Oncology and Therapy最新文献

{"title":"The Utilization of Specialist Palliative Care and Other Health Care Services at the End of Life Among Patients with Head and Neck Cancer: A Nationwide Cohort Study.","authors":"Martti Merikari, Outi Akrén, Mikko Nuutinen, Antti Mäkitie, Tiina Saarto, Timo Carpén","doi":"10.1007/s40487-025-00335-5","DOIUrl":"10.1007/s40487-025-00335-5","url":null,"abstract":"<p><strong>Introduction: </strong>The end of life of patients with head and neck cancer (HNC) is plagued by significant morbidity and high symptom burden, emphasizing the need for palliative care. Our aim was to evaluate the utilization of health care services, including specialist palliative care (SPC), among patients with HNC at the end of life. In addition, we wanted to explore the timing of SPC contact on the utilization of health care services at the end of life.</p><p><strong>Methods: </strong>The study population consisted of all 281 patients who died of HNC in 2019 in Finland. Data were collected from nationwide registries. Patients were divided into two groups according to the timing of their first contact with an SPC unit: early (> 30 days before death), and late/no (≤ 30 days before death or no contact).</p><p><strong>Results: </strong>Mean age at death was 72 years, and 66% were male. The hospital was the most common place of death (82%). Ninety-three (33%) patients had contact with an SPC unit, and the median time of the first SPC contact was 62 days before death. Comparing those with early and late/no SPC contact, the early group was significantly associated with lower secondary health care hospitalization (31% vs. 53%; p = 0.002) and emergency care utilization (33% vs. 52%; p = 0.006) during the last month of life. The early SPC group was also associated with higher utilization of home care (52% vs. 36%; p = 0.021), SPC outpatient clinic (24% vs. 5%; p < 0.001), SPC ward (22% vs. 4%; p < 0.001), and palliative hospital-at-home services (45% vs. 5%; p < 0.001) during the last month of life. Among patients with the early SPC contact, SPC ward was significantly more likely to be the place of death (18% vs. 4%, p < 0.001) compared with patients with late/no SPC contact.</p><p><strong>Conclusion: </strong>Patients with HNC utilize health care services at high rates at the end of life. Early SPC contact is associated with increased SPC service use and decreased utilization of secondary health care and emergency care, highlighting the need for early and greater access to SPC services for patients with HNC.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"397-408"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143796256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Experience with Venetoclax Treatment for Newly-Diagnosed Acute Myeloid Leukemia in Japan (VENUS Study): An Interim Analysis Focusing on Neutropenia Management.","authors":"Tatsunori Goto, Hiroki Numata, Yuna Katsuoka, Nobuhiko Uoshima, Satoru Hara, Jun Ando, Shuichi Ota, Goichi Yoshimoto, Akihito Matsuoka, Hideyuki Hashiba, Tetsuo Morita, Atsuko Tsutsui, Ryota Imanaka","doi":"10.1007/s40487-025-00329-3","DOIUrl":"10.1007/s40487-025-00329-3","url":null,"abstract":"<p><strong>Introduction: </strong>Venetoclax has demonstrated clinical benefit for newly-diagnosed acute myeloid leukemia (AML), but significant neutropenia is a concern. Data on the time course of neutrophil counts for across treatment cycles in real-world settings remain limited. We report an interim analysis of the VENUS study, which examined neutropenia management in patients with AML receiving venetoclax with azacitidine (VEN/AZA) in Japan.</p><p><strong>Methods: </strong>This multicenter (10 sites), retrospective, observational study included adults with newly-diagnosed AML ineligible for intensive chemotherapy and initiating venetoclax treatment. Treatment patterns, granulocyte colony-stimulating factor (G-CSF) use, antifungal prophylaxis, and time course of neutrophil counts were analyzed for patients who received > 1 cycle of venetoclax.</p><p><strong>Results: </strong>Venetoclax was administered for a median 27.0 days in Cycle 1 and then a median 21.0 (range 14.0-22.0) days for subsequent cycles, with median dose holds at the end of each cycle of 8.5-15.0 days. Patients (n = 81) receiving G-CSF were treated with VEN/AZA for a median of 6.0 cycles versus 3.0 in those who did not receive G-CSF (n = 39). In Cycle 1, median neutrophil counts decreased to < 500/µl during Days 8-28 but recovered to > 500/µl by Days 29-35. Median nadir neutrophil count was reached during Days 22-28 in almost all subsequent cycles until Cycle 10. Neutrophil counts decreased to < 500/µl in some cycles but improved to > 500/µl by the next week, suggesting neutrophil levels without higher risk of infection in most patients after Cycle 2 with venetoclax dosing schedule modifications and G-CSF administration. Eighty-eight (73.3%) patients received antifungal prophylaxis, but risk-based antifungal prophylaxis may be considered.</p><p><strong>Conclusion: </strong>This real-world analysis provides insight into the timing of neutrophil count recovery with dosing schedule modification of venetoclax and G-CSF use in patients with newly-diagnosed AML receiving VEN/AZA, informing timing of the use of antifungal prophylaxis for patients at higher risk.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"519-527"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130398/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective Cohort Study of Trastuzumab Biosimilar CT-P6 in HER2-Positive Gastric Cancer: Japanese Real-World Outcomes.","authors":"Hiroya Taniguchi, Kiyohiro Nishikawa, Tatsuo Haneji, Naoki Izawa, Hiroshi Imamura, Hironori Yamaguchi","doi":"10.1007/s40487-025-00341-7","DOIUrl":"10.1007/s40487-025-00341-7","url":null,"abstract":"<p><strong>Introduction: </strong>CT-P6, the first trastuzumab biosimilar, was approved on the basis of data limited to human epidermal growth factor receptor-2 (HER2)-positive early breast cancer. Usage for other indications was granted by extrapolation, and post-approval clinical studies were conducted to confirm the effect of CT-P6 in HER2-positive gastric cancer.</p><p><strong>Methods: </strong>After approval in Japan in 2018, a prospective post-marketing surveillance was conducted in 171 patients (130 male, 41 female) with HER2-positive unresectable advanced or recurrent gastric cancer. The safety and efficacy of CT-P6 were evaluated over 1 year.</p><p><strong>Results: </strong>CT-P6 was primarily combined with fluoropyrimidine and/or platinum agents. Adverse events occurred in 151 patients (88.3%), with 55 patients (32.2%) experiencing grade 3 or higher. Infusion reactions occurred in 12.3%. Four cardiac disorders were reported: two of grade 1 cardiac dysfunction and two of severe ischemic heart disease. Interstitial lung disease was reported in four patients (2.3%). The objective response rate was 34.4%, and the disease control rate was 82.4%. The progression-free survival (PFS) was 7.4 months. Significant risk factors for PFS included gastroesophageal junction, ≥ 3 metastases, no gastrectomy, prior chemotherapy, and no platinum agent.</p><p><strong>Conclusions: </strong>In this cohort study, CT-P6 demonstrated sufficient efficacy and no new safety concerns in HER2-positive advanced gastric cancer, serving as a cost-effective alternative to originator trastuzumab.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials, Trial ID: jRCT2071230094 (November 2023).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"485-503"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130418/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Shared Decision-Making for Advanced Renal Cell Carcinoma: Focus on Adverse Event Management of Axitinib Plus IO: A Vodcast.","authors":"Edwin M Posadas, Nancy Moldawer, Greg Biddulph, Dharanija Rao","doi":"10.1007/s40487-025-00330-w","DOIUrl":"10.1007/s40487-025-00330-w","url":null,"abstract":"<p><p>Shared decision-making is essential to the care of patients with advanced renal carcinoma which can empower patients and help the healthcare team understand the patient's goals of care. An important topic during the shared-decision making process is identification and management of treatment-related adverse events. A patient author and two healthcare professionals with real-world experience provide insight into the importance of shared decision-making and its utility in the management of treatment-related adverse events in patients with renal cell carcinoma who are receiving axitinib in combination with an immunotherapy agent.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"263-274"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Increasing Awareness of Soft-Tissue Sarcoma: Podcast of a Patient-HCP Discussion.","authors":"Gillian Faskin, Sam Hackett","doi":"10.1007/s40487-025-00342-6","DOIUrl":"10.1007/s40487-025-00342-6","url":null,"abstract":"<p><p>Soft-tissue sarcoma is a rare cancer, making up less than 1% of new cancer diagnoses. They comprise tumours of the connective tissue, and as such can arise in any part of the body and can mimic other conditions. In addition, there are over 80 subtypes of sarcoma which, combined with the fact that most general practitioners may only see one case of sarcoma in their working lifetime, makes them difficult to diagnose. Sarcoma UK's national sarcoma survey (2020) showed that 23% of patients started their treatment for an incorrect diagnosis before receiving their correct sarcoma diagnosis. Given the rarity of sarcoma, it is critical that patients are seen by a specialised sarcoma service as soon as possible so that all appropriate treatment pathways can be made available. However, 13% of patients never get to see a specialist multidisciplinary team. It is clear that many challenges remain in identifying patients with sarcoma and ensuring that they receive the best care possible. In this podcast a patient with sarcoma and a specialist sarcoma nurse discuss the patient's journey from initial diagnosis through to treatment and recovery. They will also discuss the physiological, emotional and mental impact that sarcoma had, as well as the critical role of the cancer nurse specialist within the treatment plan, alongside a patient support group. Listeners to the podcast will gain a better understanding of the challenges in diagnosing soft-tissue sarcoma, the tools that are already available to assist physicians in diagnosis, and the importance of providing patients with clear information throughout the treatment journey. Podcast Audio (MP4 804666 KB).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"293-305"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12129877/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144014645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding Patients' Experiences in Newly Diagnosed Adult B Cell Acute Lymphoblastic Leukemia: Qualitative Interviews to Develop a Patient-Centric Conceptual Model.","authors":"Michael Chladek, Maria Virginia Meza, Jessie Wang, Maria Sae-Hau, Ana Buenfil, James Turnbull, Faraz Zaman, Nicolas Despiegel","doi":"10.1007/s40487-025-00336-4","DOIUrl":"10.1007/s40487-025-00336-4","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment outcomes for older adults with B cell acute lymphoblastic leukemia (B cell ALL) are poor, partially because of poor tolerance to intense chemotherapy. Information on patient experience-an important consideration in drug development-is lacking. We investigated the signs, symptoms, and impacts of B cell ALL on older patients (or those with comorbidities that may reduce chemotherapy tolerance).</p><p><strong>Methods: </strong>This observational study involved teleconference-based, qualitative, semi-structured interviews with patients newly diagnosed with B cell ALL, aged ≥ 55 years, or 30-54 years with ≥ 1 comorbidity. Participants described their B cell ALL experience, including signs, symptoms, and impacts, and how bothersome/disturbing these were from 0 (not at all) to 10 (greatly) at three timepoints (around diagnosis, at worst, and at interview). Salient signs/symptoms were those reported by ≥ 40%, with average disturbance ratings of ≥ 4. A conceptual model of key disease- and treatment-related signs, symptoms, and impacts was developed.</p><p><strong>Results: </strong>Interviews with 20 participants (mean age 57.9 years; 80% diagnosed within 18 months) revealed 63 signs/symptoms and 37 impacts. All reported fatigue-related symptoms, and most reported gastrointestinal (n = 18, 90%), central/peripheral nervous system (n = 16, 80%), and pain-, respiratory-, blood-, and mouth-related (all n = 14, 70%) symptoms. Eight signs/symptoms were salient around diagnosis (fatigue, tiredness, weakness, exhaustion, shortness of breath, sweating, general pain, and diarrhea) and 16 were salient \"at worst\"; four remained salient at interview (all fatigue-related). All participants reported emotional impacts, and most reported physical and social impacts (both n = 16, 80%). The most frequent impact was inability to do previous hobbies/activities (n = 15, 75%), followed by decreased ability for activities of daily living and worry/fear/nervousness (both n = 12, 60%).</p><p><strong>Conclusion: </strong>This study provides insight into patients' experience with newly diagnosed B cell ALL among older patients or those with clinically significant comorbidities. This enhances understanding of what matters most to patients and informs future treatment development and clinical care.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"409-428"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144029113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Promising Drugs Targeting Specific Mechanisms of Deregulation in T Cell Lineage Acute Lymphoblastic Leukemia.","authors":"Xavier Thomas","doi":"10.1007/s40487-025-00339-1","DOIUrl":"10.1007/s40487-025-00339-1","url":null,"abstract":"<p><p>T cell acute lymphoblastic leukemia (T-ALL) is a class of hematological malignancies predominantly affecting children, adolescents, and young adults, marked by aggressive behavior and poor clinical response, especially in relapsing cases. Advances in molecular biology for the last decade have led to the identification of potential targetable alterations, which should lead to the development of new therapies. T oncogenesis involves not only overexpression of some oncogenes, but also deregulation of some signaling pathways, epigenetic mechanisms, and apoptosis. The present review presents the promising therapeutic agents targeting these specific alterations involved in the development of T-ALL.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"325-338"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144057378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oncological Management of Adrenocortical Carcinoma: An Update and Critical Review.","authors":"Nicholas P Rowell","doi":"10.1007/s40487-025-00327-5","DOIUrl":"10.1007/s40487-025-00327-5","url":null,"abstract":"<p><p>Adrenocortical carcinoma is a very rare cancer that commonly presents with hormonal abnormalities or, more rarely, as an incidental finding of an adrenal mass. Following optimal surgical management, ideally in the form of open adrenalectomy, meta-analyses show that adjuvant mitotane significantly increases recurrence-free and overall survival (HR 0.62 and 0.69 respectively) and tumour bed radiotherapy reduces locoregional recurrence and overall survival for higher risk cancers by at least 40-50%. Those with recurrent or metastatic cancers can be considered for the combination of etoposide, doxorubicin, cisplatin and mitotane (EDP-M) on the basis of results of a single randomised trial. There are significant pharmacological interactions within this regime that have yet to be satisfactorily addressed. Patients of borderline performance status may be treated with various modifications of this regime. More recent approaches with immune checkpoint inhibitors (ICI) and targeted therapy (TT), either alone or in combination, show some promise, but progression-free survival for the majority of regimes does not exceed 6 months. Cabozantinib or lenvatinib alone or in combination, show the greatest promise with disease control rates of 50% or greater, and progression-free survival in excess of 6 months. Studies combining ICIs and TT as a means of overcoming the immunosuppressive environment are ongoing. There are several ongoing clinical trials in this area although only a small proportion of patients may be able to access these. Local therapies with radiotherapy, thermal ablation or arterial embolisation may be helpful for selected patients, particularly those with oligometastatic disease or those with symptomatic metastases.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"307-323"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143442367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A US Survey Across Seven Early-Stage Cancers Assessing the Humanistic Burden of Recurrence on Patients and Caregivers.","authors":"Raquel Aguiar-Ibáñez, Kelly McQuarrie, Ana Martinez, Hannah Penton, Laura DiGiovanni, Rutika Raina, Marieke Heisen, Sayeli Jayade","doi":"10.1007/s40487-025-00328-4","DOIUrl":"10.1007/s40487-025-00328-4","url":null,"abstract":"<p><strong>Introduction: </strong>Patients diagnosed with an early-stage cancer are at risk of recurrence. Although the economic burden of a cancer recurrence is described in the literature, little is known about the humanistic burden of an early-stage cancer recurrence. Therefore, we surveyed patients and caregivers to understand the impact of a first cancer recurrence on patient and caregiver quality of life (QoL).</p><p><strong>Methods: </strong>Patients with early-stage bladder, gastric, head and neck (HN), melanoma, non-small cell lung, renal cell, and triple-negative breast cancers (TNBC) that recurred and caregivers of such patients completed a self-administered, online survey exploring QoL impacts. QoL was evaluated using de novo questions and the following instruments: EQ-5D-5L (patients and caregivers), European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (patients only), and CareGiver Oncology Quality of Life questionnaire (caregivers only). Patient and caregiver responses and scores were stratified by type of cancer and type of recurrence (locoregional or distant/metastatic).</p><p><strong>Results: </strong>Among patients (N = 202), QoL was found to differ significantly across tumor types at time of survey, with lower scores seen in patients with renal cell carcinoma, gastric cancer, and HN cancer and higher scores seen in patients with melanoma and TNBC. Among caregivers (N = 100), QoL did not differ across tumor types. In both patients and caregivers, decreases in QoL were observed from pre-recurrence to post-recurrence, with greater worsening in QoL seen with distant/metastatic versus locoregional recurrences. Most patients reported worrying and feeling anxious and stressed about their condition. Most caregivers reported worrying about the cared-for person's cancer getting worse or coming back and that caring for the person was challenging post-recurrence.</p><p><strong>Conclusion: </strong>Our findings demonstrate the importance of preventing recurrences and their negative impact on patients' and caregivers' QoL. Early-stage cancer treatments that prevent recurrences can provide better QoL.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"339-361"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143711498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oncotype DX Recurrence Score and Germline BRCA Variants in Patients with HR-Positive/HER2-Negative Early Breast Cancer: A Retrospective Observational Study.","authors":"Stefania Morganti, Rabia A Khan, Luis C Berrocal-Almanza, Miguel Miranda, Linlin Luo, Xiaoqing Xu, Ann H Partridge, Filipa Lynce","doi":"10.1007/s40487-025-00332-8","DOIUrl":"10.1007/s40487-025-00332-8","url":null,"abstract":"<p><strong>Introduction: </strong>The Oncotype DX (ODX) recurrence score (RS) is prognostic and predictive of chemotherapy benefit in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Data on the distribution of germline BRCA1 and/or BRCA2 pathogenic variants (gBRCA PV) by RS are limited. This retrospective, real-world study explored demographics, clinical characteristics, gBRCA testing rates, and gBRCA PV prevalence in HR-positive/HER2-negative stage I-III breast cancer, stratified by RS.</p><p><strong>Methods: </strong>Deidentified patient data (from 1 January 2011 to 30 September 2022) from US electronic health records in a nationwide database were used. Patients aged ≥ 18 years with HR-positive/HER2-negative breast cancer and a known ODX RS were included. Demographics, clinical characteristics, and genetic testing rates were compared in patients with low, intermediate, and high tumor RS. gBRCA PV prevalence was compared across categories in patients who underwent genetic testing.</p><p><strong>Results: </strong>Of 3637 patients (median age: 62 years), 950 (26.1%) had low, 2155 (59.3%) had intermediate, and 532 (14.6%) had high tumor RS. Despite increases in genetic testing over time, gBRCA status was determined in only 31.5% (n = 1147/3637) of patients. Among tested patients, 37/1147 (3.2%) had gBRCA PV; median age was lower in gBRCA PV carriers than in noncarriers (52 versus 56 years; p = 0.034); tumors from gBRCA PV carriers had significantly higher grade (p = 0.002) and median RS (p = 0.001) than tumors from noncarriers; prevalence of gBRCA PV was highest among tested patients with high tumor RS (n = 14/185; 7.6%), but gBRCA PVs were identified among patients with intermediate (n = 19/674; 2.8%) and low (n = 4/288; 1.4%) tumor RS.</p><p><strong>Conclusions: </strong>Prevalence of gBRCA PV was highest among patients with high tumor RS, but not negligible in patients with intermediate and low tumor RS. Wider implementation of genetic testing, irrespective of ODX RS, could help optimize the management of patients with HR-positive/HER2-negative early breast cancer.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"363-379"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144041199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}