tbuckley/cabot-search huggingface dataset:
Patient-reported symptom interference with activity- and mood-related functioning prior to start of an early-phase oncology combination trial including immune checkpoint blockade.
Authors: Goldy C George, Sarina A. Piha-Paul, Ecaterina Elena Dumbrava, Vivek Subbiah, Siqing Fu, Apostolia Maria Tsimberidou, Shubham Pant, Grace Appleton, Laila Noor, Timothy A. Yap, Jordi Rodon Ahnert, Funda Meric-Bernstam, Charles S Cleeland, Tito R. Mendoza, David S. Hong
Journal: Journal of Clinical Oncology (2024)

12084 Background: We examined symptom interference with activity- and mood-related functioning at baseline in early-stage trials of combination treatments that included at least one immune checkpoint inhibitor, and its association with quality of life (QOL)-, clinical-, and trial-related factors. Methods: Patients scheduled to begin an early-phase trial of a combination treatment with immune checkpoint blockade, and who had not received trial-related treatment were recruited into a prospective longitudinal study design (NCI R01CA242565), and completed the following validated patient-reported outcome (PRO) measures prior to trial start: MD Anderson Symptom Inventory- Immunotherapy (score range: 0-10, higher scores = worse symptom interference); NCI’s PRO Common Terminology Criteria for Adverse Events (0-4, higher = worse severity); EuroQoL-5 dimensions assessing health status (0-100, higher = better health) and problems with self-care, and the Sloan Global QOL scale (0-10, higher = better QOL). Statistical tests included Spearman’s correlation rho (r) and multivariable linear regression. Results: 977 baseline PRO measures were completed by 247 patients (median age = 59 y; 46% female). Worst symptom-related interference was with activity (3.0 on a 0-10 scale), work (2.9), and enjoyment of life (2.4). Composite score means were 2.8 for symptom interference with walking, activity, and work (WAW; activity-related functioning), and 2.1 for interference with relationships, enjoyment of life, and mood (REM; mood-related functioning). Symptoms most associated with worse WAW were fatigue (P&lt;0.001) and appetite loss (P=0.001). Worse WAW was linked to worse REM (r=0.78, P&lt;0.001). Diminished sexual interest/mood (DSI) was associated with worse WAW (r=0.35, P&lt;0.001) and REM (r=0.33, P&lt;0.001). Worse WAW was linked to shorter trial duration (P=0.003) and worse response (progression of disease/immune-related progression) on the clinical trial (P=0.05). Conclusions: This first, comprehensive and prospective examination of symptom interference with functioning at trial baseline found that worse symptom interference was linked to worse QOL, poorer clinical outcomes, and shorter trial duration. These findings suggest that baseline patient-reported symptom interference with functioning can serve as a potential biomarker of poor prognosis in investigational trials, and that trial patients may benefit from initiation of supportive care prior to trial start. [Table: see text]
Incidence and outcomes of atrial fibrillation in different cancer subtypes: A propensity-matched analysis of Nationwide Readmissions Database.
Authors: Faryal Farooq, Manoj Kumar, Muhammad Sultan, Muhammad Sohaib Afzal, Bilal Nasir, Laxman Yashwant Byreddi, Vishal Devarkonda, Sundeep Atluri, Shafaqat Ali
Journal: Journal of Clinical Oncology (2024)

e23324 Background: Significant concern exists over the cardiotoxic effects of chemo &amp; radiation therapy used in the management of cancer patients. With different cancers requiring different chemo-radiotherapy regimens, cardiotoxicity risk is quite variable. We aim to evaluate the rates of atrial fibrillation (AF) in various cancers. Methods: The national readmission database (2016-2020) was queried to identify all-cause admissions for patients with active malignancy of any origin. The study population was divided into six subgroups based on the type of cancer (colorectal, renal, lung, breast, prostate, and hematological). Multivariate regression analysis was utilized for adjusted odds of mortality. A propensity score matching (PSM) model matched malignancy of interest with other malignancies to obtain incidence rates. Results: Among 10.6 million all-cause cancer-related hospitalizations, about 1.5 million (14%) developed atrial fibrillation (AF). On propensity-matched cohorts, AF had its highest incidence in hospitalizations associated with hematological malignancies (17%), followed by prostate (16.5%), lung (15.9%), renal (12.5%), colorectal (11.5%) &amp; breast (10.5%) malignancies [p &lt; 0.05]. Moreover, cancer hospitalizations complicated by AF were associated with higher mortality. AF was associated with the highest odds of mortality in breast cancer (aOR:1.60), followed by colorectal (aOR:1.59), hematological (aOR:1.55), prostrate (aOR:1.52), renal (aOR:1.51) &amp; lung (aOR:1.51) malignancies [p &lt; 0.001]. The rates of 30-day AF-related readmission were highest in hematological malignancies (21%), followed by lung (18.8%), colorectal (17.1%), breast (16.1%), prostate (15.7%) &amp; renal (12.5%) malignancies [p &lt; 0.05]. Conclusions: The rate of AF in nationwide hospitalizations among cancer patients was ~ 14%. AF was found to have the highest incidence &amp; readmission in hematological malignancies, while AF-related mortality was highest among breast cancer.
Prevalence of polypharmacy, drug-drug interactions, and inappropriate prescription in elderly patients with urological cancers.
Authors: Clara Castro Carballeira, María Ibañez Alda, María Lanza, Laura Sánchez, Marta Sotelo, Diego Cacho, Borja Gómez, Ignacio Duran
Journal: Journal of Clinical Oncology (2024)

e23312 Background: Around 50% of new cancer diagnoses occur in patients (pts) &gt; 65 years. Older adults tend to have more comorbidities and therefore prescription of several drugs. Polypharmacy (PP) [defined as prescription of &gt; 5 drugs] has been identified as a prognostic factor and might also lead to relevant drug-drug interactions (DDI) and it is also associated in occasions with inappropriate prescriptions (IP). This study aims to determine prevalence of PP, DDI and potential IP in a uro-oncology clinic. Methods: Pts ≥ 70 years with urological tumors consecutively seen in a medical oncology clinic [May 1st- August31 st 2023] were offered to complete a questionnaire that included questions about drugs regularly taken, doses, frequency, objective of the treatment along with some key epidemiological data. A descriptive analysis of this information was performed to identify PF along with a search for DDI ( DrugDex ®) and IP (STAR/STOPP criteria). Results: 91 pts agreed to participate and 87 complete the questionnaires. Mean age was 76 years (range 70-91) and 84.5% were men; 64%, 31 and 5% had ECOG 0,1 and 2 respectively. The predominant cancer type was bladder (41%), followed by prostate (40%) and kidney cancer (19%). Polypharmacy was identified in 54 pts (62%), with 12 pts (22%) having ≥ 10 drugs prescribed. Two cases (2%) of duplicity of treatment were found (laxative; hypnotic). Ninety-five major and 37 moderate DDI were detected, of which 8 occurred between anticancer drugs (abiraterone, pazopanib, everolimus and carboplatin) and outpatient treatments. An IP analysis is being currently conducted and data will be presented at the meeting. Conclusions: Our study shows a high prevalence of polypharmacy in older adults with urological tumors and a significant rate of drug-drug interactions including interferences with oncological treatments. These results highlight the need for careful reviewing and monitoring the drugs prescribed to our patients in the clinic and calls for strengthen collaborations with pharmacists and nurses to optimize integral management of GU cancer patients.
Juxtacortical chondrosarcoma: An NCDB analysis of demographics and socioeconomic factors.
Authors: Michael Peterson, Yanick Tade, Braden M. Lopez, Nikhita Tandon, Peter T. Silberstein, Craig Heise, Beau Hsia
Journal: Journal of Clinical Oncology (2024)

e23505 Background: Juxtacortical chondrosarcoma (JCC) is a rare cartilaginous tumor—accounting for less than 2% of all chondrosarcomas—and typically appears on the external surfaces of long bones. The prognosis of JCC is relatively promising compared to other chondrosarcomas, with the current therapy of choice being en-bloc resection. However, a significant amount of information regarding JCC remains unknown. Therefore, exploring diagnostic trends may provide greater insight into this cancer’s epidemiology and potential forms of treatment. The National Cancer Database (NCDB) was assessed to uncover the demographic factors in patients diagnosed with JCC. Methods: A retrospective cohort analysis utilizing the 2004–2020 National Cancer Database (NCDB) included 131 subjects with a histologically-confirmed diagnosis of JCC (ICD-0-3 code 9221). Demographic factors (age, sex, race, Hispanic status, insurance status, facility type, distance from facility, and Charleson-Deyo comorbidity score) were analyzed by descriptive statistics and incidence trends were interpreted in regression analysis. Results: Between 2004 and 2020, the NCDB reported a total of 131 patients with a confirmed diagnosis of JCC. This data indicated a rising incidence of patients diagnosed per year (R² = 0.0855), with an average age of diagnosis of 45 years (SD = 18, range = 8-88). Patients with JCC were more likely to be White (82%), of non-Hispanic origin (86%), and male (63%). The tumor was most commonly found in the long bones of the lower limbs (35%). Surgical removal was the primary treatment for the majority of patients (95%), while others received radiation (7%) or chemotherapy (4%). Most patients (83%) had a Charlson-Deyo comorbidity score of 0. Patients were commonly treated at academic and research facilities (61%), and no patients received palliative care. More than half of individuals were privately insured (57%) and resided in a metropolitan area with a population size of at least 1 million (59%). The mean distance between patient residence and treatment site was 104.1 miles (SD = 221, range = 11-1194 miles). Conclusions: To the best of our knowledge, this is the first study on juxtacortical chondrosarcoma utilizing NCDB data to address the significant lack of research on this subject. The majority of JCC patients are non-Hispanic, White, and have a primary site of diagnosis at the long bones of the lower limbs. This paper is the first to describe the socioeconomic factors of patients diagnosed with JCC: patients tend to be privately insured, live in large metropolitan areas, and are mostly treated in academic research facilities. Additional research is necessary to comprehend how socioeconomic and demographic factors influence the manner in which JCC patients are diagnosed and treated.
Evaluation of tumor immune microenvironment for PD-L1 score and tumor infiltrating lymphocytes in high grade osteosarcomas and their correlation with disease progression.
Authors: Shah Alam Khan, DEEPAM PUSHPAM, Asit R. Mridha, Adarsh Barwad, Venkatesan Sampath kumar, Sameer Bakhshi
Journal: Journal of Clinical Oncology (2024)

e23510 Background: Tumor Immune Micro-environment is being increasingly recognised as a potential target for improving overall survival for osteosarcomas, especially in the metastatic setting. Our study purpose was to evaluate the PD- L1 (Programmed cell Death- Ligand 1) expression in neoplastic cells well as Tumor Infiltrating Lymphocyte (TIL) density of osteosarcoma specimens and correlate it with oncological outcomes. Materials &amp; Methods: A prospective cohort study was conducted between March 2017 and March 2022 among osteosarcoma patients who underwent primary biopsy and neo-adjuvant chemotherapy followed by surgical excision at our centre. We excluded patients who had alternative diagnoses such as low grade osteosarcoma, secondary osteosarcoma, recurrent osteosarcoma as well as patients who had undergone initial treatment (chemotherapy/ surgery) outside our institute. De-paraffinized sections (4μ) incubated with primary antibody (PDL1) and a universal secondary detection kit used. Average percentage of positive cells calculated from at least 10 representative fields at 400X magnification. Positive staining was considered when ≥1% cells showed positivity. IHC scoring of PD-L1 was graded as negative, low positive and high positive. We calculated the number of TILs under 400X magnification in ten fields and then took their average. TILs staining was scored semi quantitatively using a 3 tiered scale. Results: Forty patients who fulfilled the inclusion &amp; exclusion criteria were included in the study with most common age group being 10 to 19 years (27 patient, 68%). The male: female ratio was 1.6: 1 and the most common location of tumor was distal femur. Majority of patients had the histological subtype of conventional osteosarcoma (37 patients, 92.5%). Lung metastasis was present at time of initial diagnosis in 27 patients (67.5%). At the end of 2 years, 27 patients were alive (60%) while 13 patients had died due to disease. PD-L1 expression was negative in 17.5%, low positive in 15% and high positive in 67.5%. Among TIL category, 19 patients belonged to category 1, 10 belonged to category 2 &amp; 11 belonged to category 3. There was significant correlation between PD-L1 expression score &amp; TIL category. PD-L1 score did not correlate with percentage of necrosis following chemotherapy, metastasis on presentation or overall survival. Conclusions: PD-L1 score had significant correlation with density of Tumor Infiltrating lymphocytes (TIL). However, PD-L1 score did not correlate with overall survival, tumor-free survival, progression of metastasis or local recurrence.
Clinical pathways utilization and concordance with standard of care.
Authors: Steven Anthony Manobianco, Emily Hansinger, Aditya Kulkarni, Adam F Binder
Journal: Journal of Clinical Oncology (2024)

e23226 Background: The rising cost and complexity of cancer care has generated interest from clinicians, healthcare institutions, and payors in creating decision-making tools to help provide consistent, high-quality, and cost-effective care. In accordance with national best practices, the Sidney Kimmel Cancer Center (SKCC) at Thomas Jefferson University Hospital began using system-based clinical pathways (Elsevier’s ClinicalPath™) in August 2019. We hypothesized that regardless of pathway utilization, our treatment decisions by subspecialists would align with clinical pathway algorithms. Methods: Chemotherapy orders for breast, genitourinary (GU), and gastrointestinal (GI) cancers between August 1, 2019 and December 31, 2022 at SKCC were identified via database review. Those ordered outside ClinicalPath were selected for chart review to identify characteristics including disease stage, line of treatment, cycles administered, and treatment response. Orders were compared to contemporaneous versions of ClinicalPath to assess if they were on- or off-pathway. Finally, off-pathway treatments were compared to the NCCN guidelines to determine if they were consistent with the national standard of care. Results: 1670 breast, GU, and GI chemotherapy ordering encounters were identified. Of these, only 105 (6.3%) were ordered outside of the clinical pathways tool and underwent chart review. 41 (39%) treatments agreed with ClinicalPath recommendations despite being ordered outside this system, and 87 (82.2%) were aligned with national guidelines. Treatment of higher stage diseases was more commonly ordered outside of ClinicalPath, with 67.7% having stage 4 disease. Of the orders, alignment with ClinicalPath decreased by stage (57.1% stage 1 vs 36.6% stage 4) and further lines of therapy (48.8% first line vs 25.0% fourth line and beyond). Discordance with national guidelines also correlated with progressive lines of therapy, though not with increasing stage. Conclusions: 93.7% of breast, GU, and GI chemotherapy orders at our institution were entered in ClinicalPath. Often, a goal of staying “on-pathway” is 80%. Of those ordered without ClinicalPath, many agreed with the ClinicalPath recommendation and more than 80% agreed with national guidelines. Differences in pathway and guideline adherence by stage and line of therapy may reflect the complexity of treatment decisions in advanced disease and suggest difficulty capturing these nuances in ClinicalPath. While only a minority of treatment decisions are made outside of ClinicalPath, those decisions largely agree with national guidelines. At a large academic center with oncology subspecialists, further investigation is needed to better understand the additional value of widespread adoption of clinical pathway tools.
Financial toxicity (FT), quality of life (QoL), and medication adherence patient-reported outcomes (PROs) in CLL on first-line (1L) oral oncolytics.
Authors: Keegan Carroll, Dennis Gurfinkel, Caroline Tietbohl, Brooke Dorsey Holliman, Joseph Krongold, Fay J. Hlubocky, Christopher K Daugherty, Ajay Major
Journal: Journal of Clinical Oncology (2024)

e23157 Background: While oral oncolytics have transformed CLL treatment, high costs may cause significant FT adversely impacting patients beyond direct out-of-pocket (OOP) costs. The association of FT with QoL and medication adherence has not been characterized with oral oncolytics in CLL. Methods: Electronic PRO surveys were longitudinally administered to patients initiating any 1L oral oncolytic therapy for CLL within the last 6 months at two academic centers. PROs included FACIT-COST (significant FT: score &lt; 26), FACT-LEU QoL, MARS-5 (suboptimal adherence: score &lt; 25) and PROMIS PMAS to assess medication adherence. PROs were administered at baseline, 3 months, and 6 months after enrollment. Pearson’s correlation ( r) was calculated between PRO domains. Semi-structured, qualitative interviews were conducted after 3-month timepoints and analyzed. Results: 34 patients were enrolled: median age 65 yrs (range 33-80), 59% male, 6% Black, 9% Hispanic. Majority received BTK inhibitors (56%, acalabrutinib/zanubrutinib) followed by venetoclax (44%); 50% received concurrent obinutuzumab. Most had private insurance (50%) followed by Medicare (44%). Median time from 1L initiation to study enrollment: 1.5 months. PRO completion rates: 100% (baseline), 85% (3 mo) and 74% (6 mo). Summarized PRO and interview outcomes are displayed below. Conclusions: Patients with CLL on 1L oral oncolytics experienced worsening FT associated with poor medication adherence and worse QoL over time. PROs were discordant with qualitative interviews and suggested that FT may be driven by factors other than OOP costs. Although funding and patient assistance programs were beneficial, uncertainty over losing funding may be a long-term driver of FT and merits further study. [Table: see text]
Real-world safety and healthcare resource utilization (HCRU) of lurbinectedin (lurbi) in patients (pts) with small cell lung cancer (SCLC): Jazz EMERGE 402 updated analysis.
Authors: Firas Benyamine Badin, Philip Edward Lammers, Mehul P. Patel, Leonid Shunyakov, Dennis Slater, Catherine Labbé, Navit Naveh, Anne Boccuti, Raj Hanvesakul, Wenyan Li, Badri Rengarajan, Balazs Halmos
Journal: Journal of Clinical Oncology (2024)

e23266 Background: Lurbi monotherapy received approval in multiple countries, including accelerated US FDA approval and conditional Health Canada approval for adults with metastatic (US) or stage III/metastatic (Canada) SCLC with disease progression on or after platinum-based chemotherapy, based on a phase 2, open-label, single-arm trial (Trigo et al, Lancet Oncol 2020). Jazz EMERGE 402 (NCT04894591) is a phase 4 observational study assessing the effectiveness, safety profile, and HCRU of lurbi in pts with extensive-stage SCLC treated in real-world clinical settings. Here, we report updated safety data and HCRU. Methods: This study is enrolling pts with extensive-stage SCLC treated with lurbi according to the local approved label in the US and Canada. Results: Enrollment is ongoing with a target of 300 pts. Between 28JUN2021 and 27DEC2022, 105 pts were enrolled and followed for ≥6 months after the first dose of lurbi (data cutoff: 27JUN2023). The median (range) age was 67 (44-87) years; 72 (69%) pts had prior immunotherapy; 22 (21%) had an Eastern Cooperative Oncology Group performance status of ≥2; and 25 (24%) had central nervous system involvement. All pts received ≥1 cycle of lurbi; 56 (53%) as second-line (2L) and 37 (35%) as third-line (3L) therapy. The median (range) number of lurbi cycles was 4 (1-31) and the median (range) duration of exposure was 97 (21-694) days. Dose modifications occurred in 27 (26%) pts, with 17 (16%) requiring dose reductions. Granulocyte colony-stimulating factor was administered in 43 (41%) pts (34 [79%] as primary and 7 [16%] as secondary prophylaxis; 2 [5%] were unknown). At the time of data extraction, lurbi treatment was ongoing in 11 (10%) pts and 23 (22%) pts received subsequent anticancer therapy after lurbi. Treatment-related adverse events (TRAEs) were reported in 40 (38%) pts and treatment-related serious adverse events (SAEs) in 13 (12%) pts. The most common TRAEs were anemia (n = 13, 12%), neutropenia (n = 10, 10%), nausea (n = 8, 8%), and fatigue (n = 7, 7%). Thirty-six pts were hospitalized for a median (interquartile range [IQR]) duration of 10 (4, 18) days (Table). No pts were hospitalized on the first day of treatment; 4 pts were hospitalized during the first 21-day cycle. The most common reasons for hospitalization were pneumonia (n = 10, 28%) and sepsis (n = 6, 17%; one was an SAE). Conclusions: In this phase 4 study, lurbi was well tolerated, with low rates of HCRU and a safety profile generally consistent with that reported in the phase 2 trial. Clinical trial information: NCT04894591 . [Table: see text]