Sequential therapy with ramucirumab and/or checkpoint inhibitors for non-small-cell lung cancer in routine practice.

Aim: To describe treatment patterns and outcomes for advanced/metastatic non-small-cell lung cancer (aNSCLC) treated with single-agent or combination ramucirumab (ramucirumab-based) and/or immune checkpoint inhibitor (ICI-based) therapy. Materials & methods: Retrospective study of aNSCLC patients (n = 4054) identified in the Flatiron Health database, who received at least two treatment lines including ramucirumab- and/or ICI-based regimens between December 2014 and May 2017. Results: Median overall survival (95% CI) from aNSCLC diagnosis was 29.3 (25.5-33.0) months for patients receiving sequential ramucirumab- and ICI-based therapy (n = 245), 15.1 (12.6-18.2) months for patients receiving sequences including ramucirumab- without ICI-based therapy (n = 112), and 23.1 (21.9-24.2) months for patients receiving ICI-based therapy without ramucirumab-based therapy in sequence (n = 3697). Conclusion: Results provide real-world survival estimates for aNSCLC treated with sequences including ramucirumab- and/or ICI-based therapies.

Treatment sequencing for the care of patients with advanced or metastatic non-small cell lung cancer in the United States.

OBJECTIVES: Therapeutic advances for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) have led to additional options for care. This observational study was designed to describe emerging treatment patterns and survival outcomes. MATERIALS AND METHODS: Flatiron Health's oncology electronic health records database was to identify eligible patients who were age 18+ who initiated second-line therapy for NSCLC Survival analyses were conducted using Kaplan Meier methods and Cox proportional hazard model using SAS 9.4. both unadjusted and adjusted, using generalized propensity score, to account for imbalances between groups. RESULTS: The 10,060 eligible patients from Dec 2014 to Feb 2019 were 52.6% male; mean age 67.1 years; 70.3% white; 26.0% squamous/70.0% non-squamous (4.1% not specified); and 92.7% were treated at community practices. Immune checkpoint inhibitors (ICIs) were used by 79.9% of the cohort during any line of therapy; 12.1% and 53.7% used ICIs during first- and second-line therapy, respectively. There was heterogeneity in treatment sequencing, as the three most common first→second line sequences accounted for 7.7% (carboplatin + paclitaxel→nivolumab), 5.0% (carboplatin + pemetrexed→nivolumab), and 3.8% (carboplatin + nab-paclitaxel→nivolumab) of the total population, respectively. Unadjusted median overall survival was 21.1 months (95% confidence interval, CI: 20.5-21.6) from metastatic diagnosis. Median survival was 23.0 months (95% CI, 22.3-23.6) for non-squamous and 18.1 months (95% CI, 17.3-18.8) for squamous disease. CONCLUSION: There is heterogeneity in sequencing strategies that limit the ability to conduct robust comparative effectiveness research of treatment sequences. Since few patients follow a similar treatment trajectory, comparative effectiveness research will be challenged to identify treatment sequences with sufficient sample size.

Reliability of Conclusions from Early Analyses of Real-World Data for Newly Approved Drugs in Advanced Gastric Cancer in the United States.

BACKGROUND: As real-world data resources expand and improve, there will increasingly be opportunities to study the effectiveness of interventions. There is a need to ensure that study designs explore potential sources of bias and either acknowledge or mitigate them, in order to improve the accuracy of findings. The objective of this study was to understand newly approved drug utilization patterns in real-world clinical settings over time. METHODS: This retrospective study included three sources of real-world data (claims, electronic health records, and recoded data from a quality care program) collected from patients diagnosed with gastric cancer who initiated therapy with either trastuzumab or ramucirumab. Linear regression was used to investigate trends in the use of these drugs for the care of patients with gastric cancer over time from Food and Drug Administration (FDA) approval. RESULTS: Eligible patients (n=1700) had consistent demographic and clinical characteristics over time. After regulatory approval, trastuzumab was used in later lines of therapy and then shifted to earlier lines (p=0.002), while ramucirumab utilization remained consistent over time after FDA approval (p=0.49). Ramucirumab augmentation, defined as the addition of the drug after initiation of a line of therapy, decreased over time (p=0.03), and trastuzumab augmentation remained consistent over time (p=0.58). CONCLUSION: Since treatment effectiveness may change across lines of treatment, bias may arise if there are changes in the use of the drug (such as line migration) during the time period of analysis using real-world data.

Drug wastage and costs to the healthcare system in the care of patients with non-small cell lung cancer in the United States.

BACKGROUND: Lung cancer is one of the most prevalent cancers in the US. This study was designed to evaluate the actual drug wastage and cost to the healthcare system using patient-level retrospective observational electronic medical record (EMR) data from a cohort of lung cancer patients in the US. METHODS: Data from the Flatiron Health advanced non-small cell lung cancer (NSCLC) cohort was used for this study. Drug administered amount (in mg) was used to determine an optimal set of available vial sizes to minimize waste. Drug wastage was defined as the difference between the drug amount in the optimal set of vials and the administered amount. Wholesale acquisition costs were used to value the cost of drugs, with and without vial sharing assumptions. The amount and cost of waste were quantified over the 2-year study period (January 2015-December 2016). RESULTS: There were 8,467 eligible patients included in this study, providing data from 103,826 unique drug administrations across multiple lines of therapy. Overall wastage was 4.37% of the total medication used to care for patients. While costs per administration were low, the total cost of wastage for the study population represented $16,630,112 across the 2-year study period. Assuming that vial sharing occurred at the site level slightly reduced waste to 3.74% (reducing costs to $15,953,212 over 2 years). CONCLUSIONS: Drug wastage is an important concern and has implications on healthcare costs in NSCLC. Evaluation of these real-world data suggest that pharmacists and physicians are able to reduce drug wastage by optimizing vial combinations and sharing vials among patients. Even small amounts of reduction in wastage could be useful in reducing healthcare costs in the US; however, caution is needed with drug rounding efforts to ensure patients do not receive a sub-optimal dose of medication.