bluuebunny/crossref_metadata_2025 huggingface dataset:
Udenyca has equivalent efficacy to the pegfilgrastim originator in breast cancer patients receiving highly myelosuppressive chemotherapy.
Authors: Webster Jennifer , Scott Jeffrey A. , Smith Helen , Wieland Danielle , Donaldson Joseph , Catasus Casey , Smith Robert E.
Published: May 2020

e19273

Background: In late 2019, the Center for Medicare and Medicaid Innovation (CMMI) issued a request for information (RFI) for the Oncology Care First (OCF) program, which will extend the evaluation of value-based care in the community oncology setting for an additional five years, through 2026. We have learned through the Oncology Care Model (OCM) that there are savings to be found by reducing inpatient admissions and emergency department visits and controlling for things such as duplicate labs. However, it has become increasingly clear that further savings will require practices to evaluate their use of both cancer-directed therapy and supportive therapy. To this end, Integra Connect has developed a tool, the Value Monitor, that allows for statistically rigorous comparative effectiveness research at scale, using real world data. As an initial proof of concept, we used the Value Based Care Monitor to compare the efficacy for febrile neutropenia prophylaxis between two pegfilgrastims: Udenyca, a biosimilar, and Neulasta, the originator. Methods: The Integra Connect Value Monitor was used to perform a matched cohort analysis of breast cancer patients receiving Udenyca vs patients receiving Neulasta from 1/1/2017 – 8/31/2019. Patients were matched on age (within 5 years), gender, OCM participation status and date of treatment (within 90 days). Each Udenyca patient (n = 496) was matched to 5 Neulasta patients. The efficacy endpoint was neutropenia rate, where neutropenia was defined as the presence of a neutropenia ICD-10 code (D70*), and/or an Absolute Neutrophil count less than 1,500. We are in the process of adding grade IV neutropenia (ANC < 500) to the tool. Results: Udenyca and Neulasta showed similar rates of neutropenia at 28.6% and 29.1% respectively (McNemar’s p-value 0.82). These rates are likely higher than those reported in the literature due to the very broad definition of neutropenia used in this study. Follow up will include neutropenia rates by grade. Conclusions: This proof of concept study established two key findings. First, that it is possible to do comparative effectiveness research at scale in order to drive value-based decisions in oncology care. Secondly, it confirms that we are seeing equivalent pegfilgrastim efficacy for neutropenia prophylaxis when comparing Udenyca, a biosimilar, to the originator agent.
Rates of primary prophylaxis for venous thromboembolism in high-risk patients with pancreatic and gastric cancer: A single tertiary care academic center experience.
Authors: Martin Karlyn , Molsberry Rebecca , Khan Sadiya S , Benson Al Bowen
Published: May 2020

e19274

Background: Venous thromboembolism (VTE) causes significant morbidity and mortality in patients with cancer. The International Society of Thrombosis and Hemostasis published guidelines in 2014 recommending a risk-based approach to VTE prophylaxis in ambulatory cancer patients, but uptake in real-world clinical practice is unknown. This study's objective was to describe rates of primary VTE prophylaxis in ambulatory patients with gastric and pancreatic cancer receiving chemotherapy and at increased risk of VTE. Methods: We identified patients at a single academic tertiary care center who received chemotherapy from 1/1/2015 to 10/1/2018 for a diagnosis of pancreatic or gastric cancer through retrospective query of electronic health records. Data abstracted included the Khorana score components (body mass index, leukocyte, hemoglobin, and platelet counts) on day of chemotherapy initiation, anticoagulation prescription, and VTE diagnosis within 6 months of chemotherapy initiation. Patients were excluded if they had contraindications to anticoagulation or alternate indications for anticoagulation. Results: We identified 437 patients, of which 72% had pancreatic cancer and 29% had gastric cancer. Mean (standard deviation) age was 64.2 (11.7) years, and patients were predominately male (54%) and white (75%). Overall, only 13% of patients received a prescription for anticoagulation with similar rates in patients with pancreatic cancer (14%) compared to gastric cancer (9%). Anticoagulation prescription rates by Khorana score (2 or ≥3) are shown in Table. Approximately 10% of patients had a VTE within 6 months of chemotherapy initiation. Conclusions: Our results show that in a cohort of patients with gastric and pancreatic cancer at intermediate to high-risk of VTE by Khorana score (≥2), only 1 in 10 received a prescription for prophylactic anticoagulation. In addition, we observed high rates of incident VTE in 6-month follow-up confirming the high-risk nature of this group. Opportunity remains to enhance implementation of primary VTE prevention in clinical practice to reduce VTE morbidity and mortality in patients with cancer. [Table: see text]
Real-world sustained minimal residual disease (MRD) negativity using NGS in multiple myeloma.
Authors: Demaree Audrey , Hewitt Anthony , Lee Lik Wee , Eckert Benjamin
Published: May 2020

e19280

Background: MRD assessment has been increasingly incorporated into guidelines and routine care for patients (pts) with multiple myeloma (MM). It has been widely shown that pts who achieve deep MRD negativity (MRD-) have longer PFS/OS. Clinical guidelines now include sustained MRD- (two consecutive MRD- results; (10−5, 12 mo. apart) as a response criterion. . NGS MRD (clonoSEQ; Adaptive Biotechnologies; Seattle, WA) is the only FDA authorized method for bone-marrow MRD assessment in MM. A large longitudinal database of quantitative NGS MRD values from routine patient care now enables real-world analysis. We used our data to provide insight into testing patterns and sustained MRD-. Methods: The population included internal data of NGS MRD clinical samples from Jan 2018 to Jan 2020. We examined MRD- achievement overall and sustained MRD- as defined by guidelines. For pts who achieved sustained MRD- and had subsequent MRD testing, we examined if they remained in an MRD- state. Results: We identified 1,675 pts with MM who had ≥1 MRD tests after baseline Clonality (ID) assessment. The age/sex distribution (med. age = 65; 58% male) was consistent with epidemiologic data. 837 (49.9%) and 541 (32.2%) achieved MRD- at 10−5 or 10−6 thresholds, respectively. Of the 190 pts with ≥2 MRD tests at least 12 mos. apart, 82 (43.2%) and 45 (23.7%) had sustained MRD- at 10−5 and 10−6 thresholds, respectively. Of 82 pts who achieved 12 mo. sustained MRD- at 10−5, 15 had a subsequent MRD test, of which all remained MRD-. Of 45 pts who achieved 12 mo. sustained negativity at 10−6, 4 had a subsequent MRD test, of which all remained MRD-. Conclusions: We believe this represents one of the earliest real-world study examining NGS MRD attainment of sustained MRD- defined by guidelines. It is notable that many pts reached deep MRD negativity, with a significant percentage having sustained MRD negativity meet guideline-defined criteria. Long-term follow-up and incorporation of clinical parameters & outcomes data will enable further insights from this real-world dataset. [Table: see text]
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.
The shift in therapies for the treatment of chronic lymphocytic leukemia (CLL) patients in the US Veterans Health Administration (VHA) from 2013-2018.
Authors: Nooruddin Zohra , Le Hannah , McHugh Daniel , Ryan Kellie , Jones Xavier , Obodozie-Ofoegbu Obiageri O , Teng Chengwen , Eaves Alyssa C , Frei Christopher R
Published: May 2020

e19339

Background: The first novel agent for use in CLL was approved in 2014; however, the extent of novel agent uptake in the VHA is largely unknown. Objective: This study described the pharmacoepidemiology of three novel agents (ibrutinib, idelalisib, venetoclax), and traditional chemotherapies/chemoimmunotherapies (CT/CIT) in the VHA. Methods: This was a retrospective study of 26,879 adults with CLL in the VHA from 10/01/2013 to 5/31/2018. All were followed for at least 6 months. Data were extracted from the VHA electronic health record. Patients came from all 18 Veterans Integrated Service Networks, spanning all 50 states and US territories. Descriptive statistics were used to summarize baseline characteristics, CLL treatments, next therapies, and secondary complications. Results: A total of 3670 patients received at least one of 12 CLL therapies of interest. Patients had a median age of 69 years (47% were 65+ and 26% were 75+), a median age-adjusted Charlson comorbidity score of 6, and 6% had a history of exposure to Agent Orange. Ibrutinib accounted for 89% of the novel agent use. Ibrutinib use across all lines of therapy (LOTs) increased sevenfold over the study period (Table). Venetoclax (42%) and idelalisib (30%) were the most common therapies for the next LOT after ibrutinib. Across all LOTs, traditional CT/CIT use declined steadily over the study period. However, in fiscal year (FY) 2018, there were still 17% of patients receiving CT/CIT. Ibrutinib was the most common therapy for the next LOT in these patients (43–74%). Incidence of diffuse large B cell lymphoma post-index was 2–6 times higher in patients on CT/CIT than those on ibrutinib. Other secondary complications were similar between ibrutinib and CT/CIT. Conclusions: To our knowledge, this is the largest study looking at CLL treatment patterns among VHA patients in the real world. There has been a major shift in the treatment of CLL, with fast adoption of novel agents in the VHA from 2013 to 2018. The impact of this shift on healthcare resource use and cost burden in the VHA will need to be examined. [Table: see text]
Analyzing the outcome of clostridium difficile infection in cancer patients.
Authors: Sahu Kamal Kant , Mishra Ajay , George Susan V , Abraham George , Siddiqui Ahmad Daniyal
Published: May 2020

e19340

Background: Clostridium difficile infection (CDI) is a considerable health burden, and now identified as the leading cause of acquired diarrhea in patients receiving antibiotics. Cancer patients are more prone to acquire CDI, owing to their frequent exposure to risk factors. This study aims to investigate the factors affecting the outcome of Clostridium Difficile Infection in patients with cancer at our community center. Methods: This is a retrospective study that included a total of 59 cancer patients who were hospitalized for clostridium difficile infection. Results: The median age of the study population was 79 years with 39 males and 20 females. The patients were suffering from cancer located at the following sites: Prostate (25), lung (19), colon (7), bladder (4), breast (3) and renal (1). There were 52 cases of 1st and 7 cases of recurrent CDI admissions. 40 patients detected to have CDI at presentation while 19 patients developed CDI during hospitalization. CDI categories were as follows: Non-severe (29), severe (28), and very severe (3). There were 33 and 20 patients on chemotherapy and radiotherapy respectively. 27 patients had a recent history of cancer care-related procedures or interventions. 29 patients were from either rehab or nursing facility. There were 39 recent hospitalizations with 29 patients receiving antibiotics. Almost half of the patients were on PPI (29) and 12 were on steroids (20.3%) at the time of developing CDI. Patients with a high-risk qSOFA Score of 2 or more (p-value = 0.008) or a high white blood cell count of > 15 X 109/L (p-value = 0.016) were found to have higher in-hospital mortality. Critical care data suggested that 9 patients required intensive care, 7 patients required vasopressor support, and 6 needed mechanical ventilation. Patients were treated with either vancomycin alone (13), or metronidazole alone (25), or combination therapy with vancomycin + metronidazole (21). The median duration of hospital stay was 6 days with 11 fatalities (18.64%). Conclusions: CDI causes significant morbidity in cancer patients. Factors like high qSOFA score and leukocytosis can help to prioritize and intensify the care and in prognosticating the patients.
Hematologic neoplasms incidence categorised by WHO classification and centralization of treatment facilities in Japan: Analysing a nationwide Hospital-Based Cancer Registry data.
Authors: Okuyama Ayako , Tsukada Yoichiro , Izutsu Koji , Higashi Takahiro
Published: May 2020

e19348

Background: More than 55,000 patients are diagnosed as hematologic neoplasms in Japan. In this study incidence of hematologic neoplasms was categorised based on the World Health Organisation (WHO) classification, and centralisation of treatment facilities was analysed, using the nationwide Hospital-Based Cancer Registries (HBCR) which covers more than 65% of new cancer patients. Methods: The HBCR data for patients diagnosed in 2017 was used. We categorized patients in line with the 2017 Revision of WHO classification of lymphoid, myeloid neoplasms, and acute leukaemia. Incidence and age distribution was analysed by subtype. Centralisation of treatment facilities for haematological malignancy patients was also analysed. Hospitals were classified into four approximately equal groups based on patient volume per year (very high: over 108 patients; high: 43-107; low: 10-42; and very low: under 10). Results: In total, 51,936 patients in 809 hospitals were identified. Overall average age was 68.4 years (SD 16.5). 43.6% were diagnosed as mature B-cell neoplasms except plasma cell neoplasms, followed by 12.6% of myelodysplastic/myeloproliferative neoplasms and myelodysplastic syndromes, 10.1% of plasma cell neoplasms, 9.4% of myeloproliferative neoplasms, and 8.8% of acute myeloid leukaemia and related precursor neoplasms. 1,438 patients (2.8%) were diagnosed as precursor lymphoid neoplasms and 54.7% of these patients were under 10 years old. Looking at the age distribution of mature B-cell neoplasms, 70s were accounted for 32.6% and 60s were accounted for 26.4%. Among hematologic patients aged 70s, 46.4% were mature B-cell neoplasms and remaining 14.3% of myelodysplastic/myeloproliferative neoplasms. Most of patients received treatment at very high (62.1%, 206 hospitals) or high patient volume hospitals (28.5%, 200 hospitals). Only 1.8% of patients received treatment at very low patient volume hospitals (221 hospitals) which have less than 10 hematologic patients per year. Most of patients received treatment at very low patient volume hospitals were mature B-cell neoplasms. Conclusions: In this study, the first detailed analysis of the number of hematologic neoplasms by subtype was performed. Treatment facilities for hematologic neoplasms patients was almost centralised.
The value of immunotherapy: Comparison of annual cost per patient receiving immunotherapy versus chemotherapy in patients with non-small cell lung cancer.
Authors: Vasekar Monali K. , Agbese Edeanya , Leslie Doug
Published: May 2020

e19364

Background: Checkpoint Inhibitors (CPI) has revolutionized cancer treatment but financial toxicity can be incurred due to high cost. We performed a population-based analysis examining the cost of CPI vs. conventional chemotherapy (CT) in patients with NSCLC to capture the real-world value of CPI on an individual and community level. Methods: Population based claims database of privately insured individuals, MarketScan was interrogated. Pts in years 2015 and 2016 with ICD 9 or 10 diagnosis of lung cancer who were continuously enrolled in insurance plan for at least 12 months were included. CPT codes for CPIs and CT were used. Outcome Measure was Health Service Use ( surrogate for treatment related toxicity) such as Inpatient Admissions and Emergency Department Use. Cost Categories (US Dollars) noted were Total Costs,Total Out-of-Pocket Costs,Total Outpatient Infusion Costs, Outpatient Infusion Out-of-Pocket Costs, Inpatient Admissions Costs and Emergency Department Use Costs.Statistical tests “paired t tests” and “unpaired t tests” were used to compare the above variables using SAS software. Results: In 2015 of 22,193 with lung cancer 554 received CPI vs CT in 21,639. In 2016 of 22,810 pts 2478 received CPI vs CT in 20,332. Data for CPI vs. CT in years 2015 (a) and 2016 ( b) respectively. p value for each pair was <0.0001 unless as noted below 1. Mean Total Cost: a) 228504 vs. 140,970 b) 202202 vs. 147801 2. Mean Total Out of Pocket Cost: a) 3381 vs. 3308 p=0.4829 b) 3500 vs. 3343 p=0.0021 3. Mean Total Outpatient Infusion Cost: a) 51158 vs. 18634 b) 60087 vs. 18999 4. Mean Total Out of Pocket Outpatient Infusion Cost: a)159 vs. 282 b) 359 vs. 263 5. Inpatient Admission rate: a) 33.75% vs. 59.40% b) 43% vs. 58% 6. Mean Inpatient Admission Cost: a) 53045 vs 69810 p =0.0025 b) 54124 vs 73903 7. ED Visit rate: a) 38.2% vs. 61.4% b) 50% vs. 61% 8. Mean ED Cost: a) 4117 vs. 5265 p=0.0379 b) 4947 vs. 6025 p=0.0001. Conclusions: Despite the higher individual total cost in pts receiving CPI vs CT; the cost of CPI could potentially be offset at healthcare level by lesser expenditure through lower ED visits and inpatient hospitalization. Though the out of pocket costs/patient was statistically different, the mean numerical difference was small between CPI vs CT. Future prospective trials of CPI should also incorporate costs to individual and healthcare systems in addition to evaluating the impact of CPI on Quality of life vs CT to understand the real “value” of CPI. This novel study can serve as a benchmark for future population based studies.
The impact of clinical trial (CTr) participation on savings performance in the oncology care model (OCM).
Authors: Adelson Kerin B. , Canavan Maureen , Mun Sophia , Gross Cary Philip , Sinanis Naralys , Davidoff Amy J.
Published: May 2020

e19367

Background: The OCM is a Centers for Medicare and Medicaid Services (CMS) alternative payment model, which seeks to curb costs while improving care for patients receiving systemic cancer therapy. CMS models the expected total cost (spending target) for each 6-month episode using historical, geographic and clinical factors including CTr participation. We evaluated the relationship between CTr participation, actual cost of care and performance in the OCM. Methods: We used claims for OCM episodes attributed to the Yale Cancer Center between July 2016 and July 2018. We stratified episodes by CTr participation and used t-tests and chi-square tests to compare total cost, drug costs (Part B and D) and whether actual episode costs were above or below CMS targets. Analyses were conducted for the total sample, and among the most common cancer types. Results: Among 9,387 OCM episodes (5,270 unique patients), 815 (8.7%) episodes involved a CTr. Among non-CTr patients, the mean Medicare cost per episode ($32,909) was modestly higher than the mean episode spending target ($31,746; p < 0.001), while in the CTr group, the mean Medicare cost per episode ($36,590) was substantially lower than the mean episode spending target ($48,124 p < 0.001). Mean drug cost was lower with CTr vs without ($15,650 vs $19,587, p < 0.001). Drug costs also accounted for a lower percentage of total costs for episodes with CTr vs not (41% vs 57%). CTr episodes were more likely to meet spending targets than non-CTr episodes (66% vs 56%, p < 0.001) overall and in breast, lung, and myeloma cancers, although only statistically significant for lung cancer (76% CTr vs 48% non-CTr, p < 0.001). Mean difference between target and actual costs was greater for episodes with CTr (- $11,534) than for episodes without CTr (+ $1,163) (p < 0.001). Conclusions: On average, episodes with CTr participation had substantially lower costs compared with their spending targets, while non-CTr episodes had slightly higher costs compared with their spending targets. While total cost of care was higher for episodes with CTr (as the CMS model predicts), drug costs were significantly lower. As drugs comprise a large proportion of total cost, lower drug costs in CTr episodes likely contribute to savings. Additional research should explore whether other OCM centers with higher rates of CTr participation are more likely to meet spending targets in value-based payment models.
Simulation modeling of cost-savings from conversion of pegfilgrastim to biosimilar pegfilgrastim-cbqv for the prophylaxis of chemotherapy-induced (febrile) neutropenia (CIN/FN) and expanded access to biosimilar prophylaxis.
Authors: McBride Ali , MacDonald Karen , Abraham Ivo
Published: May 2020

e19372

Background: Biosimilars have the potential to reduce the cost of prophylaxis of CIN/FN. To demonstrate this, we: 1) conducted a US comparative cost-efficiency analysis of CIN/FN prophylaxis with biosimilar pegfilgrastim-cbqv over reference pegfilgrastim without or with on-body injector (PEG/PEG-OBI), 2) modeled budget-neutral expanded access to biosimilar pegfilgrastim-cbqv from cost-savings achieved from conversion from PEG/PEG-OBI, and 3) estimated the number-needed-to-convert (NNC) to biosimilar pegfilgrastim-cbqv from PEG/PEG-OBI to purchase one additional treatment of biosimilar pegfilgrastim-cbqv. Methods: Simulation modeling from the US payer perspective utilizing: average selling price (ASP) derived from CMS Q1 2020 reimbursement limits for PEG/PEG-OBI and pegfilgrastim-cbqv;between one and six cycles of prophylaxis in a panel of 20,000 cancer patients at risk for CIN/FN; and conversion rates from PEG/PEG-OBI to biosimilar pegfilgrastim-cbqv ranging from 10% to 100% in this panel. Results: Using current ASP, cost-savings per patient of biosimilar pegfilgrastim-cbqv over PEG/PEG-OBI ranged from $223 (for 1 cycle) to $1,335 (6 cycles). In a panel of 20,000 cancer patients, the savings range from $445,163 (for one cycle of prophylaxis at 10% conversion) to $26,709,788 (6 cycles at 100% conversion). In a single cycle of chemotherapy, these savings translate into expanded access to prophylaxis with biosimilar pegfilgrastim-cbqv ranging from 115 doses at 10% conversion from PEG/PEG-OBI to 1,154 doses at 100% conversion. The savings over six cycles of chemotherapy could provide between 692 additional doses of biosimilar pegfilgrastim-cbqv prophylaxis (at 10% conversion) to 6,921 doses (at 100% conversion). The NNC from PEG/PEG-OBI to purchase one additional dose of biosimilar pegfilgrastim-cbqv is 18. Conclusions: These models demonstrate that CIN/FN prophylaxis with biosimilar pegfilgrastim-cbqv can generate significant cost savings that could be reallocated on a budget-neutral basis to provide more patients and/or more cycles with CIN/FN prophylaxis.
Successful transition from bortezomib subcutaneous to generic intravenous bortezomib: Cost savings initiative with global economic impact.
Authors: Shah Bhavesh , Jhaveri Radhika , Sanchorawala Vaishali , Lerner Adam , Sloan John Mark , Sarosiek Shayna
Published: May 2020

e19375

Background: It is estimated that the U.S. will spend $370 billion in 2019 on pharmaceuticals and by 2020 the cost of cancer care will be approximately 158 billion. Cost containment strategies for high cost drugs are needed. There exists an opportunity to decrease overall cost related to bortezomib by switching patients to generic bortezomib. Generic bortezomib was first approved by the FDA in January 2018 but it can only be administered intravenously. Based on previous studies on occurrence of peripheral neuropathy we hypothesized that patients who have not developed bortezomib induced peripheral neuropathy (BIPN) after or during 4 cycles of subcutaneous (subQ) bortezomib could be switched to IV bortezomib without greatly increasing neuropathy. Methods: A protocol was implemented to switch patients from SubQ to IV bortezomib at our hematology outpatient clinic. Patients had to complete 4 cycles of SubQ bortezomib and have either Grade 1 or no BIPN to qualify to switch to IV bortezomib generic formulation. After approval from the hematology/oncology providers and nursing department, this protocol was implemented to start accrual in November 2018. After provider approval for eligible patients, pharmacists would update the treatment plan orders and also notify nursing and patients of the change. Results: Fifteen patients have received at least 1 cycle of IV generic bortezomib for various indications from Nov 2018 to Nov 2019, ranging from 1 cycle to 12 cycles. The diseases for which bortezomib was being used included multiple myeloma (n = 8) and AL amyloidosis (n = 2), renal transplant rejection and thrombotic thrombocytopenic purpura (TTP). Two of the 15 patients had Grade 1 BIPN prior to switching, while all others reported no neuropathy prior to the switch. None of the patients have developed new neuropathy after making the switch from subQ to IV bortezomib. Nursing and patient satisfaction surveys showed that majority of both groups did not have a preference for IV versus subQ administration. Conclusions: We describe a method to switch from subcutaneous bortezomib to generic IV bortezomib instituted at a large academic medical center as a cost containment strategy. This has resulted in no new cases of neuropathy in our growing data set.