tbuckley/cabot-search huggingface dataset:
Effects of preoperative breast MRI on surgical management in women aged 40 years and younger with breast cancer.
Authors: Tugce Erguven, Ayah Arafat, Rachel Brem
Journal: Journal of Clinical Oncology (2024)

e13656 Background: Evaluating the use of preoperative breast MRI on the management of breast cancer can help guide surgical decision making for young female patients newly diagnosed with breast cancer. Methods: A retrospective chart review of the George Washington University database between January 2015 and December 2020 identified 125 women age 40 or younger diagnosed with breast cancer. Of the 125 women, 23 were excluded from the study as they were lost to follow up due to care transfers. The management impact of pre-operative MRI was examined and variables collected include age, race, family history, genetic predisposition, breast density, method of detection, initial imaging findings, initial biopsy results, preoperative MRI findings, additional biopsies, additional biopsy results, and surgery type. Results: Patient ages ranged from 22 to 40 (mean 34.5), 69 (67.6%) had a family history of breast cancer, 81 (79.4%) had dense breasts (30 extremely dense and 51 heterogeneously dense), and 82 (80.4%) had the cancer detected due to clinical symptoms with the remaining during surveillance due to high risk. Of all women included, 55 (53.9%) had additional findings on MRI warranting biopsy of which 25 (45.5%) were biopsy proven cancer. 39 (39.4%) patients had lumpectomy and 59 (59.6%) had mastectomy. 1 (0.01%) patient did not undergo surgery due to widespread metastasis. The use of preoperative MRI identified additional carcinoma in 25 (24.5%) out of 102 patients. 24 (96%) in the ipsilateral breast, and 1 (4%) in the contralateral breast. Conclusions: Overall, this data indicates that the use of preoperative MRI for the treatment of breast cancer in young patients increases the detection of occult breast cancer prior to definitive therapy in 24.5% of patients, critically important information for optimal management. We recommend that all young women with newly diagnosed breast cancer undergo pre-operative MRI to further optimize patient care.
H3B-6545 + palbociclib in patients (pts) with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (–) breast cancer (BC).
Authors: Stephen R. D. Johnston, Timothy J. Pluard, Judy S. Wang, Erika P. Hamilton, Tingting Song, Yuanxin Rong, Kohei Yamaguchi, Dejan Juric
Journal: Journal of Clinical Oncology (2024)

1051 Background: H3B-6545 — a novel selective ER covalent antagonist (SERCA) that potently inactivates wild-type and mutant ERα — has shown preliminary antitumor activity and tolerable safety in pts with advanced/metastatic, ER+, HER2– BC. Palbociclib (palbo), an oral CDK4/6 inhibitor, has shown activity in metastatic disease when combined with endocrine therapy. The dose escalation part of this open-label, multicenter, phase 1b study of H3B-6545 + palbo in pts with ER+, HER2– BC aimed to identify the recommended phase 2 dose (RP2D) of H3B-6545 + palbo and characterize safety and efficacy. Methods: Females aged ≥18 years with ER+, HER2–, locally advanced/recurrent/metastatic BC, ECOG PS 0–1, and progression on/after standard therapy were eligible. In the dose escalation phase, pts had to have received ≥2 prior hormonal therapies. Palbo was to be escalated no higher than 125 mg orally QD (days 1–21) and H3B-6545 no higher than 450 mg orally QD (days 1–28). The MTD was the highest dose at which ≤1 of 6 pts had a dose-limiting toxicity (DLT). The primary endpoint was determination of the MTD and/or RP2D. Secondary endpoints included safety and efficacy (by investigator per RECIST v1.1). Results: At data cutoff (16 Sept 22), 31 pts were treated: Cohort (C) 1: H3B-6545 300 mg + palbo 100 mg (n=7); C2: H3B-6545 300 mg + palbo 125 mg (n=8); C3: H3B-6545 450 mg + palbo 125 mg (n=8); C3b: H3B-6545 450 mg + palbo 100 mg (n=8). 3 DLTs (grade 3/4 neutrophil count decreased [n=2] and grade (G) 3 QTcF prolongation [n=1]) were observed in C3 (5 DLTs were observed at C3b); C2 dose was deemed the MTD. Of all pts, 90.3% had G ≥3 TEAEs, 32.3% had serious TEAEs, and 6.5% had TEAEs leading to drug withdrawal. Sinus bradycardia (67.7% [G ≥3, 0%]) and anemia (54.8% [G ≥3, 19.4%]) were the most frequent TEAEs. QT prolongation and rash occurred in 19.4% [G ≥3, 12.9%] and 16.1% [G ≥3, 9.7%] of pts, respectively. ORR in response evaluable pts was 23.1% (95% CI 9.0–43.6). The Table shows additional results. Conclusions: H3B-6545 300 mg + palbo (100/125 mg) had manageable safety and encouraging preliminary antitumor activity. Further studies are warranted to identify the RP2D. Clinical trial information: NCT04288089 . [Table: see text]
Inflammatory biomarkers and frailty transitions in older adults with cancer: Findings from a national cohort study.
Authors: Weijiao Zhou, Junlan Pu, Youmin Cho
Journal: Journal of Clinical Oncology (2024)

e13772 Background: Approximately 67% of cancer survivors were aged 65 or older in the U.S.; they face a heightened risk of frailty, as both cancer and anti-cancer treatment impose additional stressors on the older adults’ physiological reserves. Inflammatory biomarkers such as serum C-reactive protein (CRP) and Interleukin-6 (IL-6) levels were associated with frailty. However, the role of inflammatory biomarkers on the transitions of frailty states remains unclear. This study aimed to describe transitions between frailty states and death and quantify the predictive effect of inflammatory biomarkers on transitions. Methods: We used data from the National Health and Aging Trends Study (NHATS) from 2017 to 2022. A total of 1,219 older cancer survivors (&gt;67 years) were included. Frailty was assessed annually using the Fried Frailty Phenotype (exhaustion, low physical activity, shrinking, low walking speed, and weakness) to categorize participants as “non-frail,” “pre-frail,” and “frail.” Inflammatory biomarkers were obtained via dried blood spots at baseline (2017). Plasma-equivalent values of CRP and IL-6 were used. Covariates included sex, age category, race, education level, marital status, obesity, and number of comorbidities. We defined four states that included three frailty states (non-frail, pre-frail, and frail) and an absorbing state of death. The multi-state Markov models were performed to capture possible transitions between frailty states and examine the effect of CRP and IL-6 on the five main transitions between states (non-frail to pre-frail, pre-frail to non-frail, pre-frail to frail, frail to pre-frail, frail to death). Results: At baseline, 25.27% were non-frail, 52.34% were pre-frail, and 22.40% were frail. During the follow-up time of 5 years, 1,396 transitions were observed, with 950 (68.05%) progressions (or to death) and 446 (31.95%) reversals. For participants who were non-frail, they were highly likely to develop pre-frailty (transition intensity=0.63). For participants with pre-frailty, progression to frailty was a little more likely than recovery to non-frailty (0.25 vs 0.21). Once entering the frail state, the likelihood of death outweighed that of recovery (0.30 vs 0.28). A higher level of CRP or IL-6 was associated with frailty progression (non-frail to pre-frail and frail to death), while a lower level of CRP or IL-6 was associated with recovery of frailty (pre-frail to non-frail and frail to pre-frail). Conclusions: This study is the first to investigate the longitudinal relationship between inflammatory biomarkers and frailty transitions in older cancer survivors using a nationally representative survey dataset. Our findings outlined potential transitions between frailty states and death, highlighting the role of elevated serum CRP and IL-6 levels on the increased risk of frailty progression and reduced risk of frailty recovery over 5 years.
Effect of a 12-week remote exercising program (ExIOnc) on quality of life and symptoms of older patients with cancer in Brazil.
Authors: Paulo Gustavo Bergerot, Cristiane Decat Bergerot, Jonas Ribeiro Gomes Silva, Marcos V S Franca, Dr. Paulo Sergio Lages, Daniel Vargas Pivato de Almeida, Marcio Almeida Paes, William Hiromi Fuzita, Daniel Sobreira de Oliveira Buso, Andressa Cardoso Azeredo, Cristiano Menezes Fernandes, Joao Nunes Matos Neto, Murilo Buso, Murilo Buso, William Dale, Kathryn Schmitz, Narjust Florez, Enrique Soto Pérez de Celis
Journal: Journal of Clinical Oncology (2024)

1623 Background: Leading organizations, including ASCO, recommend physical activity for patients with cancer. However, numerous barriers hinder patients from maintaining regular physical activity, particularly among older adults, who have lower participation in exercise programs. This study aims to evaluate the effects of a 12-week supervised remote exercise program on the health-related quality of life (HRQOL) of older patients with cancer (aged ≥65) undergoing treatment in Brazil. Methods: This was a single-arm pilot study evaluating a remote physical activity program which combined supervised and remote exercise. Eligible patients were contacted through WhatsApp for the initial assessment and received guidance on weekly exercises. The Vedius platform was employed to demonstrate proper home exercise techniques. The prescribed regimen consisted of 3-5 hours per week (4-6 days a week), encompassing both resistance and aerobic exercise. Outcome measures included overall HRQOL (FACT-G, scale 0-108) and symptom assessment (ESAS). Assessments were conducted at baseline and after 12 weeks. Descriptive statistics were calculated, and linear mixed models were employed to analyze changes from before to after the intervention. Results: Out of 46 approached patients, 41 patients were enrolled, with a median age of 70 years (range 65-88). Of the participants, 56.1% were female, 70.7% were white, and 58.2% were married, with 53.5% holding a college degree. The most common cancer types were breast (26.8%), genitourinary (22.0%), and lung (17.1%), all diagnosed at advanced stages. A significant improvement was observed in overall HRQOL (M T1 =83.2 to M T2 =94.4, P=0.001). Improvements were also seen in the severity of various symptoms, including pain (M T1 =1.6 to M T2 =0.7, P=0.001), fatigue (M T1 =3.8 to M T2 =1.3, P=0.001), nausea (M T1 =0.8 to M T2 =0.2, P=0.01), depression (M T1 =2.6 to M T2 =0.8, P=0.001), anxiety (M T1 =3.2 to M T2 =1.2, P=0.001), drowsiness (M T1 =1.8 to M T2 =0.4, P=0.001), and appetite (M T1 =2.2 to M T2 =0.6, P=0.001). Conclusions: This study demonstrates a positive impact of a 12-week remote physical activity program on HRQOL and symptom management for older patients with cancer, and set the stage for future randomized trials. Despite the challenges posed by cancer treatment, incorporating such programs into patient care could be an effective strategy to enhance overall well-being and mitigate treatment-related symptoms.
Geriatric enrollment patterns in clinical trials at a National Cancer Institute.
Authors: Andre Khazak, Kian Parsa, Evelyn Elias, Bobby Chi-Hung Liaw
Journal: Journal of Clinical Oncology (2024)

e13762 Background: Despite the majority of new cancer diagnoses occurring within the geriatric population, there is a disproportionate rate of clinical trial enrollment within this population. Previous data has estimated enrollment rate to be 18.9% in treatment trials among all adult cancer patients at designated National Cancer Institute Cancer Centers. The objective of this study is to assess geriatric cancer patient clinical trial enrollment rates in a single National Cancer Institute and highlight inequities within cancer care delivery. Methods: We performed a retrospective review of the electronic health record and included patients with cancer ≥ 65 years of age who died at our institution between January 2020 and July 2022. We examined the relationship between cancer type, patient race/ethnic identity, and age and analyzed enrollment in clinical trials. Analyses were conducted using descriptive statistics. Results: Of 117 decedent records analyzed, 11 (9%) were enrolled in treatment clinical trials of which 5 (4.3%) identified as White, 4 (3.4%) Other, and 2 (1.7%) Hispanic. Among the 117 geriatric patient records reviewed, there were 21 Black patients (17.9%) of which 0 (0%) Black patients were enrolled in clinical trials. In comparing enrollment by malignancy type, 5 patients had a hematologic malignancy (leukemia, lymphoma, or multiple myeloma), 3 patients had a genitourinary malignancy, 1 patient had a pancreatic malignancy, 1 patient had an endometrial malignancy, and 1 patient had a breast malignancy. Among all patients analyzed, 37 patients (31.6%) had a hematologic malignancy and 80 patients (68.4%) had a solid tumor malignancy. The average age of enrolled patients was 73, consistent with the average age of all patients analyzed (73.78). Conclusions: Geriatric patients with cancer are disproportionately underrepresented in treatment clinical trials. The inequity is exacerbated when analyzing enrollment among minoritized patients. There was a greater proportion of clinical trial enrollment in patients with hematologic malignancies than solid tumor malignancies, however analysis in larger population samples is necessary. Additional research to identify barriers to clinical trials and methods of increasing geriatric enrollment, including the use of geriatric specific performance scales, is necessary to ensure equitable access and representation in clinical trials. While these results may be skewed in the setting of the COVID-19 pandemic and selection of a decedent population, further research into geriatric accessibility in clinical trials is paramount.
Feasibility of universal breast cancer risk assessment in a diverse, publicly insured obstetrician gynecology clinic.
Authors: Allan Enriquez, Jessica M. Weiss, Isabelle Chandler, Jesse T. Brewer, Emily M. Webster, Muhammad Danyal Ahsan, Ann Wang, Auja McDougale, Ravi N. Sharaf, Melissa Kristen Frey
Journal: Journal of Clinical Oncology (2024)

e13759 Background: Breast cancer is the most diagnosed cancer among women in the United States. Established breast cancer risk assessment (BCRA) tools can estimate a woman’s lifetime risk and inform the need for enhanced breast screening which can improve cancer-associated morbidity and mortality. Currently, critical disparities exist both in breast cancer prognosis and screening uptake. We aimed to evaluate the feasibility of routine BCRA in a diverse, publicly insured obstetrician gynecology clinic. Methods: All patients presenting to the obstetrician gynecology clinic were offered a BCRA using the Tyrer Cuzick (TC) risk model. Patients completed paper surveys and the information was input into the TC model to generate lifetime risk estimates. Printed evidence-based management guidelines were reviewed with and provided to those at ≥ 20% lifetime breast cancer risk and shared with the patient’s provider. Results: Between June 2023 and February 2024, 300 patients were approached and 208 (69.3%) completed the survey. One hundred seven (51.4%) survey respondents were presenting for obstetrical care and 101 (48.6%) for gynecologic care. Respondents had a median age of 33 years (IQR: 12). Ninety-six (46.2%) responding patients self-identified as Hispanic, 45 (21.6%) as Black, 25 (12.0%) as Asian, 28 (13.5%) as Non-Hispanic White, and 14 (6.7%) did not identify in these categories. One hundred eighty-nine (90.9%) survey respondents were publicly-insured. Ten (4.8%) patients were assisted by an interpreter. Overall, 12 (5.8%) patients had an elevated lifetime breast of breast cancer, defined as ≥ 20% based on the TC model (6 (50.0%) among obstetrical patients and 6 (50.0%) among gynecology patients). All patients at elevated risk were referred to a genetics clinic for counseling on options for enhanced breast surveillance. Conclusions: As leaders in women’s cancer care, gynecologic oncologists can lead and support programs to identify those women at highest risk for cancer, especially among historically underserved populations. Our feasibility study demonstrated that 69.3% of patients were willing to complete a BRCA and this tool identified 5.8% of patients to have a significantly elevated lifetime breast cancer risk. Providers should consider incorporating such tools in gynecologic oncology and obstetrical/gynecology clinics.
Multi-cancer early detection (MCED) test performance in cancer survivors.
Authors: Catherine Marinac, Elizabeth O'Donnell, Rita Shaknovich, Christina A. Clarke, Guneet Walia, Karen Chung, Jennifer Farese, Margarita Lopatin, Eric T. Fung, Jeffrey M. Venstrom, Eric A. Klein, Jordan J. Karlitz
Journal: Journal of Clinical Oncology (2024)

1628 Background: Cancer survivors (CS) are at risk for recurrent or new primary tumors in any organ, but there is lack of clear guidance and options for long-term surveillance. We analyzed the performance of a blood-based MCED test that detects cancer-specific methylation patterns and predicts cancer signal origin (CSO) in CS in the PATHFINDER study (PF; NCT04241796). Methods: PF enrolled6662 participants (pts) ≥50 yr without clinical suspicion of cancer; 6578 samples were analyzed with a refined MCED test. Pts were stratified by CS status (treated cancer &gt;3 yr prior to study vs no prior cancer); in CS, prior cancer type and time from diagnosis were recorded. Cancers diagnosed during PF were classified as recurrent or new primaries. Positive predictive value (PPV), number needed to screen (NNTS), and CSO accuracy were assessed. Results: CS comprised 25% (1609/6578) of pts analyzed; 73% were female. Median age was 66 yr; age at prior diagnosis was 8% &lt;40, 22% 40-49, 70% ≥50 yr. Most common prior cancers were breast (749, 47%), melanoma (163, 10%) and prostate (141, 9%). A higher proportion of pts with cancer diagnosis was observed in CS vs those with no prior cancer (Table). Among 20 CS with cancer signal detected, 10 cancers were diagnosed in 9 pts; 5 recurrent (all metastatic breast) and 5 new primaries (uterine stage 1 [found as incidental lesion on imaging during MCED-triggered workup for recurrent breast cancer], sarcoma stage 2, ovarian stage 3, lymphoma and CRC stage 4). During 1-yr follow-up in those with negative MCED result, new cancer diagnoses in CS included 13 recurrences (all local) and 15 new primaries. Of the 13 new primaries with known stage, 46% were stage 1 (2 breast, 1 melanoma, 1 thyroid, 1 lymphoma, 1 lung), 31% stage 2 (2 lymphomas, 1 melanoma, 1 breast), 15% stage 3 (1 pancreas, 1 pleural mesothelioma), and 7% stage 4 (1 prostate). Yield, PPV, NNTS, and CSO accuracy were similar in CS and no prior cancer group. Years between MCED cancer detection and prior cancer in CS was 4-11 for recurrent and 8-15 for new primaries. Most (4/5) new primaries were cancers with no USPSTF-recommended screenings. Conclusions: The MCED test detected both cancer recurrences and new primaries in CS for whom multiple years had elapsed since their original diagnosis, potentially expanding surveillance options for this patient group. Cancers in CS not detected by MCED were predominantly early stage. Test performance was similar in those with and without a cancer history. Clinical trial information: NCT04241796 . [Table: see text]
Rapid survey assessment: Barriers and facilitators to mammogram completion in English and Spanish-speaking patients in a federally qualified health center (FQHC) setting.
Authors: Daniela Anderson, Jamie Ellingwood, Allison Halvorsen, Anne Tarricone, Helen Lam, Nita Karnik Lee
Journal: Journal of Clinical Oncology (2024)

1587 Background: Mammography has decreased breast cancer mortality in the US by 40% since the 1980s; yet disparities in screening and outcomes persist in underserved populations. Many studies note language as a barrier to screening with lower mammogram completion amongst Spanish-speaking patients versus those with English language proficiency. At our health center, Spanish-speaking patients were more likely to complete screening mammography compared to patients with English proficiency (53% vs 31% in 2022). To understand this pattern and barriers and facilitators to breast cancer screening, we conducted a mixed methods rapid assessment survey as part of a quality improvement initiative. Methods: We developed a patient bilingual survey measuring knowledge, attitudes, and behaviors about breast cancer prevention and screening. We identified consecutive female patients (age 40-75 years) and extracted baseline demographic data from the electronic medical record. Surveys were distributed via our health center’s patient messaging service and responses stored on a secure platform. Data analysis included descriptive statistics, chi-squared testing between groups and qualitative analysis to identify common themes from free-text answers. Results: The overall response rate was 14% (N=732/5,332) in 30 days. Of the surveys completed, 37% were in Spanish. Spanish-speaking patients more strongly regarded mammography as safe and effective compared to English-speaking patients (p&lt;0.001). Spanish-speaking patients were more likely to view getting a mammogram as a priority (79% vs 65% p&lt;0.001) and noted speaking about breast cancer prevention in their communities more often (p&lt;0.006) as an important factor. Spanish-speaking patients primarily cited cost, scheduling, and language (p&lt;0.05) as barriers to mammogram completion, while English-speaking patients cited time constraints, transportation, and discomfort (p&lt;0.05) more frequently. Spanish-speaking patients were more likely to prefer speaking with a trusted community member or attending health fairs than English-speaking patients (P&lt;0.05). Conclusions: Our study demonstrates differences in attitudes, behaviors, and perceived barriers to mammography in English vs Spanish-speaking patients. The increased mammogram completion rate in Spanish-speaking patients may reflect more positive attitudes about screening and more discussion in the community amongst Spanish-speaking patients queried. Reported barriers to screening differed and will guide targeted QI interventions. We demonstrated feasibility and patient engagement in a diverse population using a message system built into our EHR in an FQHC setting. This survey study allows us to elevate patient voices, better understand gaps and preferences, and better tailor future interventions for cancer screening.