tbuckley/cabot-search huggingface dataset:
Correlation of ctDNA with hematologic ratios (NLR, MLR, PLR, ELR) in predicting disease progression in soft tissue sarcomas among non-Hispanic Whites and Hispanics: Single-center experience.
Authors: Jonathan Braat, DIana Zamora, Waleed Ikram, Murali Ranjani Behara, Chelsea Azevedo, Han Dinh, Shyamal Patel, Jason T. Wiseman, Miguel Gonzalez Velez
Journal: Journal of Clinical Oncology (2024)

e23536 Background: Circulating tumor DNA (ctDNA) has gained prominence as a potential indirect marker for minimal residual disease (MRD) in various cancers, including soft tissue sarcomas (STS). Previous studies have suggested that indirect hematologic ratios – such as Neutrophil-Lymphocyte Ratio (NLR), Monocyte-Lymphocyte Ratio (MLR), Platelet-Lymphocyte Ratio (PLR), and Eosinophil-Lymphocyte Ratio (ELR) may correlate with worse outcomes. We sought to evaluate the correlation of NLR, MLR, PLR and ELR in a real world cohort of Non-Hispanic Whites (NHW) and Hispanics (H) with advanced STS. Methods: We performed a retrospective chart review at Dignity Health Cancer institute using our Electronic Medical Records (EMR) and Signatera™ assay to obtain our data points. Inclusion criteria were STS patients of all ages and stages of disease with complete records. We reviewed 33 patient charts, 14 NHW and 19 H patients. Of the NHW population, 11 were male (M) and 3 females (F). For the H population, 14 were M, and 5 were F. We utilized Spearman's rank correlation coefficient to assess monotonic relationships between ct-DNA levels and the hematologic ratios. ct-DNA was quantified through standardized assays per Protocol, with the resultant values treated as continuous variables in our statistical analyses. Power considerations, based on expected effect sizes and type I error rate adjustments were performed. Results: The Spearman’s correlation coefficients and p-values indicated varied associations across ethnic groups. For NHW, the correlations were generally weak and non-significant (NLR: r = 0.18, p = 0.54; MLR: r = -0.04, p = 0.89; PLR: r = 0.35, p = 0.21; ELR: r = 0.001, p = 1.00). Conversely, in the Hispanic cohort, stronger and statistically significant correlations were observed, particularly with NLR (r = 0.78, p &lt; 0.0001) and MLR (r = 0.70, p &lt; 0.001). Overall, the correlations across the entire study population did not reach statistical significance. Conclusions: This study revealed notable racial variations, particularly in the H population, in the relationship between ctDNA levels and hematologic ratios. The noteworthy associations found with NLR (r = 0.78, p &lt; 0.0001) and MLR (r = 0.70, p &lt; 0.001) highlight the possible usefulness of these ctDNA and these indirect biomarkers in assessing disease status in STS. These findings suggest the possibility of using hematologic ratios, particularly in the Hispanic population, as markers of disease progression similar as ctDNA. Hematologic ratios are more easily accessible to the general population compared to ctDNA in many underserved countries and communities. Future studies with larger cohorts are need to further analyze its validity.
Evaluation of recurrence rate in Canadian patients with stage II/III HR+/HER2- early breast cancer in the real-world setting.
Authors: Maud Marques, Karen Gambaro, Mark Basik, Fred Saad, Saima Noor Hassan, Dominique Boudreau, Francois Vincent, Eve St-Hilaire, Helen Mackay, Mahmoud Abdelsalam, Stephanie Guillemette, Ricardo Leite, Marc-Andre Caron, Chandni Patel, Gerald Batist
Journal: Journal of Clinical Oncology (2024)

e23303 Background: Breast cancer is the most prevalent cancer and second leading cause of cancer-related mortality among Canadian women. Most of cases belong to the HR+/HER2- subtype, representing approximately two-thirds of all instances. Treatment for this subtype encompasses a multifaceted approach with a curative intent. This real-world evidence study aims to comprehensively analyze the clinical outcomes of Canadian patients diagnosed with early-stage HR+/HER2- breast cancer, focusing on recurrence rates after initiation of adjuvant endocrine therapy to identify opportunities for enhancing patient care. Methods: This is a retrospective, longitudinal cohort study involving 541 patients enrolled in the pan-Canadian cancer patient registry PMT (Personalize My Treatment), with newly diagnosed or recurrent stage II or III HR+/HER2- breast cancer between January 1 st , 1996, and May 31st, 2022. We evaluated disease recurrence rates, time to recurrence, and overall survival (OS). Furthermore, the study explored duration of endocrine therapy (ET) in the adjuvant setting. Results: 409 patients received adjuvant ET representing 75.6% of the total cohort, emphasizing the role of ET as standard of care for adjuvant treatment in this patient population. The median duration of adjuvant ET was 4.5 years. In the overall adjuvant patient population, recurrence rates progressively increased over time from 13.2% after 2 years, 21.4% after 3 years, 30.3% after 5 years, and peaking at 58.4% after 10 years. Median time to recurrence for the overall patient population on ET was 7.76 years. OS rate for patients on ET was 94.6% at 5 years and 78.3% at 10 years. Conclusions: This study marks a pioneering real-world analysis utilizing pan-Canadian EHR data, demonstrating increasing recurrence rates over time in HR+/HER2- early breast cancer. It highlights the high unmet need in stage II and stage III breast cancer, with 1 patient out of 3 recurring after 5 years, and more than half recurring after 10 years despites adjuvant treatment with ET alone. This indicates the need for more efficacious and tolerable treatment options to reduce short- and long-term recurrence and to prolong survival, not only in the higher risk patient population, but in the overall HR+/HER2- breast cancer patients at increased risk of recurrence.
Effects of prehab or rehabilitation on upper extremity disability and quality of life after breast cancer surgery.
Authors: Kelley C Wood, Jessica Bertram, Kim Love, Tiffany Kendig, Ashley N Lightner, Stacye Mayo, Lynn DiDonato Canavan, Mackenzi Pergolotti
Journal: Journal of Clinical Oncology (2024)

11090 Background: Growing evidence and NAPBC guidelines support the need for physical and/or occupational therapy (PT/OT) to optimize recovery from surgery. Research is needed to better understand the benefits of prehab (PT/OT before surgery and continuing afterward). We performed a retrospective study to understand the effect of participating in prehab or rehab-only on outcomes after surgery. Methods: Outpatient medical record data was extracted for cases who attended prehab (n=328) or rehab-only (n=306). Outcomes were upper extremity disability (Quick-DASH) and HRQOL (PROMIS measures of physical functioning, social role functioning, and global health [physical and mental]). Outcome time points included the post-surgery PT/OT assessment (T1, M=4 weeks), and PT/OT re-assessment (T2, M=15 weeks). We used linear mixed-effect models to examine the effect of prehab on T1/T2 outcomes while controlling for covariates (age, PT/OT, payer, and time), and to examine changes in outcomes from T1 to T2 for both groups. Results: Attending prehab was associated with better outcomes at T1 (upper extremity disability, p&lt;.001; physical functioning, p&lt;.001; social role functioning, p&lt;.001; and physical health p&lt;.001) and T2 (upper extremity disability, p=.025; physical functioning, p=.045; and social role functioning, p=.028; Table). From T1 to T2, each group improved significantly: upper extremity disability (prehab: M∆=8.92, p&lt;.001; rehab-only: M∆=17.65, p&lt;.001), physical functioning (prehab: M∆=1.89, p&lt;.001; rehab-only: M∆=3.51, p&lt;.001), social role functioning (prehab: M∆=1.61, p=.009; rehab-only: M∆=3.66, p&lt;.001), and physical health (prehab: M∆=1.73, p&lt;.001; rehab-only: M∆=3.50, p&lt;.001). There was no significant effect of prehab on mental health and improvement from T1 to T2 was non-significant for both groups (p&gt;0.05). Conclusions: In this study, attending outpatient prehab PT/OT services was associated with less upper extremity disability and greater HRQOL after breast cancer surgery. After post-surgery PT/OT, prehab and rehab-only cases each improved significantly; and upper extremity disability, physical functioning and social role functioning remained better among prehab cases. Although more research is needed, these findings support the integration of PT/OT in routine care and suggest that early PT/OT may optimize outcomes. [Table: see text]
Cancer care service use intensity in Medicare Advantage versus traditional Medicare.
Authors: Aaron Philip Mitchell, Yamini Kalidindi, Roger Feldman, Caroline Carlin, Ge Song, Jeah Jung
Journal: Journal of Clinical Oncology (2024)

11054 Background: Prior studies have found evidence of lower cost of care and preserved care quality among Medicare Advantage (MA) plans vs. traditional Medicare (TM). However, MA performance for patients with serious conditions such as cancer is yet to be explored. MA plans are incentivized to reduce expenditures, and the high financial cost (often with marginal clinical benefit) of chemotherapy might be an opportunity for savings. We compared service use intensity and quality between MA and TM cancer patients receiving systemic therapy. Methods: Medicare claims data and MA encounter records (including only MA contracts that had highly complete data), 2015-2019. We included patients with select major cancer types, and measured outcomes during a 6-month chemotherapy episode, defined by the date of systemic therapy initiation after a 1-year washout period. Service use intensity was measured in dollar terms using standardized Medicare prices. Quality measures included treatment-related emergency department (ED) visits and hospitalizations, avoidable ED visits, preventable hospitalizations, and overall survival. To estimate the association between MA enrollment and these outcomes, we used regression models with county-level fixed effects and inverse probability of treatment weighting to balance the MA and TM samples on patient demographics, cancer type, health-risk score, metastatic status, frailty, and area characteristics. We performed separate analyses by cancer type. Results: The study sample comprised 96,501 MA and 206,274 TM beneficiaries who had one of seven cancer types: breast cancer, chronic leukemia, colon cancer, lung cancer, lymphoma, multiple myeloma, and prostate cancer, and who initiated systemic therapy between 2016 and 2019. Estimated mean overall service use among MA enrollees was $62,599, compared to $71,317 for TM beneficiaries (-$8,718, p&lt;0.01). A majority of the overall difference was accounted for by Part B-covered systemic therapy drugs ($20,691 in MA versus $25,723 in TM, difference -$5,032, p&lt;0.01). Although MA enrollees received slightly cheaper drugs (-$277 per treatment day, p&lt;0.01), the lower cost of systemic therapy was driven largely by a lower number of treatment days occurring per 6-month episode for MA enrollees (-1.06 days, p&lt;0.01). MA enrollees had fewer treatment-related ED visits and hospitalizations (-2.5%, p&lt;0.01 and -0.7%, p&lt;0.01 respectively) but had more avoidable ED visits (+0.5%, p&lt;0.01). There was no difference in survival or preventable hospitalizations. Results were similar within individual cancer types. Conclusions: MA enrollment is associated with reduced service utilization but not shorter survival among cancer patients receiving systemic therapy. Further research is needed into the mechanisms of these savings to identify areas where care may be delivered more cost-effectively without negatively impacting outcomes.
Accelerating cancer research trial startup in the community setting: A quality-improvement study.
Authors: Jason Joseph Claes, James F. Maher, Wayne Thompson, Lisa Benoit, Billie Cook, Patrick Newbury, Alyssa Adams, Melinda O'Connor, Emma Ohlhaut, Chelsea Wirthlin
Journal: Journal of Clinical Oncology (2024)

11066 Background: There is a large variation in activation times for cancer clinical trials, delaying the opportunity for patients to benefit from cutting edge treatments. Academic medical centers typically take longer to activate a clinical trial as compared to community settings. Some academic medical centers have adopted quality improvement processes to reduce clinical trial start-up time. Our center, TriHealth Cancer &amp; Blood Institute (TCBI) in the SW Ohio community has also adopted quality improvement processes to further reduce startup time within our oncology research group. Methods: This study encompassed July 2022-June 2023, with baseline data drawn from January 2021 to December 2021 prior to the study period which revealed a mean clinical trial start-up time of 116 days. The research group used a swim-lane process to define the typical process &amp; stakeholders for clinical activation time at our institution prior to the study time. Our group identified three major areas with significant lag-time - contracts, budgets, &amp; IRB/ICF - with the overarching root cause for delays due to lack of organizational process &amp; expertise in these major areas. Using Plan-Do-Study-Act (PDSA), we instituted interventions, which included utilizing a central IRB, identifying a responsible member with extensive research budgeting to review research study budgets, &amp; identified a responsible member with extensive contracts review &amp; negotiations working with Central Legal throughout the contracts negotiation process with sponsor(s). Results: During this 12-month study time, our center demonstrated a 44% reduction in trial start up time (141 days to 79 days), while at the same time doubling the number of active trials. This process change resulted in sustainability that carried into 2023, further reducing start-up time to 70 days. In 2021, we opened 6 studies and after adoption of these process improvements (2022) we doubled the number of studies by 117%, while opening 67% more in 2023 than in 2021. The ability to open more studies has allowed us to shift patient enrollment to more investigational trials while increasing treatment enrollment from 2022 to 2023 by 24%. Through process improvement, more treatment studies are open &amp; available for our community. Conclusions: By implementing interventions to streamline clinical trial activation time, our center was able to significantly &amp; sustainably reduce the time required to start a clinical trial in our community health system in a 12-month period, resulting in our ability to initiate more clinical trials. As a result, more treatment trial patients were able to be enrolled in these clinical trials at TCBI, with the hope of improved outcomes. We anticipate that further adoption of just-in-time studies may help to decrease this activation time further. [Table: see text]
Post-acute care facility utilization and outcomes among Medicare beneficiaries undergoing inpatient cancer surgery.
Authors: Daniel E Lage, Mary Beth Landrum, Alexander Melamed, Alexi A. Wright, Spencer H Luster, Robert E Wolf, Nancy Lynn Keating
Journal: Journal of Clinical Oncology (2024)

11088 Background: Patients with cancer using post-acute care facilities have poor outcomes, including delayed return home and increased health care utilization. However, little is known about post-acute care use and outcomes among patients with cancer undergoing surgery. Methods: We examined Medicare claims of 100% of fee-for-service Medicare beneficiaries from 2010-2022, to identify patients who underwent inpatient cancer-directed surgery and were thus eligible for a post-acute facility stay. We used billing codes within 3 days of hospital discharge to identify post-acute facility stays, defined as skilled nursing facility (SNF), long-term acute care hospital (LTACH), or inpatient rehabilitation facility (IRF) stays. We used logistic regression to identify patient sociodemographic and clinical factors associated with post-acute care facility use. We also compared hospital readmissions within 30 days and days at home (defined as days not in an acute or post-acute facility) in the 90 days after discharge by setting, using Chi-square and Wilcoxon rank sum tests. Results: We studied 1,637,792 Medicare beneficiaries who underwent inpatient cancer surgery from 2010 to 2022. About half (48.9%) were women; median age was 73.0 years. The most common cancer diagnoses were colorectal (28.4%), lung (14.4%), and prostate (12.1%), and 22.7% had a Charlson comorbidity index (CCI) of ≥3. Overall, 16.0% of patients were discharged to a post-acute care facility (11.4% SNF, 4.5% LTACH/IRF). Discharge to post-acute care was greater among patients who were aged ≥80 vs 65-69 (Adjusted Odds Ratio[AOR] 3.85, 95% Confidence Interval[CI] 3.79,3.90), had CCI ≥3 versus 0 (AOR 2.92, 95%CI 2.88,2.95), were dual-eligible (AOR 2.01, 95%CI 1.99,2.04), or had metastatic cancer (AOR 1.26, 95%CI 1.24,1.28). Patients undergoing brain or spinal surgeries for primary or metastatic cancers had highest odds of PAC facility utilization. Compared to those discharged home, patients discharged to post-acute care facilities had a higher 30-day hospital readmission rates (18.6% vs. 9.5%, p&lt;0.0001), and fewer days at home in the 90 days after discharge from their index surgical admission (median 68 vs. 90 days, p&lt;0.0001). Conclusions: Patients with cancer undergoing inpatient surgery who are older, have comorbidities, or have advanced disease have higher rates of post-acute care facility use, and such post-acute care is associated with higher hospital readmissions and fewer post-operative days at home. Further work is needed to improve pre-operative decision-making and optimization as well as to develop supportive care and rehabilitative interventions that can improve post-operative outcomes for patients who need post post-acute care.
Characterizing the authorship of phase 3 randomized clinical trials in oncology, 1960-2023.
Authors: Jeremy Lyle Warner, Brianna R. Bakow, Alaina J. Brown, Jennifer Hsing Choe, Elaine Fan, Teja Ganta, Michael Glover, Matthew James Hadfield, C. Beau Hilton, Ali Raza Khaki, Shalin Kothari, Mark Lythgoe, Seema Nagpal, Ryan Huu-Tuan Nguyen, David H Noyd, Irbaz Bin Riaz, Michael Kevin Rooney, Tarsheen Kaur Sethi, Eric Kumar Singhi, Sam Rubinstein
Journal: Journal of Clinical Oncology (2024)

11079 Background: Phase 3 randomized clinical trials (RCTs) inform the standard of care in cancer treatment yet have a mixed track record of success. In this study, we sought to 1) determine the overall success rate of phase 3 RCTs; 2) assess whether authorship patterns differ between successful (positive) and unsuccessful (negative) trials; and 3) explore if individual authors have distinct track records of success. Methods: The HemOnc knowledgebase (KB) was queried for initial publications of phase 3 RCTs of systemic anticancer therapy; those without primary outcome described were excluded. RCTs were labeled positive if the primary endpoint was met per HemOnc standard criteria (P value ≤ 0.05 or hazard ratio upper bound ≤ 1 for any experimental arm[s]) and negative if they did not meet these criteria or if the experimental arm was statistically inferior. Trial metadata and author information were extracted from the HemOnc KB. Author positive publication rate (PPR) was defined as % of publications reporting a positive result divided by total number of eligible publications. Prolific authors were defined as those with 6+ eligible publications. Author count for manuscripts reporting positive vs negative results was evaluated with the Mann-Whitney U test; other statistics were descriptive. Results: 3328 studies met criteria as of February 5, 2024; these were associated with 3305 initial publications between 1960-2023, involving 25,412 unique authors. 1474 (44.3%) of the studies were positive. Publications reporting positive trial results had, on average, 3 more authors, median (interquartile range) of 18 (12-23) vs 15 (11-20), p&lt;0.0001. The mean (±SD) PPR for n=1967 prolific authors was 47.7% (±22.3%). The PPR was not related to individual author output; mean PPR for non-prolific authors was 48.0% (SD not reported). Differences in PPR were apparent by the disease under study and the years of publication (Table). Among the 46 prolific authors who had a PPR 2+ SD above the mean, 26 (55%) were from China followed by Italy with 3 (6%). Conclusions: Despite known positive publication bias, the success rate of published phase 3 RCTs remains &lt;50%. Publications reporting positive results had significantly more authors; this finding requires further study including adjustment for trial sample size. Significant variation in PPR amongst fields could be due to watershed therapeutic advances, differential selection of primary endpoints, and/or selective reporting of results. Finally, a signal for geographic association of outlier PPRs suggests the need for further investigation. [Table: see text]
Trends in pharmaceutical industry payments to US cancer centers, 2014-2021.
Authors: Aaron Philip Mitchell, Nirjhar Chakraborty, Meredith Brown, Sonia Persaud, Grace B Gallagher, Niti U. Trivedi, Peter Brian Bach
Journal: Journal of Clinical Oncology (2024)

11065 Background: US National Cancer Institute-designated comprehensive cancer centers (NCICCCs) receive federal funding to support their public missions. However, these institutions also receive substantial funds (both research and non-research) from the pharmaceutical companies, which have private, for-profit goals. The amount of industry money received by NCICCCs, with respect to their federal funding, is poorly understood. The goal of this study was to examine trends in industry payments to US cancer centers. Methods: NCICCCs were identified (N=51). Industry payments to each NCICCC from 2014-2021 were obtained from Open Payments, and NIH grant funding from NIH RePORT. Given our interest in NCICCCs, we focused on the subset of industry payments (those designated as being related to a cancer drug, both research and non-research) and NIH grant funding (grants awarded by the NCI specifically, as opposed to other institutes) that were likely to be cancer-related (we also measured overall industry payments and overall NIH funding). In order to capture both industry payments and grant funding broadly, we manually identified teaching hospitals and research universities affiliated with each NCICCC and included payments and grants to these as well. All amounts were inflation-adjusted to 2021 dollars. Results: Oncology-related industry payments increased from $320 million in 2014 to $896 million in 2021. NCI funding increased slightly during the same period, from $2,481 million to $2,691 million. Overall industry payments increased from $1,811 million in 2014 to $3,015 million in 2019 (exceeding NCI funding in that year), though overall industry payments subsequently declined to $1,977 million in 2021. Non-research (as opposed to research) payments were the minority of industry payments; the year with the greatest proportion of non-research payments was 2019, at 39%. NCI funding exceeded oncology-related industry payments at all NCICCCs except for two: City of Hope ($1,137 million oncology-related industry payments vs. $311 million in NCI funding) and MD Anderson ($1,040 million vs. $1,001 million). Conclusions: Oncology-related industry payments to NCICCCs has increased substantially more than NCI funding in recent years. Although most industry payments are research-related, a substantial portion are not. A small number of NCICCCs receive comparable or greater amounts of money from industry than they receive in grant funding from the NCI. These trends raise concerns regarding the influence of industry payments and the ability of these institutions to maintain their public missions.