tbuckley/cabot-search huggingface dataset:
The journey of patients with lung cancer: The gap between symptom onset and treatment.
Authors: Maistros Linaras, Konstantinos Skampardonis, Evangelia Chantzara, Vasiliki Leontopoulou, George Christodoulopoulos, Athanasios Kotsakis, Filippos Koinis
Journal: Journal of Clinical Oncology (2024)

e23119 Background: Prompt access to health care services is a priority in public health policies. The aim of this study was to map the journey of patients (pts) diagnosed with lung cancer (LC) and determine the time interval (TI) from symptom onset (SO) to treatment initiation and assess the impact on survival. Methods: A retrospective cohort study was conducted at the University Hospital of Larissa. Pts’ demographic and disease-related data were captured from medical records. The TI from SO to first doctor visit (StD), SO to first oncologist visit (StO), diagnosis to treatment initiation (DtT) and SO to treatment initiation (StT) were estimated. Overall survival (OS) was defined as the TI between treatment initiation and the date of death or the date of last follow-up. OS were estimated using the Kaplan–Meier analysis and the comparisons were computed with the log-rank test. Results: Overall, 251 sequential pts with metastatic LC were included in the study. Pts’ mean age was 71 years (range 35-88). The majority were men (82%) and 24%, 32%, 28% and 16% were diagnosed with small cell lung cancer (SCLC), squamous cell (SCC), adenocarcinoma (ADC) and large cell (LCC) LC, respectively. The median StD and StO was 32 (0-212) days and 102 (11-608) days, respectively. No difference was detected across genders, age ( &gt; or &lt; 70), family history of cancer or not, and area of residence (rural, urban). The median StT and DtT was 123 (30-851) days and 26 (1-105) days, respectively, with this time intervals being shorter among pts with SCLC compared to pts with non-small cell LC (NSCLC) ( p: 0.006 and p&lt; 0.001, respectively). Pts with sort StT intervals had significantly improved OS, compared to pts with longer StT intervals (SCLC p:0.044, NSCLC p:0.004). Conclusions: To the best of our knowledge, this is the first study aiming to determine specific TI from SO to treatment initiation for pts with LC in Greece and assess the potential impact on OS. Our data revealed a substantially prolonged StT (~4months) that is associated with worse survival rates. This indicates a need to improve public awareness of LC symptoms, enable pts’ access to specialized health care services and facilitate earlier diagnosis and treatment.
Climate therapy: Developing a climate change charter for Cancer Trials Ireland (CTI).
Authors: Seamus O'Reilly, Catherine Weadick, Lucy Murphy, Patrick Kivlehan, Angela Clayton-Lea, Eibhlin Mulroe
Journal: Journal of Clinical Oncology (2024)

e23214 Background: Climate change is a threat to human existence. Healthcare is the 5 th leading cause of CO 2 emissions globally, while clinical trials generate the equivalent of half the CO 2 emissions of Denmark. Consequently, both enterprises represent significant, potentially modifiable, causes of climate change. In response to this climate toxicity (PMID 36773799), CTI launched the National Green Cancer Clinical Trials Initiative in 2022. A climate charter, which was to consist of a living document of actionable areas, was commissioned by the CTI board to implement them. Methods: Carbon footprint touch points of CTI’s activity on climate change were identified such as travel, procurement, energy use, financial management. An online scoping review of existing academic and non-academic sustainability initiatives, funding agency and national policy documents, peer reviewed and grey literature sources was conducted using the terms climate change and sustainability. Action points were categorised and collated. No exemplar climate charters for clinical trial organisations were identified in the search. Results: 5 pillars of interaction with sustainability initiatives were evident. These were education, engagement, empowerment, embedding, and emphasising. These pillars related to 8 themes for climate smart involvement by CTI staff and members. Personal commitment to sustainability at an individual level eg dietary choices, EU climate pact participation. Trial design and management eg sustainability assessment &amp; integration into protocols Recycling and waste management at central office and sites. Energy and water use eg optimise computing infrastructure, prioritise low carbon sources. Procurement and contracts eg promote green purchasing, integrate environmental and social sustainability clauses in contracts, sustainability assessment of financial services including pensions Meetings and conferences eg prioritising virtual meetings, select conference venues and accommodation with environmental certs. Commuting and business travel. Outreach eg, to University partners, trainees, network with Green Trial groups. Conclusions: The climate charter provides a structure to facilitate sustainability integration at CTI. This living document registers existing activities, highlights areas for engagement, facilitates horizon scanning and outreach to emerging initiatives, empowers staff , and demonstrates an organisational commitment to climate smart, clinical trial conduct.
Impact of multidisciplinary tumor boards on clinical decision making in a genitourinary oncology clinic in Mexico city.
Authors: Alec Seidman Sorsby, Rosa Caballero, Fernanda Estefanía Rivera, Yuly Andrea Remolina Bonilla, Karina G. Vazquez-Narváez, Sara E. Vazquez-Manjarrez, Christian Haydeé Flores Balcázar, Ricardo A. Castillejos-Molina, Francisco Rodriguez-Covarrubias, Maria T. Bourlon
Journal: Journal of Clinical Oncology (2024)

e23217 Background: Effective management of genitourinary neoplasms demands a comprehensive approach due to the diverse treatment options and the need for multiple specialists. Multidisciplinary tumor board (MDTB) meetings are a platform for experts to collectively assess and discuss the latest evidence and provide their expertise to tailor treatment plans for patients. Methods: Cases discussed during uro-oncology MDTB meetings at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City over a five-year period (01/2018 to 12/2022) were included. We analyzed the type of neoplasm, reason for case discussion, specialties involved and whether the final decision led to a modification of the original plan. Descriptive statistics were used for analysis. Chi-squared test was used to determinate differences and p value &lt; 0.05 was considered statistically significant. A logistic regression analysis was performed for multivariate analysis. Results: Over the study period, 500 discussions involving 399 patients were included. 87% were men. Prostate, kidney, testicular, upper tract urothelial and bladder carcinoma, represented: 223 (44.6%), 117 (23.4%), 84 (16.8%), 37 (7.4%), 32 (6.4%) of cases, respectively. The majority were presented by urology (319 cases; 63.6%). The primary reason for presentation was surgical decisions in 54.6%. Regarding final conclusions, 55.8% underwent modifications in the treatment plan, 33.2% had no changes and 11% remained inconclusive, requiring further assessment. Individuals with metastatic disease had a higher likelihood of treatment plan changes in 61.6% vs 52.3% (OR 1.46 95%CI 1.01-2.12; p = 0.042). The 163 cases (32.6%) presented during the COVID-19 pandemic were more prone to have treatment modifications 62.6% vs 52.5% (OR 1.51 95%CI 1.03-2.22; p = 0.034); cases presented for surgical reasons during this period were more likely to have a change in treatment modality 74% vs 52.3% (OR 2.6 95%CI 1.34-5.04; p = 0.004). Implementation of results was successful in most cases (72%), with a median time of 3.6 weeks. Reasons for not implementing the plan included: patient decision, treating physician decision, comorbidities, death, and lack of resources. Factors associated with implementation in the multivariate analysis included: male gender (OR 2.81), cases presented during pandemic (OR 2.0), and by urology service (OR 1.92). Conclusions: Among patients presented in our uro-oncology MDTB meetings, more than half will have a change in the original treatment plan, and this agreed strategy is successfully implemented in most individuals. These sessions remained key for patient management during the COVID-19 pandemic.
Longitudinal race/ethnicity (R/E) specific trends in patient-reported outcomes (PRO) in elderly women with breast cancer (BC) in the SEER-MHOS database.
Authors: Keith A. Dookeran, Nicolette A. Meyer, Jennifer Landeta Vidal, Kristen E. Champion
Journal: Journal of Clinical Oncology (2024)

e23189 Background: PRO can be used to characterize health-related quality of life in cancer survivors; however, few studies have reported on longitudinal trends. Hence, we examined R/E specific (White/Black/Hispanic) longitudinal trends in physical and mental PRO for elderly women with BC. Methods: Data is from the Surveillance, Epidemiology, and End Results- Medicare Health Outcomes Survey (SEER-MHOS). The analytic sample (n = 33,386) included 25,267 White, 4,553 Black, and 3,566 Hispanic women newly diagnosed between 2010-2017 with 10 years of follow-up survey data. Generalized linear models with age/time-stratified predictive margins [means with 95% confidence intervals (CI)] were used to examine age/body mass index-adjusted physical and mental health PRO by R/E as physical and mental component summary t-scores [PCS/MCS: are linear transformation of the 0-100 possible range scoring for 8 Veterans RAND 12 Item Health Survey (VR-12) sub-scales, with mean of 50 and standard deviation (SD) of 10, normed to the US population]. Results: Overall PRO trends for all R/E groups were observed to decrease (i.e., worsen) over the 10 year period, however, trends remained highest for Whites and lowest for Hispanics [average Black/White Risk Difference (RD) (PCS: -3.2; -3.7, -2.8), (MCS: -3.4; -3.8, -2.9); average Hispanic/White RD: (PCS -3.3; -3.8, -2.8), (MCS: -5.4; -5.8, -4.9)]. Compared with White, Black and Hispanic women aged 45 years at diagnosis had significantly worse PRO at 10 years of follow-up [PCS: (White: 39.7; 38.2, 41.2), (Black: 33.7; 29.6, 37.9), (Hispanic: 31.4; 26.7, 36.1); MCS: (White: 47.1; 45.6, 48.5), (Black: 41.2; 37.2, 45.2), (Hispanic: 35.4; 30.8, 38.9)]. Similar disparity in R/E trends was also observed at older age strata (i.e., 55, 65, 75 and 85). For PCS the R/E disparity was no longer significant after 8 years follow-up for age strata 55, 65, and 75, and after 4 years for age strata 85. But for MCS the R/E disparity remained significant up to 8 years follow-up for age strata 55, 65, 75, and 85. With regards to VR-12 sub-scale examination, most of the PCS R/E disparity was likely due to differences in the general-health score; whereas for MCS disparity, it was likely due to differences in social-functioning, role-limitation, and emotional-well-being. Conclusions: Our findings show durable R/E specific disparities in longitudinal physical and mental PRO trends in elderly women with BC; this should inform strategies to optimize healthy aging for BC survivors.
Trends and landscape of clinical outcome assessment use to support oncology product approvals.
Authors: Kelly Dumais, Reina Davis-Aoki
Journal: Journal of Clinical Oncology (2024)

e23186 Background: The regulatory landscape in oncology trials has evolved with growing emphasis on patient-focused drug development. Further to tumor and survival outcomes, measuring how patients feel and function via clinical outcome assessments (COAs) provides critical information on symptoms and treatment burden and may help to inform risk/benefit evaluation for new treatments. This study aimed to examine trends in the use of COAs to support efficacy or safety in oncology product labeling. Methods: Product labeling information was obtained from PROLABELS (Mapi Research Trust), a database containing COA-related data sourced from the efficacy or safety sections of FDA Product labels and EMA SmPC where at least one COA is mentioned. Oncology product labels were screened based on therapeutic indications and study information. The clinical study details published in the label/SPC between 1990 and 2022 were used for further analysis. Results: A total of 180 EMA and FDA approved drugs and devices for oncology indications where COAs were mentioned in the product label were identified. 288 studies with COAs supported these drug approvals. These studies were in 52 different indications, with most in multiple myeloma (31), followed by non-small-cell lung cancer (24), prostate cancer (22), and breast cancer (22). Of the COAs that were used, 47% were patient-reported outcomes, 18% were clinician-reported outcomes, 30% were composites, and 5% were unspecified. The number of studies conducted with COAs supporting a product label increased over time, with 3x more studies in the past 10 years (189 from 2013-2022) compared to the previous 10 years (60 from 2003-2012). For studies listing specific COA names, 63 unique COAs were used. Excluding response criteria assessments, the most common COAs were the EORTC-QLQ-C30 (57 studies), EORTC-QLQ-LC13 (18 studies), and EQ-5D-3L (17 studies). The two indications with the largest variety of COAs used were prostate cancer (10 unique COAs) and non-small-cell lung cancer (9 unique COAs). Conclusions: In line with regulators highlighting the utility of COAs in evaluating clinical benefit, results show an increase in studies using COAs to support efficacy and safety in oncology product approvals. With COAs providing critical information on symptoms, side effect impact, and quality of life, including this information on labels may help patients and providers make more informed healthcare decisions, and for market differentiation.
Patient-centered perspectives: Examining quality-of-life integration in phase III lung cancer trials (2019-2023).
Authors: Shreyas Kalantri, Chiranjeevi Sainatham, Jayanth Reddy Tallapalli, Rishabh Singh, Goetz Hans Kloecker
Journal: Journal of Clinical Oncology (2024)

e23181 Background: In the dynamic landscape of lung cancer treatment, marked by precision medicine advancements, addressing the persistent global health challenge of lung cancer requires nuanced evaluations beyond traditional endpoints like Overall Survival (OS). Aligned with the emphasis on patient-centered care, both the US FDA and ASCO advocate for consistent integration of Quality of Life (QoL) and Patient-Reported Outcomes (PRO). The FDA's 2021 guidance underscores standardized assessment strategies, and ASCO's conceptual framework highlights the pivotal role of QoL and PRO data in elucidating the genuine value of cancer treatment options. This investigation aims to illuminate the extent to which recent trials consider patients' subjective experiences without presupposing an impact on QoL. Methods: This systematic review analyzed PubMed for Phase III lung cancer clinical trials involving anticancer drugs conducted between 2019 and 2023 to assess if QoL was included as an endpoint. Subgroup analyses categorized trials by cancer subtype (e.g., non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC]). Analyses were also stratified by publication year to explore potential temporal trends. The total prevalence of QoL as an endpoint was calculated across all lung cancer subtypes for the entire 5-year period. Subanalyses included impact factor categories (≥ 10 and &lt; 10) and differentiation between superiority and noninferiority trials. Results: The systematic analysis identified 191 Phase III lung cancer clinical trials published between 2019 and 2023, meeting the criteria. QoL was included in 31.93% of trials across all subtypes. Subgroup analyses showed that 33.72% of NSCLC trials incorporated QoL, with variations observed in early-stage resectable disease (26.31%) and unresectable advanced and metastatic cases (34.66%). For SCLC, 19.04% of trials included QoL, with none in the limited stage and 22.22% in the extensive stage. Stratified by publication year, 2019 had 33.33%, 2020 had 39.02%, 2021 had 33.33%, 2022 had 23.33%, and 2023 had 28.94% trials with QoL assessments. Stratification based on impact factor (IF) and trial type revealed 29.4% in Journals ≥10 IF, 35.6% in Journals &lt; 10 IF, 35.5% in superiority trials, and 21.6% in non-inferiority trials. Conclusions: Our analysis reveals a significant shortfall in incorporating QoL as an endpoint. Across all subtypes and stages, a limited percentage of trials included PRO, highlighting a crucial gap in evaluating the comprehensive impact of interventions. The underrepresentation of QoL assessments signals a need for greater attention to the holistic patient experience in lung cancer research. Moving forward, a more standardized and comprehensive integration of QoL assessments in Phase III trials is essential to enhance our understanding of treatment impact and inform more patient-centered care decisions.
Exploring outcomes in hospitalized patients with COVID-19 based on nutritional status: Comparing those with and without a cancer diagnosis.
Authors: Muhammad Mujtaba Bhinder, Elaine A. Davis, Christine A. Welch, Amir Shahzad Kamran
Journal: Journal of Clinical Oncology (2024)

e23068 Background: This study explores how nutritional status impacts COVID-19 outcomes, particularly in patients with cancer. Obesity is known to heighten risk of adult respiratory distress syndrome in COVID-19, malnutrition and its associated effects related to the immune response, respiratory compromise, debility, and other adverse outcomes has not been well defined in this patient population. Methods: In this retrospective cohort study, we examined data from the Charleston Area Medical Center’s (CAMC) COVID-19 Registry, involving 5,479 adult, symptomatic, PCR-positive COVID-19 hospitalized patients (3/1/20 to 1/20/24). Low nutritional status (LNS) was defined as Body Mass Index (BMI) &lt; 18.5 kg/m² or serum albumin &lt; 3.5g/dL). Demographics, comorbidities, lab values, treatments, and outcomes were assessed. Propensity score matching (3:1) non-cancer patients vs those with an active cancer diagnosis was undertaken using sex, age, and BMI. SAS 9.4 was utilized for the analysis. The groups were compared using Chi-square/Fisher’s Exact tests for categorical variables and t-tests for continuous variables. Multivariate analysis was utilized to determine predictors of adverse outcomes. Results: A cohort of 1,146 non-cancer and 382 active cancer patients were included in the study. The LNS subgroup had a higher frequency of active cancer (29.2% vs 19.3%, p &lt; 0.001), higher rates of diabetes (27.0% vs17.8%, p = 0.03) and chronic kidney disease (18.8% vs 11.7%, p = 0.02). They had greater frequencies of abnormal ferritin levels (57.8% vs 42.7%, p &lt; 0.001), CRP levels &gt; 3 mg/L (96.6% vs 90.3%, p &lt; 0.001), and elevated procalcitonin levels &gt; 0.05 ng/mL (71.2% vs 50.1%, p &lt; 0.001). LNS patients had a higher mortality rate (22.3% vs 9.7%, p &lt; 0.001), a higher need for mechanical ventilation (19.3% vs 9.5%, p &lt; 0.001), and intensive care unit (ICU) admission (35.7% vs 19.5%, p &lt; 0.001. Predictors of mortality included LNS (OR = 2.2, 95%CI [1.5-3.2], p &lt; 0.001), an active cancer diagnosis (OR = 1.7, 95% CI [1.2-2.6], p = 0.003), chronic kidney disease (OR = 1.8 95%CI [1.3-2.5], p = 0.004) and concurrent bacterial pneumonia (OR = 4.9 95%CI [3.3-7.2], p &lt; 0.001). Conclusions: In patients with COVID-19, those with LNS had higher rates of co-morbid conditions including active cancer, higher rates of elevated inflammatory markers, mechanical ventilation, ICU admission, and mortality. Predictors of mortality included concurrent bacterial pneumonia, cancer diagnosis and chronic kidney disease, with LNS increasing the risk of mortality by more than two-fold. These results support the recommendation of early nutritional assessment and a multi-disciplinary approach to aggressive nutritional support in the COVID-19 patient population particularly in those with a concurrent high-risk condition such as cancer.
Adherence and persistence of encorafenib in combination with cetuximab among patients with BRAF metastatic CRC in the United States (US) based on two claims databases.
Authors: Aparna Raj Parikh, Maria Cecilia Vieira, Michelle Silver, Andrew Rava, Reina Rau, Benjamin Li
Journal: Journal of Clinical Oncology (2024)

e23146 Background: The BRAF V600E mutation (BRAF-m) occurs in approximately 7% of patients with metastatic CRC (mCRC). Encorafenib (enco) in combination with cetuximab (cetux) was approved in April 2020 as the first targeted regimen for the treatment of adult patients with mCRC with BRAF-m. The purpose of this study is to analyze the post-approval real-world persistence and adherence to treatment with enco in combination with cetux or with panitumumab (pani), an alternative EGFR, in mCRC, based on two claims databases in the US. Methods: This was a retrospective cohort study in the IQVIA PharMetrics Plus database and the Merative MarketScan Commercial Database (2013-2022). Adults ≥18 years old with ≥1 claim for enco (first claim for enco on/after its date of approval in April 2020) with concurrent EGFR (cetux or pani), ≥2 ICD-9/10 codes for malignancy of the colon or rectum ≥30 days apart in the 1 year before index date, and ≥1 day of pharmacy and medical continuous enrollment during the index date were included. Patients were excluded if they had a record of melanoma or non-small cell lung cancer during the year before index date, were enrolled in a clinical trial any time after the CRC diagnosis date or did not have a treatment regimen starting on or after CRC diagnosis date (-14 days). Index date was the date of first treatment of enco + EGFR during the identification period (4/1/2020-3/31/2022). Patient demographics and disease characteristics were assessed at baseline, adherence (measured as at least 80% of days covered) and persistence (measured as time to discontinuation by Kaplan-Meier method) were estimated during the follow-up period. Results: 205 patients were included. Median (Q1 [1 st quartile], Q3 [3 rd quartile]) age at index was 59 (50, 64) years and 51.7% were female. Metastases were present in 3 or more sites in 62.9% of the patients, in 1 or 2 sites in 35.6%. The 2011 Modified Quan Charlson Comorbidity Index was 0 for 44.9% of the patients, 1-2 for 38.5%, and 3 or more for 16.6%. Most patients received cetux as their EGFR combined with enco (76.1%). Adherence to enco + EGFR was high (87.8%); enco + cetux vs. enco + pani: 89.7% vs. 82.6%. Median (Q1, Q3) proportion of time on cetux while on enco was 87% (78%, 95%) and median (Q1, Q3) proportion of time on pani while on enco was 85% (71%, 91%). Median (95% confidence interval) time to enco regimen discontinuation during follow-up was 6.1 (5.3–7.7) months. Conclusions: This up-to-date study provides current real-world evidence on the use of enco + EGFR in mCRC BRAF-m patients in the US. The results show high levels of adherence to the treatment, suggesting high tolerability to encorafenib, and persistence consistent with clinical trial evidence.