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Safety profile of sacituzumab govitecan in patients with breast cancer: A systematic review and meta-analysis
IF 5.7 2区 医学
Breast Pub Date : 2024-11-23 DOI: 10.1016/j.breast.2024.103853
Maria Inez Dacoregio , Isabella Michelon , Caio Ernesto do Rego Castro , Francisco Cezar Aquino de Moraes , Guilherme Rossato de Almeida , Lis Victória Ravani , Maysa Vilbert , Ricardo Lima Barros Costa
{"title":"Safety profile of sacituzumab govitecan in patients with breast cancer: A systematic review and meta-analysis","authors":"Maria Inez Dacoregio ,&nbsp;Isabella Michelon ,&nbsp;Caio Ernesto do Rego Castro ,&nbsp;Francisco Cezar Aquino de Moraes ,&nbsp;Guilherme Rossato de Almeida ,&nbsp;Lis Victória Ravani ,&nbsp;Maysa Vilbert ,&nbsp;Ricardo Lima Barros Costa","doi":"10.1016/j.breast.2024.103853","DOIUrl":"10.1016/j.breast.2024.103853","url":null,"abstract":"<div><h3>Background</h3><div>Sacituzumab Govitecan (SG), a first-in-class anti-trophoblast cell surface antigen-2-directed antibody-drug conjugate (ADC), has shown clinically meaningful improvement in outcomes of patients with breast cancer (BC). However, it has also been accompanied by significant toxicity. Thus, we conducted a systematic review and meta-analysis to evaluate the safety and tolerability of SG in this patient population.</div></div><div><h3>Methods</h3><div>We comprehensively searched PubMed, Embase, and Cochrane databases, and ASCO and ESMO websites for clinical trials (CTs) assessing the safety of SG in BC patients. All analyses were performed in R software (v.4.2.2) using random effects models. Heterogeneity was assessed using I<sup>2</sup> test.</div></div><div><h3>Results</h3><div>Seven studies – three randomized clinical trials (RCTs) and four single-arm phase I/II – were included, comprising 928 patients receiving SG and 576 on treatment of physician's choice (TPC). Most patients had triple negative BC (54.4 %, n = 505), metastatic disease (89.8 %, n = 833), and were heavily pretreated (at least two lines of prior therapy). Most common all-grade adverse events (AEs) were: neutropenia (70 %, 95 % CI, 64–76 %), followed by nausea (62 %, 95 % CI, 55–68 %), diarrhea (54 %, 95 % CI 47–60 %) and anemia (51 %, 95 % CI, 38–65 %). Regarding high-grade AEs, 46 % of patients developed grade ≥3 neutropenia. Compared to TPC, we observed a higher risk of neutropenia (OR 3.11, 95 % CI 1.62–5.99, I<sup>2</sup> = 81 %; p &lt; 0.001), diarrhea (OR 6.82, 95 % CI 3.99–11.66, I<sup>2</sup> = 64 %; p &lt; 0.001) and anemia (OR 2.26, 95 % CI 1.20–4.27, I<sup>2</sup> = 78 %; p = 0.012) for those on SG. Dose reductions and treatment discontinuation were reported in 22 % and 4 % of patients, respectively, and 19 deaths (2 %) were documented. Most of them were not deemed to be treated-related.</div></div><div><h3>Conclusion</h3><div>This systematic review and meta-analysis provides extensive data on the safety and management of SG toxicity in BC patients across clinical trials. Concerning rates of neutropenia, nausea diarrhea, and anemia were reported. We highlight the need for protocols establishing prophylactic measures and strategies to mitigate SG-related toxicity.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103853"},"PeriodicalIF":5.7,"publicationDate":"2024-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142748083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Inequality in breast cancer: Global statistics from 2022 to 2050 乳腺癌的不平等:2022 至 2050 年全球统计数据
IF 5.7 2区 医学
Breast Pub Date : 2024-11-22 DOI: 10.1016/j.breast.2024.103851
Ling Liao
{"title":"Inequality in breast cancer: Global statistics from 2022 to 2050","authors":"Ling Liao","doi":"10.1016/j.breast.2024.103851","DOIUrl":"10.1016/j.breast.2024.103851","url":null,"abstract":"<div><div>This study evaluates the global inequalities of breast cancer incidence and mortality from 2022 to 2050 with the latest GLOBOCAN estimates. It focuses on disparities across continents, age groups and Human Development Index (HDI) levels. In 2022, Africa shows the highest positive slope values of age-standardized rates (world) of mortality vs. incidence, both for those under 40 (0.346) and those 40 and older (0.335). These values contrast with those for Asia (0.085, 0.208), Europe (0.002, −0.014), Latin America and the Caribbean (0.17, 0.303), Northern America (−0.078, −0.188), and Oceania (0.166, −0.001). In both age groups, lower HDI levels are correlated with higher slope values and vice versa. Projections to 2050 indicate significant increases in the burden of breast cancer, with persistent yet varied disparities and differences. This highlights the need for differentiated strategies in breast cancer prevention, early-stage diagnosis, and treatment.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103851"},"PeriodicalIF":5.7,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142706171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A patient-led survey on information and communication needs of patients with metastatic breast cancer in Ireland and Northern Ireland (CTRIAL-IE 23–05) 由患者主导的爱尔兰和北爱尔兰转移性乳腺癌患者信息和交流需求调查(CTRIAL-IE 23-05)
IF 5.7 2区 医学
Breast Pub Date : 2024-11-20 DOI: 10.1016/j.breast.2024.103837
Siobhan Gaynor , Yvonne O'Meara , Emer Mulvaney , Rachel J. Keogh , Catherine S. Weadick , Fran J. Duane , Ann Mc Brien , Helen Greally , Mary Jane O'Leary , Ieva Teiserskyte , Isabel Beristain , Jacinta Marron , Eibhlin Mulroe , Vicky Donachie , Sarah Mc Loughlin , Seamus O'Reilly
{"title":"A patient-led survey on information and communication needs of patients with metastatic breast cancer in Ireland and Northern Ireland (CTRIAL-IE 23–05)","authors":"Siobhan Gaynor ,&nbsp;Yvonne O'Meara ,&nbsp;Emer Mulvaney ,&nbsp;Rachel J. Keogh ,&nbsp;Catherine S. Weadick ,&nbsp;Fran J. Duane ,&nbsp;Ann Mc Brien ,&nbsp;Helen Greally ,&nbsp;Mary Jane O'Leary ,&nbsp;Ieva Teiserskyte ,&nbsp;Isabel Beristain ,&nbsp;Jacinta Marron ,&nbsp;Eibhlin Mulroe ,&nbsp;Vicky Donachie ,&nbsp;Sarah Mc Loughlin ,&nbsp;Seamus O'Reilly","doi":"10.1016/j.breast.2024.103837","DOIUrl":"10.1016/j.breast.2024.103837","url":null,"abstract":"<div><h3>Introduction</h3><div>Although treatment advances have improved survival rates for patients with metastatic breast cancer (MBC), patient expressed needs have not been evaluated in Ireland to date.</div></div><div><h3>Methods</h3><div>A 76 item questionnaire was designed by the lead author and a cohort of 41 other MBC patients in collaboration with a multidisciplinary team. The online survey was publicised nationally on all media platforms.</div></div><div><h3>Results</h3><div>246 patients completed the survey between July and October 2023. Most patients were satisfied with the manner of disclosure of their diagnosis but 77 % wanted more prognostic information. Disparate information sources were used to provide support. Only 35 % of patients had access to their records, yet 99 % of patients without access desired to have it. The majority (83 %) of patients were amenable to earlier palliative care referral. The symptom burden of respondents was high, 87 % experienced mental health issues and 68 % of those with menopausal symptoms were dissatisfied with the support. These burdens were compounded by financial stress with 20 % of patient unable to meet monthly expenses and by time toxicity with 25 % attending emergency departments in the previous 6 months.</div></div><div><h3>Conclusion</h3><div>Currently the needs of MBC patients in Ireland and Northern Ireland have many unmet needs. The routine early provision of palliative care, psycho-oncology, medical social worker and dedicated liaison nurse supports guided by national guidelines and education for healthcare professionals, integrated with living well with cancer clinics and a dedicated medically verified website would provide an ecosystem where MBC care could be optimised for patients and their families.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103837"},"PeriodicalIF":5.7,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142706170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Factors associated with breast lymphedema after adjuvant radiation therapy in women undergoing breast conservation therapy 接受保乳治疗的妇女在辅助放疗后出现乳房淋巴水肿的相关因素
IF 5.7 2区 医学
Breast Pub Date : 2024-11-19 DOI: 10.1016/j.breast.2024.103846
Summer Sami Yono , Cara Cannella , Madeleine Gonte , Sanjay Rama , Simeng Zhu , Jenna Luker , Maristella S. Evangelista , Jessica Bensenhaver , Eleanor M. Walker , Dunya Atisha
{"title":"Factors associated with breast lymphedema after adjuvant radiation therapy in women undergoing breast conservation therapy","authors":"Summer Sami Yono ,&nbsp;Cara Cannella ,&nbsp;Madeleine Gonte ,&nbsp;Sanjay Rama ,&nbsp;Simeng Zhu ,&nbsp;Jenna Luker ,&nbsp;Maristella S. Evangelista ,&nbsp;Jessica Bensenhaver ,&nbsp;Eleanor M. Walker ,&nbsp;Dunya Atisha","doi":"10.1016/j.breast.2024.103846","DOIUrl":"10.1016/j.breast.2024.103846","url":null,"abstract":"<div><h3>Purpose</h3><div>Breast lymphedema after post-lumpectomy radiation therapy (RT) is poorly defined and difficult to treat. The aim of this study was to define the incidence of breast lymphedema and identify factors associated with the risk of developing breast lymphedema (BL) in women undergoing breast-conserving therapy.</div></div><div><h3>Methods</h3><div>A retrospective cohort study of patients with early-stage breast cancer who underwent breast-conserving surgery (lumpectomy) followed by RT between January 1, 2014 and July 31, 2019 at a single institution. Women who developed BL, defined as swelling of the breast persisting ≥1 year after RT, were compared with women who did not. Univariate and multivariate regression analyses were used to identify factors associated with risk of BL.</div></div><div><h3>Results</h3><div>A total of 1052 patients were included in the study: 99 (9.6 %) developed BL and 953 (90.6 %) did not develop BL. The mean ± standard deviation age was 62.9 ± 11.1 years and the mean breast volume was 1352.0 ± 744.9 cm<sup>3</sup>. Patients with breast volume ≥1500 cm<sup>3</sup> (adjusted odds ratio [aOR] = 2.34; 95 % CI, 1.40–3.91; <em>p</em> = 0.001), Black patients (aOR = 1.78; 95 % CI, 1.12–2.82; <em>p</em> = 0.015), those who received neoadjuvant (aOR = 3.05; 95 % CI, 1.28–7.30; <em>p</em> = 0.012) or adjuvant chemotherapy (aOR = 2.14; 95 % CI, 1.29–3.55; <em>p</em> = 0.003), those with postoperative cellulitis (aOR = 3.94; 95 % CI, 2.20–7.06; <em>p</em> &lt; 0.001), and women who developed arm lymphedema (aOR = 2.94; 95 % CI, 1.50–5.77; <em>p</em> = 0.002) had significantly higher odds of developing BL.</div></div><div><h3>Conclusion</h3><div>Patients with larger breast volumes, Black patients, those receiving chemotherapy, and those who develop arm lymphedema or cellulitis may be at higher risk of BL after lumpectomy and RT, suggesting that patients with these risk features may benefit from complementary or alternative surgical approaches and heightened monitoring to avoid BL.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103846"},"PeriodicalIF":5.7,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142706554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Treatment of oligometastatic breast cancer: The role of patient selection 寡转移乳腺癌的治疗:患者选择的作用
IF 5.7 2区 医学
Breast Pub Date : 2024-11-14 DOI: 10.1016/j.breast.2024.103839
Riccardo Ray Colciago , Maria Carmen De Santis , Carlotta Giandini , Maria Grazia Carnevale , Serena Di Cosimo
{"title":"Treatment of oligometastatic breast cancer: The role of patient selection","authors":"Riccardo Ray Colciago ,&nbsp;Maria Carmen De Santis ,&nbsp;Carlotta Giandini ,&nbsp;Maria Grazia Carnevale ,&nbsp;Serena Di Cosimo","doi":"10.1016/j.breast.2024.103839","DOIUrl":"10.1016/j.breast.2024.103839","url":null,"abstract":"<div><div>Up to 90 % of death from solid tumors are caused by metastases. By 2040, breast cancer (BC) is predicted to increase to over 3 million new cases. Additionally, with the personalization and intensification of BC follow-up, many patients will relapse with oligometastatic disease (OMD). Over the past decades, advances in treatment planning, image guidance, target position reproducibility, and online tracking, along with a compelling radiobiological rationale, have led to the implementation of Stereotactic Body Radiation Therapy (SBRT). This has become a valid ablative treatment option for OMD patients.</div><div>However, there are still concerns about which patients benefit the most from ablative treatment. In this review, we will analyze the literature regarding SBRT for OMD in BC patients. We aim to present the current data on its effectiveness and define the optimal tailored scenarios for SBRT outcomes.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103839"},"PeriodicalIF":5.7,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Targeted therapeutic strategies for Nectin-4 in breast cancer: Recent advances and future prospects 乳腺癌 Nectin-4 靶向治疗策略:最新进展与未来展望。
IF 5.7 2区 医学
Breast Pub Date : 2024-11-14 DOI: 10.1016/j.breast.2024.103838
Yufei Wang , Guangliang Li , Hanying Wang , Quan Qi , Xian Wang , Haiqi Lu
{"title":"Targeted therapeutic strategies for Nectin-4 in breast cancer: Recent advances and future prospects","authors":"Yufei Wang ,&nbsp;Guangliang Li ,&nbsp;Hanying Wang ,&nbsp;Quan Qi ,&nbsp;Xian Wang ,&nbsp;Haiqi Lu","doi":"10.1016/j.breast.2024.103838","DOIUrl":"10.1016/j.breast.2024.103838","url":null,"abstract":"<div><div>Nectin-4 is a cell adhesion molecule which has gained more and more attention as a therapeutic target in cancer recently. Overexpression of Nectin-4 has been observed in various tumors, including breast cancer, and is associated with tumor progression. Enfortumab vedotin(EV)is an antibody-drug conjugate (ADC) targeting Nectin-4, which has been approved by FDA for the treatment of urothelial carcinoma. Notably, Nectin-4 was also investigated as a target for breast cancer in preclinical and clinical settings. Nectin-4-targeted approaches, such as ADCs, oncolytic viruses, photothermal therapy and immunotherapy, have shown promising results in early-phase clinical trials. These therapies offer novel strategies for delivering targeted treatments to Nectin-4-expressing cancer cells, enhancing treatment efficacy and minimizing off-target effects. In conclusion, this review aims to provide an overview of the latest advances in understanding the role of Nectin-4 in breast cancer and discuss the future development prospects of Nectin-4 targeted agents.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103838"},"PeriodicalIF":5.7,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Current and future burden of breast cancer in Asia: A GLOBOCAN data analysis for 2022 and 2050 亚洲目前和未来的乳腺癌负担:2022 年和 2050 年 GLOBOCAN 数据分析。
IF 5.7 2区 医学
Breast Pub Date : 2024-11-12 DOI: 10.1016/j.breast.2024.103835
Mengxia Fu , Zhiming Peng , Min Wu , Dapeng Lv , Yanping Li , Shuzhen Lyu
{"title":"Current and future burden of breast cancer in Asia: A GLOBOCAN data analysis for 2022 and 2050","authors":"Mengxia Fu ,&nbsp;Zhiming Peng ,&nbsp;Min Wu ,&nbsp;Dapeng Lv ,&nbsp;Yanping Li ,&nbsp;Shuzhen Lyu","doi":"10.1016/j.breast.2024.103835","DOIUrl":"10.1016/j.breast.2024.103835","url":null,"abstract":"<div><h3>Background</h3><div>Breast cancer remains a significant health concern in Asia. This study seeks to analyze the burden of breast cancer in Asia based on the most recent GLOBOCAN 2022 estimates.</div></div><div><h3>Methods</h3><div>Data were obtained from GLOBOCAN 2022. Age-standardized rates for incidence and mortality per 100,000 person-years were calculated using direct age standardization with the Segi-Doll World standard population. Pearson's correlation coefficient was utilized to evaluate the relationship between human development index and incidence or mortality rate. The future number of breast cancer cases and deaths by 2050 was estimated based on global demographic projections.</div></div><div><h3>Results</h3><div>In 2022, breast cancer accounted for 2296.8 thousand new cases and 666.1 thousand deaths worldwide. In Asia, an estimated 985.4 thousand new cases and 315.1 thousand deaths were reported, corresponding to age-standardized incidence and mortality rates of 34.3 and 10.5 per 100,000, respectively. Both incidence and mortality rates were notably higher among older individuals, especially in countries with high human development index. A positive correlation between human development index and incidence rates was observed, while mortality rates were highest in countries with low human development index. China and India are the leading contributors to both new cases and deaths, with projections indicating that by 2050, around 1.4 million new breast cancer cases and 0.5 million deaths are expected to occur in Asia.</div></div><div><h3>Conclusion</h3><div>Breast cancer is the most common cancer among women in Asia. Global collaboration is essential to reduce its growing burden, especially in low-HDI countries facing rising incidence and high mortality rates.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103835"},"PeriodicalIF":5.7,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Influence of ethnicity on cyclin-dependent kinase inhibitor efficacy and toxicity: A systematic review and meta-analysis 种族对细胞周期蛋白依赖性激酶抑制剂疗效和毒性的影响:系统回顾和荟萃分析。
IF 5.7 2区 医学
Breast Pub Date : 2024-11-04 DOI: 10.1016/j.breast.2024.103833
Roberto Buonaiuto , Aldo Caltavituro , Margherita Tafuro , Alessandra Longobardi , Giuliana Pavone , Pierluigi De Santis , Roberta Caputo , Carmine De Angelis , Lucia Del Mastro , Fabio Puglisi , Mario Giuliano , Grazia Arpino , Martina Pagliuca , Michelino De Laurentiis
{"title":"Influence of ethnicity on cyclin-dependent kinase inhibitor efficacy and toxicity: A systematic review and meta-analysis","authors":"Roberto Buonaiuto ,&nbsp;Aldo Caltavituro ,&nbsp;Margherita Tafuro ,&nbsp;Alessandra Longobardi ,&nbsp;Giuliana Pavone ,&nbsp;Pierluigi De Santis ,&nbsp;Roberta Caputo ,&nbsp;Carmine De Angelis ,&nbsp;Lucia Del Mastro ,&nbsp;Fabio Puglisi ,&nbsp;Mario Giuliano ,&nbsp;Grazia Arpino ,&nbsp;Martina Pagliuca ,&nbsp;Michelino De Laurentiis","doi":"10.1016/j.breast.2024.103833","DOIUrl":"10.1016/j.breast.2024.103833","url":null,"abstract":"<div><h3>Background</h3><div>The combination of cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) with endocrine therapy (ET) is the standard of care for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (aBC). While the efficacy and safety profiles of CDK4/6i and ET have been extensively evaluated in phase II and III trials worldwide, it remains unclear whether the response to CDK4/6i and toxicity profile vary among Asian and non-Asian patients. Therefore, we aimed to assess the treatment efficacy of ET with and without CDK4/6i by comparing outcomes in Asian and non-Asian subgroups included in these clinical trials. In addition, we evaluated the toxicity profiles of the treatments by estimating the risk of treatment-related adverse events (AEs).</div></div><div><h3>Methods</h3><div>We conducted a meta-analysis including the most recent randomized trial data systematically searched from PubMed, Embase, Web of Science, Cochrane CENTRAL (from inception to May 31st, 2024) or presented in abstracts or oral presentations at the ESMO, ASCO, and SABCS international congresses. We included studies comparing CDK4/6i (palbociclib, ribociclib, abemaciclib, dalpiciclib) + ET versus placebo + ET. Progression-free survival (PFS) and overall survival (OS), hazard ratios (HR), and 95 % confidence intervals (CI) were extracted for the two subgroups of interest. To evaluate the treatment-related toxicity profiles, we extracted the number of side effects to estimate the risk of treatment-emergent AEs.</div></div><div><h3>Results</h3><div>Eleven studies (n = 5129) were included in this meta-analysis. The addition of CDK4/6i to ET consistently improved PFS in both Asian (HR = 0.52, 95 % CI 0.47–0.60; p &lt; 0.001) and non-Asian (HR = 0.58, 95 % CI 0.52–0.64; p &lt; 0.001) groups. Similarly, the combination of CDK4/6i + ET led to an OS improvement in both Asian (HR = 0.75, 95 % CI 0.62–0.91; p = 0.003) and non-Asian (HR = 0.81, 95 % CI 0.73–0.89; p &lt; 0.001) patients. The risk of treatment related toxicity was higher in the CDK4/6i + ET arm in both Asian and non-Asian groups. Interestingly, a numerically higher rate of treatment-related hematological toxicity was observed in Asian patients, although no significant interethnic difference was found in the relative risk of these events.</div></div><div><h3>Conclusions</h3><div>The combination of CDK4/6i and ET significantly improves PFS and OS compared to ET alone in both Asian and non-Asian patients with HR+/HER2-aBC. Although the magnitude of benefit appears to be independent of ethnicity, future clinical trials should devise a standardized method for stratifying patients by ethnicity to more effectively assess potential differences in treatment benefits.</div></div><div><h3>Systematic review registration</h3><div>PROSPERO registration number: CRD42024543217.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103833"},"PeriodicalIF":5.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142695330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Olaparib monotherapy in advanced triple-negative breast cancer patients with homologous recombination deficiency and without germline mutations in BRCA1/2: The NOBROLA phase 2 study 奥拉帕利单药治疗同源重组缺陷且无 BRCA1/2 基因突变的晚期三阴性乳腺癌患者:NOBROLA 2 期研究。
IF 5.7 2区 医学
Breast Pub Date : 2024-11-03 DOI: 10.1016/j.breast.2024.103834
Alfonso Cortés , Elena López-Miranda , Adela Fernández-Ortega , Vicente Carañana , Sonia Servitja , Ander Urruticoechea , Laura Lema-Roso , Antonia Márquez , Alexandros Lazaris , Daniel Alcalá-López , Leonardo Mina , Petra Gener , Jose Rodríguez-Morató , Gabriele Antonarelli , Antonio Llombart-Cussac , José Pérez-García , Javier Cortés
{"title":"Olaparib monotherapy in advanced triple-negative breast cancer patients with homologous recombination deficiency and without germline mutations in BRCA1/2: The NOBROLA phase 2 study","authors":"Alfonso Cortés ,&nbsp;Elena López-Miranda ,&nbsp;Adela Fernández-Ortega ,&nbsp;Vicente Carañana ,&nbsp;Sonia Servitja ,&nbsp;Ander Urruticoechea ,&nbsp;Laura Lema-Roso ,&nbsp;Antonia Márquez ,&nbsp;Alexandros Lazaris ,&nbsp;Daniel Alcalá-López ,&nbsp;Leonardo Mina ,&nbsp;Petra Gener ,&nbsp;Jose Rodríguez-Morató ,&nbsp;Gabriele Antonarelli ,&nbsp;Antonio Llombart-Cussac ,&nbsp;José Pérez-García ,&nbsp;Javier Cortés","doi":"10.1016/j.breast.2024.103834","DOIUrl":"10.1016/j.breast.2024.103834","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline <em>BRCA1/2</em> mutations (g<em>BRCA1/2</em>mut).</div></div><div><h3>Methods</h3><div>NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without <em>gBRCA1/2mut</em> and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1.</div></div><div><h3>Results</h3><div>Six of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8–88.2).</div></div><div><h3>Conclusions</h3><div>The observed results could prompt further investigation.</div></div><div><h3>Trial</h3><div>ClinicalTrials.gov identifier NCT03367689.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"78 ","pages":"Article 103834"},"PeriodicalIF":5.7,"publicationDate":"2024-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preoperative reference values for breast cancer patients using the BREAST-Q 使用 BREAST-Q 为乳腺癌患者提供术前参考值
IF 5.7 2区 医学
Breast Pub Date : 2024-10-31 DOI: 10.1016/j.breast.2024.103832
Charlotta Kuhlefelt , Jussi P. Repo , Veera Rasi , Tuomo Meretoja , Tiina Jahkola , Susanna Kauhanen , Pauliina Homsy
{"title":"Preoperative reference values for breast cancer patients using the BREAST-Q","authors":"Charlotta Kuhlefelt ,&nbsp;Jussi P. Repo ,&nbsp;Veera Rasi ,&nbsp;Tuomo Meretoja ,&nbsp;Tiina Jahkola ,&nbsp;Susanna Kauhanen ,&nbsp;Pauliina Homsy","doi":"10.1016/j.breast.2024.103832","DOIUrl":"10.1016/j.breast.2024.103832","url":null,"abstract":"<div><h3>Introduction</h3><div>The BREAST-Q can be used to evaluate the health-related quality of life (HRQL) of breast cancer patients. Data interpretation is limited by the lack of previous reference values based solely on patients with a recent breast cancer diagnosis.</div></div><div><h3>Methods</h3><div>A total of 627 patients, all with newly diagnosed breast cancer, were asked to participate in the study. The BREAST-Q modules for mastectomy and breast-conserving surgery were used. The results for the scales were reported as mean with standard deviation (SD). The effect of patient characteristics, including age, body mass index (BMI), and ASA-classification on the HRQL were analyzed with multiple linear regression.</div></div><div><h3>Results</h3><div>In total, 315 patients (50.2 %) participated. The mean (SD) age was 60.3 (10.1) years. Mean scores (SD) were the following: Psychosocial Well-being 70.8 (15.0), Sexual Well-being 58.2 (15.1), Satisfaction with Breasts 59.9 (15.6), and Physical Well-being: Chest 81.7 (15.7). The psychosocial well-being, sexual well-being, and satisfaction with breasts were all similar compared to the normative mean scores of the scales. The physical well-being of the chest was lower than the normative mean value (p &lt; 0.001). Psychosocial well-being (p = 0.007), sexual well-being (p = 0.007), and satisfaction with breasts (p &lt; 0.001) were lower in patients with higher BMI. Younger patients reported lower physical well-being of the chest (p &lt; 0.001).</div></div><div><h3>Conclusions</h3><div>This study established preoperative reference values for the BREAST-Q in breast cancer patients. This data can be used to evaluate the HRQL in breast cancer patients accurately.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"78 ","pages":"Article 103832"},"PeriodicalIF":5.7,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142578477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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