bluuebunny/crossref_metadata_2025_split huggingface dataset:
Disruptions to U.S. medical oncology care during the COVID-19 Pandemic: CancerLinQ Discovery (CLQD) analysis.
Authors: Jazieh Abdul-Rahman , Riffon Mark , King Jennifer C. , Rocque Gabrielle Betty , Paskett Electra D. , Potter Danielle M. 
Published: June 2021

6547 Background: The COVID-19 pandemic disrupted all facets of healthcare delivery including cancer care. This study evaluates the disruptions to US medical oncology practice during the pandemic in terms of number and type of patients (pts) encounters to determine the impact on continuity of patient care. Methods: We conducted a retrospective cohort analysis using the CLQD electronic health record database, containing data from 2+ million pts from all 50 states. We assessed changes in the monthly proportions of visit encounter types (in-person outpatient [IPOP] and telehealth [TE]) for new and established patients (NP and EP) with an invasive malignancy, benign or in situ neoplasm, or benign hematology diagnosis having an encounter between 1/1/2018 and 9/30/2020. Results: 781,945 pts were studied. Median age on 1/1/2018 was 64 years (IQR: 53-73), 38% were female, and 58% had an invasive malignancy. From 12/2019 to 9/2020, total monthly encounters dropped from 157,964 to 90,662. Monthly IPOP visits for NP dropped from 11.2% to 7.9%, an absolute drop of 3.3% and a relative drop of 30%; TE for NP increased by 1.1% (Table). Monthly IPOP visits for EP, as a percentage of all visits, dropped from 94.4% to 86.6% from 12/2019 to 6/2020 but rebounded to 90.4% by 9/2020. Fraction of TE increased substantially during the pandemic period reaching a peak in 6/2020 (13.8% for EP and 1.6% for NP) and decreased in 9/2020 to 9.6% and 1.1% for EP and NP, respectively. Compared to non-Hispanic patients, Hispanic patients had a larger reduction in IPOP and more TE during the study period. Percentage of monthly encounters, by type, from baseline*. Conclusions: We observed a reduction in the absolute number and monthly percentage of IPOP encounters during the COVID-19 pandemic. For EP, increases in TE does not fully compensate for reductions in IPOP. The reduction in IPOP NP encounters is particularly concerning since it was not accompanied by a compensatory increase in TE. The reduction in NP is consistent with reported pandemic-associated reductions in cancer screening and suggest a notable delay in cancer diagnoses during the pandemic. Reduction in Hispanic IPOP encounters warrants further evaluation.[Table: see text]
Effect of income on patient decision-making in localized prostate cancer.
Authors: Shen Xinglei , Cao Ying , Katz Aaron J. , Usinger Deborah , Walden Sarah , Chen Ronald C. 
Published: June 2021

6552 Background: Socioeconomic status affects goals of care and treatment choices. We investigated the impact of low household income on diagnosis, goals of care, and treatment choice in patients with localized prostate cancer. Methods: The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) is a population-based cohort of prostate cancer patients identified at the time of diagnosis, enrolled from 2011-2013, and followed prospectively. Sociodemographic information and decision making factors including goals of care were collected by patient report. Patients were asked to rate the importance of quality of life, cure, burden to friends and family, cost, and effect on daily activity as well as which of these goals was the most important in their treatment decision making. Annual household income was stratified in to 3 levels: < 40K (low), 40-90K (middle),>90K (high). Results: Of 1382 patients, 539 (39%), 553 (40%), and 290 (21%) reported low, medium, and high household income. Lower income patients were less college educated, more frequently unemployed, and had higher rates of either no insurance or government sponsored insurances. Low income patients had higher PSA and worse clinical stage at diagnosis. In goals of care, low income patients more frequently rated high importance on burden (78.8% vs 76.0% vs 65.2% p<0.01) and cost of cancer (61.2% vs 38.5% vs 14.5% p<0.01), and factors other than cure as the most important treatment decision factor. While overall treatment rate at 1 year was similar by income group, the type of treatment differed. On multivariate analyses, adjusting for age, race, clinical risk group, employment, insurance, and treatment goal, high income was associated with increased odds of having surgery (OR 1.81, CI 1.16 – 2.81), and reduced odds of having radiation (0.60, CI 0.36-0.99). Conclusions: Poor patients with low household income have worse prostate cancer at diagnosis. These patients have different goals of care which impact their choice of treatment. These findings provide novel insight into disparities in diagnosis and outcome in prostate cancer.[Table: see text]
Long-term trend of quality-adjusted time without symptoms or toxicities (Q-TWiST) of nivolumab+ipilimumab (N+I) versus sunitinib (SUN) for the first-line treatment of advanced renal cell carcinoma (aRCC).
Authors: Motzer Robert J. , Choueiri Toni K. , May Jessica , Kwon Youngmin , Rusibamayila Nifasha , Botteman Marc , Hamilton Melissa , Ejzykowicz Flavia , Cella David 
Published: June 2021

6568 Background: After a minimum follow-up of 48 months (mos), the CheckMate 214 trial (phase 3, NCT02231749) continued to demonstrate a significant overall (OS) and progression-free (PFS) survival benefit for N+I vs. SUN in aRCC patients (pts) with intermediate (I) or poor (P) International Metastatic RCC Database Consortium (IMDC) risk factors (median OS: 48.1 vs. 26.6 mos, HR: 0.65, 95% confidence interval [95% CI]: 0.54, 0.78; 48-mos PFS: 32.7% vs. 12.3%, HR: 0.74, 95% CI: 0.62, 0.88) (Albiges et al. ESMO Open 2020). To further understand the clinical benefits and risks of N+I vs. SUN, we evaluated the Q-TWiST over time using up to 57 mos of follow-up in CheckMate 214. Methods: OS was partitioned into 3 states: time with any grade 3 or 4 adverse events (TOX), time without symptoms of disease or toxicity (TWiST), and time after progression (REL). The Q-TWiST is a metric that combines the quantity and quality (i.e., “utility”) of time spent in each of the 3 states TWiST, TOX, and REL. Prior research (Revicki et al, Qual Life Res, 2006) has established that relative gains in Q-TWiST (i.e., Q-TWiST gain divided by OS in SUN) of ≥ 10% and ≥ 15% can be considered as “clinically important” and “clearly clinically important”, respectively. Non-parametric bootstrapping was used to generate 95% CIs. To observe changes in quality-adjusted survival gains over time, absolute and relative Q-TWiST were calculated up to 57 mos at intervals of 12-mos. Results: With 57-mos follow-up, compared to SUN pts, N+I pts (N = 847) had significantly longer time in TWiST state (+7.1 mos [95% CI: 4.2, 10.4]). The between-group differences in TOX state (0.3 mos [95% CI: -0.2, 0.8]) and REL state (-1.2 mos [95% CI: -4.1, 1.5]) were not statistically significant. The Q-TWiST gain in the N+I vs. SUN arms was 6.6 mos (95% CI: 4.1, 9.4), resulting in a 21.2% relative gain. Q-TWiST gains progressively increased over the follow-up period and exceeded the “clinically important” threshold around 27 mos (Table). These gains were driven by steady increases in TWiST gains from 0.4 mos (after 12 mos) to 7.1 mos (after 57 mos). Conclusions: In CheckMate 214, N+I resulted in a statistically significant and “clearly clinically important (≥ 15%)” longer quality-adjusted survival vs. SUN, which increased over the longer follow-up time. Q-TWiST gains were primarily driven by time in “good” health (i.e., TWiST), which largely resulted from the long-term PFS benefits seen for N+I vs. SUN. Clinical trial information: NCT02231749. [Table: see text]
Post-intervention lung cancer screening compliance among internal medicine resident physicians at a primary care clinic in Hartford, Connecticut.
Authors: Lopetegui-Lia Nerea , Condit Daniel , Castor Lima Gian Carlo , Drekolias Dimitrios , Hundal Jasmin , Jafri Syed Imran Mustafa , Vredenburgh James 
Published: June 2021

6569 Background: Lung cancer (ca) screening has shown to reduce mortality by up to 20%.Despite this, only 4% of eligible patients in the US undergo screening. Our initial analysis revealed that 18.3% of patients who met screening criteria had an appropriately ordered LDCT scan, with an 8.7% completion rate. The aim of this study was to improve lung ca screening compliance following the USPSTF guidelines among residents from the University of Connecticut Internal Medicine (IM) residency program at a Clinic in Hartford, Connecticut. Methods: Care provided to patients by an IM resident at the Gengras Clinic were included. After initial data was gathered, we implemented an intervention to improve screening compliance between October 2019 and March 2020, when SARS-CoV-2 pandemic occurred and routine services were interrupted. USPSTF screening guidelines were emailed monthly to residents and attendings; they were reminded of the importance of lung ca screening; updating the pack-year smoking history; as well as instructions on correctly ordering LDCT and documenting shared decision making, which is needed for insurance approval. In-person reminders also occurred at the clinic. Results: Post-intervention, 601 charts were reviewed. 168/601 (27%) patients met screening criteria. 433 patients were excluded due to unclear pack-year, did not meet screening criteria, were deceased or last seen at the clinic prior to the intervention. 63/168 (37.5%) met the criteria and had an appropriately ordered LDCT; 51/168 (30.35%) had a completed LDCT in chart. The remaining 12/168 (7.14%) with an appropriately ordered LDCT, had it scheduled at the time of data collection or it had been cancelled for unclear reasons. 20 patients’ LDCT was ordered by their pulmonologist. 94 (62.5%) who met screening criteria did not have a LDCT ordered. 11 patients with a smoking history, who did not meet screening criteria had a LDCT ordered because of clinical suspicion for cancer. Lastly, 4/168 (2.4%) had a diagnosis of personal history of lung ca. Conclusions: After our educational intervention, patients who qualified had an increase of LDCT being ordered (37.5% from 18.3%) and completed (30.3% from 8.7%). This is, to our knowledge, the first study of its kind. We identified areas of improvement that were key to achieving higher screening rates: educating all residents and attendings on lung ca screening guidelines; educating patients on the importance of undergoing screening tests; creating a best practice advisory in the electronic medical record system that reminds provider to input pack-year smoking history and if the criteria for screening is met, a pop-up prompting the provider to order LDCT; obtaining insurance approval; and lastly, stressing the importance on screening and overall outcomes.
A review of evidence supporting NCCN category 2B off-label recommendations for determination of Medicare reimbursement eligibility.
Authors: DiScala Molly Erin , Carson Kenneth Robert , Grad Gary Irving , Mahon Brett 
Published: June 2021

6576 Background: Antineoplastic indications supported by a category 1 or 2A NCCN recommendation are reimbursed by insurance and Medicare, as are FDA-approved indications. While initial reimbursement requests for “off-label” NCCN category 2B indications may be denied, Medicare will reimburse off-label antineoplastic use supported by evidence from a peer-reviewed publication from one of 26 designated journals. Here, we evaluated the published clinical evidence supporting NCCN category 2B indications. Methods: Category 2B drug indications for the 10 most common solid tumor types were identified in the NCCN compendium (n=104). The results were then filtered to include drugs with only category 2B indications in a particular tumor type (n=14). Similarly, FDA-approved indications were excluded, resulting in a list of drugs with only a 2B indication that are not FDA approved in the specified cancer type (n=8). Published clinical studies supporting these category 2B indications were assessed for study type and journal name in PubMed, and journal names were cross-referenced with the CMS-supported list. Results: Among the 8 non-FDA-approved drug indications with only category 2B recommendations, 7 (87%) had at least one publication of a clinical trial in one of the 26 designated journals. The only 2B indication without supporting literature was single-agent gemcitabine hydrochloride in bladder cancer. For further details, see Table. Conclusions: These results suggest that clinicians should consider pursuing the appeals process and provide supporting evidence in cases of claim denial. While coverage is not guaranteed, the evidence supporting 2B indications frequently meets the criteria identified in the Medicare statute. Further studies will evaluate if these findings extrapolate to less common tumor types.[Table: see text]
Clinical trial representativeness and treatment intensity in a real-world sample of women with early-stage breast cancer.
Authors: Caston Nicole E. , Williams Courtney , Franks Jeffrey , Aswani Monica S. , Azuero Andres , Gidwani Risha , Rocque Gabrielle Betty 
Published: June 2021

6584 Background: Early stage breast cancer (EBC) treatment is used in women of all ages, races, and health states. However, as clinical trials often do not represent real-world populations, the extent to which evidence-based treatments are prescribed to populations not well represented in these trials is not known. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials. Methods: This retrospective cohort study used the nationwide de-identified electronic health record derived Flatiron Health database for patients diagnosed with EBC between 2011-2020. We categorized treatments as either high- (AC-TH [doxorubicin, cyclophosphamide followed by paclitaxel or docetaxel, trastuzumab]; ACT [paclitaxel or docetaxel, doxorubicin, cyclophosphamide]; TCH [paclitaxel or docetaxel, carboplatin, trastuzumab]; TCHP [paclitaxel or docetaxel, carboplatin, trastuzumab, pertuzumab]) or low-intensity (AC [doxorubicin, cyclophosphamide]; TC [paclitaxel or docetaxel, cyclophosphamide]; TH [paclitaxel or docetaxel, trastuzumab]). Unrepresented patients often have one or more comorbidities and/or prior cancer; underrepresented patients are typically Black, Indigenous, people of color, or of age extremes ( < 45, 70+); well represented patients are White and between the ages of 45-69. Odds ratios (OR), predicted proportions, and 95% confidence intervals (CI) from a two-level (patients nested in practice) hierarchical logistic regression model evaluated associations between receipt of high-intensity chemotherapy and patient characteristics of clinical trial representation (age, race/ethnicity, presence of comorbidity). Results: Our study included 970 patients with EBC with 13%, 45%, and 41% characterized as unrepresented, underrepresented, and well represented in clinical trials, respectively. In the adjusted model, those aged ≥ 70 vs 45-69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26-0.60), while those aged < 45 vs 45-69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10-3.01). The predicted proportion of patients receiving a high-intensity treatment was 87% (95% CI: 80%-92%) for patients aged < 45, 79% (95% CI: 74%-84%) for patients aged 45-69, and 60% (95% CI: 50%-70%) for patients aged ≥ 70. Neither race/ethnicity nor comorbidity status were associated with odds of receiving high-intensity chemotherapy. Conclusions: Over half of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity, despite a lack of evidence that these differences are appropriate. Widening clinical trial eligibility criteria is one way to better understand survival outcomes, identify potential toxicities, and ultimately make evidence-based treatment decisions using a more diverse sample.
Efficacy and cost-effectiveness of breast cancer (BC) screening in female survivors of childhood Hodgkin lymphoma (HL).
Authors: Wong Florence Lennie , Lee Janie M. , Leisenring Wendy M. , Neglia Joseph Philip , Howell Rebecca M. , Smith Susan A. , Oeffinger Kevin C. , Moskowitz Chaya S. , Henderson Tara O. , Mertens Ann , Nathan Paul C. , Yasui Yutaka , Landier Wendy , Armstrong Gregory T. , Robison Leslie L. , Bhatia Smita 
Published: June 2021

6593 Background: Female childhood HL survivors treated with ≥10 Gy of chest radiation are at high risk of developing BC. The Children’s Oncology Group (COG) guidelines recommend lifetime annual mammography (MAM) and breast Magnetic Resonance Imaging (MRI) starting 8y after chest radiation or age 25, whichever is later, and clinical breast examination (CBE) annually from puberty and semiannually from age 25. Initial model results suggest that CBE adds no survival benefit in this cohort. Digital breast tomosynthesis (DBT) is increasingly replacing digital MAM in clinical practice. Here, we present the efficacy and cost-effectiveness of COG’s imaging-based screening recommendations. Methods: Life-years (LYs), quality-adjusted LYs (QALYs), BC mortality, and costs (2017 U.S.$) were estimated from simulating the lifetimes of 5-million chest-irradiated 25y old HL survivors who underwent BC screening with each of the following strategies: annual digital MAM, MRI, MAM+MRI, annual DBT or DBT+MRI from age 25 onward. Treatment-related BC risk (in-situ and invasive) and non-BC mortality were estimated from female 5y HL survivors in the Childhood Cancer Survivor Study and from U.S. population rates. Test sensitivity was 70-74% for MAM (based on prior HL studies) and 89% for DBT and MRI (based on women at high risk of de novo BC). Costs and quality of life weights were obtained from medical literature. Results: For HL survivors with no screening, lifetime BC risk was 42.7% and BC mortality was 18.1%. BC risk and non-BC mortality were, respectively, 7.4- and 5.2-fold higher at age 50 in HL survivors relative to the general population. Screening at ages 25-74 had similar LY gain and BC mortality reduction compared to lifetime screening; hence, we focused on screening for ages 25-74. For all strategies screening provided LY gain of 0.34-0.47 and reduced BC mortality by 6.7-9.8% compared with no screening; incremental cost-effectiveness ratio (ICER), or cost per QALY gained, for MAM alone was $58,726 and for DBT alone was $62,989. ICER of adding MRI to MAM ($385,285) or to DBT ($513,358) indicated lower cost-effectiveness of supplemental MRI (Table). Conclusions: Annual screening at ages 25-74y in chest-irradiated HL survivors appears beneficial. Using $100K per QALY gained as cost-effectiveness threshold, annual MAM or DBT are more cost-effective, whereas adding MRI to MAM is less cost-effective.[Table: see text]
OPTIC primary analysis: A dose-optimization study of 3 starting doses of ponatinib (PON).
Authors: Cortes Jorge E. , Apperley Jane , Lomaia Elza , Moiraghi Beatriz , Undurraga Sutton Maria , Pavlovsky Carolina , Chuah Charles , Sacha Tomasz , Lipton Jeffrey Howard , Schiffer Charles , McCloskey James K. , Hochhaus Andreas , Rousselot Philippe H. , Rosti Gianantonio , De Lavallade Hugues , Mauro Michael J. , Hall Tracey , Lu Vickie , Srivastava Shouryadeep , Deininger Michael W 
Published: June 2021

7000 Background: PON, a third-generation tyrosine kinase inhibitor (TKI), demonstrated deep and long-lasting responses and survival in patients (pts) with chronic-phase chronic myeloid leukemia (CP-CML) resistant/intolerant to second-generation TKI therapy (PACE; NCT01207440); post hoc analysis suggested a relationship between dose and both adverse events and response. Here we present the primary analysis of OPTIC (NCT02467270), an ongoing, randomized, phase 2 trial with a novel response-based dosing regimen of PON in pts with resistant/intolerant CP-CML. Methods: Pts with CP-CML resistant/intolerant to ≥2 TKIs or with the BCR-ABL1 T315I mutation were randomized to PON starting doses of 45 mg (cohort A; 45 mg → 15 mg), 30 mg (B; 30 mg →15 mg), and 15 mg (C) once daily. Doses were reduced to 15 mg with achievement of ≤1% BCR-ABL1IS in cohorts A and B. The primary endpoint is ≤1% BCR-ABL1IS at 12 mo; secondary endpoints include cytogenetic and molecular responses and safety outcomes. AOEs were adjudicated prospectively by an independent review committee. Results: 283 pts were randomized (A/B/C: n=94/95/94) and had the following baseline characteristics: median age 48 y (18‒81 y); 98% received ≥2 (55% ≥3) TKIs; 99% had resistant disease; 40% had ≥1 baseline mutations (23% T315I). At the primary analysis with 32 mo median follow-up, 134 pts (47%; n=50/41/43) remained on treatment and 204 pts (72%) had PON exposure ≥12 mo. At 12 mo, 44% (41/93) in A, 29% (27/93) in B, and 23% (21/91) in C achieved ≤1% BCR-ABL1IS (Table); primary endpoint was met by cohort A. Dose reductions to 15 mg after achieving response (A/B) were 48/29%. Most common grades ≥3 TEAEs were thrombocytopenia, 27%; neutropenia, 17%; and anemia, 7%. AOEs/serious AOEs were reported in cohorts A (10%/4%), B (5%/4%), and C (3%/3%). Dose reductions or discontinuations for TEAEs (A/B/C) were 46/35/32% and 19/16/14%, respectively. Conclusions: The OPTIC primary analysis demonstrates the optimal benefit:risk profile for PON was achieved with a response-based dosing regimen starting with 45 mg/d, followed by dose reduction to 15 mg/d upon achieving ≤ 1% BCR-ABL1IS; 30 mg→15 mg and 15 mg cohorts may provide benefit, especially in pts without T315I mutation (Table). The observed ≤1% BCR-ABL1IS responses are supported by robust survival outcomes in pts with CP-CML resistant to second-generation BCR-ABL1 TKI therapy, both with and without BCR-ABL1 mutations. Clinical trial information: NCT02467270. [Table: see text]