bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect and acceptability of jasmine compound essential oil for premenopausal breast cancer survivors suffering from genitourinary syndrome of menopause: A prospective interventional study.
Authors: Zou Mo , Li Xiaorui , Sun Tao 
Published: June 2024

1063 Background: Genitourinary syndrome of menopause (GSM) includes dyspareunia, vaginal dryness, vaginal burning, urinary urgency, and recurrent urinary tract infections. Breast cancer survivors (BCSs) exhibit more severe symptoms of GSM than healthy aging women, especially premenopausal BCSs in sexually active lifetime. GSM detrimentally impacts their quality of life and contributes to the premature cessation of endocrine therapy for breast disease. This study aims to explore the efficacy and safety of Jasmine compound essential oil in the treatment of GSM in premenopausal breast cancer women. Methods: Premenopausal sextually-active women with hormone receptor (HR) positive stage I to III BC taking ovarian function suppression (OFS) treatment and endocrine therapy with self-reported vaginal dryness, dyspareunia, or decreased libido were enrolled to the 12 weeks topically applied Jasmine compound essential oil trial. E2 and FSH was measured at baseline and weeks 12. A series of validated sexual quality-of-life questionnaires were completed at baseline, and subsequently at weeks 4, 8, and 12. The primary endpoint is the improvement in sexual pain evaluated based on the Female Sexual Function Index scale (FSFI). Acceptability was measured by patient preference and reported intention to continue using the products. Gynecologic examinations and metagenomic profiling of the vaginal microbiota were conducted at baseline and post-treatment for patients in an exploratory cohort. Results: Overall, 96 BCSs signed consent (mean [range] age, 45 [32-55] years) and 89 completed 12 weeks of treatment. E2 and FSH were maintained within the postmenopausal range without significant fluctuations during the treatment. Topically applied Jasmine compound essential oil resulted in significant improvements in dyspareunia, vaginal dryness, irritation and quality of life over time (all P< 0.001). Both BCSs and their sexual partners reported being satisfied with the essential oil treatment and the adherence rate reached 95% (SD 10). In the 20-patient exploratory cohort, there were improvements in vaginal pH (baseline mean 6.07 compared with 12-week mean 4.68[ P<.001]), and vaginal maturation index (45.3 compared with 52.1[ P<.001]). We also observed a positive influence on the vaginal microbiota after intervention. In patients with elevated baseline abundance of Lactobacillus in the vaginal microbiome, there was a more pronounced improvement in scale scores following essential oil access. Conversely, a high baseline abundance of Escherichia coli may be considered a detrimental factor associated with less benefit from essential oil. Conclusions: Jasmine compound essential oil could relieve vaginal symptoms and improve vaginal health in breast cancer survivors who have experienced menopause after cancer treatment.
Real-world treatment patterns, healthcare resource utilization and costs of care among newly-diagnosed patients with HR+/HER2- metastatic breast cancer.
Authors: Basho Reva K. , Ng Carmen , Dillon Allison , Chen Lu , Cheng Anna , Du Toit Yolande , Abbass Ibrahim M. 
Published: June 2024

1073 Background: Current literature on the treatment patterns and economic burden among newly diagnosed patients (pts) with HR+/HER2- metastatic breast cancer (mBC) is outdated and may not adequately capture the rapidly evolving treatment landscape. This study addresses this gap by providing a contemporary and comprehensive summary of real-world treatment patterns, healthcare resource utilization (HRU) and cost of care among HR+/HER2- mBC pts, through their first 3 lines of treatment (LOT) following metastatic diagnosis (met dx). Methods: We retrospectively identified adult women with newly diagnosed HR+/HER2- mBC between 10/01/2016 - 06/30/2022 from the IQVIA PharMetrics Plus database. Pts were required to have≥ 6 months of follow up post met dx. The study classified pts hierarchically into mutually exclusive treatment categories across 3 LOTs following met dx: endocrine therapy only (ET), CDK4/6 inhibitor-based therapy (CDKi), alpelisib-based therapy (ALP), mTOR inhibitor-based therapy (mTOR), PARP inhibitor (PARPi), or chemotherapy (CT). Categories with < 30 pts in each line or those with overlapping targeted treatments were grouped into “Others'' (OTH). Baseline characteristics were assessed in the 12 months prior to met dx. HRU and costs of care (in 2022 USD) were measured during the follow-up period and reported in per patient per month (PPPM). Results: The study included 2,449 pts, with 64.6%, 10.5%, 22.8%, 2.1% pts receiving CDKi, CT, ET and OTH in 1LOT, respectively. In 2LOT (n=1,164), 41% of pts received CDKi, 24% CT, 20% ET, 9% mTOR, 4% ALP and 3% OTH. In 3LOT (n=479), 44% of pts received CT, 21% CDKi, 15% ET, 9% mTOR, 6% ALP and 4% OTH. The median treatment duration in 1LOT was longest for pts receiving CDKi (23.5 months) compared to 17.1 months for ET. The PPPM total costs were $15,396, $16,955 and $17,853 in 1, 2 and 3LOT. In 1LOT, CDKi pts had the highest PPPM costs [Table]. In the 2/3 LOT, ALP-treated pts incurred the highest costs followed by CDKi in 2LOT and mTOR-treated pts in 3LOT (Table). CT and ALP had the highest ER visits in 2 (0.18 and 0.13) and 3 LOT (0.20 and 0.27). Conclusions: The majority of patients received CDKi treatment as their 1LOT with a more fragmented treatment landscape in the 2/3LOTs. The incorporation of agents targeting the PI3K pathway (ALP and mTOR) remained low in the 2/3LOTs. Costs associated with the same targeted treatment increased when used in later lines of therapy. Early optimization of targeted therapy and a focus on adverse event management may be associated with economic benefits. [Table: see text]
Real world outcomes of sequential ADC therapy in metastatic breast cancer: Patients treated with sacituzumab govitecan and trastuzumab deruxtecan.
Authors: Mai Nicholas , Klar Miriam , Ferraro Emanuela , Bromberg Maria , Chen Yuan , Razavi Pedram , Modi Shanu , Chandarlapaty Sarat , Walsh Elaine M. , Drago Joshua Z. 
Published: June 2024

1085 Background: Sacituzumab govitecan (SG) and trastuzumab deruxtecan (TDXd) are antibody drug conjugates (ADCs) that are approved for the treatment of HER2 low metastatic breast cancer (MBC). Both carry payloads which inhibit topoisomerase 1, and it is unknown whether these ADCs retain clinical activity when used sequentially to each other. Here we present a retrospective study of patients treated with both SG and TDXd at our institution and report real world progression free survival (PFS), clinical factors associated with longer PFS, and whether ADC sequence impacts outcome. Methods: All patients with MBC treated at MSKCC who had received both SG and TDXd (in any order) were eligible for inclusion. Clinicopathological and demographic data were obtained from retrospective chart review. PFS was determined clinically and calculated using Kaplan-Meier survival analysis. Univariate and multivariate associations of survival were assessed using Cox proportional hazards models. Results: Eighty-five patients met eligibility per the criteria above: 54 with estrogen receptor positive (ER+) MBC and 31 with triple negative breast cancer (TNBC). 33 patients received SG followed by TDXd (14 ER+, 19 TNBC), and 52 received TDXd followed by SG (40 ER+, 12 TNBC). Median age at time of second ADC treatment (ADC2) was 59 among all patients, 62 among SG first, and 58 among TDXd first. This cohort was heavily pre-treated, with median 5 prior therapies at the time of first ADC (ADC1) and 7 at the time of ADC2. Both the SG first and TDXd first cohorts had median 1 line of intervening therapy between ADCs. In the SG first group, median ADC2 (TDXd) PFS was 3.5 months (95%CI 2.7-7.7), and in the TDXd first group median ADC2 (SG) was 2.8 months (95%CI 2.6-3.7). On multivariate analysis, neither ADC sequence (SG first vs. TDXd first, HR 1.30, 95%CI 0.71-2.37, p=0.4) nor ER status (TNBC vs. ER+, HR 1.21, 95%CI 0.63-2.32, p=0.6) showed statistically significant differences in ADC2 PFS between these groups. Instead, later treatment line at the time of ADC2 was significantly associated with shorter ADC2 PFS (continuous, HR 1.11, 95%CI 1.01-1.23, p=0.03). To separately evaluate differences in PFS for each ADC depending upon whether it was first or follow-up therapy, median ADC1 vs. ADC2 PFS is summarized by ADC (Table). Conclusions: In this heavily pre-treated patient cohort, the clinical activity of both SG and TDXd appear modest in the ADC2 setting. Further studies are needed to confirm these findings and to determine whether payload cross-resistance may undermine the benefit of sequential ADC therapy. [Table: see text]
Impact of HER2 low status on genomic signatures in triple negative breast cancer (TNBC).
Authors: Taylor Melissa , Reddy Shilpa , Ashok Kumar Prashanth , Hariri Dana , Sokol Ethan , Sivakumar Smruthy , Quintanilha Julia , Pavlick Dean , Levy Mia Alyce , Ross Jeffrey S. , Lustberg Maryam B. 
Published: June 2024

1092 Background: HER2 status has become more important with new treatment regimens subcategorizing HER2 to into low (1+or 2+ FISH-) or absent HER2 expression. Through comprehensive genomic profiling (CGP), we aim to identify distinctive molecular features associated with various immunohistochemistry (IHC) categories of HER2 low tumors. Methods: Retrospective review of pathology specimens submitted to Foundation Medicine were done and 514 TNBC (ER-/PR-/HER20,1+,2+FISH-) and 191 3+/HER2 amplified clinically advanced BC underwent hybrid capture-based CGP to evaluate genomic alterations (GA) in 324 genes, MSI status and tumor mutational burden (TMB, mutations/Mb). PD-L1 expression was determined by IHC (Dako 22C3 TPS). Chi-square test and Mann Whitney U test were used in the statistical comparisons of the 2 groups. Statistical significance was defined as p < 0.05. Results: 53.5% were HER2 IHC 0+, 31.5% were HER2 IHC 1+ and 15.0% were IHC 2+/FISH negative. The HER2 3+/amplified BC were 59% ER+ and 41% ER-. Notable differences in GA frequencies included a significant increase in PIK3CA GA in the HER2 2+ vs the HER 0+ and 1+ groups (p=.0003). A lower frequency in BRCA1 GA in the HER2 2+ (5.2%) vs the HER2 0+ (9.8%) was significant when compared to the 1.0% in the HER2 3+/amplified cases (p<.0001). BRCA2 GA frequencies did not show statistically significant differences among the TNBC HER2 IHC score groups. TP53 and RB1 had the highest frequency in HER2 0+ samples, with decreasing prevalence in the HER2 1+, 2+ and 3+/amplified cases (p<.0001 for both). There was also a trend towards higher frequency of CDH1 GA as the HER2 IHC score increased from 0 to 2+ among TNBC. There were no significant differences in immunotherapy biomarkers (MSI, TMB and PD-L1) based on HER2 status among the TNBC groups. TMB >= 10 mutations/Mb was significantly higher in the HER2 3+/amplified group (p=.004). Conclusions: We found that TNBC HER2 2+ positive FISH show key molecular differences from their HER2 low (1+) or absent (0+) counterparts. The most substantial difference was an increase in GA in PIK3CA. While this is targetable in the hormone positive setting, its potential role as a target in the hormone negative setting is uncertain. Also noted but did not reach significance was a decrease in GA within BRCA1/2 and a positive linear relationship with CDH1 and HER2 IHC expression. These GA differences may indicate potential treatment options for different HER2 subgroups and warrant further investigation. Limitations of our study include the retrospective nature and the lack of clinical data. [Table: see text]
Real-world immune-related adverse events in patients with early triple negative breast cancer who received pembrolizumab.
Authors: Jayan Athira , Sukumar Jasmine S , Fangman Benjamin David , Patel Tejal Amar , Raghavendra Akshara Singareeka , Liu Diane D. , Rauch Ronald , Basen-Engquist Karen , Tripathy Debashish , Barcenas Carlos Hernando 
Published: June 2024

1099 Background: The addition of pembrolizumab to chemotherapy (KEYNOTE-522 regimen) in high risk early triple negative breast cancer (TNBC) has improved clinical outcomes. However, this treatment can result in immune-related adverse events (irAEs) involving any organ and in some cases, life-long toxicities or even death. This retrospective study describes real-world patterns of irAEs in patients (pts) with early TNBC who received pembrolizumab at two academic centers. Methods: We evaluated irAEs in pts with stage II-III TNBC from MD Anderson Cancer Center and Lyndon B Johnson diagnosed between January 2018 and May 2023 who received neoadjuvant pembrolizumab plus chemotherapy. We excluded those enrolled on clinical trials. We utilized ASCO irAE and CTCAE v5 guidelines for toxicity grading. Logistic regression assessed the effect of clinical variables on irAEs, adjusting for covariates. Results: We identified 233 pts with a median age of 51 ± 12 years; 62% with stage II and 35% with stage III TNBC; 25% were Hispanic/Latino, 21% non-Hispanic Black and 42% were non-Hispanic White. In total, 80 pts (34%) developed 100 separate irAEs (94 with definite and 6 with possible/probable attribution). The most common irAEs were endocrine (52%) followed by gastrointestinal (23%). Grade ≥ 3 irAE occurred in 26 instances, with the most common being gastrointestinal (13 instances). A fatal irAE occurred in 2 pts where both were colitis. A total of 26 irAEs resulted in hospitalization, 45 required systemic steroids, and 15 required additional immunosuppressive therapy. Most (66) irAEs were unresolved at last follow up, although the majority had improved to grade 1 (37/66) and 32 patients discontinued pembrolizumab early due to irAEs. No clinical factor (race, stage, tumor grade, age, body mass index) was associated with development of an irAE. Conclusions: In this real-world diverse population, we identified a similar rate and severity of irAEs as reported in the KEYNOTE-522 trial. Hospitalizations occurred in 26% of irAEs while most developed persistent immune toxicity. Gastrointestinal irAEs were more common compared to KEYNOTE-522 reported data. Research is needed to better predict and mitigate the burden of irAEs and to improve the long-term survivorship care of pts with early TNBC pts who receive pembrolizumab. [Table: see text]
A single center retrospective cohort study of patients with metastatic breast cancer and leptomeningeal disease: Updated survival data and subgroup analyses by breast cancer subtype.
Authors: Fisch Samantha Catherine , Tsopurashvili Elene , Somepalle Sai Sahitha , Salans Mia , Vasudevan Harish , Chien Amy Jo , Majure Melanie , Rugo Hope S. , Balassanian Ronald , Boreta Lauren , Melisko Michelle E. , Huppert Laura Ann 
Published: June 2024

1108 Background: Patients (pts) with metastatic breast cancer (MBC) and leptomeningeal disease (LMD) have a poor prognosis with limited therapies. We previously reported data from our retrospective LMD registry; here we provide an update with additional pts and subgroup analyses highlighting differences in treatment and survival by breast cancer subtype. Methods: In this single center retrospective cohort study, we identified pts with MBC and LMD who received care from 2000-2024 and abstracted key clinical, treatment, and overall survival (OS) data. Results: We identified 111 pts with MBC and LMD, including pts with the following subtypes: HR+/HER2- (n=53, 47.7%), HER2+ (n=30, 27.0%), and triple negative breast cancer (TNBC; n=28, 25.2%). The majority of pts had concurrent brain metastasis (n=82, 73.9%). Median time from diagnosis of MBC to LMD was 16.4 months (mo) (range 0-101.3 mo). Pts received a median of 3 lines of therapy prior to the diagnosis of LMD (range 0-10) and 1 line after the diagnosis of LMD (range 0-4). Most pts received central nervous system-directed (CNS)-directed therapy (n=94, 84.7%), including intrathecal (IT) therapy (n=42, 37.8%) and/or CNS radiation (n=70, 63.1%). Median OS from the diagnosis of LMD to death was 4.1 mo (range 0.1-78.1 mo) and varied by subtype, with pts with HR+/HER2- or HER2+ MBC and LMD living longer than those with TNBC and LMD (4.2 and 6.8 mo respectively vs. 2.0 mo, p<0.01, HR 2.15, 95% CI 1.36-3.39). There was no difference in OS by histology ductal vs. lobular or by presence or absence of concurrent parenchymal brain metastases. Pts who received IT therapy survived longer than those who did not (7.1 vs. 2.7 mo, p=0.01, HR 0.60, 95% CI 0.40-0.90). There was difference in OS by receipt of CNS-directed radiation therapy. Pts diagnosed with LMD from 2015-2024 lived longer than those diagnosed from 2000-2014 (6.4 vs. 2.9 mo, p=0.04, HR 0.67, 95% CI 0.46-0.99). On multivariable analysis, having TNBC was associated with shorter OS from time of LMD to death (p=0.004, HR 2.03, 95% CI 1.25-3.30). Conclusions: This study represents one of the largest case series of pts with MBC and LMD, including the most pts diagnosed after 2015 to our knowledge. Pts with lobular histology, HER2+ BC, TNBC, and those with de novo MBC were over-represented compared to the general MBC population. Pts with HR+/HER2- or HER2+ disease, LMD diagnosed after 2015, and those who received IT therapy survived longer than their respective cohorts. Novel diagnostic and therapeutic strategies for pts with MBC and LMD remains an area of unmet clinical need.
Male breast cancer survival in Mexico between 2007 and 2016: A retrospective cohort.
Authors: Contreras Sergio , Verduzco-Aguirre Haydee Cristina , Huerta-Gutierrez Rodrigo , León-Rodriguez Eucario , Lajous Martin 
Published: June 2024

1116 Background: Male breast cancer represents around 1% of all breast cancers worldwide. Due to its rarity, it is more likely to be diagnosed at advanced stages than in women, and survival rates tend to be lower than in female patients. Information about survival in male breast cancer in low- and middle-income countries (LMIC) is scarce. Methods: We conducted a retrospective cohort study cross-linking nationwide reimbursement claims for breast cancer cases between 2007 and 2016 treated within the Seguro Popular health financing scheme to a national mortality registry in Mexico. Age, municipality of residence, clinical stage, and year of treatment initiation were described. Facilities were classified according to location, total breast cancer patient volume, and type of funding. We estimated 5-year overall survival (OS) with 95% confidence intervals (95% CI) through the Kaplan Meier method and used the log-rank test to compare differences between patient groups. Patients with in situ disease and missing data for clinical stage were excluded from survival analyses. Results: We identified 268,703 claims representing 60,846 patients, from which 328 were male (0.53%). Median age was 56 years (IQR 48-67). At treatment initiation, 20.7% of patients had early disease, 46.3% had locally advanced (LA) disease and 15.5% metastatic disease; clinical stage information was missing in 16% of patients Most patients (86.6%) were treated at public facilities, and 40.5% were treated at high volume facilities. With a median follow-up of 4.1 years, five-year OS in the whole cohort was 64.3% (CI 95% 58.1-71.2). In patients with early-stage disease, 5-year OS was 78.7% (95% CI 67.0-92.4), in LA disease 66.3% (95% CI 58.4-75.3) and in metastatic disease 39.7% (95% CI 27.5-57.5) (p <0.001). Patients with LA disease treated at a private facility had improved 5-year OS (88.9%) compared to those who were treated at a public facility (62.8%) (p=0.033). We did not find any other significant differences in survival according to patient or facility characteristics, including patient volume. Conclusions: These results represent the largest cohort to describe survival in men with breast cancer in Latin America. We found a larger proportion of men diagnosed with metastatic disease than described in women in Mexico, and lower than expected survival in patients with early-stage and LA disease.
Patterns and risk factors of immune-related adverse events in a real-world cohort with lung cancer receiving immunotherapy.
Authors: Hu Xiao , Gurinovich Anastasia , Pan Stacey , Salei Yana , Lin Jeffrey , Parsons Susan K. 
Published: June 2024

12130 Background: Immune checkpoint inhibitors (ICIs) have emerged as a core pillar of lung cancer (LC) therapy, but ICIs are commonly associated with a spectrum of immune-related adverse effects (irAEs). The real-world patterns and risk factors of irAEs in LC remain uncertain. Methods: Patients with LC newly started on ICIs between 10/01/2018 and 09/30/2021 were retrospectively collected from the Tufts Medical Center cancer registry and pharmacy records. irAEs occurring within 12 months after initiation of ICIs were identified. Univariable logistic regression was used to assess the risk factors of irAEs. Those with p-value<0.20 were included in multivariable logistic regression analysis (MVA), along with clinically relevant factors. Results: Of 125 LC adult patients (median age: 70 years, 68 males), 104 had non-small cell lung cancer (NSCLC), 123 had advanced stages, and 16 had preexisting autoimmune diseases (ADs). Six patients were treated with dual-agent ICIs. Pembrolizumab was the most often used single agent (67.2%). In total 50 irAEs occurred in 39 patients. The most common irAEs were endocrinopathies (34%), pneumonitis (20%), dermatitis (14%), and gastrointestinal toxicity (14%) with the median onset time of 148, 136, 19, and 68 days, respectively. 70% of irAEs were grade 1 or 2. 44% of irAEs were treated with immunosuppression, 38% were referred to specialist care, and 30% required hospitalizations. 56% of irAEs resolved within 12 months and 67.9 % of those were rechallenged with ICIs. In exploratory univariable analyses among all the patients, age, small cell lung cancer (SCLC), PDL1 positivity (TPS≥1%), concurrent NSAIDs use, and radiation therapy had p< 0.2. In MVA, SCLC remained significantly associated with irAEs (OR=4.14, 95% CI [1.50, 12.09], p=0.007). Among NSCLC subset (N=104), age, PDL1 positivity, concurrent NSAIDs, and acetaminophen use had p<0.2. Age (OR=0.94, 95% CI [0.883, 0.990], p=0.026) and PDL1 positivity (OR=3.17, 95% CI [1.12, 9.87], p=0.036) remained significant in MVA (Table). Conclusions: Our study described the real-world patterns of irAEs in LC patients. SCLC was found to be an independent risk factor of irAEs in our cohort. In NSCLC, younger age and PDL1 positivity were associated with irAEs occurrence. Future studies are required to validate these findings in larger samples. [Table: see text]