bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comorbidities and patient-reported outcomes among individuals with cancer enrolled in a digital health coaching program.
Authors: Brassil Kelly Jean , Patterson Jonathan , Allison Matthew , Burton Stephen , Norbu Thupten , Rasulnia Mazi , Patel Dhiren 
Published: May 2020

e19278 Background: Many individuals with cancer, as high as 90% in some studies, experience co-morbidities, which are associated with survival, quality of life and health care costs. Patient reported outcomes (PRO) have demonstrated efficacy in tracking outcomes for individuals with cancer and other chronic conditions. We present real world evidence of co-morbidities and PRO data from a cohort of individuals with cancer engaged in a digital health coaching program. Methods: A retrospective analysis was conducted of self-reported co-morbidity data and PROs collected from individuals with cancer upon enrollment in a digital health coaching program. Descriptive statistics define frequency of co-morbidities and means of PRO, including the Patient Reported Outcome Measures Information System-Global Health (PROMIS-GH)10, for individuals with cancer only compared with those who also had a co-morbid condition. Results: Of 570 individuals, 127 reported a co-morbid condition on enrollment into the coaching program (22%). Of these, 49.6% (n = 63) reported 1, and 50.4% (n = 64) reported 2 or more conditions, of which the most commonly reported were cardiovascular (45.6%), metabolic (39.3%), and immune-related (22.8%). Mean PRO scores at baseline are presented for each measure for individuals who reported either no or 1 or more co-morbid conditions at baseline (Table). Interestingly individuals with at least 1 comorbidity reported higher PRO scores for physical and mental health at baseline than those with cancer alone. Conclusions: Co-morbid conditions, while known to influence clinical outcomes among individuals with cancer, may also influence trends in PRO. Higher scores in this cohort may suggest that experience with a pre-existing condition may support the individual’s ability to cope with a cancer diagnosis and its physical and emotional sequelae. Digital health coaching may offer a unique non-clinical approach to gather this data and to support individuals to optimize self-efficacy, improving health outcomes beyond the clinical setting. [Table: see text]
An evaluation of administrative data linkage for measurement of real-world outcomes of large clinical panel sequencing for advanced solid tumors.
Authors: Saleh Ramy , Bedard Philippe L. , Nguyen Paul , Malone Eoghan Ruadh , Yu Celeste , Amir Eitan , Earle Craig , Gyawali Bishal , Hansen Aaron Richard , Mittmann Nicole , Peng Yingwei , Pugh Trevor J , Abdul Razak Albiruni Ryan , Sabatini Peter , Spreafico Anna , Stockley Tracy , Torchia Jonathon , Williams Christine , Siu Lillian L. , Hanna Timothy P 
Published: May 2020

e19303 Background: There is limited real-world evidence of impact of large clinical panel sequencing on treatment-matching for patients with advanced solid tumors. The province of Ontario has a single payer, publicly funded health care system. We linked genomic testing results from a prospective province-wide trial, OCTANE (Ontario-Wide Cancer TArgeted Nucleic Acid Evaluation), to administrative data to determine the feasibility of this approach for evaluating survival and the impact of sequencing on treatment matching. Methods: We linked all Ontario patients from Princess Margaret (PM) with panel testing results (tumor-only 555-gene panel) to province-wide administrative data on treatments and outcomes. Patients were recruited from August 2016 to August 2018. Only clinically actionable variants based upon OncoKB annotation (Level 1 and 2) were assessed for genotype-informed treatment matching. Results: All 888 eligible patients were successfully linked to administrative data. Mean age was 58 (±13) years, 635 (71.5%) were female. Most common disease sites were ovary (26.4%), uterus (14.0%), colorectal (11.8%) and breast (9.5%). Administrative data vital status was more complete than trial collected data with 262 of 476 deaths only recorded in administrative data. Median survival was 1.70 years (95% confidence interval 1.50-1.91). 247 (27.8%) had actionable mutations, most commonly PIK3CA (54.7%), BRCA1 (15.8%), BRCA2 (15.0%) and BRAF (8.9%). 37 (15.0%) and 42 (17.0%) patients with actionable mutations received targeted therapy within 6 and 12 months of test report date, respectively. Conclusions: This is the first known feasibility study of linked administrative data to measure outcomes of large clinical panel sequencing for patients with advanced solid tumors. Vital status was more complete with administrative data compared to trial-collected data, and treatment data was successfully linked. About one in twenty-one enrolled patients received genome-informed treatments within 12 months, or about one in six of all patients with actionable mutations. This may be due to short interval follow up, trial and drug access, successful standard of care treatments, early patient deterioration or limited alterations covered by the panel, among other causes.
Profile of cancer patients admitted in a emergency room of a charity hospital in Southeast Brazil.
Authors: Aleixo Sabina B. , Meneguelli Daiana , Molina Nicolly Del Carmen Parra , Pulido Jose Zago 
Published: May 2020

e19307 Background: Given the increase in cancer cases worlwide, there has been a high demand for urgent and emergency care by oncologic patients. Despite the high demand there is still a lack of studies on the oncological population in the context of urgency and emergency especially in the developing countries like Brazil. Methods: Retrospective longitudinal study. Sample consisted of the medical records of cancer patients who were admitted to the service, selected according to the inclusion and exclusion criteria, covering a period of one year. The variables evaluated were: age, gender, comorbidities, primary site, metastasis, intrahospital transfer, discharge type, days of hospitalization, hospitalizations within one year. Results: Identified 388 patients with a total of 1235 consults among them.; 237 (60.9%) were male, with mean age of 66.5 years old; 151 (39.1%) were female with a mean age of 59.77 years old. The most frequent primary site of cancer was intestine/colon/rectum (14.9%), followed up by hematological cancer (13.8%), and breast cancer (11.5%). Metastasis was identified in 93 patients, with liver as the most commom site of metastasis. The most commom complaints were pain(37.3%), dyspnoea (9.7%), weakness (7.6%), and nausea/vomiting (7.6%). Most patients were not transfered for other hospital units, 20.6% of the consults resulted in transfer to the Oncology Nursery, and 2.7% of the consults resulted in transfer to the Intensive Care Unit. Regarding to type of discharge, 85% of the admissions resulted in discharge, 10% resulted in death, 0.89% resulted on evasion, and the rest of the patients were still hospitalized at the end of this research. The minimum of consults in one year was 1, while one patient visited the ER 35 times. Conclusions: We found that the oncology population seek frequently for ER consults, with pain as the most common complaint.The most common cancer on our service was intestine, followed up by hematological cancer and breast cancer. The majority of the consults resulted in discharge. We suggest more research approaching different ways to assess, classify and to treat oncologic pain, considering that most patients have follow up with their attending physician and yet they seek ER to treat this symptom. Also,we suggest that the population must be clarified and educated about the real role of the ER service to avoid excessive consults.
Utilization of next-generation sequencing and associated systemic therapy initiation in metastatic prostate cancer.
Authors: Yang Daniel X. , Leapman Michael , Gross Cary Philip , Yu James B. 
Published: May 2020

e19308 Background: There is emerging evidence for using clinical genomic classifiers for prognostication and to guide treatment choice in metastatic prostate cancer (mPC). While clinical-grade next generation sequencing (NGS) tests are increasingly available, how NGS has impacted systemic therapy selection for mPC is unclear. Methods: We performed retrospective observational study using the nationwide US Flatiron Health EHR-derived de-identified database. We identified patients with mPC diagnosed between January 1, 2013 and September 31, 2019. Receipt of NGS testing was chart-confirmed. “Short-interval” systemic therapy initiation in association with NGS testing was defined as line of therapy start within 30 days of documented NGS test result date. Results: A total 11548 mPC patients were included in our cohort, of which 1034 patients (8.9%) had documented NGS after metastatic diagnosis. There were 1210 documented NGS tests total, with 146 (14.1%) patients documented as undergoing NGS testing on more than one occasion. Median time from metastatic diagnosis to initial NGS test results was 560 days (IQR 194 to 1016 days). NGS test documentation increased from 7.1% of cases diagnosed in 2013 to 12.1% of cases diagnosed in 2017 (p < 0.001). A new line of systemic therapy was initiated within 30 days for 207 NGS test results (17.1%). Although the percent of NGS tests associated with short-interval initiation of a new line of therapy increased from 11.1% in 2013-2014 to 16.5% in 2018-2019, the difference was not statistically significant (p = 0.540). The most common systemic therapies initiated within 30 days after NGS testing were docetaxel (18.8%), cabazitaxel (16.8%), and abiraterone (15.4%). Conclusions: While there has been an increase in documented NGS tests in mPC, rates of short-interval systemic therapy initiation after NGS did not change significantly from 2013-2019. Further study is needed as to whether this will increase in years to come, as well as potential improvements in clinical outcomes due to therapy change.
Use of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer receiving immunotherapy.
Authors: Yang Daniel X. , Jairam Vikram , Park Henry S. , Decker Roy H. , Chiang Anne C. , Gross Cary Philip , Yu James B. 
Published: May 2020

e19309 Background: Prophylactic cranial irradiation (PCI) use is controversial in extensive-stage small cell lung cancer (ES-SCLC). In addition to lack of survival benefit of PCI compared to close MRI surveillance in a 2017 published trial, the role of PCI is being further challenged in the modern immune-oncology (IO) era. The IMpower133 trial reporting a survival benefit to atezolizumab for ES-SCLC published in 2018 did not require PCI use. Contemporary practice patterns of PCI in relation to immunotherapy are unknown. Methods: We performed a retrospective cohort analysis of patients with ES-SCLC diagnosed between January 1, 2013 to September 31, 2019 from the nationwide Flatiron Health electronic health record-derived de-identified database. First-line chemotherapy (Chemo) was defined as Chemo given alone, while first-line IO therapy was IO alone or combined with chemotherapy as initial systemic therapy. Results: The cohort included 3047 ES-SCLC patients who received first-line Chemo, and 324 patients who received first-line IO. For first-line IO patients, 268 (82.7%) received first-line atezolizumab. The use of first-line IO increased from 1.2% of patients diagnosed in 2013 to 11.3% of patients diagnosed in 2018 (p < 0.001), and 54.5% of patients diagnosed in 2019 (p < 0.001). Overall documented PCI for patients receiving either first-line IO or first-line Chemo decreased from 14.7% in 2013 to 7.0% in 2018-2019 (p < 0.001). For first-line IO patients, 23 (7.1%) had documented PCI over our study period, with 5.3% of patients diagnosed in 2018-2019 having received PCI. In contrast, for first-line Chemo patients, 428 (14.0%) received PCI over our study period, and PCI use significantly decreased from 14.8% in 2013 to 7.9% in 2018-2019 (p = 0.001). In 2018-2019, use of PCI was not significantly different between patients receiving first-line IO compared to first-line Chemo (5.3% vs 7.9%, p = 0.163). Conclusions: The use of first-line IO has significantly increased in ES-SCLC. Overall PCI rates for ES-SCLC patients decreased significantly over the study period, although documented PCI use rates do not differ between patients receiving upfront IO or Chemo in 2018-2019. Further investigation is warranted regarding effectiveness of PCI in the modern IO era.
Trends in immunotherapy use in patients with advanced non-small cell lung cancer (aNSCLC) patients: Analysis of real-world data.
Authors: Kushi Lawrence H. , Lasiter Laura , Belli Andrew J. , Boyd Marley , Bruinooge Suanna S. , Christian Jennifer , Garrett-Mayer Elizabeth , Hansen Eric , Honnold Rebecca , Pe Benito Ruth , Natanzon Yanina , Sakoda Lori , Rivera Donna R. R , Rhodes Whitney , Robert Nicholas J. , Sharon Elad , Sweetnam Connor , Wagner Joseph , Walker Mark S. , Allen Jeff 
Published: May 2020

e19311 Background: Leveraging data from a collaboration with 9 data partners, Friends of Cancer Research convened the Real-world Evidence Pilot 2.0, to examine trends and real world (rw) data endpoints in immunotherapy (IO) use for the front line treatment of aNSCLC. Methods: This study leveraged parallel analyses of rw data elements across heterogenous data sources (EHR, administrative claims, and registry) to: a) describe trends in uptake and use of novel IO frontline therapy after advanced diagnosis in NSCLC patients treated in usual care settings and b) examine associations between treatment and rw outcomes at one-year follow-up. The proportion of patients treated on each regimen (IO single agent, chemo, or IO + chemo) from 2011 through 2017 were calculated. Analysis included proportion of patients across treatment regimens stratified by year to describe post approval uptake of IO. Kaplan-Meier survival estimates were reported to adjust for follow-up time and stratified by PD-L1 status and stage. Results: Seven datasets identified a range of 999 to 4617 patients per dataset for this analysis. Across datasets, 2508, 3446, and 4176 patients initiated treatment in 2015, 2016, and 2017, respectively. No patients received IO or IO + chemo regimens prior to 2015. Initial approvals for IO use in aNSCLC occurred in October 2015 and for first line in metastatic NSCLC in October 2016. When examining survival at 1 year, overall, OS in PD-(L)1 + patients appeared longer than those with a PD-(L)1 - status. Conclusions: RWE analyses may reveal important trends in clinical cancer patient care including patterns of off-label use. The heterogeneity in the timing of IO uptake across datasets ranged from immediately after approval to ~12 months post-approval. [Table: see text]
Uptake of first-line immune checkpoint inhibitors among medically frail patients with advanced solid malignancies.
Authors: Parikh Ravi Bharat , Cohen Roger B. , Min Eun Jeong , Wileyto E. Paul , Riaz Fauzia , Gross Cary Philip , Long Qi , Mamtani Ronac 
Published: May 2020

e19316 Background: There are concerns about use of immune checkpoint inhibitor (ICI) therapy in medically frail patients, for whom ICIs do not have a proven survival or quality-of-life benefit. We compared uptake of first-line ICI treatment in routine practice between frail and non-frail patients with advanced solid malignancies. Methods: This retrospective cohort study used data from the Flatiron Health electronic health record-derived database. We included patients who started first-line systemic therapy from 2014 through 2018 for stage IV non-small cell lung cancer (NSCLC) without a targetable mutation, urothelial cell carcinoma (UCC), renal cell carcinoma (RCC), or hepatocellular carcinoma (HCC). We identified medically frail patients using literature-based criteria: Eastern Cooperative Oncology Group performance status (ECOG) ≥ 2, Elixhauser comorbidity index ≥ 3, or grade ≥3 liver or renal dysfunction as defined by NCI CTCAE v5. We used multivariable logistic regressions to examine associations between frailty and the probability of first-line use of an ICI-containing regimen (monotherapy or combination therapy), adjusted for age, insurance type, academic vs. community practice setting, type of cancer, and year of treatment. Results: Of 23,972 patients in the cohort, 17,122 (71.4%) were white, 10,237 (42.7%) were female, 9,666 (40.3%) were commercially-insured, and 13,144 (54.8%) met criteria for frailty. ICI use steadily increased over time in frail patients: among frail patients diagnosed in the last quarter of 2018, ICI-containing regimens represented 55% of first-line therapy starts in NSCLC; 35% in UCC; 55% in RCC; and 23% in HCC. Frail patients had a slightly higher likelihood of ICI use compared to non-frail patients (adjusted odds ratio [aOR] 1.12, 95% CI 1.04-1.20, p=0.002). This was primarily driven by greater use in patients with high comorbidity (aOR 1.15, 95% CI 1.08-1.23, p<0.001) (Table). Associations were consistent when examining first-line ICI monotherapy use only. Conclusions: First-line ICI use is common and increasing among frail patients with advanced solid malignancies. Prospective evidence is needed to assess the benefit (or lack thereof) of ICI use in medically frail patients. [Table: see text]
MET status and treatment outcomes in papillary renal cell carcinoma (PRCC): Pooled analysis of historical data.
Authors: Albiges Laurence , Heng Daniel Yick Chin , Lee Jae-Lyun , Walker Stephen , Mellemgaard Anders , Ottesen Lone , Frigault Melanie M. , L'Hernault Anne , Wessen Jonathan , Choueiri Toni K. , Cancel Mathilde , Signoretti Sabina 
Published: May 2020

e19321 Background: PRCC accounts for 10–15% of RCCs, but there are limited biomarker-based data to inform targeted treatment. Treatments for patients (pts) with advanced/metastatic PRCC include those approved for clear cell RCC such as sunitinib or everolimus, however their activity in PRCC can be limited. A subset of PRCCs are MET-driven, and it has been suggested that this may be a negative prognostic factor, although the role of MET activation in advanced/metastatic disease is unclear. We explored the prevalance of MET status in pts with advanced/metastatic PRCC treated with targeted therapies and impact on clinical outcomes. Methods: This large, international, retrospective, observational study included pts with previously treated, locally advanced/metastatic PRCC. MET status was determined retrospectively by NGS of archival tissue. MET-driven disease was defined as MET and/or HGF amplification, chromosome 7 gain (requiring > 30% tumor content) and/or MET kinase domain mutations. Study objectives included progression-free survival (PFS), time to treatment failure (TTF) and overall survival (OS) by MET status. Results: 305/308 pts (International Metastatic RCC Database Consortium, n = 72; The Asan Genito-Urinary Cancer Center, n = 40; Groupe Français d’Etude des Tumeurs Uro-Génitales, n = 196) received first-line (1L) treatment; sunitinib was most common (68%). 214 (69%) pts received 2L therapy; everolimus was most common (20%). Of 179 pts with valid NGS results, 38%, 49% and 13% had MET-driven, MET-independent (ind) tumors and chromosome 7 ploidy unevaluable, respectively. Baseline demographics were mostly balanced among groups. In sunitinib-treated pts, PFS and TTF were numerically longer in pts with MET-driven tumors vs pts with MET-ind tumors, but OS was similar (Table). In everolimus-treated pts, PFS and TTF were similar for both MET groups; however the sample size was small. Conclusions: MET alterations are frequent in advanced/metastatic PRCC and have potential to impact PFS and TTF, although our results show limited effect on OS. These data show that MET-driven tumours may not predict for poorer outcome vs MET-ind tumours and there is a need for suitable therapies for MET-driven PRCC. [Table: see text]
Use and outcomes in men with metastatic castration-sensitive prostate cancer (mCSPC) treated with docetaxel in addition to androgen deprivation therapy (ADT): Analysis of real-world data in the United States (US).
Authors: Agarwal Neeraj , Mundle Suneel , Dearden Lindsay , Potluri Ravi C. , Nair Sandhya , Mehra Maneesha 
Published: May 2020

e19322 Background: mCSPC patients treated with docetaxel + androgen deprivation therapy (D+ADT) demonstrate increased overall survival (OS)1,2. However, limited real-world outcome data is available for such patients. This study assesses the real-world use and outcomes with D+ADT in mCSPC in the US. Methods: Adult (≥18 years old) men with mCSPC (defined as men with metastasis at index diagnosis of prostate cancer [de novo] or those who progressed to mCSPC after prior diagnosis of localized disease) were retrospectively identified from the Optum (2007–2018) and SEER Medicare (2007–2016) databases. Men diagnosed with mCSPC in or after 2014 with exposure to docetaxel and no brain metastasis were included for analysis. Patients were characterized based on age; baseline prostate specific antigen (PSA) level; administration of ADT; prior radiotherapy (RT); prior radical prostatectomy (RP); presence of visceral disease, bone or bone + visceral metastases; and treatment duration of docetaxel. OS and time to metastatic castration-resistant prostate cancer (mCRPC) were measured. Results: Among 4959 men identified with mCSPC during or after 2014, 192 (3.8%) received D+ADT ± Bicalutamide as first line systemic therapy. Baseline characteristics are presented in the Table below. Mean ± SD duration of docetaxel exposure was 115 ± 84.2 days (median 118 days). Median OS among these men was 30.5 (28.1, 36.7) months and median time to mCRPC was 18.3 (14.5, 24.6) months. Only 9% of men received docetaxel for ≥6 cycles (180 days); median OS in these men was NR (19.1- NR) with 74% surviving at 2 years compared to 65% surviving at 2 years in those with docetaxel duration <6 cycles. Conclusions: Use of docetaxel in the real-world mCSPC patient population in the US is limited. Majority of men received less than the recommended dose of 6 cycles. OS with D+ADT in real-world patients with mCSPC appears to be lower than the OS reported in published trials. References:1) Sweeney CJ, et al. N Engl J Med. 2015;373:737–46. 2) James ND, et al. Lancet. 2016;387:1163–77. Funding: Janssen Research & Development, LLC. [Table: see text]