bluuebunny/crossref_metadata_2025 huggingface dataset:
Optimizing rural healthcare: A retrospective review of initial diagnostic workup for multiple myeloma or monoclonal gammopathy.
Authors: Schmoyer Jeremy , Sekayan Tro , Rocca Neychelle
Published: June 2022

e18653

Background: An estimated 65 million people or approximately 20% of the United State residents live in rural areas based on the Census Bureau designation. As of December 31, 2021, 61.5% of the health professional shortage areas were designated in rural primary medicine. The Northern Arizona Healthcare (NAH) system is based in a rural area and experiencing shortages in both primary care and subspecialty physicians. This is making accurate and timely diagnostic studies key to facilitating early treatment. The objective of this study is to review whether complete diagnostic work up was performed for patients with suspected multiple myeloma (MM) or monoclonal gammopathy (MG) disorders prior to the oncology referral. The future goal of this study is to prompt further reviews and creations of order modules to help optimize healthcare for individuals in rural areas. Methods: This retrospective study included patients with the diagnosis of multiple myeloma or monoclonal gammopathy in the NAH system from 2015 to 2020. Data was reviewed to determine if serum protein electrophoresis (SPEP) with immunofixation was requested prior to oncology referral or at first oncology visit. Additionally, we evaluated if the urine protein electrophoresis (UPEP) order was requested on these visits as well. Results: The data consisted of 74 patients. On review, prior to oncology referral or at first oncology visit, only 18 patients (24%) had SPEP with immunofixation and UPEP ordered. 23 patients (31%) had SPEP orders only requesting additional immunofixation for further interpretation of data on future visits, and 47 patients (63%) were missing concurrent UPEP and SPEP orders. Conclusions: This retrospective study demonstrated that for patients with a confirmed final diagnosis of either MM or MG, 31% and 63% of patients had missing immunofixation and concurrent UPEP plus SPEP results respectively. The outpatient cerner system orders were adjusted to remove SPEP and UPEP only orders in the LabCorp and Senora Quest options. These were replaced with SPEP and UPEP with reflux to immunofixation orders. The goal of this adjustment is to prevent re-ordering of labs at initial oncology visit limiting cost burden and delay of diagnosis. In the future, patient care will be further optimized at NAH with the creation of an order set module. This module will include the complete lab workup required for multiple myeloma or monoclonal gammopathy with hematology/oncology referral and allow for further integration of non-oncology clinicians into care delivery.
Factors associated with duration of care in community direct-to-patient (DTP) pharmacies among Chinese cancer patients taking PD-1/PD-L1 inhibitors: Results from a real-world study.
Authors: Han Sheng , Wen Yi , Zheng Xin , Wang Ning Ruo , Hua Jin , Zhu He
Published: June 2022

e18654

Background: Several PD-1/PD-L1 inhibitors have been approved in China for multiple cancers. Community DTP pharmacies play an important role in both drug distribution and patient management. Using real-world patient management data, we explored the factors associated with duration of care in community DTP pharmacies among cancer patients using PD-1/PD-L1 in the country. Methods: This is a retrospective cohort study using real-world sales and follow-up data routinely collected from 79 Medbanks community DTP pharmacies between Jan 1, 2019 and Mar 31, 2021. Duration of follow-up (DoFU) was defined as the time interval between first PD-1/PD-L1 purchase and last follow-up contact. Duration of drug purchase (DoDP) was defined as the time interval between the first and the last PD-1/PD-L1 purchase date plus a buffer period which was determined based on the amount of last purchase. Covariates included: gender, age, enrollment in a patient access program (PAP), experience of adverse events (AE) during treatment, patient’s awareness of the disease, and follow-up response rate (FRR; < 30%, 30-70%, > 70%). Uni- and multivariate Cox regression models were conducted to assess the association of DoFU/DoDP with predicting variables among both total population and cancer specific sub-populations. Results: A total of 23,559 patients were evaluated (median age: 61 yrs; male: 73%). The three most common cancer types were lung cancer (51.90%), hepatobiliary cancer (19.69%) and esophageal cancer (9.98%). The median DoFU and DoDP were 6.3 month (95% CI: 6.23̃6.50) and 2.3 months (95% CI: 2.27̃2.33). In multivariate Cox regression model, factors associated with longer DoFU included enrollment in PAP (HR = 0.52, p < 0.001), experience of AE during treatment (HR = 0.71, p < 0.001), FRR 30-70% (HR = 0.66, p < 0.001; ref: < 30%) and FRR > 70% (HR = 0.56, p < 0.001; ref: < 30%); factors associated with longer DoDP included enrollment in PAP (HR = 0.90, p < 0.001), experience of AE during treatment (HR = 0.84, p < 0.001) and FRR > 70% (HR = 0.80, p < 0.001; ref: < 30%). The protective effects of PAP, AE and higher FRR on DoFU and DoDP were also observed in the three main cancer specific sub-populations. Conclusions: High quality patient management service provided in community DTP pharmacies is significantly associated with longer duration of care, which implies the important role of DTP pharmacies in the longitudinal care of cancer patients. A comprehensive service package should be developed and applied in community DTP pharmacies for cancer patients in order to better address their medical needs and financial strain.
Impact of establishing a precision oncology program at a rural academic cancer center on cancer care delivery.
Authors: Brewer Idona , Kettle Jacob , Johnson Alexander James , Vosuri Venkata , Tuncer Tolga , Papageorgiou Christos N.
Published: June 2022

e18660

Background: The use of molecular profiling, biomarkers, and other targetable tumor alterations is becoming a central component of modern cancer care. Many oncologists use Next Generation Sequencing to guide treatment decisions. There are many challenges of implementing precision oncology through traditional clinical operations. The purpose of this project is to enhance patient care by establishing a new clinical program with the specific focus of advancing and expanding the utilization of precision oncology. Methods: The precision oncology program (POP) was designed as a consult service and functions to assist oncologists in appropriate testing, interpreting results, and identifying additional treatment options. After referral, the POP committee discusses each patient case and offers testing and/or therapeutic recommendations to the referring provider. POP predominantly focused on patients with unresectable or metastatic solid tumors that had relapsed after at least one line of standard of care therapy. The effect of the program will be measured by the volume of patient consults, the number and nature of recommendations from the consulting program, and the direct impact of recommendations on patient care. Results: There were approximately 323 new diagnoses of advanced stage solid tumors in 2021 at the Ellis Fischel Cancer Center (EFCC) at the University of Missouri-Columbia. There were 205 FoundationOne liquid and tissue Next Generation Sequencing (NGS) of solid tumors ordered since initiation of this service. Utilization of NGS testing has increased by 100% year-over-year from 2020 to 2021 since the implementation of this program. The impact of this program is reflected in the increased NGS testing for multiple malignancy types. Specifically, 34% more NGS tests in advanced lung cancers, 733% in breast, 60% in head and neck cancers, 166% colorectal and 500% in prostate cancer. Since the launch of POP in late 2020, we obtained consults on 46 patients. Additional biomarker testing was recommended for 39% of all consults, with a new actionable target being identified in 33% of patients. The amount of biomarker testing increased from averaging 6-7 tests per month to averaging 21 tests per month with an average number of 5 mutations per sample. Conclusions: The POP consult service has improved the testing and the identification of actionable mutations of patients at EFCC. The program has led to new treatment options in 33% of patients reviewed.
Prevention of venous thromboembolism in ambulatory patients with active cancer: Results from ACT4CAT study.
Authors: Tsoukalas Nikolaos , Christopoulou Athina , Koumarianou Anna , Timotheadou Eleni , Athanasiadis Ilias , Samelis Georgios , Peroukidis Stavros , Psyrri Amanda , Kapodistrias Nikolaos , Nikolakopoulos Achilleas , Demiri Stamatina G , Andreadis Charalampos , Bokas Alexandros , Ardavanis Alexandros , Samantas Epaminondas , Mavroudis Dimitrios , Barbounis Vasileios , Athanasiadis Athanasios , Papakotoulas Pavlos , Boukovinas Ioannis
Published: June 2022

e18677

Background: Venous ThromboEmbolism (VTE), might be a challenge with a lot of negative consequences for patients with active cancer. VTE affects ongoing anticancer treatment, worsening morbidity and mortality, increases economic burden and escalates psychological distress. Incidence of VTE in patients with cancer reported 20%. Current guidelines recommend pharmacologic prophylaxis in ambulatory cancer patients with Khorana score ≥2. Methods: ACT4CAT is a prospective observational phase IV study conducted by HeSMO Greece, aiming to record the clinical practice of VTE prophylaxis in active cancer patients. Ambulatory patients who received thromboprophylaxis enrolled after signing informed consent. Study was approved by bioethics committee. Results: 691 patients from 19 oncology departments received thromboprophylaxis in 1st line 57.6%, 2nd line 14.8%, adjuvant 9.0% and neoadjuvant 7.5%. Age ≥65 found 55%, BMI≥30 17.5% and males 63%. Tumor types: gastrointestinal 45.4%, lung 25.8%, urological 11.6%, gynecological 6.0%, breast 4.2% and others 7.0%. High-Risk for Thrombosis Agents (HRTAs) received 87.2%, specifically: platinum agents (56.3%), antimetabolites (54.2%) and immunotherapy (12.1%). 54,5% of the anticancer agents had potential drug-drug interaction (DDI) with anticoagulation treatment. Thromboprophylaxis duration lasted 5.3±3.5 months. Main agents were: tinzaparin 89.6%, fondaparinux 6.0%, bemiparin 2.2%, enoxaparin 1.6%, apixaban 0.3% and rivaroxaban 0.3%. Intermediate thromboprophylaxis dose received 68% of patients, lower in adjuvant setting (45.2%), with a preference in metastatic cases (OR: 1.5 95% CI: 1.02-2.3, p = 0.026). 14 thrombotic events reported (efficacy: 98.0%, 95%CI: 96.6-98.8%) and 12 grade 1 bleeding (1.7%, 95%CI: 1.0-3.0%). Conclusions: Prevention of VTE in ambulatory patients with active cancer found effective and safe. Apart from the Khorana score, specific patient characteristics, metastasis, HRTAs and DDIs seemed that affect clinical decision for thromboprophylaxis mainly with LMWHs and often on intermediate dose regardless the clinical setting. Oncologists appeared informed that CAT is not negligible risk. Clinical trial information: NCT03909399. [Table: see text]
Towards a more systematic evaluation of cancer endpoints: A method for synthesis and analysis of NSCLC regulatory filings and clinical evidence.
Authors: Hinkel Jennifer M.
Published: June 2022

e18681

Background: Ongoing debate surrounds the use of surrogate and proxy endpoints in oncology such as Progression Free Survival (PFS) and Overall Response Rate (ORR); the oncology community has debated the utility, meaningfulness, validity, and evidentiary definitions of such outcomes. Literature across disease states points to potential inconsistencies in the reporting of, and definition of, clinical trial endpoints more broadly. No data source currently exists to robustly analyze how endpoints are defined, deployed, and applied across a number of trials within a particular tumor type, let alone across oncologic diseases more broadly. This study presents a systematic method to build such a dataset using regulatory filings and clinical evidence publications. Methods: This study developed a five-step method to synthesize and analyze data in a systematic manner. Given the number of new therapeutic approvals in NSCLC, it was selected as a disease area of focus to test the method. For each step of the method, data was extracted and recorded in a Google Sheets database. Step 1 identified therapy FDA approvals from 2016-2020 via systematic search of the FDA website. Step 2 searched the Drugs@FDA database to identify approval packages. Step 3 synthesized the clinical evidence supporting approvals through systematic analysis of FDA Review Documents. Step 4 identified the published protocol for each study from Step 3 using ClinicalTrials.gov. Step 5 identified publications reporting results from Step 4 using the National Clinical Trial identifier numbers and keywords. Results: A systematic search and synthesis of FDA and clinical trial documentation in this manner yielded a dataset of six first approvals for NSCLC and 27 line extensions for NSCLC indications between 2016 and 2020. Conclusions: Informed debate around the use of proxy and surrogate endpoints is difficult to achieve without an evidentiary basis for the discussion. At present, no data source exists for researchers to answer questions such as: “How frequently was PFS used as the primary endpoint in registrational trials for lung cancer over the past ten years?” By developing and deploying a systematic method as described above, researchers can build such a dataset, and then apply the same method across additional disease states and tumor types to understand a more comprehensive picture of how endpoints are defined, measured, and applied in clinical trials. Not only can such a dataset enable research that informs clinical trial design, but it can also enable research and policy development regarding endpoint fidelity, utility, and meaningfulness.
Reporting consistency in radiation therapy after breast conservative surgery between Arkansas Cancer Registry and all payers claims database.
Authors: Li Chenghui , Malapati Sindhu Janarthanam , Hutchins Laura Fulper
Published: June 2022

e18685

Background: Cancer registries linked to insurance claims databases are an important source for real-world evidence cancer research. However, most studies used SEER-Medicare linked data, which limits studies by location and age. Arkansas has developed an all-payers claims databases (APCD) that includes insurance claims from both public and private payers, enabling tracking patients of all ages throughout the continuum of care and across payers. However, APCD lacks tumor-specific characteristics. Arkansas is one of only four known states that have linked APCD to the state cancer registry. Using Arkansas APCD linked to Arkansas cancer registry (ACR), we evaluated the reporting consistency of radiation therapy (RT) in the two sources. Methods: We identified women > = 18 years who were diagnosed in 2013-2017 with stage 0-3 hormone receptor positive breast cancer who received breast-conserving surgery. Patients must have continuous insurance coverage (any private plans, Medicaid, Medicare Part A and B without any Part C coverage) in the 13 months (month of diagnosis and 12 months after). Receipt of RT was identified independently from ACR and APCD. ACR collects information on RT if it is part of the first course of therapy. In APCD, RT claims within one year of breast cancer diagnosis were identified using procedure codes. We calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for receipt of RT coded by the registry compared with APCD billing claims as the gold standard. We assessed the degree of concordance between the data sources by Cohen’s kappa statistic. Results: Of the 2348 patients, 1477 (62.9%) were documented in the ACR as received RT and had RT claims in the APCD, 498 (21%) were documented in the ACR as not received RT and had no RT claims in the APCD, 183 (7.8%) were documented as received RT in ACR but had no RT claims in the APCD, and 190 (8.1%) were documented as not received RT but had RT claims in the APCD. Using APCD claims as the gold standard, the sensitivity, specificity, PPV and NPV were 88.8%, 72.8%, 88.6%, and 73.1%. Findings were very similar using ACR as the gold standard, the sensitivity, specificity, PPV and NPV were 88.6%, 73.1%, 89.0% and 72.4%. The kappa statistic for agreement between the two sources was 0.62 (95% CI: 0.58-0.65, p = 0.7170). Conclusions: In patients who received BCS, recording of RT receipt was moderately consistent between Arkansas APCD and ACR. Future studies are needed to identify factors affecting reporting consistency to better utilize this unique resource in addressing population health problems.[Table: see text]
Real-world outcomes of neoadjuvant chemotherapy for breast cancer: Reflections from a community cancer center.
Authors: Bhardwaj Prarthna V , Kaufman Seth , Mason Holly , Visintainer Paul , Makari-Judson Grace
Published: June 2022

e18690

Background: Neoadjuvant chemotherapy (NAC) has been historically reserved for patients with locally advanced breast cancers. The utilization of NAC remains highly variable in clinical practice based on tumor size and receptor status. The decision to pursue NAC is often based on discussions by a multidisciplinary team (MDT). This study aims to look at real-world data describing the contemporary use of NAC in patients with early-stage operable breast cancer in a community cancer center and evaluate the effectiveness of MDT at our institution. Methods: We conducted a retrospective descriptive study at UMass Chan-Baystate between Oct 2018 and Oct 2020. We included patients receiving NAC for early-stage operable or locally advanced breast cancer. We excluded patients receiving neoadjuvant endocrine therapy. Primary outcomes were rates of pathological complete response (pCR) after surgery. Secondary outcomes were referral timeliness back to the breast surgeon and radiation oncologist, downstaging of cancer in the breast and axilla. Results: Ninety-three patients underwent NAC, of which 84% were white. The mean age was 56.6 yrs. Of these, 86 (93%) had clinical stage II or III cancer, and 80 (86%) had positive lymph nodes. Forty-two patients (46%) were ER positive, 28 (30%) were HER2 positive and 39 (43%) were triple negative. The most common indication for NAC was to downstage axilla (42%) and for HER2 tailoring of treatment (26%). Of the 93 patients, 23 (25%) achieved pCR; 12 (52%) had triple-negative, 7 (30%) had ER-HER2+, 3 (13%) had ER+HER2+ and 1 (4%) had ER+HER2- breast cancer. Eighty-four patients (91%) had downstaging of breast tumor, and 30 (32.3%) had axillary downstaging. Seventy-eight patients (84%) received adjuvant radiation (RT). All patients (N = 93, 100%) followed up with a surgeon prior to completion of NAC, although only 48 (50%) returned to radiation oncology. The mean time from surgery to RT was 64 days, and 6% underwent RT for more than two weeks beyond the expected time. Conclusions: Overall pCR rates were low; however, a third of patients had axillary downstaging, and the majority had breast tumor downstaging. Of the patients in our cohort who achieved pCR, the majority were triple-negative, followed by HER2 positive, consistent with overall trends. All patients were re-referred to the surgeon prior to completion of NAC for surgical planning and the average time from surgery to radiation was within national standards highlighting effective MDT involvement in the care of patients at our institution.[Table: see text]
Accuracy of magnetic localisation device placement and retrieval in breast cancer patients from a single internationally accredited breast center in Johannesburg, South Africa.
Authors: Benn Carol , van Loggerenberg Dominic
Published: June 2022

e18697

Background: A variety of techniques are used to localise breast cancers prior to breast surgery. One such technique involves the placement of a magnetic device (Magseed). the magnetic device placement data from one radiology unit in a multi-disciplinary unit consisting of 4 radiology units over a 6 month period which sees 450 newly diagnosed breast cancer patients per year and places with over 360 Magseeds in a 6 month period. The aim of the study was to conduct a review of Magseed placement and ease and efficacy of retrieval across varying depths within the breast. Methods: The device used and analyzed in this study is constructed of medical-grade stainless steel magnetized, 1x5mm in size and can be implanted long term. The seeds were placed both under ultrasound guidance and stereotactically, there were no complications at the time of placement. Post-placement ease of localization and retrieval of the Magseed Measurements of distances from the nearest perpendicular skin surface was provided by the radiologist. markers were assessed by confirmation of the presence of the Magseed(s) in the specimen through the use of the Sentimag probe and confirmation visualized by intraoperative radiology and intra-operative pathology. Results: All of the seeds were localised during surgery and retrieved without difficulties reported by surgeons. The use of intraoperative radiology confirmed retrieval of all seeds in all patients. The minimum placement depth was 8.33mm, the maximum placement depth was 87mm and the average placement depth was 47mm. The placement of the seeds were place over a range of times before surgery, from 3 days prior to surgery to up to 249 days. Localisation was 100% successful using the Sentimag probe in theatre, and the retrieval rate was 100% across the full 368 analyzed patient set. . Radiological confirmation of the Magseed placement was confirmed through the use of an intraoperative radiological Biovision machine. Our data shows that Magseeds can be placed across a wide range of breast sizes and at variable depths with no complications or difficulty experienced during intraoperative localization and retrieval of the seeds. Conclusions: The data collected, and the demographic analyzed, shows that magnetic marker placement and retrieval is possible across a wide range of depths in the breast with no complications arising in radiological placement and intraoperative localisation and retrieval. Surgeons reported ease of transcutaneous localisation. A 100% retrieval rate was reported. In all cases, clear margins were achieved with: aid from audio and visual confirmation from the Sentimag probe; intraoperative radiology and intraoperative pathology.
Enabling tandem repeat sequence genotype analysis across capture kits.
Authors: Yip Shun H , Diamreyan Michael , Wong Edmund , Ramamurthy Raghuraman , Tobias Sidney , Cheng Hao , Solovyev Victor , Tang Cheuk Ying
Published: June 2022

e18700

Background: Previous studies on mutation calling have documented capture kit batch effects in Whole Exome Sequencing (WES) data from The Cancer Genome Atlas (TCGA) database, hindering direct comparison between samples from different capture kits. For example, in classification, a cancer type exclusively sampled by a specific capture kit in the training set would have very low accuracy if the testing set was sampled by another capture kit. To enable cross-capture-kit between-cancer genotype analyses with the TCGA dataset, a novel read count transformation algorithm is developed to remove capture kit batch effects. This algorithm was tested with our Machine Learning model which uses Tandem Repeat Sequence (TRS) mutation markers as training features. Methods: The proposed algorithm transforms TRS read count data to remove low quality samples, read depth differences, and capture kit batch effects from the dataset. Results: 1) TRS read count of WES samples are investigated. Particularly, we show that TRS site read counts do not correlate across capture kits but correlate within capture kits. This suggests that WES read count is largely independent from an exon’s location in the genome and is more strongly correlated with capture kit probes. 2) TRS detection rate for each sample within each capture kit is found to be normally distributed. Outliers with very low TRS detection rate can be used for quality filtering. 3) The transformation algorithm effectively removes capture kit batch effects from the dataset. At the same time, it retains cancer-specific signals in the samples. Before applying the transformation algorithm, cancer type classification accuracy is low (̃0-25%) if the testing data set uses a different capture kit from the training data set. We show that applying the transformation algorithm allows cancer type classification accuracy to improve by over 65%. Conclusions: We demonstrated that direct comparison of WES TRS read count data across capture kits is possible after application of our transformation algorithm. This opens the path to cross-capture-kit between-cancer genotype analyses with the TCGA dataset, which were previously unfeasible due to capture kit batch effects.
COVID-19 vaccine uptake in patients with cancer and Sars-Cov-2 infection in 2020: Results from the ASCO registry.
Authors: Hanley Williams Jen Hanley , Bruinooge Suanna Steeby , Kaltenbaugh Melinda , Gralow Julie R. , Garrett-Mayer Elizabeth
Published: June 2022

e18713

Background: The availability of safe and effective COVID-19 vaccines has enabled protections against serious outcomes from SARS-CoV-2 infection. The ASCO Registry provides an opportunity to study the rate of vaccine uptake among patients (pts) with cancer who had SARS-CoV-2 infection prior to availability of vaccines. Methods: Participating US medical oncology practices identify pts eligible for inclusion: pts with a positive SARS-CoV-2 test and, at the same time, either (a) or (b) cancer-free less than 12 months (i.e., in complete remission or post-resection) and receiving adjuvant treatment. Registry data were extracted on 2/4/22. Pts in this analysis had a SARS-CoV-2 positive test between 3/1/2020 and 12/31/2020 and at least one clinical encounter on or after 1/1/21, documenting receipt or not of 1st and 2nd vaccine shots. Pts lacking data on vaccination status in their medical records were excluded from analysis. When the exact date of 1st vaccine shot was known, the primary endpoint was number of days from 1/1/21 to 1st shot date. If the exact date of 1st shot was unknown, date was categorized as within 7 days from the clinical encounter, 2-4 weeks, or more than 1 month prior. Summary statistics and 95% confidence intervals (CIs) were calculated using Kaplan-Meier methods. Results: The Registry included 1260 pts with SARS-CoV-2 infection in 2020. Time to vaccination (described using cumulative incidence) across age categories is shown in Table, with 1/1/21 as the baseline. Median time to vaccination ranged from 63 days in the oldest pts (> 80 years of age) to 220 days in the youngest pts (< 45 years of age). Differences in rates of vaccination uptake were most pronounced in the early months (Jan – Mar) and diminished in April and beyond. Conclusions: Older pts with cancer who were infected with SARS-CoV-2 in 2020 received COVID-19 vaccinations in 2021 at higher rates than those of younger ages. Delayed uptake by younger aged pts at outset could be related to lack of clarity on pts with cancer qualifying for early vaccine access and state policies on availability.[Table: see text]
Effectiveness of COVID -19 vaccine on cancer patients in one Latin American country: A follow-up of ACHOC-C19 study.
Authors: Ospina Serrano Aylen Vanessa , Bruges Maya Ricardo Elias , Ramos Pedro , Triana Ivan , Aruachan Sandra , Quiroga Alicia , Rivas Tafurt Giovanna Patricia , Munevar Isabel , Mantilla William , Avendaño Ana Cristina , Gonzalez Florez Hector Alirio , Jimenez Paola , Pacheco Javier orlando , Pinilla Paola , Manneh Kopp Ray , Ortiz Diaz Juan David , Insuasty Jesus , Alcala Marcela , Barrero Angela , Sanchez-Vanegas Guillermo
Published: June 2022

e18721

Background: In our experience during the first year of development of ACHOC-C19 study, we observed 26% mortality in patients with cancer and COVID 19 infection. The impact of vaccination was not evaluated prior to the implementation of this strategy worldwide in this kind of population. It was proposed to evaluate the effectiveness of immunization during the second phase of our investigation. Methods: Cohort study derived from the National Registry of Patients with Cancer and COVID-19 (ACHOCC-19). Data were collected from June 2021 since vaccine was available. Patients were: older than 18 years, diagnosed with cancer (solid tumors), treated and/or under follow-up, and with COVID-19 infection. The comparative analysis of the vaccinated and non-vaccinated cohort is presented. Outcomes included: all-cause mortality within 30 days of infection diagnosis, hospitalization, and mechanical ventilation. Effect estimation was performed through relative risk (RR) and multivariate analysis for each event, using generalized linear models of the binomial family. Results: 896 patients were included, 470 were older than 60 years (52.4%) and 59% women (n = 530). 172 patients were recruited in the vaccinated cohort and 724 in the non-vaccinated cohort (ratio: 1 to 4.2). The cumulative incidence of hospitalization among the unvaccinated was 42.4% (n = 307), and among the vaccinated, 29% (n = 50); invasive mechanical ventilation requirement was 8.4% (n = 61) in unvaccinated, and 4.6% (n = 8) in vaccinated. The cumulative incidence of mortality from all causes in the unvaccinated was 17% (n = 123) and in the vaccinated 4.65% (n = 8). Table summarizes the multivariate analysis. The adjusted RR for mortality for the unvaccinated is 3.4 (95% CI: 1.7-6.8), for hospitalization 1.36 (95% CI: 1.08-1.72), and for mechanical ventilation 2.1 (95% CI: 1.02-4.2). Conclusions: The incidence of complications and death in patients with cancer and COVID-19 infection is significantly higher in those who have not received a vaccination schedule compared to those who have been vaccinated. Immunization should be promoted and intensified in this population group.[Table: see text]
A single institution cohort of patients with classical Hodgkin lymphoma treated with brentuximab vedotin plus nivolumab.
Authors: Jordan Aryanna , Rose Ashley , Bangash Alizain , Isenalumhe Leidy Lismeri , Gaballa Sameh , Chavez Julio C. , Shah Bijal D. , Sokol Lubomir , Pinilla-Ibarz Javier , Bello Celeste M. , Saeed Hayder
Published: June 2022

e18738

Background: Classical Hodgkin lymphoma (cHL) is a B-cell neoplasm which affects approximately 8,500 new patients annually. The initial remission rate is greater than 80%; however, 10-30% will have refractory or relapsed disease (R/R). Both Brentuximab vedotin (BV) and nivolumab (Nivo) have recently been approved for the treatment of R/R cHL. Previous studies have shown BV+Nivo to be well tolerated, with high response rates and progression free survival (PFS) in two prospective studies. However, no real-world data is available yet for this combination. Here we present clinical characteristics and outcomes of a single institution cohort of patients with cHL who received BV+Nivo. Methods: A retrospective chart review was completed of all patients with cHL who were treated with BV+Nivo at Moffitt Cancer Center between 2018 and 2021. Baseline characteristics and treatment details were obtained. PFS and overall survival (OS) were evaluated using the Kaplan-Meier curve. Results: A total of 29 patients were included in the cohort. Median follow up time was 3 months (range 1-21). 69% (n = 20) of patients were male. Histology types included unclassifiable 48.3% (n = 14), nodular sclerosis 27.6% (n = 8), lymphocyte depleted 13.8% (n = 4), and lymphocyte rich 10.3% (n = 3). 55.2% (n = 16) of patients had B symptoms at presentation. Initial stage included stage 2 (48.3%, n = 14), stage 3 (20.7%, n = 6), and stage 4 (24.1%, n = 7). 34% of the patients were primary refractory to their first line therapy. Median time from last chemo to BV+Nivo was 4.4 months (range 0.5-50 months). BV+Nivo was most often used as 2nd line therapy (51.7%, n = 15) followed by 3rd line therapy (20.7%, n = 6). One patient received BV+Nivo as first line therapy. Median number of cycles was 4 (range 1-15). The overall response rate was 65.5% (n = 19) (complete response 44.8%), and 17.2% (n = 5) had no response. Of the 15 patients receiving BV+Nivo as 2nd line therapy, 66% proceeded to autologous hematopoietic stem cell transplant. 4 patients did not proceed with transplant per their choice, and one patient could not proceed due to progressive disease. The median PFS was 21 months (95% CI: 9 months-non reached). OS was 100%. Conclusions: Here we describe the first real-world outcomes of BV+Nivo in classical Hodgkin lymphoma. In a high risk and refractory population, BV+Nivo showed excellent responses. Further studies are needed to focus on comparing the outcome to a more traditional chemotherapy based approach.
Real-world outcomes of immunotherapy regimens in first line non small cell lung cancer in lebanese patients.
Authors: Nasr Lewis , Diab Saada , Ghoche Ahmad , Yehia Intissar , Nasr Fadi louis
Published: June 2022

e18741

Background: Immunotherapy provides improved treatment efficacy and survival in NSCLC patients. This is well established from clinical trials. However, the effectiveness of immunotherapy in real world practice is not well assessed. We aimed to characterize real-world outcomes for patients with NSCLC treated with 1L I-O in Lebanon. Methods: Patients aged ≥18 years with confirmed metastatic NSCLC who received either 1L I-O monotherapy or single-agent I-O combined with chemotherapy on or after January 1, 2014. Primary objectives were to examine overall survival (OS) and real-world progression-free survival. Multivariable analysis were made on correlation of different factors and survival. Results: among 135 patients, Median age at diagnosis was 68 years Most patients received chemotherapy alone as first line(54%), 18.3 % received immunotherapy and 27.8% received the combination treatment of chemotherapy and immunotherapy. Median PFS 1 was 7.7, 14, 11.1 months for chemotherapy, immunotherapy and chemo-immunotherapy respectively (p = 0.062). Median OS was 22.9 months (CI 95%, 17.7-28.1) with no significant correlation with treatment type (p = 0.85) multivariate analysis showed that having PDL levels between 1 and 49 (HRa = 0.15) and ≥50 (HRa = 0.12) compared to < 1 were significantly associated with longer PFS period, whereas having squamous (HRa = 3.45) and other (HRa = 27.36) type of cancer compared to adenocarcinoma was significantly associated with shorter PFS period. (HRa = 3.28) was significantly associated with lower overall survival period (p = 0.10).Concerning adverse effects, rash was the most frequent (14%) followed by pneumonitis (12.2%). Conclusions: In real world practice, IO was well tolerated in lebanese patients. Patients with high (≥50) and intermediate (between 1 and 49) tumor programmed death ligand 1 (PD-L1) expression demonstrated longer median OS vs those with low expression. We hypothesize that bone metastasis impairs immunotherapy efficacy.
Predicting recurrence of venous thromboembolism in anticoagulated cancer patients using real-world data and machine learning.
Authors: Muñoz Martín Andrés J. , Huerga Domínguez Sofía , Souto Juan Carlos , Rogado Revuelta Jacobo , Sanchez Antonio , Garcia-Palomo Andres , Aparicio Jorge , Aguayo Cristina , Gutierrez Abad David , Ortega Laura , Viñuela-Benéitez Maria Carmen , Fanjul Victor , Casadevall David , Arumi Daniel , Hernández-Presa Miguel Ángel
Published: June 2022

e18742

Background: The clinical predictors of venous thromboembolism (VTE) recurrence in patients with cancer are not well known. Our objective was to develop a predictive model for risk of VTE recurrence in anticoagulant-treated cancer patients within the first 6 months following VTE diagnosis. Methods: Using the EHRead technology, based on Natural Language Processing (NLP) and machine learning (ML), the unstructured clinical data in EHRs from 9 Spanish hospitals between 2014 and 2018 was extracted and analyzed. The study population, comprising all adult anticoagulated cancer patients with VTE, was downsampled to prevent bias and class imbalance. A total of 94 patient characteristics were explored, and Random Forest (RF) feature selection was performed to identify the most relevant predictors for VTE recurrence. Multiple algorithms were used to train different prediction models, which were subsequently validated in a hold-out dataset. The model with the best performance metrics (i.e., ROC-AUC) was selected as the final model. Results: From a source population of 2,893,208 patients, 21,227 anticoagulant-treated patients with VTE and active cancer (53.9% male, median age of 70 years) were identified. Across the study period, yearly incidence of VTE remained relatively stable, ranging from 2.7 to 3.9%. The most common type of VTE was deep vein thrombosis (68.2% of patients), followed by pulmonary embolism (28.4%). Regarding primary cancer locations, the most frequent were colorectal (10.1%) and lung cancer (8.5%). Of all trained and validated models, the RF approach yielded the best performance, with a ROC-AUC = 0.72. The following predictors of VTE recurrence were identified: pulmonary embolism, deep vein thrombosis, metastasis, adenocarcinoma, hemoglobin values, serum creatinine values, platelet count, leukocyte count, family history of VTE, and patients’ age. Conclusions: Using NLP and ML, we were able to use the real-world data in EHRs to build a predictive model of VTE recurrence in cancer patients based on individual clinical features. These results may improve the clinical management of VTE recurrence in this population.
Using Charlson comorbidity index (CCI) to predict outcomes of older patients with acute promyelocytic leukemia (APL).
Authors: Dhakal Prajwal , Lyden Elizabeth , Pyakuryal Avantika , Rai Manoj P. , Bhatt Vijaya Raj
Published: June 2022

e18751

Background: A large-scale study specifically analyzing an association between comorbidity burden and outcomes is lacking in APL. We hypothesized that a greater comorbidity burden independently predicts worse outcomes in patients ≥60 years with APL. Methods: We utilized the National Cancer Database to identify patients ≥60 years diagnosed with APL between 2004 and 2015. CCI scores were used to evaluate comorbidity burden, and patients were divided into 3 groups with CCI of 0, 1, and ≥2. We used chi-square test to determine association between CCI and different variables. Multiple logistic regression analyses and Cox regression models evaluated the effects of CCI on one-month mortality and overall survival (OS), respectively. Results: Of 2221 patients, 59% had CCI of 0, 27% had CCI 1, and 14% had CCI ≥2. Compared to patients with CCI 1 or CCI ≥2, a higher proportion of patients with CCI 0 had private insurance, and higher education and income status, were treated at academic centers, and received multiagent therapy. One-month mortality was 16%, 24%, and 32% for patients with CCI 0, 1, and ≥2, respectively. After adjusting for other co-variates, patients with CCI 0 had lower one-month mortality compared to CCI 1 (Odds ratio 1.67, 95% confidence interval [CI] 1.29-2.16, p < 0.001) and CCI ≥ 2 (Odds ratio 2.31, 95% CI 1.70-3.13, p < 0.001). Three-year OS was 61%, 53%, and 38% for patients with CCI 0, 1, and ≥2, respectively. After adjusting for other co-variates, OS was worse among patients with CCI 1 (Hazard ratio 1.27, 95% CI 1.10-1.46, p-value < 0.001) and CCI ≥2 (Hazard ratio 1.74, 95% CI 1.48-2.06, p-value < 0.001), compared to patients with CCI 0. Conclusions: Our study is among the first and the largest to examine an association between comorbidity burden and outcomes in older adults with APL. Greater comorbidity burden, indicated by higher CCI, predicted worse one-month mortality and OS, after adjusting for other co-variates. Thus, our study results establish CCI as an important and independent predictor of outcomes in APL. The study results can inform personalized estimates of mortality and OS based on comorbidity burden and facilitate treatment decision-making. Given the significant differences in outcomes of older adults based on comorbidity burden, future trials in APL should present comorbidity data and consider utilizing CCI to risk-stratify patients.
Off study utilization of an unpublished trial regimen: A real-world analysis of GOG258-eligible cohorts.
Authors: Lee Sarah S. , Weil Christopher R. , Boyd Leslie R. , DeCesaris Cristina , Gaffney David K. , Suneja Gita
Published: June 2022

e18763

Background: Practice patterns in the management of advanced endometrial cancer are widely variable and treatment paradigms are rapidly changing given the evolving clinical trial landscape. Prior studies have demonstrated “medical reversals” where clinicians favor or utilize the experimental approach only to find inferiority on publication of results. The objective of this study was to examine the utilization of the GOG 258 arms-- (adjuvant chemotherapy (CT) vs chemoradiotherapy (CRT)-- for patients with advanced or high-risk endometrial cancer. Methods: Patients 18 years or older who underwent staging surgery with stage III/IVA endometrial carcinoma of any histology or stage I/II clear cell or serous histologies with positive washings diagnosed between 2004 and 2018 were identified in the National Cancer Database. Utilization of adjuvant CT and CRT were examined in the pre-GOG 258 era (before 2009), during GOG 258 enrollment (2010-2017), and after publication of results (2018). Two-sided Cochrane-Armitage test assessed trends over time. T-test and chi-square tests assessed differences in groups receiving CT alone vs CRT. Multivariable logistic regression assessed factors associated with receipt of CRT. Propensity score matching accounted for baseline differences in groups receiving CT vs CRT. Results: 40,028 patients were included. 16,342 (41%) received adjuvant CT and 23,686 (59%) received adjuvant CRT. The majority of patients (39,185, 98%) were advanced stage and 19,616 (49%) were endometrioid histology. 90% of patients receiving both CT and CRT received multiagent therapy. Utilization of CRT was 54% before GOG 258 opening, 60% during GOG 258 enrollment, and 67% after publication of results (p < 0.001). Factors associated with receipt of CT alone were age greater than 70 (adjusted odds ratio [aOR] 0.68, 95% confidence interval [CI] 0.46-0.99), non-Hispanic Black race (aOR 0.84, CI 0.77-0.92), serous and clear cell histologies (aOR 0.68, CI 0.59-0.77; aOR 0.74, CI 0.57-0.95), living greater than 50 miles from treatment facility (aOR 0.84, CI 0.77-0.92), and receiving care in the Midwest, South, and West regions (aOR 0.84, CI 0.78-0.90; aOR 0.69, CI 0.64-0.76; aOR 0.72, CI 0.66-0.78). Compared to an academic medical center, receiving care at a comprehensive community cancer center was associated with receipt of CRT (aOR 1.2, CI 1.2-1.3). Compared to pre-GOG 258 opening in 2009, patients were more likely to receive CRT during GOG 258 enrollment (aOR 1.2, CI 1.1-1.3) and immediately after results announcement in 2018 (aOR 1.7, CI 1.5-1.8), despite results showing that CRT was not associated with longer relapse-free or overall survival. Conclusions: For patients with advanced endometrial cancer, there was significant use of both study arms with increases in CRT use during the study enrollment period and immediately after reporting of GOG 258 results, despite lack of benefit in the CRT arm.
Real-world data comparing third and subsequent line regimens for treatment of metastatic triple-negative breast cancer in the United States.
Authors: Aran Dvir , Klein-Brill Avital , Fisch Michael Jordan , Amar-Farkash Shlomit
Published: June 2022

e18765

Background: Eribulin is a commonly prescribed regimen for metastatic triple negative breast cancer (mTNBC) patients pre-treated with one or more chemotherapy regimens, although no clear survival benefit has been shown when compared to treatment of physician's choice (TPC) [1]. Here, using real-world oncology data we compare the impact of treatment with Eribulin vs. other common chemotherapies as third and subsequent lines of therapy on overall survival and post-treatment hospitalizations. Methods: We performed a retrospective cohort study of third and subsequent lines (3L+) treatment of patients with mTNBC between 1/2016 and 6/2021 using administrative claims data from the Anthem Cancer Care Quality Program. Real-world overall survival (rwOS) was defined as time from diagnosis to death. Real-world overall survival (rwOS) was defined as time from diagnosis to death. A Cox model with inverse probability of treatment weighting was used to adjust for age, ECOG, socioeconomic status, comorbidity, and liver and bone metastatic sites. Median rwOS was estimated using the weighted Kaplan-Meier method. Adjusted hazard ratios (aHR) were estimated using weighted Cox proportional hazards models. Results: We identified 210 (52%) individuals with mTNBC who received Eribulin (E) for 3L+, compared to 189 patients treated with other chemotherapies (O), which include carboplatin+gemcitabine, nab-paclitaxel, vinorelbine, paclitaxel, carboplatin and nab-paclitaxel+atezolizumab, ordered by frequency. We found no significant difference in any of the demographic and clinical features tested between the groups (Table). Median rwOS in the E group was 6.4 months, compared to 7.6 months in the O group (p-value = 0.4). In adjusted survival analyses to known confounders, E showed no significant difference in mortality (aHR: 1.09, 95% Confidence Interval [CI]: 0.87-1.37, p-value = 0.46). Furthermore, we found no significant difference in hospitalizations following the treatment between the E to the O group (36% vs. 39%, p-value = 0.6), length of stay (7 vs. 8 days, p-value = 0.8) and classes of associated severe adverse events. Conclusions: Our analysis of real-world oncology data aligns with National Institute for Health and Care Excellence (NICE) recent recommendation in showing no survival benefit or reduction in post-treatment adverse events when treating with Eribulin at 3L+ in metastatic TNBC patients.[Table: see text]