoring sensitivity analyses at 36 and 48 months. Disease-free survival (DFS) and overall survival (OS) were estimated by Kaplan-Meier method and compared with log-rank tests; multivariable Cox models assessed prognostic factors.</p><p><strong>Results: </strong>Among 184 women, pCR was achieved in 40% and was associated with younger age, earlier clinical stage and high histologic grade. Survival outcomes were significantly better for patients with pCR, with an approximately 85-87% reduction in the risk of recurrence and death compared with non-pCR. Among the 111 patients with residual disease, 44 received adjuvant capecitabine. Adjuvant capecitabine did not improve DFS (HR = 0.96; 95% CI 0.52-1.78) or OS (HR = 0.70; 95% CI 0.33-1.46) in univariable analyses. In multivariable models stratified by capecitabine use, Ki-67 remained the only independent prognostic factor slightly associated with worse DFS, while capecitabine showed no significant effect.</p><p><strong>Conclusions: </strong>In this real-world cohort, achieving pCR after carboplatin-containing NACT was the strongest determinant of favorable prognosis. Adjuvant capecitabine was not associated with statistically significant improvement in survival outcomes. The role of capecitabine following prior platinum exposure remains uncertain and warrants further investigation.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13035565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147572384","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}
Hope S Rugo, T J Pluard, P Sharma, M Melisko, G Al-Jazayrly, Y Ji, N Vidula, J Ellerton, M Smakal, M Zimovjanova, D Weng
{"title":"OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer.","authors":"Hope S Rugo, T J Pluard, P Sharma, M Melisko, G Al-Jazayrly, Y Ji, N Vidula, J Ellerton, M Smakal, M Zimovjanova, D Weng","doi":"10.1007/s10549-026-07944-2","DOIUrl":"10.1007/s10549-026-07944-2","url":null,"abstract":"<p><strong>Purpose: </strong>DHP107 is an oral paclitaxel enabling administration of paclitaxel without Cremophor EL, a vehicle used to improve the solubility of intravenous (IV) paclitaxel. The randomized phase II OPERA study investigated the efficacy and safety of DHP107 versus IV paclitaxel in patients with HER2-negative breast cancer.</p><p><strong>Methods: </strong>OPERA was conducted in the USA and Czech Republic. Patients were ≥ 18 years, with measurable disease, and histologically or cytologically confirmed recurrent or metastatic breast cancer with any tumor hormone receptor status. Patients were randomized 2:1 to DHP107 (200 mg/m<sup>2</sup> po bid with premedication if needed on days 1, 8, and 15, every 28 days) or IV paclitaxel (80 mg/m<sup>2</sup> with standard premedication on days 1, 8, and 15 every 28 days). The primary objective was DHP107 efficacy; secondary objectives included DHP107 safety and tolerability.</p><p><strong>Results: </strong>72 patients were randomized, 48 to DHP107 and 24 to IV paclitaxel. There was one complete response and 11 partial responses with DHP107 (objective response rate [ORR 25.0%; 90% CI 15.1-37.3), and six partial responses with IV paclitaxel (objective response rate [ORR] 28.6%; 90% CI 13.2-48.7; p = 0.7559). Median progression-free survival (PFS) was 5.5 months for DHP107 and 4.7 months for IV paclitaxel (p = 0.8018); median overall survival (OS) was 17.1 and 13.2 months, respectively (p = 0.7629). Common all-grade adverse events were diarrhea (68.8%), nausea (64.6%), and fatigue (52.1%) for DHP107 and fatigue (47.6%), peripheral neuropathy (42.9%), and alopecia (42.9%) for IV paclitaxel.</p><p><strong>Conclusion: </strong>DHP107 is a tolerable and feasible treatment for patients with recurrent or metastatic HER2-negative breast cancer, with similar efficacy and safety to IV paclitaxel.</p><p><strong>Clinicaltrials: </strong>gov no: NCT03326102; date of registration October 19, 2017.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13035570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147572442","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":"Cost-effectiveness of DPYD genotyping prior to capecitabine administration for metastatic breast cancer.","authors":"Tanvi Chiddarwar, Anne Blaes, Karen Kuntz","doi":"10.1007/s10549-026-07948-y","DOIUrl":"10.1007/s10549-026-07948-y","url":null,"abstract":"<p><strong>Purpose: </strong>Patients with a DPYD genetic deficiency who receive capecitabine are at increased risk of severe, potentially fatal toxicities due to impaired drug metabolism. Genetic testing for this deficiency allows for proactive dose adjustments to mitigate these risks. We evaluated the cost-effectiveness of DPYD genotyping prior to capecitabine administration, followed by dose modification for patients with metastatic breast cancer.</p><p><strong>Methods: </strong>We developed a state-transition model to simulate health outcomes and costs for a cohort of 62-year-old women with metastatic breast cancer from the perspective of the U.S. healthcare payer. Costs and utilities were derived from the literature to calculate quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) for DPYD genotyping compared to no DPYD genotyping. We conducted deterministic and probabilistic sensitivity analyses to identify factors influencing cost-effectiveness.</p><p><strong>Results: </strong>The genotyping strategy was cost-effective, with a cost of $2,832 yielding 1.16 QALYs, compared to $2,677 and 1.15 QALYs for the no-genotyping strategy. This resulted in an ICER of $12,916/QALY and $10,333 per life-year-gained. In probabilistic sensitivity analysis, the genotyping strategy was cost-effective in 99% of the simulations, using a willingness-to-pay threshold of $100,000/QALY. Results from scenario analyses testing key assumptions also showed that genotyping is cost-effective.</p><p><strong>Conclusion: </strong>Our findings support the implementation of DPYD genotyping prior to capecitabine initiation in metastatic breast cancer patients. This strategy exemplifies the value of personalized medicine and pharmacogenomics in improving treatment safety and effectiveness. As sequencing technologies advance and become affordable, integration of genotyping into routine oncology care is increasingly feasible.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13032966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147572376","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 treatment patterns and outcomes in older patients with metastatic breast cancer: a multi-institutional retrospective cohort study.","authors":"Reiko Mitsueda, Yasuaki Sagara, Naoki Niikura, Shinji Ohno, Tetsuhiko Taira, Masahiro Takada, Minoru Miyashita, Hiroshi Ishiguro, Shigehira Saji, Norikazu Masuda","doi":"10.1007/s10549-026-07951-3","DOIUrl":"10.1007/s10549-026-07951-3","url":null,"abstract":"<p><strong>Background: </strong>As populations age worldwide, breast cancer mortality among older patients continues to rise despite therapeutic advances. This study investigates differences in treatment patterns and outcomes between older and younger patients with metastatic breast cancer.</p><p><strong>Methods: </strong>We analyzed clinical data from the Advanced Breast Cancer Database (ABCD) maintained by the Japanese Breast Cancer Research Group. The dataset included patients registered between June 1, 2020, and October 31, 2023, encompassing clinicopathologic information, treatment details, breast cancer specific survival (BCSS), and overall survival (OS).</p><p><strong>Results: </strong>A total of 1629 patients were included. The frequency of chemotherapy and genomic testing decreased with age, yet patients in their 70 s demonstrated treatment durations and survival outcomes comparable to those of younger patients. In contrast, patients aged ≥ 80 years exhibited shorter duration of second-line therapy (adjusted HR:0.65, 95% CI: 0.43-1.04) and poorer OS (adjusted HR:0.62, 95% CI: 0.37-1.04) and BCSS (adjusted HR:0.66, 95% CI: 0.38-1.14), despite most deaths being attributable to breast cancer rather than non-cancer-related causes.</p><p><strong>Conclusions: </strong>This multicenter retrospective study demonstrates that patients in their 70 s can achieve comparable benefits from systemic therapy to younger individuals, emphasizing the importance of not withholding treatment based solely on chronological age. Conversely, the limited effectiveness of later-line therapies in patients aged ≥ 80 highlights the need for individualized treatment strategies that balance efficacy, quality of life, and comorbidities through comprehensive geriatric assessment and shared decision-making.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"217 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147572390","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}