Breast Cancer Research and Treatment最新文献

{"title":"Limitations of locoregional and distant recurrence analysis after neoadjuvant chemotherapy.","authors":"Janhavi Venkataraman, Kefah Mokbel","doi":"10.1007/s10549-025-07680-z","DOIUrl":"10.1007/s10549-025-07680-z","url":null,"abstract":"","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"183-184"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143977065","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":"Advantages of immediate implant-based breast reconstruction over delayed breast reconstruction in women treated with postmastectomy radiotherapy for breast cancer.","authors":"Merel M L Kooijman, J Joris Hage, Astrid N Scholten, Frederieke H van Duijnhoven, Corstiaan C Breugem, Leonie A E Woerdeman","doi":"10.1007/s10549-025-07690-x","DOIUrl":"10.1007/s10549-025-07690-x","url":null,"abstract":"<p><strong>Purpose: </strong>To compare immediate with delayed breast reconstruction in the setting of postmastectomy radiotherapy (PMRT) in terms of the total number of interventions and time required for breast cancer clearance and contour restoration.</p><p><strong>Methods: </strong>The long-term prevalence and number of plannable and urgent interventions required in women receiving PMRT to finish 372 nipple-sparing or skin-sparing mastectomies combined with immediate implant-based breast reconstruction ([N]SSM/IIBR) were compared to those required for 18 mastectomies and delayed breast reconstruction (DBR) performed between 2013 and 2019.</p><p><strong>Results: </strong>Re-interventions were required in 239 of the 372 breasts (64%) after [N]SSM/IIBR, whereas all 18 DBRs (100%) implicitly required at least one re-intervention (p < 0.001). Mastectomy and reconstruction necessitated a mean of 2.24 interventions per breast after [N]SSM/IIBR, which was significantly less than the mean of 3.72 interventions per breast after DBR (p < 0.001). Breast contour reconstruction was achieved in 14.3 months after [N]SSM/IIBR and in 38.6 months after DBR (p < 0.001). [N]SSM/IIBR required more class U3 urgent re-interventions than DBR (22% vs. 4%, p = 0.002), whereas DBR necessitated more class P3 plannable re-interventions (5% vs. 16%, p = 0.004). Initiation of PMRT is not postponed after [N]SSM/IIBR (10.1 weeks) compared to DBR (14.0 weeks).</p><p><strong>Conclusions: </strong>Women potentially needing PMRT should be informed pre-operatively that [N]SSM/IIBR with PMRT may be associated with 22% severe complications and 8% failure. Still, [N]SSM/IIBR prior to PMRT required less interventions and was less time-consuming than DBR following PMRT. Therefore, the potential need of re-interventions should not be the reason for refraining from [N]SSM/IIBR in these women.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"37-46"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964910","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":"Self-administered versus lymphedema therapist-administered complex decongestive therapy protocol in breast cancer-related lymphedema: a non-inferiority randomized controlled trial with three-month follow-up.","authors":"Sukriye Cansu Gultekin, Didem Karadibak, Ahmet Burak Cakir, Zeynep Gulsum Guc, Tugba Yavuzsen","doi":"10.1007/s10549-025-07709-3","DOIUrl":"10.1007/s10549-025-07709-3","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this study was to demonstrate that a self-administered complex decongestive therapy (CDT) protocol is not inferior to certified lymphedema therapist (CLT)-administered CDT in the management of lymphedema and health-related outcomes in patients with breast cancer-related lymphedema (BCRL).</p><p><strong>Methods: </strong>Fifty patients with BCRL were randomly assigned to two experimental groups: (1) a CLT-administered CDT group (n = 25) or a self-administered CDT group (n = 25). CDT was a multimodal approach in two experimental conditions consisting of patient education, manual lymph drainage, multi-layer bandaging, therapeutic exercises and skin/nail care. Lymphedema severity was assessed using circumference measurement, and BCRL-related symptoms were assessed using a numerical rating scale. The following measurement methods were used to assess health-related outcomes: universal goniometer for range of motion (ROMs), hand grip dynamometer for peripheral muscle strength, disabilities of the arm, shoulder and hand (DASH) questionnaire for disability level, International Physical Activity Questionnaire-Short Form (IPAQ-SF) for physical activity level, the checklist for individual strength (CIS) for fatigue and upper limb lymphedema quality of life questionnaire (ULL-27) for quality of life.</p><p><strong>Results: </strong>Following CDT, there was a significant decrease in lymphedema severity and lymphedema-related symptoms in both groups (p < 0.001). There was no significant difference between the groups regarding the mean difference in health-related outcomes following CDT (post-treatment-baseline) (p < 0.05). Lymphedema severity and symptoms remained stable during the 3-month follow-up periods in the CLT-administered CDT group (p > 0.05). There was a decrease in the severity of lymphedema, stiffness, heaviness and fatigue in the self-administered CDT group at 3-month follow-up (p < 0.05), while pain and tingling remained unchanged (p > 0.05).</p><p><strong>Conclusion: </strong>The present findings demonstrated self-administered CDT protocol is not inferior to CLT-administered CDT in the management of lymphedema and reduction of lymphedema-related disabilities.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"123-138"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086114/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968578","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":"Tolerance for chemotherapy-induced peripheral neuropathy among women with metastatic breast cancer: a discrete-choice experiment.","authors":"Rotana M Radwan, Anne L R Schuster, Daniel L Hertz, Maryam B Lustberg, Hetal R Vachhani, Erin Hickey Zacholski, Vanessa B Sheppard, John F P Bridges, Teresa M Salgado","doi":"10.1007/s10549-025-07715-5","DOIUrl":"10.1007/s10549-025-07715-5","url":null,"abstract":"<p><strong>Purpose: </strong>To quantify preferences for chemotherapy-induced peripheral neuropathy (CIPN) risks and survival benefits of continuing neurotoxic chemotherapy and explore differences in preferences by race among women with metastatic breast cancer (mBC).</p><p><strong>Methods: </strong>Women with mBC and CIPN experience completed a discrete-choice experiment that included 12 choice tasks presenting paired profiles that varied four attributes across three levels each: progression-free survival (PFS) (6, 12, 24 months), neuropathy in hands (mild, moderate, severe), neuropathy in feet (mild, moderate, severe), and neuropathy persistence (short-term, long-term, permanent). Aggregate and exploratory stratified (White versus non-White) conditional logit models were estimated from which patients' minimum acceptable benefit was calculated using the willingness-to-pay approach.</p><p><strong>Results: </strong>Women (n = 189) were on average 52.5 years and 47.1% were non-White. Fewer women who were non-White held a bachelor's degree or higher (p < 0.01) and reported a household income of $85,000 or higher (p = 0.03). In both the aggregate and the stratified analyses, women preferred longer duration of PFS, less severe CIPN in hands and feet, and shorter CIPN duration. In aggregate, respondents were willing to tolerate a one-level increase in neuropathy severity (mild to moderate or moderate to severe) in their hands and feet in exchange for 6.7 and 2.9 months of PFS, respectively. In exchange for 9.3 months of PFS, respondents were willing to tolerate a one-level increase in neuropathy persistence (short-term to long-term or long-term to permanent). Exploratory stratified analysis showed that non-White women had different preferences from White women (p < 0.01), with non-White women requiring more months of PFS benefit to tolerate increases in neuropathy severity and duration compared to White women.</p><p><strong>Conclusion: </strong>Women with mBC favored longer duration of progression-free survival, less severe CIPN in hands and feet, and shorter CIPN duration. Different preferences by race warrant additional future investigation.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"149-159"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972199","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":"Brain metastases in patients with metastatic breast cancer and BRCA1/2 mutations in cell-free DNA.","authors":"Neelima Vidula, Erica Blouch, Katherine Hesler, Andrzej Niemierko, Aditya Bardia","doi":"10.1007/s10549-025-07705-7","DOIUrl":"10.1007/s10549-025-07705-7","url":null,"abstract":"<p><strong>Purpose: </strong>Brain metastases (BM) in patients with metastatic breast cancer (MBC) cause significant morbidity/mortality. A relatively high prevalence of BM is seen in patients with germline BRCA1/2 mutations. Some patients with MBC have somatic BRCA1/2 mutations but the prevalence of BM in this setting is not known.</p><p><strong>Methods: </strong>Here, we evaluated the prevalence and clinical and genomic characteristics of BM in patients with MBC with somatic BRCA1/2 mutations in cell-free DNA (cfDNA) using the Guardant360 assay. Clinical and genomic features of patients with somatic BRCA1/2 mutations and brain metastases, and those without brain metastases were compared using a Chi-squared test for categorical variables and Wilcoxon rank-sum test for continuous variables.</p><p><strong>Results: </strong>Of 36 patients with MBC and somatic BRCA1/2 mutations, 9 (25%) developed BM. The median time to development of BM was 6.7 months after somatic BRCA detection by cfDNA testing. Among patients with BM, somatic BRCA mutations were commonly BRCA1, clonal, and present at a higher mutant allelic fraction. The coexisting genomic landscape in patients with BM commonly included PIK3CA, TP53, MYC, EGFR, CCNE1, and KIT mutations.</p><p><strong>Conclusion: </strong>A relatively high prevalence of BM in patients with MBC harboring cfDNA somatic BRCA1/2 mutations was observed. CfDNA somatic BRCA1/2 mutations may help identify patients with MBC at risk for BM. To our knowledge, this is the first report linking cfDNA somatic BRCA mutations with BM, and requires further investigation in additional datasets and studies.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"107-112"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976232","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":"How can we optimize the surgical management of the axilla in breast cancer since the MonarchE trial?","authors":"Clémentine Jankowski, Gilles Houvenaeghel, Celine Renaudeau, Jean Leveque, Frederic Marchal, Amélie Benbara, Emmanuel Barranger, Roman Rouzier, Monique Cohen, Jean-Marc Classe, Sylvain Ladoire, Charles Coutant","doi":"10.1007/s10549-025-07642-5","DOIUrl":"10.1007/s10549-025-07642-5","url":null,"abstract":"<p><strong>Purpose: </strong>Results of MonarchE trial have changed adjuvant therapy for estrogen-receptor-positive (ER+), HER-2-negative breast cancer. Given the importance of the extent of nodal disease in this study, surgical management of the axilla has resurfaced as a question asked at multidisciplinary boards.</p><p><strong>Methods: </strong>Using data from a cohort of Werkoff (JCO, 2009) in which patients underwent both sentinel lymph node(SLN) biopsy and axillary node dissection (ALND), we assessed the proportion of patients in whom the absence of ALND would have led to a lack of awareness of \"high-risk\" status. We evaluated the contribution of the Katz nomogram (that predict pN2/N3 stage) to guide possible indications for complementary ALND.</p><p><strong>Results: </strong>Among the 536 patients, 88 were excluded (ER- and/or isolated cells in SLN). Of patients with 1 or 2 SLN + (n = 352), only 7.9% were pN2/N3. When the ratio (number of SLN + /total number of SLN sampled) was less than 1, only 3.9% were pN2/N3. Patients with 1 or 2 SLN + met the ACOSOG Z0011 criteria so none would benefit from an ALND, but 7.9% of patients at high risk will not receive Abemaciclib. If we use the Katz nomogram (threshold ≤ 5%), this rate decrease at 3.3% but 116 patients will have an ALND with no benefit. With a threshold ≤ 20%, 5% patients at high risk will not receive Abemaciclib but 21 patients will have an ALND with no benefit.</p><p><strong>Conclusion: </strong>The indications for adjuvant Abemaciclib should not lead to surgical escalation in the management of the axilla.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"13-21"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143954016","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":"First mammogram-detected cancers portend worse survival in young women diagnosed with breast cancer.","authors":"Avia D Wilkerson, Megan Obi, Corey Gentle, Wei Wei, Camila Ortega, Zahraa Al-Hilli","doi":"10.1007/s10549-025-07703-9","DOIUrl":"10.1007/s10549-025-07703-9","url":null,"abstract":"<p><strong>Purpose: </strong>Breast cancer (BC) screening guidelines for women ages 40-45 have differed across multiple organizations, resulting in variable ages of screening commencement among women in the US. We previously reported that delay in screening beyond age 40 increases risk for first mammogram cancer diagnoses. We hypothesize that first mammogram cancer detection may also diminish recurrence-free and overall survival (RFS, OS).</p><p><strong>Study design: </strong>This retrospective cohort study included 738 women diagnosed with BC from ages 40-45 years and treated within a single hospital system from 2010 to 2019. First mammogram cancers were defined as those with tissue diagnoses established within 3 months of baseline mammogram. RFS after surgery and OS after BC diagnosis were analyzed in patients diagnosed on first versus subsequent mammograms via the Kaplan-Meier method, with p-values generated by log rank tests. Cumulative incidences of local and distant recurrence were also assessed.</p><p><strong>Results: </strong>Of 738 women, 218 had first mammogram cancers while 520 were diagnosed on subsequent mammograms. Median follow-up was 72.2 months (0.5-155.8 months). At 5 and 10 years after diagnosis, OS was significantly worse in patients diagnosed on their first mammogram (0.88 [0.83-0.93] and 0.80 [0.73-0.87]) versus subsequent mammograms (0.95 [0.93-0.97] and 0.90 [0.86-0.93]), p = 0.003. Patients with first mammogram cancers also had inferior 5- and 10-years RFS rates (0.81 [0.71-0.88] and 0.74 [0.65-0.83] vs. 0.88 [0.85-0.92] and 0.77 [0.72-0.83]), p = 0.04.</p><p><strong>Conclusion: </strong>First mammogram cancers were associated with worse survival in our study cohort, reinforcing the importance of consistent guidelines for screening commencement at age 40.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"87-95"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143961574","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":"Association of statin use on survival outcomes of patients with early-stage HER2-positive breast cancer in the APHINITY trial.","authors":"Christian Maurer, Elisa Agostinetto, Lieveke Ameye, Matteo Lambertini, Samuel Martel, Noam Ponde, Mariana Brandão, Francesca Poggio, Arlindo Ferreira, Rachel Schiff, Carmine De Angelis, Richard D Gelber, Susan Dent, Christoph Thomssen, Martine Piccart, Evandro de Azambuja","doi":"10.1007/s10549-025-07699-2","DOIUrl":"10.1007/s10549-025-07699-2","url":null,"abstract":"<p><strong>Purpose: </strong>There is evidence that statins might improve the outcome of patients with breast cancer. The role of statins in patients with early HER2-positive breast cancer is unknown. Therefore, we explored the association between statin use and survival outcomes in early HER2-positive breast cancer patients in the phase III APHINITY trial (adjuvant pertuzumab/trastuzumab).</p><p><strong>Methods: </strong>All patients (intent-to-treat population, n = 4804) were included (6.2 years median follow-up database). The primary objective was to investigate the association of statin use on invasive disease-free survival (IDFS), distant relapse-free interval (DRFI), and overall survival (OS). Patients who received statins at baseline, or started statins within 1 year from randomization were considered statin users. Survival curves were estimated using the Kaplan-Meier method. We used a Cox proportional hazards model for multivariate analysis.</p><p><strong>Results: </strong>Overall, 423 (8.8%) patients were classified as statin users. They were older, more often postmenopausal, had a higher body mass index, more often diabetes, hypertension, coronary heart disease and hyperlipidemia, had smaller sized tumors, were treated more often with breast conserving surgery, and less often with anthracycline-containing regimens. Overall, 508 IDFS events (12.8% among statin users and 10.4% among non-statin users) and 272 deaths (8.5% and 5.4%, respectively) occurred. In multivariate analysis, statin use was not associated with IDFS (HR, 1.11; 95% CI, 0.80-1.52), DRFI (HR, 1.21; 95% CI, 0.81-1.81) nor OS (HR, 1.16; 95% CI, 0.78-1.73).</p><p><strong>Conclusion: </strong>In APHINITY, statin use was not associated with improved survival outcomes. These results must be interpreted with caution due to the exploratory nature of the analysis and the associated limitations.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"57-69"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968509","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":"Ocular adverse events of perioperative adjuvant docetaxel vs paclitaxel for breast cancer: propensity-score overlap-weighted analysis.","authors":"Chikako Iwai, Atsushi Miyawaki, Takaaki Konishi, Akira Okada, Asahi Fujita, Taisuke Jo, Hideo Yasunaga","doi":"10.1007/s10549-025-07720-8","DOIUrl":"10.1007/s10549-025-07720-8","url":null,"abstract":"<p><strong>Background: </strong>Taxanes are known to be associated with several ocular adverse events; however, large-scale data comparing the risk of ocular adverse events between the two commonly used taxanes, docetaxel (DTX) and paclitaxel (PTX), remain limited. Therefore, we aimed to compare the risks of epiphora, cystoid macular edema, and optic neuropathy between DTX- and PTX-based chemotherapy regimens.</p><p><strong>Methods: </strong>Using a nationwide claims database in Japan, we identified 6038 patients who initiated neoadjuvant or adjuvant taxane-based chemotherapy for breast cancer between April 2014 and November 2022. Data analysis was conducted in 2024. This study was conducted across multiple referral centers and community hospitals in Japan, providing a comprehensive view of taxane-based chemotherapy practices in diverse healthcare settings. Participants included 6038 patients diagnosed with breast cancer who initiated neoadjuvant or adjuvant taxane-based chemotherapy. Eligibility criteria included female patients aged 18 years or older. Participants were selected from a nationwide claims database using a consecutive sampling method. Patients who received DTX-based chemotherapy (DTX group) were compared with those who received PTX-based chemotherapy (PTX group). After adjusting for potential confounders using a propensity score-overlap weighting method, we estimated the incidence of the three ocular adverse events and hazard ratios (HRs) using Cox proportional hazards regression models.</p><p><strong>Results: </strong>Among the 6038 eligible patients, 3829 were in the DTX group and 2209 in the PTX group. The adjusted HR for epiphora in the DTX group was 1.69 [95% confidence interval (CI), 1.17 to 2.45] compared with the PTX group. For cystoid macular edema and optic neuropathy, the adjusted HRs were 0.74 (95% CI, 0.52 to 1.04) and 0.72 (0.47 to 1.11), respectively. The composite incidence of epiphora, cystoid macular edema, and optic neuropathy did not differ significantly between the DTX and PTX groups.</p><p><strong>Conclusion: </strong>Among patients receiving taxane-based chemotherapy for breast cancer, DTX was associated with a higher risk of epiphora compared with PTX. However, the incidence rates of cystoid macular edema and optic neuropathy did not differ significantly between the two groups. These findings offer valuable insights into the ocular adverse event profile of taxane-based chemotherapy in patients with breast cancer.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"173-182"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086119/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976338","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 adding palbociclib on treatment adherence to ongoing adjuvant endocrine treatment in the global randomized PALLAS randomized trial in patients with early breast cancer.","authors":"Eileen Shinn, David Zahrieh, Angela DeMichele, Nick Zdenkowski, Julie Lemieux, Jun Mao, Vesna Bjelic-Radisic, Michelle J Naughton, Georg Pfeiler, Karen Gelmon, Justin M Balko, Daniel Egle, Gabriele Zoppoli, Tiffany Traina, Miguel Martin Jimenez, Silvia Antolin Novoa, Tufia Haddad, Arlene Chan, Alistair Ring, Antonio Wolff, William Fraser Symmans, Jose Ponce Lorenzo, Dhanusha Sabanathan, Hal J Burstein, Zbigniew Ireneusz Nowecki, Gunda Pristauz-Telsnigg, Adam Brufsky, Meritxell Bellet-Ezquerra, Theodoros Foukakis, Yelena Novik, Gabor Rubovszky, Christian F Singer, Karoline Muehlbacher, Otto Metzger Filho, Theodora Goulioti, Ernest Law, Ann H Partridge, Lisa A Carey, Alex Zoroufy, Dominik Hlauschek, Christian Fesl, Erica L Mayer, Michael Gnant","doi":"10.1007/s10549-025-07653-2","DOIUrl":"10.1007/s10549-025-07653-2","url":null,"abstract":"<p><strong>Purpose: </strong>Using patient-reported outcomes (PROs) and more objective measures, we evaluated adherence to adjuvant palbociclib and ET in the PALLAS trial, and the impact of palbociclib on ET adherence.</p><p><strong>Methods: </strong>The open-label, global, phase 3 PALLAS trial randomized patients with hormone receptor-positive (HR+), HER2-negative stage II-III breast cancer (1:1) to either 26 cycles of palbociclib (125 mg/day for 21 days and then 7 days off) plus adjuvant ET, versus ET alone. After 23.7 months median follow-up, palbociclib was stopped due to futility of the intervention and patients were moved to follow-up. For each cycle, daily adherence to ET was measured with study diaries; for palbociclib, study diaries and pill counts. At cycles 2, 3, 6, 12, 18 and 24, patients completed the Morisky Medication Adherence Scale-4 plus an additional item and the McHorney Adherence Questionnaire. Mean persistence was defined in months from treatment initiation to cessation.</p><p><strong>Results: </strong>Four thousand six hundred eighty-eight of 5796 total PALLAS participants were included. Across all cycles, mean daily ET adherence values measured by study diary were > 98.0% and did not differ between treatment arms. Mean persistence to ET was similar between arms (19.2 months for palbociclib + ET vs. 19.6 months for ET alone). However, patient-reported maximal ET adherence was higher across time for palbociclib + ET compared to ET alone (p ≤ 0.0001, modified MMAS-4; p = 0.05, McHorney).</p><p><strong>Conclusion: </strong>In the PALLAS trial, addition of palbociclib did not decrease adherence to adjuvant ET. Though numbers declined over time, daily adherence for palbociclib and ET remained relatively high at each cycle.</p><p><strong>Trial registration: </strong>The trial is registered with ClinicalTrials.gov (NCT02513394; 07-31-2015) and EudraCT (2014-005181-30).</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"385-397"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718049","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}