Clinical breast cancer最新文献

{"title":"Low Dose Tamoxifen for Breast Cancer Prevention: A Real-World Experience","authors":"Rima Patel ,&nbsp;Cao Jin ,&nbsp;Diana Jaber ,&nbsp;Nicole Casasanta ,&nbsp;Mayuri Jain ,&nbsp;Weijia Fu ,&nbsp;Catherine Wu ,&nbsp;Erin Moshier ,&nbsp;Amy Tiersten","doi":"10.1016/j.clbc.2024.12.020","DOIUrl":"10.1016/j.clbc.2024.12.020","url":null,"abstract":"<div><h3>Purpose</h3><div>There is limited data on the use of low dose tamoxifen (LDT) for chemoprevention since its introduction in 2019. This study sought to determine the rate of LDT uptake at our institution and describe factors associated with its use.</div></div><div><h3>Methods</h3><div>We performed a retrospective chart review of women diagnosed with ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), and/or atypical hyperplasia from 2019 to 2021. Log-binomial models were used to compare the probabilities of receiving standard dose tamoxifen (SDT) relative to LDT by patient and disease characteristics. Since most patients did not experience any AEs, a zero-inflated poison regression model was used to estimate and compare adverse event rates between groups.</div></div><div><h3>Results</h3><div>Among 477 patients with DCIS, LCIS, and atypical hyperplasia, 27% (<em>N</em> = 129) initiated SDT, 19% (<em>N</em> = 89) LDT, 32% (<em>N</em> = 155) aromatase inhibitor, 2% (<em>N</em> = 9) raloxifene, and 20% (<em>N</em> = 95) declined therapy. LDT was used more frequently than SDT in patients with LCIS or atypical hyperplasia compared to DCIS (31.4% vs 17.4%, <em>P</em> &lt; .0001). There were no significant differences in the frequency of adverse events between patients on SDT and LDT but the incidence rate of AEs in the SDT group was higher (1.9 vs. 1.3 per 1000 days, <em>P</em> = .0186).</div></div><div><h3>Conclusion</h3><div>In our population, 19% of women with DCIS, LCIS, or atypical hyperplasia, initiated chemoprevention with LDT with higher usage in patients with atypical lesions and/or LCIS. Physicians should strongly consider LDT in women with high-risk lesions who are eligible for chemoprevention.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"25 3","pages":"Pages 283-290"},"PeriodicalIF":2.9,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001208","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":"Identification and Management of Medical Comorbidities in Patients With HR+/HER2- Metastatic Breast Cancer Treated With CDK4/6 Inhibitors: Literature Review and Recommendations From Experts in Spain Opinion.","authors":"Carmen Hinojo, Blanca Cantos, Silvia Antolín, Cristina Arqueros, Tamara Díaz-Redondo, Iria González, Elisenda Llabrés, Javier Alonso Ramírez, Manuel Barral, María Escudero, Loreto Fernández, Eva Juan Linares, Jorge V López-Ibor, Heidy Campo Palacio, María Piedra León, Susana de la Cruz","doi":"10.1016/j.clbc.2024.12.016","DOIUrl":"https://doi.org/10.1016/j.clbc.2024.12.016","url":null,"abstract":"<p><p>Approximately one-third of patients with breast cancer have comorbidities at the time of their diagnosis. Recommendations for managing metastatic breast cancer are usually based on the results of clinical trials, which often limit patients with comorbidities. However, comorbidities greatly influence the quality of life, patient survival rate and treatment choice, particularly in older patients. The objective of this review was to identify clinically relevant comorbidities in patients with metastatic breast cancer, analyze the clinical approach to the treatment of these comorbidities, and propose recommendations from experts. An expert panel of eight medical oncologists identified seven therapeutic areas associated with the most relevant comorbidities in metastatic breast cancer: cardiovascular, gastrointestinal, endocrine/metabolic, renal, geriatric, psychological, and pain related. A clinical specialist from each therapeutic area specific to the relevant comorbidities (n = 8) joined the panel of experts (n = 8) to provide guidance on the appropriate management of these comorbidities. The specific comorbidities analyzed were hypertension, atrial fibrillation, venous thromboembolism, obesity, diabetes mellitus, cancer cachexia, chronic kidney disease, age-related disorders, arthritis, and fibromyalgia. In most cases, patients with metastatic breast cancer and medical comorbidities are polymedicated and/or vulnerable to toxicity. The oncologists provided recommendations on initial assessment and monitoring, follow-up recommendations, and warning signs and symptoms for referral to corresponding specialists based on their experience. The panel of experts also explored clinical scenarios related to each comorbidity and recommended a preferred CDK4/6 inhibitor based on available evidence regarding drug-drug interactions and potential for toxicity.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063982","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":"Trends in Incidence of Invasive Lobular Carcinoma of the Breast by Race: Patterns by Age, Cancer Stage, and Socioeconomic Factors in the United States, 1992-2019.","authors":"Ryann M Quinn, Ana M Bernal, Sun Young Oh, Jesus D Anampa","doi":"10.1016/j.clbc.2024.12.015","DOIUrl":"https://doi.org/10.1016/j.clbc.2024.12.015","url":null,"abstract":"<p><strong>Purpose: </strong>There is scarce literature about the role of race/ethnicity and socioeconomic status on the incidence of invasive lobular carcinoma (ILC). We sought to assess trends in ILC incidence by race/ethnicity across age, cancer stage, and socioeconomic status subgroups in the United States from 1992 to 2019.</p><p><strong>Methods: </strong>This population-based cross-sectional study included data from SEER12 registries. We used the NCI's Join point Regression Program to estimate longitudinal trends in age-adjusted breast cancer incidence rates from 1992 to 2019, reported as average annual percent change (AAPC) or annual percent change (APC). We evaluated incidence trends by a combination of race/ethnicity and stage, county-level poverty, county-level metro/nonmetro status, high school education, and age.</p><p><strong>Results: </strong>From 1992 to 2019, ILC incidence rates increased across all race/ethnicity groups, with the greatest increase in non Hispanic Black (AAPC 2.6%), followed by Hispanic (AAPC 2.2%), and non Hispanic White women (AAPC 1.6%). The stronger increase in ILC incidence among Hispanic and non Hispanic Black women was predominantly seen among those living in low poverty or metropolitan areas and those older than 70. In recent years, from 2002 to 2019, the largest increase in ILC incidence was found in Hispanic women (APC 3.3%).</p><p><strong>Conclusion: </strong>Although the incidence of ILC continues to be highest in non Hispanic White women, in recent years the largest increases are seen in non Hispanic Black women and Hispanic women. Further research is warranted to better understand these trends and appropriately target at-risk populations for screening.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001225","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":"Safety and Feasibility of Robotic Nipple-Sparing Mastectomy With Immediate Direct-to-Implant Reconstruction – Insights From the One of the Largest Centers in Asia","authors":"Yu-Meng Claire Lin ,&nbsp;Su Ann Lui ,&nbsp;Mei-Yen Chen ,&nbsp;Yu-Yu Chou ,&nbsp;Fiona Tsui-Fen Cheng","doi":"10.1016/j.clbc.2024.12.013","DOIUrl":"10.1016/j.clbc.2024.12.013","url":null,"abstract":"<div><h3>Background</h3><div>The use of robotic-assisted nipple-sparing mastectomy (R-NSM) with immediate direct-to-implant (DTI) reconstruction in treatment of breast cancer has been a controversial topic. The adoption of robotic surgery in breast cancer treatment has gained traction globally due to its minimally invasive nature, potential for improved cosmetic outcomes and better intraoperative visualization. This study provides insights on safety and feasibility robotic mastectomy at one of the largest centers in Asia.</div></div><div><h3>Methods</h3><div>This retrospective study included patients who underwent robotic nipple-sparing mastectomy (R-NSM) with immediate direct-to-implant (DTI) reconstruction from April 2018 to September 2024. Our endpoints were mainly focused on perioperative outcomes, patient satisfaction, and oncologic outcomes.</div></div><div><h3>Results</h3><div>A total of 266 procedures were included in our series, with 233 patients undergoing unilateral R-NSM with either DTI reconstruction or a tissue expander, and 33 patients underwent surgery on both breasts. Postoperative complications were recorded in 11 patients (4.14 %). The median follow-up of this study is 37.2 ± 23.3 months. Locoregional recurrence (LRR) was observed in 6 patients (2.5 %), with isolated skin recurrence being the most common. Distant metastasis was observed in 9 patients (3.86 %). The 3-year overall survival rate was 98.3 %.</div></div><div><h3>Conclusion</h3><div>Robotic NSM is a safe and feasible novel minimal invasive surgical approach for breast cancer surgery, providing both excellent cosmetic results and oncological outcomes that are noninferior to conventional or endoscopic approaches.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"25 3","pages":"Pages 277-282"},"PeriodicalIF":2.9,"publicationDate":"2024-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001221","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":"Evaluation of the Impact of Breast Radiation Therapy on Quality of Life Requires Appropriate Instruments at Relevant Timepoints","authors":"Sarah Bayrakdarian ,&nbsp;Paula Tur ,&nbsp;Shirley SW Tse ,&nbsp;Kimberly Corbin ,&nbsp;Sara Alcorn ,&nbsp;Agata Rembielak ,&nbsp;Edward Chow ,&nbsp;Henry C.Y. Wong","doi":"10.1016/j.clbc.2024.12.012","DOIUrl":"10.1016/j.clbc.2024.12.012","url":null,"abstract":"","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"25 3","pages":"Pages e322-e323"},"PeriodicalIF":2.9,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001203","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":"Influence of Postmastectomy Radiotherapy on Overall Survival in Patients With Clinical Prognostic Stage I-III Breast Cancer With Positive Responses and Achieving YPN0 Following Neoadjuvant Therapy: A Propensity Score Matching Based on the SEER Database.","authors":"YuFeng Zhang, GuoDong Wang, Jia Si, MaoYi Xu","doi":"10.1016/j.clbc.2024.12.010","DOIUrl":"https://doi.org/10.1016/j.clbc.2024.12.010","url":null,"abstract":"<p><strong>Introduction: </strong>The role of postmastectomy radiotherapy (PMRT) in clinical prognostic stage I-III breast cancer patients with positive responses and achieving ypN0 after Neoadjuvant therapy (NAT) is controversial.</p><p><strong>Methods: </strong>3557 patients with TNM clinical prognostic stage (AJCC 8th Edition) I-III breast cancer with positive responses and achieving ypN0 following neoadjuvant therapy were selected from the Surveillance, Epidemiology, and End Results (SEER) database and followed through the end of 2020. COX proportional hazards models were employed to examine the associations between clinical or pathological parameters and OS. Propensity score matching (PSM) was employed to control for confounding variables and multiple association inference models were used for progressive sensitivity analysis.</p><p><strong>Results: </strong>In the multivariate analysis, PMRT did not demonstrate a significant improvement in OS (P = .127), while in univariate analysis, it was linked to worse OS (P < .001). PSM and multiple association inference models indicated that PMRT did not confer any significant improvement in patients' OS (all P > .05). Further stratified analysis of the prematch subgroup revealed that PMRT was linked to the 68% lower risk of mortality in patients with the cN3 subgroup (HR: 0.32; 95%CI, 0.11-0.97), and expressly enhanced the OS in cN3 subgroup patients with ER-, PR-, HER-2- status, and PR to NAT.</p><p><strong>Conclusions: </strong>Our research indicated that PMRT did not show any survival benefits for clinical prognostic stage I-III breast cancer patients who had positive responses and achieved ypN0 after NAT. PMRT was linked to the reduction in mortality among patients in the cN3 subgroup.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926561","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":"Oral Anticancer Therapies: Addressing Nonadherence in Patients With Breast Cancer.","authors":"M E Cazzaniga, J Huober, A Tamma, A Emde, K Thoele, J O'Shaughnessy","doi":"10.1016/j.clbc.2024.12.011","DOIUrl":"https://doi.org/10.1016/j.clbc.2024.12.011","url":null,"abstract":"<p><p>This review aims to investigate the issue of treatment nonadherence and to present the available strategies to improve adherence to oral treatments in breast cancer. A literature search was conducted to contextualise the issue of nonadherence, investigate the reasons behind nonadherence, and demonstrate strategies to address treatment nonadherence in breast cancer. Findings indicate that adherence rates decrease while discontinuation rates increase with increasing lengths of breast cancer treatment course. Lack of adherence is proven to be detrimental to treatment outcomes. Patients struggle to adhere to treatment due to inadequate relationships with healthcare providers, lack of information, psychological distress, and side effects. Healthcare providers should evaluate patient's experience to provide the necessary support. Following this assessment, healthcare providers may recommend interventions addressing patient knowledge, psychological distress or side effects. Treatment adherence remains an issue for oral therapeutics in breast cancer. After patient assessment, healthcare providers can offer personalised strategies to improve treatment adherence. The most crucial interventions address patient knowledge, psychological distress, and side effects.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969629","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":"Effects of Lasofoxifene Versus Fulvestrant on Vaginal and Vulvar Symptoms in Patients With ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer From the ELAINE 1 Study","authors":"Shari B. Goldfarb ,&nbsp;Sarah L. Sammons ,&nbsp;Jane L. Meisel ,&nbsp;Timothy J. Pluard ,&nbsp;Simon N. Jenkins ,&nbsp;Barry S. Komm ,&nbsp;Dominic Carroll ,&nbsp;David J. Portman","doi":"10.1016/j.clbc.2024.12.002","DOIUrl":"10.1016/j.clbc.2024.12.002","url":null,"abstract":"<div><h3>Background</h3><div>Lasofoxifene, a novel endocrine therapy (ET), showed antitumor activity versus fulvestrant in women with <em>ESR1</em>-mutated, metastatic breast cancer (mBC) that progressed on prior ET (phase 2, ELAINE 1 study). We investigated changes in genitourinary syndrome of menopause (GSM) vulvar-vaginal symptoms with lasofoxifene and how patient/disease characteristics affect baseline vulvar-vaginal symptoms in ELAINE 1.</div></div><div><h3>Methods</h3><div>Women were randomized to oral lasofoxifene 5 mg/day or IM fulvestrant 500 mg (days 1, 15, and 29, then every 28 days) until disease progression/severe toxicity. Changes in mean vaginal (VAS) and vulvar (VuAS) assessment scales, and their composite (average of all symptom scores/patient), from baseline to week 16, and mean baseline VAS/VuAS scores by patient/disease characteristics, were descriptively summarized.</div></div><div><h3>Results</h3><div>Of 103 enrolled patients, 72 (70%) completed the VAS/VuAS (mean age 61.5 years). Vaginal (40%)/vulvar (25%) dryness and vaginal pain (22%) were the most frequently reported symptoms; 26% reported ≥1 moderate/severe symptom. Lasofoxifene decreased the mean composite VAS/VuAS, VAS, and VuAS from baseline to week 16 by 74%, 74%, and 79%, respectively; fulvestrant increased them by 36%, 15%, and 63%, respectively. Baseline vaginal/vulvar symptoms were more severe if patients were under age 40, had no visceral disease, used adjuvant tamoxifen previously, or had longer AI duration in the adjuvant/metastatic settings.</div></div><div><h3>Conclusions</h3><div>Oral lasofoxifene (5 mg/day), but not fulvestrant, appears to improve GSM vaginal symptoms in women with mBC. These preliminary findings suggest further study is needed; such will be explored in the phase 3, registrational, ELAINE 3 trial in patients with <em>ESR1</em>-mutated, ER+/HER2- mBC.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"25 3","pages":"Pages 261-267.e1"},"PeriodicalIF":2.9,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001198","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":"Mutations in Necroptosis-Related Genes Reported in Breast Cancer: A Cosmic and Uniport Database-Based Study.","authors":"Banita Thakur, Rohit Verma, Alka Bhatia","doi":"10.1016/j.clbc.2024.12.008","DOIUrl":"https://doi.org/10.1016/j.clbc.2024.12.008","url":null,"abstract":"<p><p>Breast cancer (BC) now holds the top position as the primary reason of cancer-related fatalities worldwide, overtaking lung cancer. BC is classified into diverse categories depending on histopathological type, hormone receptor status, and gene expression profile, with ongoing evolution in their classifications. Cancer initiates and advances when there is a disruption in cell death pathways. In BC, the primary cell death pathway, apoptosis, experiences dysregulation across multiple stages. Ongoing studies aim to discover therapeutic targets that enhance cancer cell susceptibility to apoptosis. However, resistance to this therapy remains a significant challenge in treating BC. If apoptosis is hindered, investigating alternative pathways for cell death that can effectively eradicate BC cells during treatment becomes a valuable endeavor. In this context, necroptosis is gaining considerable focus as an alternative cell death pathway. Necroptosis represents a programmed version of necrosis which shares its key regulators with apoptosis. When apoptosis is hampered, necroptosis serves as an alternative cell death pathway even in physiological conditions like formation of limbs during embryonic development. Additionally, it comes into play during bacterial and viral infections when the apoptosis machinery is hijacked and inhibited by proteins from these pathogens. Studies reveal that in BC, mutations significantly impact molecules in the apoptosis pathway, contributing to the onset, advancement, and multiplication of cancer cells. Although some studies do indicate that the functionality of necroptosis pathway may be compromised in malignancy the status of its key molecules remains largely unknown. In this article, we aim to gather the known mutations present in key molecules of necroptosis among various subtypes of BC, utilizing data from the Cosmic and UniProt databases. The same may help to enhance the development of therapeutic strategies to effectively induce necroptosis in apoptosis-resistant BCs.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964144","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":"A Phase II Trial of Onapristone and Fulvestrant for Patients With ER+ and HER2- Metastatic Breast Cancer","authors":"Sailaja Kamaraju ,&nbsp;Amy M. Fowler ,&nbsp;Sergey Tarima ,&nbsp;Lubna N. Chaudhary ,&nbsp;Mark E. Burkard ,&nbsp;Thomas Giever ,&nbsp;Yee C. Cheng ,&nbsp;Amanda Parkes ,&nbsp;Carol A. Lange ,&nbsp;Michele Pipp-Dahm ,&nbsp;Robert Hegeman ,&nbsp;Nauman Siddiqui ,&nbsp;Amy Stella ,&nbsp;Saurabh Rajguru ,&nbsp;Kyleigh Twaroski ,&nbsp;Luke Zurbriggen ,&nbsp;Julie M. Jorns ,&nbsp;Hallgeir Rui ,&nbsp;Quinton J. Keigley ,&nbsp;Scott B. Perlman ,&nbsp;Kari Wisinski","doi":"10.1016/j.clbc.2024.11.019","DOIUrl":"10.1016/j.clbc.2024.11.019","url":null,"abstract":"<div><h3>Background</h3><div>The SMILE study is a multi-institutional phase II clinical trial to determine the efficacy and safety of an antiprogestin, onapristone, in combination with fulvestrant as second-line therapy for patients with ER+, PgR+/-, HER2- metastatic breast cancer. This study was terminated early and herein, we report patient characteristics, and outcomes.</div></div><div><h3>Methods</h3><div>Eligibility criteria included disease progression on ≥2 lines of prior therapy, ECOG performance status ≤ 2, measurable disease per RECIST 1.1 criteria, and optional ¹⁸F-fluorofuranylnorprogesterone (¹⁸F-FFNP) PET/CT imaging.</div></div><div><h3>Results</h3><div>Consented subjects received standard-dose fulvestrant plus onapristone 50 mg orally, twice daily, until disease progression, or unacceptable toxicity. The study enrolled 11 women from 2 sites within the Wisconsin Oncology Network from November 2021 through March 2023. Mean age of the subjects was 58.5 years. Other than grade 1 toxicities, the treatment was well tolerated. None of the 11 subjects met RECIST 1.1 definition of response. The median time to progression was 63 days. A total of 4 of 11 patients had stable disease as best response and 2 of them were on treatment for 5.5 and 7.7 months. Two of the 11 subjects underwent functional imaging with ¹⁸F-FFNP PET/CT before and 10 or 14 days after starting treatment. For both subjects, tumor uptake of ¹⁸F-FFNP was stable or increased in all target lesions while ¹⁸F-FFNP uptake in the uterus, a normal PgR-rich internal control organ, was decreased.</div></div><div><h3>Conclusion</h3><div>The study regimen was well-tolerated with no significant toxicities. Future studies may evaluate antiprogestins with various combinations such as targeted therapies.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"25 3","pages":"Pages 251-260"},"PeriodicalIF":2.9,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001176","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}