Treatment Patterns and Health Resource Utilization Among Patients Diagnosed With Early Stage Resected Non–Small Cell Lung Cancer at US Community Oncology Practices

AbstractBackgroundPlatin-based adjuvant chemotherapy has extended survival in clinical trials in patients with completely resected non–small cell lung cancer (NSCLC). There are few data on the use of adjuvant therapy in community-based clinical practice in the United States.Materials and MethodsThis was a retrospective observational study using electronic medical record and billing data collected during routine care at US community oncology sites in the Vector Oncology Data Warehouse between January 2007 and January 2014. Patients aged ≥ 18 years with a primary diagnosis of stage IB to IIIA NSCLC were eligible if they had undergone surgical resection. Treatment patterns, health care resource use, and cost were recorded, stratified by stage at diagnosis.ResultsThe study included 609 patients (mean age, 64.8 years, 52.9% male), of whom 215 had stage IB disease, 130 stage IIA/II, 110 stage IIB, and 154 stage IIIA. Adjuvant systemic therapy after resection was provided to 345 (56.7%) of 609 patients, with lower use in patients with stage IB disease (39.1%) than stage II to IIIA disease (64.9-68.2%) (P < .0001). The most common adjuvant regimen at all stages was the combination of carboplatin and paclitaxel. There were no statistically significant differences in office visits or incidence of hospitalization by disease stage. During adjuvant treatment, the total monthly median cost per patient was $17,389.75 (interquartile range,$8,815.61 to $23,360.85).ConclusionAdjuvant systemic therapy was used in some patients with stage IB NSCLC and in the majority of patients with stage IIA to IIIA disease. There were few differences in regimen or health care resource use by disease stage

Cost-Effectiveness Analysis of Tdap in the Prevention of Pertussis in the Elderly

Objectives: Health benefits and costs of combined reduced-antigen-content tetanus, diphtheria, and pertussis (Tdap) immunization among adults ≥65 years have not been evaluated. In February 2012, the Advisory Committee on Immunization Practices (ACIP) recommended expanding Tdap vaccination (one single dose) to include adults ≥65 years not previously vaccinated with Tdap. Our study estimated the health and economic outcomes of one-time replacement of the decennial tetanus and diphtheria (Td) booster with Tdap in the 10% of individuals aged 65 years assumed eligible each year compared with a baseline scenario of continued Td vaccination. Methods: We constructed a model evaluating the cost-effectiveness of vaccinating a cohort of adults aged 65 with Tdap, by calculating pertussis cases averted due to direct vaccine effects only. Results are presented from societal and payer perspectives for a range of pertussis incidences (25–200 cases per 100,000), due to the uncertainty in estimating true annual incidence. Cases averted were accrued throughout the patient 's lifetime, and a probability tree used to estimate the clinical outcomes and costs (US$2010) for each case. Quality-adjusted life-years (QALYs) lost to acute disease were calculated by multiplying cases of mild/moderate/severe pertussis by the associated health-state disutility; QALY losses due to death and long-term sequelae were also considered. Incremental costs and QALYs were summed over the cohort to derive incremental cost-effectiveness ratios. Scenario analyses evaluated the effect of alternative plausible parameter estimates on results. Results: At incidence levels of 25, 100, 200 cases/100,000, vaccinating adults aged 65 years costs an additional$336,000, $63,000 and$17,000/QALY gained, respectively. Vaccination has a cost-effectiveness ratio less than $50,000/QALY if pertussis incidence is >116 cases/100,000 from societal and payer perspectives. Results were robust to scenario analyses. Conclusions: Tdap immunization of adults aged 65 years according to current ACIP recommendations is a cost-effective health-care intervention at plausible incidence assumptions

Cost-Effectiveness of Tdap Vaccination of Adults Aged ≥65 Years in the Prevention of Pertussis in the US: A Dynamic Model of Disease Transmission

Objectives: In February 2012, the Advisory Committee on Immunization Practices (ACIP) advised that all adults aged ≥65 years receive a single dose of reduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap), expanding on a 2010 recommendation for adults >65 that was limited to those with close contact with infants. We evaluated clinical and economic outcomes of adding Tdap booster of adults aged ≥65 to “baseline” practice [full-strength DTaP administered from 2 months to 4–6 years, and one dose of Tdap at 11–64 years replacing decennial Td booster], using a dynamic model. Methods: We constructed a population-level disease transmission model to evaluate the cost-effectiveness of supplementing baseline practice by vaccinating 10% of eligible adults aged ≥65 with Tdap replacing the decennial Td booster. US population effects, including indirect benefits accrued by unvaccinated persons, were estimated during a 1-year period after disease incidence reached a new steady state, with consequences of deaths and long-term pertussis sequelae projected over remaining lifetimes. Model outputs include: cases by severity, encephalopathy, deaths, costs (of vaccination and pertussis care) and quality-adjusted life-years (QALYs) associated with each strategy. Results in terms of incremental cost/QALY gained are presented from payer and societal perspectives. Sensitivity analyses vary key parameters within plausible ranges. Results: For the US population, the intervention is expected to prevent >97,000 cases (>4,000 severe and >5,000 among infants) of pertussis annually at steady state. Additional vaccination costs are $4.7 million. Net cost savings, including vaccination costs, are$47.7 million (societal perspective) and $44.8 million (payer perspective). From both perspectives, the intervention strategy is dominant (less costly, and more effective by >3,000 QALYs) versus baseline. Results are robust to sensitivity analyses and alternative scenarios. Conclusions: Immunization of eligible adults aged ≥65, consistent with the current ACIP recommendation, is cost saving from both payer and societal perspectives

Overall survival of glasdegib in combination with low-dose cytarabine, azacitidine, and decitabine among adult patients with previously untreated AML: comparative effectiveness using simulated treatment comparisons.

BACKGROUND: Until recently, treatments for older patients with AML ineligible to receive intensive chemotherapies were limited to hypomethylating agents, low-dose cytarabine (LDAC), or clinical trials. In 2018, the FDA approved combination glasdegib (GLAS) plus LDAC based on Phase II results demonstrating improved overall survival (OS) versus LDAC alone in previously untreated AML. However, no randomized clinical trials have directly compared GLAS + LDAC with other AML treatments. OBJECTIVE: Using both indirect treatment comparison (ITC) and simulated treatment comparison (STC), which adjusts for baseline differences between trials, the comparative effectiveness of GLAS + LDAC was compared with hypomethylating agent azacitidine (AZA) or decitabine (DEC). METHODS: A systematic literature review identified published trials of AZA or DEC versus LDAC among older AML patients ineligible for high-intensity chemotherapy. In addition to standard and covariate-adjusted ITC, STC was performed following guidance from the NICE Decision Support Unit (DSU). Using individual patient data from the Phase II GLAS + LDAC study, population-specific OS hazard ratios (HR) for GLAS + LDAC versus AZA or DEC were compared. Furthermore, covariate-adjusted ITC (Cox multivariate models) and STC were repeated using GLAS + LDAC versus LDAC data propensity-weighted for within-trial mean cytogenetic risk. As this initial step was not specified in the DSU, results from this second method were compared to the first STC following DSU guidance only. RESULTS: Standard ITC and STC both demonstrated significantly improved OS for GLAS + LDAC versus either AZA or DEC. Adjusting for key covariates, STC stepwise exponential models demonstrated GLAS + LDAC superiority to both AZA (HR=0.424; 95% CI: 0.228, 0.789) and DEC (HR=0.505; 95% CI: 0.269, 0.949). These significant results held using full or step-wise approaches, following DSU guidance only or the weighted STC approach. CONCLUSION: Using ITC and STC, GLAS + LDAC demonstrated superior OS to AZA or DEC in an adult population with previously untreated AML for whom intensive chemotherapy is not an option

The economic impact of heart failure in post-myocardial infarction patients.

The economic impact of heart failure in post-myocardial infarction patients

Abstract PS10-32: Patient reported outcomes (PROs) with poly(ADP-ribose) polymerase inhibitors (PARPi) versus chemotherapy (CTX) in patients (pts) with germline BRCA1/2 mutated ( gBRCA1/2 mut) HER2- advanced breast cancer (ABC): Results from a multi-country real-world (RW) study

Abstract Background: In ABC, where treatment is palliative, an important goal is the maintenance or improvement of quality of life (QoL). In the past 3 years, PARPi have demonstrated improved progression-free survival and favorable PROs compared with CTX in randomized clinical trials (RCTs) in pts with ABC and a gBRCA1/2mut. These agents are now available in multiple countries for the treatment of gBRCA1/2mut HER2- locally advanced and/or metastatic breast cancer. Limited information is available on the PRO benefit of these agents in the RW setting. We assessed RW cancer-related and breast-cancer specific PROs among adult pts with gBRCA1/2mut HER2- ABC in Germany, France, Italy, Spain (EU4), US, and Israel. Methods: Oncologists were recruited to abstract data from medical records (2019/2020) for pts with gBRCA1/2mut HER2- ABC. A subset of pts completed the European Organisation for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) and the breast cancer module QLQ-BR23. PROs were compared between CTX and PARPi monotherapy utilizing inverse probability weighted regression adjustment (IPWRA) controlling for age at therapy initiation, Charlson Comorbidity Index at time of data collection, baseline symptoms, hormone receptor (HR) status, ECOG score at therapy initiation, stage of therapy initiation (locally advanced breast cancer or metastatic breast cancer) and number of lines of ABC treatment. Results: Overall 96 female pts participated; mean age was 51 years. Tumor characteristics were: 34.4% HR+/HER2-, 65.6% triple negative breast cancer. CTX (n=58) was received among 60.4% of pts [n=29 (50.0%) platinum based, n=29 (50.0%) non-platinum based], and PARPi monotherapy (n=38) was received among 39.6% of pts. Compared to pts receiving CTX, pts receiving PARPi reported significantly better scores in physical and social functioning (Table 1). Pts receiving PARPi reported significantly better symptoms scores vs. CTX in constipation, breast symptoms, arm symptoms and systemic therapy side effects (Table 1). Pts receiving PARPi reported significantly worse scores vs. CTX in nausea/vomiting (Table 1). Global health status (GHS)/QoL scores were numerically better among pts receiving PARPi vs. CTX (Table 1). Conclusions: PARPi have demonstrated superior efficacy and favorable PROs vs. CTX in RCTs in pts with gBRCA1/2mut HER2- ABC. In this RW study, the PRO benefits reported with PARPi were consistent with what has been observed in RCTs, further supporting the value of PARPi. Additional studies to validate these findings are planned. Funding: Pfizer EORTC QLQ-BR23 categories sexual enjoyment and upset by hair loss were excluded from the analysis due to low sample size Table 1. IPWRA Analysis for the EORTC QLQ-C30 and QLQ BR-23a scoresCTX (n=58)PARPi Monotherapy (n=38)P valueEORTC QLQ-C30 GHS/QoL and functional scalesGHS/QoL56.5665.240.10Physical71.9079.980.045Role64.5568.060.55Emotional61.2464.580.61Cognitive78.2078.840.89Social63.5781.950.01EORTC QLQ-BR23 Functional scalesSexual12.3717.230.31Future perspective46.6844.530.81Body Image53.2265.360.13EORTC QLQ-C30 Symptoms scalesFatigue40.6739.620.87Nausea/vomiting18.2834.510.005Pain34.2638.880.42Dyspnea22.1523.290.82Insomnia30.7832.400.82Appetite loss24.8531.990.29Constipation18.751.85<.001Diarrhea16.2614.570.81Financial difficulties16.2616.830.92EORTC QLQ-BR23 Symptoms ScalesBreast symptoms13.280.350.008Arm symptoms11.392.600.001Systemic therapy side effects29.3913.48<.001 Citation Format: Reshma Mahtani, Alexander Niyazov, Katie Lewis, James Pike, Alex Rider, Bhakti Arondekar, Michael Patrick Lux. Patient reported outcomes (PROs) with poly(ADP-ribose) polymerase inhibitors (PARPi) versus chemotherapy (CTX) in patients (pts) with germline BRCA1/2 mutated (gBRCA1/2mut) HER2- advanced breast cancer (ABC): Results from a multi-country real-world (RW) study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS10-32

<i>BRCA1/2</i> Mutation Testing in Patients with HER2-Negative Advanced Breast Cancer: Real-World Data from the United States, Europe, and Israel

Poly(adenosine diphosphate-ribose) polymerase inhibitors are approved to treat patients harboring a germline breast cancer susceptibility gene 1 or 2 mutation (BRCA1/2mut) with human epidermal growth factor receptor 2—negative (HER2−) advanced breast cancer (ABC). This study evaluated differences in patient demographics, clinical characteristics, and BRCA1/2mut testing within the United States (US), European Union 4 (EU4; France, Germany, Italy, and Spain), and Israel in a real-world population of patients with HER2− ABC. Oncologists provided chart data from eligible patients from October 2019 through March 2020. In the US, EU4, and Israel, 73%, 42%, and 99% of patients were tested for BRCA1/2mut, respectively. In the US and the EU4, patients who were not tested versus tested for BRCA1/2mut were more likely to have hormone receptor—positive (HR+)/HER2− ABC (US, 94% vs. 74%, p p BRCA1/2-related cancer (US, 6% vs. 19%, p = 0.002; EU4, 10% vs. 28%, p p p BRCA1/2 testing rates in the US and Europe