tbuckley/cabot-search huggingface dataset:
Evaluation of a self-reported G8 screening tool on Epic MyChart for older patients with cancer.
Authors: Kuang-Yi Wen, Kristine Swartz, Tingting Zhan, Amy R. MacKenzie, Andrew E. Chapman
Journal: Journal of Clinical Oncology (2024)

e13766 Background: The Geriatric 8 (G8) is a screening tool validated for cancer patients to identify those in need of a comprehensive geriatric assessment (CGA). It evaluates eight domains encompassing mobility, polypharmacy, age, and self-rated health. The existing original-G8 requires administration by a healthcare professional, limiting its accessibility and practicality. An electronic, patient-reported version could broaden its reach, enhancing care coordination. This study focuses on the implementation and evaluation of a self-reported G8 tool on Epic MyChart and its alignment with the original-G8. Methods: The MyChart-G8 underwent adaptation from the original-G8, retaining all domains while optimizing questions for patient self-completion and adhering to health communication design principles. We introduced MyChart-G8 across our Jefferson health system for all patients aged ≥ 65 with a new cancer diagnosis. For a subset of patients, an oncology nurse or medical assistant also administered the original G8 during the new patient visit rooming process. Agreement between MyChart-G8 and original-G8 for individual items was measured using Kappa statistics. Diagnostic accuracy of MyChart-G8 compared to the original-G8 was also assessed. Results: Our cohort comprised 203 older cancer patients who completed both MyChart-G8 and the original-G8. The frequency of abnormal scores (≤14) for the original-G8 and MyChart-G8 was 40.0% and 67.7%, respectively. Discrepancies between the two tools were partly attributed to less than moderate agreement for three individual items: neuropsychological problems (Kappa 0.15), BMI (Kappa 0.27), and self-rated health (Kappa 0.31). A MyChart-G8 cutoff of 14.5 demonstrated the best balance of sensitivity (0.86 ± 0.13) and specificity (0.57 ± 0.06) when compared to the original G8. Conclusions: The incorporation of self-reported G8 assessments into Epic MyChart is feasible and implementable. Persistent challenges arise in accurately assessing self-reported problems among older adult cancer patients in the electronic format, potentially resulting in MyChart over-flagging abnormalities. The introduction of the Practical Geriatric Assessment (PGA) presents an opportunity to streamline the CGA. By subsequently conducting a PGA for individuals identified as vulnerable through the MyChart G8, we can confirm frailty domains, inform treatment decisions, and address impairments through targeted interventions. This integrated, stepped-up assessment approach holds significant potential to optimize resource utilization, enhance patient engagement, and tailor individualized treatments, ultimately with the goal of maximizing treatment outcomes. The Sidney Kimmel Cancer Center is in the process of developing a decentralized model of PGA using MyChart G8 as a step-up approach across the Jefferson Health enterprise.
Abemaciclib dose escalation to maintain intensity (ADE-MI).
Authors: Kevin Prescott, VK Gadi, Oana Cristina Danciu, Kent Hoskins, Abiola Falilat Ibraheem, Jovonne Owens, Zhengjia Chen
Journal: Journal of Clinical Oncology (2024)

TPS618 Background: Abemaciclib is a an oral CDK4/6 inhibitor that is FDA-approved as adjuvant therapy for certain patients with early-stage HR+HER2- breast cancer in combination with endocrine therapy. The major toxicity of abemaciclib is diarrhea, which often occurs within the first 6-8 days of treatment initiation. Across several registrational trials, roughly 25% of patients with diarrhea from abemaciclib treatment required dose interruptions with roughly 20% required dose reductions. Because diarrhea happens early in the treatment course, one concern is this might dissuade people from continuing on or being fully adherent to adjuvant therapy. Incorporating strategies to minimize diarrhea may improve adherence and permit more patients to stay on the target recommended dose of 150mg BID for the full 2 years of adjuvant therapy. Our trial-in-progress evaluates dose escalation to address diarrhea as a cause of dose interruptions, reductions, and discontinuations, a strategy that has worked with other therapeutic agents. Specifically, our study tests the hypothesis that gradual up-titration of abemaciclib dose over a course of 4 weeks will decrease the rate of grade 3 or worse diarrhea. Methods: This is a post-marketing, single arm, phase IV trial for patients with high-risk early-stage HR+HER2- breast cancer who are eligible for treatment with adjuvant abemaciclib in combination with endocrine therapy. Fifty (50) subjects will be enrolled. Patients will gradually up-titrate the dose of abemaciclib over the course of 4 weeks before reaching the FDA recommended dose of 150mg BID (Table). The primary objective of this study is to increase the proportion of patients on the FDA recommended dose of abemaciclib at 3 months of treatment. At the significance level of 0.05, a minimum of 43 patients will achieve a power of at least 80% to detect the improvement (80% vs the historical control of 60%), using a two sized exact binomial test. Additional objectives are determining the number of days with greater than grade 1 diarrhea in the first month of treatment, determining rates of grade 3 or greater diarrhea, determining DFS and OS, and to assess patient reported outcomes regarding adverse events. The trial opened to enrollment on 12/21/2023. The first patient on the study was enrolled 1/25/2024. Clinical trial information: NCT06169371 . [Table: see text]
Paramedical staffs' perception of their role during the continuum of care from detection to treatment in nursing homes: Results of the ONCOPAD-Pre survey.
Authors: Claire Falandry, Charlène Tavernon, Judith Bret, Arnaud Simeone
Journal: Journal of Clinical Oncology (2024)

e13768 Background: Prevalence of cancer in nursing homes (NH) increases. ONCOPAD is a 4-step program dedicated to identifying and acting on educational needs, cultural and ethical barriers associated with cancer treatment in NH. The program included a scoping review (step 1), semi-directive interviews with care providers (step 2) designed to identify the major topics to be included in a tailored intervention and evaluated before and after it. Here we report the results of the survey before the intervention. Methods: Questions were mainly presented as 7-point Likert scales and classified into 6 sections: interviewee’s description, detection phase, treatment phase, relations and communication at work, ethical questioning, continuing education. Statistical analyses included descriptive statistics, exploratory factorial analyses, testing of model sphericity and sampling adequation. Results: From 06/2022 to 03/2023, 65 participants (median age 41 years; females: 84.6%) completed the questionnaire; 40.0% were nurses, 35.4% nurse assistants; 87.7% were full-time employees, and 73.8% were post holder. Interviewees considered their role as important at the detection stage (mean 4.82), to inform the physician (5.58) and their colleagues (5.45), their role during the decisional process (4.40) and to inform the patient on his diagnosis (4.05) were perceived as less important; organizational problems (lack of staff, time, facilities) could impede this stage. Factors perceived important for treatment decision were related to the patient (physical performance, cognition, age), his opinion (4.49), the opinion of his family (4.38), of his physician (5.17) and less to the paramedical team (4.02). The decision to pursue was mainly focused on care: pain relief (5.48), detection of clinical and psychological signs (5.18); the organizational barriers were perceived as major as well. Relations and communication at work, both internal and external to the institutions, were perceived as poor quality; 8 (12.3%) of the interviewees even skipped this section. The ethical questioning was permanent and homogeneous. Considering education, the interviewees felt insufficiently trained and the preferred model for training was short sequences integrated into daily work schedules; coordinating physicians appear as good mediators for such training courses. Conclusions: In this survey, paramedical staffs perceived their role as important during both detection and treatment of cancers, focusing more on care than cure; however, organizational constraints and poor quality of internal and external relations, and communication appear as major barriers in the completion of their role. Educational intervention should be tailored, favoring short sequences integrated into daily work schedules, coordinating physicians appear as good mediators for improvement in the future.
Mobile health–supported comprehensive intervention model (CIMmH) improved physical fitness of patients with esophageal cancer after esophagectomy: Prospective randomized controlled trial.
Authors: Weixiong Yang, Yan Guo, Chuanbao Deng, Shuyu Zhuo, Qi Liang, Zihao Huang, Nanxiang Zhang, Xiaotong Lin, Yingqi Li, Chuanchuan Yu, He Xu, Yiran Li, Ziyue Tang, Yao Liu, Zengli Fang, Wenfang Chen, Shuishen Zhang, Bo Zeng, Saiching Jim Yeung, Chao Cheng
Journal: Journal of Clinical Oncology (2024)

1634 Background: Esophageal cancer (EC) significantly impacts patients’ quality of life (QOL) post-esophagectomy, with malnutrition, reduced physical activity, and psychological distress being common. Our preliminary study indicated that a Mobile Health-Supported Comprehensive Intervention Model (CIMmH) is safe, feasible, and efficacious in improving QOL and physical fitness for EC patients. This randomized controlled trial (RCT) evaluates the effectiveness of CIMmH in promoting post-surgery recovery for EC patients. Methods: EC patients undergoing modified McKeown esophagectomy were randomly allocated to either the intervention group, receiving the CIMmH protocol (nutrition, exercise, psychological support), or the control group, receiving standard postoperative care. Outcomes were assessed at baseline, 1 month, and 3 months post-surgery. Key metrics included sarcopenia (assessed via skeletal muscle index and psoas muscle thickness on CT scans), quality of survival (EORTC-QLQ-C30 and EORTC-QLQ-QES-18), physical fitness (six-minute walk distance, SMWD), and nutritional status (body weight). Results: Of 111 screened patients, 80 were enrolled (40 per group). Follow-up assessments were completed by 76 patients at 1 month and 69 at 3 months. At 1 month, the intervention group showed a significant improvement in SMWD compared to the control group ( P=0.020), though no difference was observed at 3 months ( P=0.835). The intervention group also demonstrated a significant increase in the skeletal muscle index at 3 months ( P=0.039), alongside notable improvements in the 30-second arm curl test and cough symptom relief ( P=0.027 and P=0.045, respectively). No significant differences in QOL scores or body weight were observed between groups at any time point. Conclusions: CIMmH significantly enhances short-term physical fitness in EC patients post-esophagectomy. These findings suggest the need for further refinement and optimization of the intervention to maximize its long-term effectiveness and impact on QOL. Clinical trial information: ChiCTR2000041007 .
Risk of VTE in TNBC treated with neoadjuvant immunotherapy.
Authors: Ayesha Farooqui, Jeremy Kao, Marwah Wafa Farooqui, Oana Cristina Danciu
Journal: Journal of Clinical Oncology (2024)

e12658 Background: Triple-negative breast cancer (TNBC) has limited treatment options. KEYNOTE 522 led to the approval of neoadjuvant (NT) Pembrolizumab in July 2021 changing the treatment paradigm for early stage TNBC. While improving pathologic complete response it also slightly increased treatment related adverse events. Some studies show increased risk of venous thromboembolism (VTE) with Pembrolizumab; however, it is unclear if immunotherapy (IO) increases the risk of VTE in a NT setting. Breast cancer is not classically associated with high risk for VTE. Here, we assess the incidence of VTE in TNBC patients receiving NT Pembrolizumab. Methods: All women diagnosed with TNBC and treated with NT Pembrolizumab between August 2021-December 2023 (t = 29 months) at our institution were included (N = 26). Stage 4 disease at time of diagnosis was excluded. The study endpoint was the development of VTE at any time following the initiation of Pembrolizumab as identified by CT chest angiography or venous duplex ultrasound. Risk factors and protective factors for VTE including body mass index, prior VTE, concurrent chest port, illicit drug use, smoking, hypertension, diabetes, kidney disease, hyperlipidemia, and prior antiplatelet/anticoagulant use were assessed for each patient. Results: In our study population, 1 patient developed VTE following initiation of Pembrolizumab (3.8%). This patient developed a pulmonary embolism 13 days after the 2nd dose of Pembrolizumab (179 days after 1st dose). Risk factors for this patient were obesity (BMI = 52.9), concurrent chest port, and hypertension. Protective factors included no prior history of VTE, illicit drug use, smoking, diabetes, kidney disease, or hyperlipidemia. A comparison of the risk factors is summarized (Table). Conclusions: The cumulative VTE incidence for all immune therapies is reported as 7-10% in the 1st year. Patients with breast cancer have a 6% incidence of VTE in the 1st year. This rate does not account for cancer subtype, stage, or treatment type. Our exploratory study is novel in looking at incidence of VTE in the NT immunotherapy use setting. These results suggest a lower incidence compared to the cumulative studies previously mentioned. There is a possible synergistic interaction between Pembrolizumab therapy and other traditional risk factors in the development of VTE in TNBC. Further analysis will seek to stratify the individual risk of Pembrolizumab in VTE compared to other risk factors. Future work will include expanding our study population to additional solid tumors utilizing NT Pembrolizumab including melanoma and non-small cell lung carcinoma. Once risk is definitively established, it will be important to take measures to mitigate the risks to improve cancer related outcomes. [Table: see text]
The use of telehealth in a large community oncology practice prior to and during the COVID-19 pandemic.
Authors: Dana Nickleach, Priya Saravanan, Gary Meyer, Kiana Mehring, Ganiat Mumuney, Lucio N. Gordan
Journal: Journal of Clinical Oncology (2024)

1631 Background:The COVID-19 pandemic prompted implementation of telehealth services in oncology following CMS approval for reimbursement. Using data from a single large US-based community oncology practice, we characterized the adoption of telehealth, evaluated telehealth’s impact on patient transit to the site of care, and the frequency of ER visits and hospitalizations. Methods: A retrospective cohort analysis was conducted using data from January 2019 through June 2022 from the FCS EMR database, IQSS’s RefineIQ database, which captures and standardizes patient treatments for consistent analysis, InfoDive, a reimbursement platform with data on clinic visits, and Oncology Care Model data. The target population included all patients with cancer aged 18 or older under active management at FCS during the study window with at least 60 days of follow-up. Patient disease and demographic characteristics and ER/hospital care visits were compared between telehealth groups, as well as impact of telehealth use on transit time and distance traveled for patients was summarized using descriptive statistics. Results:178,531 patients were analyzed. Median age was 68, with 64% female and 47% white. 97% of patients lived in a metropolitan area, 97% in Florida, and 77% in areas with less than $78,000 median income. Median duration of disease was 41 months, 24% of patients were stage IV and 93% ECOG 0-1. 20% of patients used telehealth, with 81% having only one telehealth use per year. Patients using telehealth, compared to those that did not, were more likely to be white (50% vs 46%), have commercial insurance (30% vs 27%), live in areas where annual median income was &gt; $78,000 (25% vs 22%) and ≥95% of the population graduated high school (31% vs 26%). Telehealth saved a median of 5 miles driven per user annually. Users tended to have more advanced disease than non-users, with a higher proportion of metastatic disease (27% vs 23%), high CMS risk score (16% vs 15%), and line of therapy 2 or greater (10% vs 7%). Users had higher median annual oncology clinic visits both pre- (5 vs 3) and post-telehealth approval (6 vs 5). Hospital admissions after ER visits were more frequent among users both pre- (14% vs 13%) and post-telehealth approval (29% vs 25%). Conclusions: Telehealth was somewhat more likely to be used by patients with cancer in more affluent communities, white patients, patients who had more advanced disease and more frequent clinic and hospital visits. Most patients who used telehealth used it only once, and the low utilization of telehealth had limited impact on patient transit effort to the clinic. This study is limited by its concentration at a single large practice in Florida, the relatively low use of telehealth, retrospective design, and selection bias, as the telehealth population had more advanced disease and likely needed more frequent intervention.
Enfortumab vedotin (EV) in triple-negative breast cancer (TNBC) and HR+/HER2- breast cancer (BC) cohorts of EV-202.
Authors: Antonio Giordano, Arif Ali Ali Awan, Justine Yang Bruce, Hope S. Rugo, Jennifer Robinson Diamond, Yelena Novik, Joaquina Celebre Baranda, Kei Muro, Makiko Ono, Rita Nanda, Jason Kaplan, Seema Rao Gorla, Shubin Liu, Michele Wozniak, Anthony Lee, Tiffany A. Traina
Journal: Journal of Clinical Oncology (2024)

1005 Background: EV, a Nectin-4–directed antibody–drug conjugate, is approved for use in urothelial cancer. Nectin-4 is expressed in several solid tumors, including BC. EV monotherapy was evaluated in TNBC and HR+/HER2- BC in EV-202 (NCT04225117). Methods: In this open-label, multicohort, phase 2 trial, eligible adults had locally advanced or metastatic (la/m) solid tumors, measurable disease, and ECOG PS 0–1. In BC cohorts, patients (pts) had prior taxanes or anthracyclines, ≥1 standard-of-care cytotoxic regimen and ≤2 lines (L) of cytotoxic therapy for la/mBC, and prior PD-1/L1 inhibitor (TNBC) or endocrine treatment (tx) with a CDK4/6 inhibitor (HR+/HER2- BC). Nectin-4 expression was not required but was assessed retrospectively. Pts received EV 1.25 mg/kg intravenously days 1, 8, and 15 of each 28-d cycle until discontinuation criteria (eg, disease progression, unacceptable toxicity) were met. Primary endpoint was confirmed objective response rate (ORR); ≥10 (TNBC) or ≥12 (HR+/HER2- BC) responders out of 40 evaluable pts were needed to claim promising antitumor activity. Secondary endpoints were duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety/tolerability. Antitumor activity was investigator-assessed per RECIST v1.1. Results: In the TNBC cohort, 42 female pts received EV as of Mar 3, 2023 (median follow-up, 11.8 mo). Median age was 53 y, 64% had ≥2L systemic tx for metastatic BC, and 33% had prior sacituzumab govitecan. ORR was 19.0%. Grade ≥3 tx-related adverse events (TRAEs) in &gt;1 pt were decreased neutrophil count (n=3, 7%), decreased white blood cell count (n=2, 5%), and increased aspartate aminotransferase (n=2, 5%). Selected TRAEs of special interest were skin reactions (n=25, 60%), peripheral neuropathy (n=11, 26%), and hyperglycemia (n=2, 5%). In the HR+/HER2- BC cohort (median age, 57.0 y), 45 female pts received EV as of Dec 3, 2022 (median follow-up, 11.2 mo). Most (73%) had ≥3L systemic tx for metastatic BC. ORR was 15.6%. Grade ≥3 TRAEs in &gt;1 pt were maculopapular rash (n=7, 16%), pruritus and increased aspartate aminotransferase (both n=3, 7%), and abdominal pain and erythema (both n=2, 4%). Selected TRAEs of special interest were skin reactions (n=28, 62%), peripheral neuropathy (n=12, 27%), and hyperglycemia (n=5, 11%). Additional efficacy data for both cohorts are in the table. Conclusions: EV showed antitumor activity in heavily pretreated TNBC. Safety in both cohorts was manageable and consistent with previous reports. Clinical trial information: NCT04225117 . [Table: see text]
Treatment outcomes of the KEYNOTE-522 regimen in an ethnically diverse patient population: A real world experience.
Authors: Mukuhi Ng'ang'a, Susan Burdette-Radoux, Patrick I. Borgen, Abhigna Kodali, Charusheela Andaz, Anna Urazov, Gene Sobol, Michael Silver, Joshua Feinberg
Journal: Journal of Clinical Oncology (2024)

e12663 Background: Pembrolizumab (pembro) in combination with neoadjuvant chemotherapy (NACT) became standard of care for high risk, early stage TNBC on July 26, 2021, as a result of the KEYNOTE-522 trial. Black women are disproportionately affected by TNBC with more advanced stage at diagnosis, however the KEYNOTE-522 did not collect data on race. This retrospective review evaluates response to pembro plus NACT in a racially diverse population to assess the generalizability of the trial findings to potentially under-represented patient populations. Methods: This is a single center, retrospective review of patients with stage II/III TNBC diagnosed between 08/2020 to 08/2023, treated with pembro plus NACT at Maimonides Medical Center, a safety-net hospital in Brooklyn, New York serving a diverse patient population. Exclusion criteria included age &lt; 18 years, ER/PR/Her2 positivity, NACT without pembrolizumab and unreported race. Data were collected from electronic health records and analyzed using SPSS Statistics. Results: 50 patients met inclusion criteria, among whom 40 patients had complete information available for review. 52.5% (95% CI: 38% - 69%) of patients had a pCR. Nearly half of the patient population (47.5%) were African American. Subgroup analysis of ethnicity demonstrated a lower pCR amongst African American women, but this was not statistically significant (table). 5 patients had progression of disease with the development of distant metastasis (2 whilst on treatment and 3 following completion of therapy). 3 patients had grade 3/4 adverse events (pembro associated endocrine and cardiac dysfunction). Notably, lack of complete imaging response to treatment was significantly associated with lack of pCR (p=0.003). Conclusions: In this retrospective review of a racially diverse patient population, the pembrolizumab-NACT regimen was well tolerated with an acceptable side effect profile. While our rate of pCR is lower than the findings of the Keynote-522 trial; 52.5 % (95% CI: 38% - 69%) vs. 64.8% (95% CI: 59.9%-69.5%), our sample size is not large enough to detect a statistically significant difference. Sub-analysis of patient ethnicity demonstrated varying rates of pCR, however findings are limited by a small sample size. Additional data collection is in progress and future analysis will provide insight into a potential correlation between race and therapy response. [Table: see text]