bluuebunny/crossref_metadata_2025_split huggingface dataset:
Venous thromboembolism (VTE) incidence and risk factors in patients (pts) with non-small cell lung cancer (NSCLC) receiving front-line therapy.
Authors: Patel Jai Narendra , Robinson Myra M. , Hill Hailey , Lu Lauren , Slaughter Daniel , Kim Edward S. , Amin Asim , Mileham Kathryn Finch 
Published: May 2020

e19293 Background: VTE incidence varies based on factors such as tumor type, stage, and treatment. There is limited data on VTE incidence and risk factors in NSCLC pts receiving first-line therapies, including immune checkpoint inhibitors (ICIs) and targeted therapies (TTs). Methods: This is a single institution retrospective cohort study of adult NSCLC pts who received first-line treatment between July 2003 and July 2019. Treatments included chemotherapy (chemo) (platinums, taxanes, pemetrexed, gemcitabine, etoposide, bevacizumab), ICI (pembrolizumab, nivolumab, atezolizumab, durvalumab), chemo + ICI, or TT (erlotinib, gefitinib, afatinib, osimertinib, crizotinib, alectinib, ceritinib). Diagnosis codes (ICD 9/10 codes) confirmed VTE (deep vein thrombosis and/or pulmonary embolism) and presence of risk factors which are summarized in Table. Landmark VTE incidence was estimated from cumulative incidence curves for time to VTE, death as a competing risk. Time to VTE distributions were compared between groups with Gray’s tests. Univariable and multivariable competing risk analyses identified risk factors for time to VTE. Results: In 1,618 evaluable pts, the median age was 66 years, 53% were male, 79% White, 18% Black, 58% had adenocarcinoma, 32% squamous cell carcinoma, and 47% metastatic disease. 1178 received chemo, 172 ICIs, 157 chemo + ICI, and 111 TTs. 6-month VTE rates per arm were 5.3%, 7.0%, 7.2%, and 12.0% and 12-month rates were 8.9%, 8.1%, 11.7%, and 13.3%, respectively. Cumulative incidence of VTE was not significantly different between treatment groups (p = .27). Univariable and multivariable analyses are summarized in the Table below. Conclusions: Treatment type was not associated with VTE risk in first-line NSCLC, but rates were numerically highest in pts receiving TTs. Khorana risk score was significantly associated with VTE risk and may identify those likely to benefit from thromboprophylaxis. [Table: see text]
Comparison of characteristics and outcomes among veterans receiving first-line immunotherapy versus chemotherapy for stage IV non-small cell lung cancer.
Authors: Williams Christina D , Gu Lin , Vashistha Vishal , Press Ashlyn , Kelley Michael J. 
Published: May 2020

e19295 Background: Immunotherapy (IO) has revolutionized the treatment paradigm for patients with advanced non-small cell lung cancer (NSCLC). Study objectives were to evaluate utilization of IO as first-line (1L) therapy and compare clinical characteristics between patients receiving IO and those receiving CT in 1L setting. Methods: Using the U.S. Department of Veterans Affairs corporate data warehouse, patients with stage IV NSCLC diagnosed 2012-2017 and initiated non-targeted systemic therapy within 120 days of diagnosis were selected. Unadjusted descriptive statistics were used to compare patient characteristics, inpatient and outpatient clinic visits, and prevalence of select adverse events (AE) between patients receiving IO monotherapy and CT. Kaplan-Meier and Cox regression approaches with and without propensity score matching (PSM) were used for overall survival (OS) analyses. OS was calculated from treatment initiation date to death or end of study period in June 2019. Results: 4609 patients were included in the analysis: 3.4% (n = 156) received IO monotherapy, 96% (n = 4426) received CT, and 0.6% (n = 27) received IO+CT (IO+CT not included in analysis). IO patients were older than CT patients (median age 69 vs. 66 years, p < 0.0001) and more frequently resided in the Midwest and West regions whereas CT patients were more likely to live in the Northeast and South (p = 0.0024). There were no significant differences in IO and CT by other demographic and clinical characteristics. Estimated median OS was 7.5 months (95% CI 7.2-7.7) for CT and 7.9 months (95% CI 5.3-12.6) for IO patients. The unadjusted HR for IO compared to CT patients was 0.81 (95% CI 0.67-0.98). With 1:4 PSM (144 and 559 patients matched in the IO and CT groups, respectively), the HR was 0.75 (95% CI 0.60-0.93). The mean number of outpatient visits for IO and CT patients were 47 and 36, respectively (p = 0.003). No difference in number of hospitalizations or length of hospital stays between the two groups was observed. Common AEs in the IO group were dyspnea (58%), colitis/enterocolitis (42%), and anemia (30%). Common AEs among CT patients were colitis/enterocolitis (36%), anemia (32%), and nausea/vomiting (31%). Conclusions: In a real-world 1L setting among veterans with NSCLC, improvement in OS was observed among patients receiving IO monotherapy compared to those receiving CT, and IO patients had a greater number of outpatient visits. Continued assessment of treatment patterns and impact of IO are needed as the use of IO continues to expand.
An analysis of inpatient and ED admissions within 30 days of chemotherapy: An OP-35 review.
Authors: Carlson Jay , Chen Jiajing , Smith Michelle , Snider Jessica N. , Tummala Mohan K. , Dalia Samir , Kurkjian Carla , Sleckman Bethany G. 
Published: May 2020

e19302 Background: To evaluate patients who were within 30 days of outpatient chemotherapy infusion for an admission or ED visit associated with a primary or secondary diagnosis of anemia, dehydration, diarrhea, emesis, fever, nausea, neutropenia, pain, pneumonia or sepsis. Methods: A review of Epic was performed on all Mercy patients with cancer who received at least one outpatient chemotherapy between 1/1/16-12/31/18. Non leukemia patients ≥ 18 years of age with an inpatient admission(IPA) or ED visit (EDV) were further evaluated for either the primary or secondary diagnosis for referral with at least one of the following diagnoses: anemia, dehydration, diarrhea, emesis, fever, nausea, neutropenia, pain, pneumonia, or sepsis. Univariate and multivariable analyses were performed to identify significant clinical variables associated with the risk of referral. Adjusted Odds Ratios were calculated for the significant variables with a p value < 0.05 being significant. Results: Of the 9,590 cancer patients who presented to an outpatient infusion center during the study interval, there were 8,319 eligible patients excluding those with leukemia or age < 18 (n = 503) or for a presentation in which a chemotherapy agent was not infused. There were 90,030 eligible chemotherapy encounters of which 16.8% of patients (n = 1400) had an IPA and 11.8% (n = 980) had an EDV within 30 days of infusion. Age, social deprivation status, NCI comorbidity index, Epic readmission score, ECOG performance score, smoking, and malnutrition were significantly associated with either an IPA or EDV in both settings. Sepsis, pneumonia, and anemia were the most common OP35 related diagnoses for an IPA at 47.2%, 26.9%, and 23.2%, respectively. Similarly, pain, dehydration and nausea were the most common OP35 related diagnosis for an EDV at 48.1%, 14.2%, and 14.1% respectively. Factors having the strongest association with an IPA were malnutrition (OR: 2.34 2.08-2.65; p < 0.00001) and an antibiotic type of chemotherapy (OR: 2.16 1.72-2.72; p < 0.0001). Factors having strongest association with an EDV were severe pain score (OR: 2.56 2.21-2.97; p < 0.0001) and moderate to most deprived social deprivation status (OR: 2.10 1.62-2.72; p < 0.0001). ER referrals for pain, dehydration, and anemia most commonly occurred during clinic hours. Conclusions: Many clinical variables were found to be significantly associated with an IPV or EDV. These variables are opportunities for outpatient interventional algorithms to enhance patient care.
Predictors of and longitudinal assessment of health utility scores in patients with small cell lung cancer using real-world data.
Authors: Kuehne Nathan , Hueniken Katrina , Xu Wei , Shakik Sharara , Vedadi Ali , Pinto Dixon , Brown Catherine , Bradbury Penelope Ann , Shepherd Frances A. , Sacher Adrian G. , Leighl Natasha B. , Lok Benjamin H. , Liu Geoffrey , O'Kane Grainne M. 
Published: May 2020

e19306 Background: Recent advances in small cell lung cancer (SCLC) treatments necessitate a better understanding of health utility scores (HUS) of patients treated under standard regimens to facilitate robust pharmaco-economic assessments. HUS collected in clinical trials may be inherently skewed due to restrictive eligibility criteria, highlighting the need for real-world data. Methods: In this cohort observational study, HUS were evaluated in SCLC patients through EQ-5D surveys. We also evaluated patient reported (pr) ECOG performance status (PS)), treatment toxicities (modified patient reported (mpr) CTCAE) and symptoms (Edmonton Symptom Assessment System, ESAS). Clinical data were abstracted from electronic medical records. The impact of these variables on HUS was explored using regression. Results: Of 282 clinical encounters (12% newly diagnosed; 37% stable on treatment; 22% progressing; 29% stable off therapy/other) in 111 SCLC patients (58% male; 64% extensive stage), 29% had pr-ECOG PS ≥ 2 at the first encounter. Mean HUS in treatment naïve patients with limited disease was 0.848 (SEM = 0.028); for extensive stage, mean HUS = 0.715 (SEM = 0.046). Extensive stage (β = -0.12; p = 0.03), bone metastases (β = -0.10; p = 0.04), females (β = -0.07; p = 0.006), and pr-ECOG PS ≥ 2 (β = -0.21; p < 0.001) were each associated with decreased HUS in multivariable analyses. When excluding pr-ECOG PS from the model (highly correlated with HUS), progressive disease (β = -0.07; p = 0.02) was also associated with decreased HUS. Longitudinally, in patients with disease stability, HUS were unchanged in limited disease, but slowly decreased for extensive stage over time. HUS were inversely associated with increasing severity of most measured toxicities (mpr-CTCAE rho values ranged from -0.34 to -0.47) and symptoms (rho values -0.27 to -0.54). Conclusions: HUS in SCLC is impacted by the presence of extensive stage and bone metastases, in addition to cancer symptoms and treatment toxicities. The values reported from this real-world sample provides a basis in which to compare with new SCLC therapies in health technology assessments. [Table: see text]
Metastatic melanoma patient outcomes since introduction of immune checkpoint inhibitors in England between 2014 and 2018.
Authors: Corrie Philippa Gail , Sarah Lawton , Smittenaar Rebecca , Board Ruth 
Published: May 2020

e19310 Background: Population-based research provides real world information about prescribing trends, as well as benefits and harms associated with new interventions first evaluated in randomized clinical trials (RCTs). The national health service in England collects data on systemic anti-cancer therapy (SACT) prescribed to patients. We retrospectively examined outcomes including overall survival (OS) and treatment toxicity for patients (pts) prescribed checkpoint inhibitors (CPIs) approved for 1st line use in metastatic melanoma. Methods: National Cancer Registration and Analysis Service (NCRAS) datasets were used to identify metastatic melanoma pts prescribed 1st line CPIs and calculate survival outcomes. The Hospital Episode Statistics database was used to identify emergency department attendances and emergency hospital admissions. Results: Between April 2014 and March 2018, 5,465 melanoma pts were prescribed SACT. Of these, 2,322 pts received 1st line CPIs for metastatic disease at 56 different hospitals in England: 1,174 were prescribed pembrolizumab (pembro), 724 ipilimumab (ipi), 52 nivolumab (nivo), 372 ipinivo. Prescribing reflected national access, starting with ipi in July 2014, replaced by pembro in Nov 2015 and ipinivo prescriptions started in July 2016. By 2018, 1 in 3 pts were receiving ipinivo as treatment of choice. There was high concordance for 3yr OS with RCT outcomes for ipi (32%) and ipinivo (58%), but pembro outcomes were poorer (40%). Pts prescribed pembro were significantly older (51% vs. 12% >70 years) and frailer (38% vs. 61% ECOG PS 0) than pts prescribed ipinivo (p<0.0001). 30-day rates of emergency hospital attendances/admissions from the earliest SACT and last SACT treatment dates were significantly higher for ipinivo (16%/37% and 19%/55%) compared with pembro (8%/17% and 14%/29%). Colitis was the most common IrAE associated with hospitalization: 25% with ipinivo and 4% with pembro. 30-day mortality from last SACT was 3.8% with ipinivo and 9.1% with pembro (p<0.0001). Conclusions: Linked real world datasets demonstrated OS outcomes remarkably similar to RCTs associated with ipi and ipinivo, while poorer outcomes associated with pembro may reflect patient selection bias. Ipinivo generated the highest rates of emergency hospital visits and admissions, but 30-day mortality was not compromised, potentially reflecting efficient and effective management of complications. Hospital-level outcomes and 30-day mortality causes are now being assessed to explore variations in care.
Real-world evidence of treatment patterns and pharmacy costs among patients with metastatic castration-resistant prostate cancer (mCRPC) in a managed care population in the United States.
Authors: Moses Kelvin A. , Wallace Katrine , Landsteiner Adrienne , Bunner Scott , Engel-Nitz Nicole , Lal Lincy S. , Golsorkhi Anthony A. 
Published: May 2020

e19319 Background: Prostate cancer (PC) is the most common cancer among men in the United States. Once the disease progresses to mCRPC, initial castration modalities may not be sufficient. This real-world data study describes the treatment patterns and pharmacy costs of US-insured patients with mCRPC. Methods: Adult males in an administrative claims database who had ≥1 claim for PC (ICD-9: 185 or 233.4; ICD-10: C61 or D075), had undergone pharmacologic or surgical castration, and had a code for metastatic disease during the identification period were included in the analysis. A minimum of 6 months of continuous enrollment (CE) pre- and post-index date (first metastatic claim) was required. Patients with metastatic claims at baseline were excluded. Patients were followed until the earliest of death (unless prior to 6-month CE), end of study period, or disenrollment. Claims-based algorithms were used to identify locally advanced and distant mCRPC patients and lines of therapy (LOT). The entire study period (baseline period through follow-up) was January 2008-March 2018. Results: 3690 patients with mCRPC were identified, of which 3150 received at least one LOT; 85.4% had ≥1 LOT, 69.4% had ≥2 LOTs, and 50.7% had ≥3 LOTs following metastatic diagnosis (Table). The average duration of treatment was similar across groups: 83.8, 86.5, 71.7, and 70.2 days for LOTs 1–4, respectively. The five most common LOTs were leuprolide (36.6%), bicalutamide-leuprolide (6.6%), abiraterone (5.9%), bicalutamide (5.0%), and enzalutamide (4.7%). Mean monthly per-patient pharmacy costs increased with each LOT ($2683, $2654, $2911, $2924, $3611, for LOTs 1–5, respectively). Conclusions: This is the first study to examine treatment patterns and drug costs of patients with mCRPC. Given the large number of LOTs this population moves through and the increasing costs associated with each, the development of more efficacious novel therapies for use earlier in the metastatic treatment regimen to prolong life is warranted. [Table: see text]
Assessing the significance of KRAS G12C mutation: Clinicopathologic features, treatments, and survival outcomes in a real-world KRAS mutant non-small cell lung cancer cohort.
Authors: Cui Wanyuan , Franchini Fanny , Alexander Marliese , Officer Ann , Wong Hui Li , IJzerman Maarten J. , Desai Jayesh , Solomon Benjamin J. 
Published: May 2020

e19324 Background: KRASG12C mutations are present in 15% of non-small cell lung cancer (NSCLC) and have recently been shown to confer sensitivity to KRAS(G12C) inhibitors. This study aims to assess the clinical features and outcomes with KRASG12C mutant NSCLC in a real-world setting. Methods: Patients enrolled in an Australian prospective cohort study, Thoracic Malignancies Cohort (TMC), between July 2012 to October 2019 with metastatic or recurrent non-squamous NSCLC, with available KRAS test results, and without EGFR, ALK, or ROS1 gene aberrations, were selected. Data was extracted from TMC and patient records. Clinicopathologic features, treatment and overall survival was compared for KRAS wildtype ( KRASWT) and KRAS mutated ( KRASmut) patients, and between KRAS G12C ( KRASG12C) and other ( KRASother) mutations. Results: Of 1386 patients with non squamous NSCLC, 1040 were excluded for: non metastatic or recurrent (526); KRAS not tested (356); ALK, EGFR or ROS1 positive (154); duplicate (4). Of 346 patients analysed, 202 (58%) were KRASWT and 144 (42%) were KRASmut, of whom 65 (45%) were KRASG12C. 100% of pts with KRASG12C were smokers, compared to 92% of KRASother and 83% of KRASWT. The prevalence of brain metastases over entire follow-up period was similar between KRASmut and KRASWT (33% vs 40%, p = 0.17), and KRASG12C and KRASother (40% vs 41%, p = 0.74). Likewise, there was no difference in the proportion of patients receiving one or multiple lines of systemic therapy. Overall survival (OS) was also similar between KRASmut and KRASWT (p = 0.54), and KRASG12C and KRASother (p = 0.39). Conclusions: In this real-world prospective cohort, patients had comparable clinical features regardless of having a KRASmut, KRASG12C or KRASother mutation, or being KRASWT . Treatment and survival were also similar between groups. While not prognostic, KRASG12C may be an important predictive biomarker as promising KRAS G12C covalent inhibitors continue to be developed.
Financial toxicity (FT) real-world data evidence (RWDE) in American patients (pts) receiving cancer immunotherapy drugs (IOT).
Authors: Vorobiof Daniel A. , Hasid Lior , Litvin Alon , Deutsch Irad , Malki Eliran 
Published: May 2020

e19331 Background: Real-word data obtained through cutting edge technology paired with consumer mobile devices on 310 worldwide pts, members of Belong.life, an international mobile application, who received immunotherapy for diverse solid tumors, was obtained following a short, targeted survey related to the potential development of FT as a result of the reported diagnosis and IOT. Methods: 310 worldwide pts anonymously and voluntarily replied to a 14 questions survey describing their demographics and FT related points including reported causes, health insurances coverages and personal financial coping strategies. In this abstract we present the data on 205 American pts. Results: All 205 pts were US based. 29 pts (14 %) were <50 years of age (yoa), 68 pts (33%) were 51-60 yoa and 108 (53%) were >61 yoa. Pts’s stages were 3 in 39(19%) and 4 in 141 (69%). There were 72 males and 133 females. The most common cancer diagnosis was lung in 96 pts (47%), malignant melanoma in 37(18%), kidney in 29(14%), colorectal in 14(7%) and bladder in 12(6%). The frequent administered immunotherapy drugs were pembrolizumab in 44%, nivolumab in 39%, ipilimumab in 18 % and durvalumab in 13%. Of the 172/205 pts that replied in full to the FT survey, 82/172 (48%) reported FT during their treatment journey. Of them 24/82 (29.3%) received pretreatment FT information from their medical team while 58/82 pts (70.7%) mentioned that they did not receive FT information. Common reported FTs were high medical copayments in 50 % of the repliers, loss of income in 47% and high drugs and treatment copayments in 38 %. 41 % of the pts were insured by Medicare and 23 % by Medicaid and other HMOs. When asked about coping strategies, 62 % used personal savings, 35% received financial support from family and friends and 32 % trimmed their household expenses. Conclusions: 205 American pts members of the Belong.life application reported on their FTs experiences while receiving cancer immunotherapy. 172/205 replied to the complete survey. FT was most prevalent in the older group (>61 yoa) due to high medical and treatment copayments. Nearly half of the pts were not aware of the possible development of FT before treatment and only 29.3% received pre-treatment advisory information from their doctors. Reduced FT incidence (from 70.7% to 29.3%) was reported by those pts who received financial advice prior to initiation of treatment. Physicians should become aware of their pts’ possible risks for FTs and follow it up with relevant advice prior to immunotherapy initiation.
A real-world comparative analysis of pomalidomide (POM) and other antimyeloma treatments following lenalidomide (LEN) discontinuation among patients with multiple myeloma.
Authors: Rifkin Robert M. , Clancy Zoe , Copher Ronda , Aguilar Kathleen M. , Xie Yiqiong , Boyd Marley , Wentworth Chuck 
Published: May 2020

e19337 Background: In clinical trials, POM has demonstrated favorable clinical outcomes in patients with multiple myeloma (MM) who received prior LEN. Few studies, however, have examined POM treatment for MM in the community oncology setting. This retrospective cohort study compared treatment patterns and outcomes between patients who received a post-LEN treatment, either POM or another antimyeloma regimen. Methods: Adult patients with MM in the US Oncology Network (USON) who initiated a post-LEN treatment within 60 days of LEN discontinuation between Jan 1, 2016 and May 1, 2018, were not clinical trial participants, and had ≥ 2 subsequent clinic visits, were eligible. Data were sourced from USON’s iKnowMed electronic health records. Among patients observed to have discontinued treatment, time to treatment discontinuation (TTTD) was estimated from date of initiation of post-LEN treatment (index treatment) to date of discontinuation. Among patients who started a new treatment after the index treatment, time to next treatment (TTNT) was estimated from date of initiation of index treatment until date of initiation of the next treatment. TTTD and TTNT were analyzed using the Kaplan–Meier (KM) method across the whole study sample; patients who did not discontinue or start a next treatment were censored. Results: Of 547 eligible patients, 155 (28.3%) initiated POM and 392 (71.7%) initiated another antimyeloma regimen. Demographic characteristics were similar between the groups (for all patients, median age was 68 years, 54.5% patients were male and 71.7% were white). In total, 74.2% and 83.7% of patients discontinued the index treatment in the POM and other-treatment groups, respectively. Among the entire study population, KM estimates of median TTTD were 3.5 months (95% CI 2.8–4.6) and 1.9 months (95% CI 1.6–2.4) in the POM and other-treatment group, respectively (log-rank P < 0.001). In total, 65.2% and 71.2% of patients initiated subsequent treatment in the POM and other-treatment groups, respectively. KM estimates of median TTNT were 6.2 months (95% CI 4.5–7.8) and 4.5 months (95% CI 3.9–5.3) in the POM and other-treatment groups, respectively (log-rank P = 0.38). Conclusions: For patients with MM the use of POM following LEN treatment resulted in longer TTNT and TTTD compared with those who received other antimyeloma therapy. These findings support the use of POM treatment after LEN as an option for patients with relapsed/refractory MM.