Real-world adherence in patients with metastatic colorectal cancer (mCRC) treated with trifluridine/tipiracil (FTD/TPI) or regorafenib (REG).

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 11-11
Author(s):  
Anuj K. Patel ◽  
Victoria Barghout ◽  
Mihran Ara Yenikomshian ◽  
Guillaume Germain ◽  
Philippe Jacques ◽  
...  
Keyword(s):  
Real World ◽  
Lower Risk ◽  
Proportional Hazards ◽  
Medication Possession Ratio ◽  
Baseline Period ◽  
Cox Proportional Hazards ◽  
Data Availability ◽  
Real World Data ◽  
World Data ◽  
Nationally Representative

11 Background: Adherence to oral chemotherapies is a critical but difficult to measure factor in the care of patients with advanced cancer. FTD/TPI and REG have both demonstrated prolonged survival in patients with refractory mCRC, but with notably different side effect profiles. This study utilizes real-world data to assess adherence and discontinuation of patients treated with FTD/TPI or REG and explore the effect of sequencing on adherence. Methods: Adults diagnosed with mCRC were identified using the nationally representative IQVIA Real-World Data Adjudicated Claims – US database (10/2014–07/2017). The first dispensing date of FTD/TPI or REG (if after FTD/TPI approval [10/2015]) was defined as the index date and the 3 months before as the baseline period. The observation period spanned from the index to the earliest date of a switch to another mCRC agent, end of continuous enrollment, or end of data availability. Medication possession ratio (MPR), proportion of days covered (PDC) at 3 months, and discontinuation (i.e., allowable gap≥45 days) were compared. Logistic (odds ratio [OR]) and Cox proportional hazards (hazard ratio [HR]) regressions, adjusting for baseline characteristics, were used to compare adherence and discontinuation, respectively. A subgroup analysis was conducted among switchers (FTD/TPI to REG vs REG to FTD/TPI). Results: A total of 469 FTD/TPI and 311 REG users were identified. FTD/TPI users had higher compliance with an MPR ≥ 80% (OR = 2.47; p < 0.001) and PDC ≥ 80% (OR = 2.77; p < 0.001). FTD/TPI users had lower risk of discontinuation (HR = 0.76; p = 0.006). Among switchers (96 FTD/TPI to REG; 83 REG to FTD/TPI), those switching from FTD/TPI to REG were more likely to have an MPR ≥ 80% (OR = 2.91; p < 0.001) and PDC ≥ 80% (OR = 4.60; p < 0.001) compared to REG to FTD/TPI switchers. Additionally, FTD/TPI to REG switchers had a lower risk of first treatment discontinuation (HR = 0.66; p = 0.009). Conclusions: In this study, FTD/TPI users had significantly higher compliance, lower discontinuation rate, and switchers treated first with FTD/TPI had better compliance, demonstrating that claims data can provide insight into oral chemotherapy adherence patterns in mCRC.

scholarly journals Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin

2016 ◽  
Vol 116 (11) ◽  
pp. 975-986 ◽  
Author(s):  
Allison Keshishian ◽  
Shital Kamble ◽  
Xianying Pan ◽  
Jack Mardekian ◽  
Ruslan Horblyuk ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Lower Risk ◽  
Proportional Hazards ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Baseline Period ◽  
Cox Proportional Hazards ◽  
Significant Difference

SummaryIn addition to warfarin, there are four non-vitamin K antagonist oral anticoagulants (NOACs) available for stroke prevention in non valvular atrial fibrillation (NVAF). There are limited data on the comparative risks of major bleeding among newly anticoagulated NVAF patients who initiate warfarin, apixaban, dabigatran, or rivaroxaban, when used in ‘real world’ clinical practice. The study used the Truven MarketScan® Commercial & Medicare supplemental US claims database. NVAF patients aged ≥18 years newly prescribed an oral anticoagulant 01JAN2013–31DEC2014, with a ≥1-year baseline period, were included (study period: 01JAN2012–31DEC2014). Major bleeding was defined as bleeding requiring hospitalisation. Propensity score matching (PSM) was used to balance age, sex, region, baseline comorbidities, and comedications. Cox proportional hazards models were used to estimate the PSM hazard ratio (HR) of major bleeding. Among 45,361 newly anticoagulated NVAF patients, 15,461 (34.1 %) initiated warfarin, 7,438 (16.4 %) initiated apixaban, 17,801 (39.2 %) initiated rivaroxaban, and 4,661 (10.3 %) initiated dabigatran. Compared to matched warfarin initiators, apixaban (HR: 0.53; 95 % CI: 0.39–0.71) and dabigatran (HR: 0.69; 95 % CI: 0.50–0.96) initiators had a significantly lower risk of major bleeding. Patients initiating rivaroxaban (HR: 0.98; 95 % CI: 0.83–1.17) had a non-significant difference in major bleeding risk compared to matched warfarin patients. When comparisons were made between NOACs, matched rivaroxaban patients had a significantly higher risk of major bleeding (HR: 1.82; 95 % CI: 1.36–2.43) compared to apixaban patients. The differences for apixaban-dabigatran and dabigatran-rivaroxaban matched cohorts were not statistically significant. Among newly anticoagulated NVAF patients in the real-world setting, apixaban and dabigatran initiation was associated with significantly lower risk of major bleeding compared to warfarin initiation. When compared to apixaban, rivaroxaban initiation was associated with significantly higher risk of major bleeding.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.

scholarly journals Methotrexate Reduces the Probability of Discontinuation of TNF Inhibitors in Seropositive Patients With Rheumatoid Arthritis. A Real-World Data Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Borja Hernández-Breijo ◽  
Claudia M. Brenis ◽  
Chamaida Plasencia-Rodríguez ◽  
Ana Martínez-Feito ◽  
Marta Novella-Navarro ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Real World ◽  
Proportional Hazards ◽  
Serum Levels ◽  
Cox Proportional Hazards ◽  
Real World Data ◽  
World Data ◽  
Kaplan Meier ◽  
Cox Proportional Hazards Models ◽  
Necrosis Factor

Tumor necrosis factor inhibitors (TNFi) are widely used for the treatment of patients with rheumatoid arthritis (RA), however a considerable percentage of patients discontinued the therapy. The aim of this study is to explore real-world TNFi survival, stratified for seropositivity, and to determine the factors that may influence it. This is a retrospective, observational and longitudinal study, using real-world data of patients, who started their first TNFi therapy between 1999 and 2018 from the RA-PAZ cohort. Patients were considered seropositive if they showed positive serum levels of either RF, ACPA, or both. Treatment survival was analyzed using Kaplan-Meier curves, and Cox proportional hazards models were used to compare the risks of TNFi discontinuation for seronegative and seropositive patients. Of the included 250 patients, 213 (85%) were seropositive. Results showed that TNFi survival did not depend on seropositivity status. However, median survival time was significant longer for seropositive patients who received concomitant MTX compared to patients who did not receive it (median [95% CI]: 3.3 yr. [2.3–4.2] vs. 2.6 yr. [1.7–3.6], respectively; p = 0.008). Furthermore, seropositive patients who received concomitant MTX were 49% less likely to discontinue TNFi therapy than patients who did not receive it (HR: 0.51; 95% CI: 0.35–0.74). In addition, we found that in seropositive patients, the use of prednisone throughout the TNFi treatment was associated with a higher likelihood of therapy discontinuation (OR: 2.30; 95% CI: 1.01–5.23). In conclusion, these data provide evidence to support the use of concomitant MTX in seropositive patients to prolong the effectiveness and the survival of the TNFi therapy. Moreover, the co-administration of prednisone in seropositive patients receiving TNFi was highly associated with TNFi discontinuation.

Comparison of the real-world adherence and compliance patterns with trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) for the treatment of metastatic colorectal cancer (mCRC).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 666-666
Author(s):  
Anuj K. Patel ◽  
Mei Sheng Duh ◽  
Victoria Barghout ◽  
Mihran Ara Yenikomshian ◽  
Yongling Xiao ◽  
...  
Keyword(s):  
Real World ◽  
Index Date ◽  
Proportional Hazards ◽  
Medication Possession Ratio ◽  
Cox Proportional Hazards ◽  
Clinical Activity ◽  
Cox Proportional Hazards Models ◽  
The Us ◽  
Before And After ◽  
Observation Period

666 Background: FTD/TPI and REG both prolong survival in refractory mCRC and have similar indications with different side effect profiles. This study compares real-world treatment patterns with FTD/TPI and REG for mCRC in a large, representative US claims database. Methods: Retrospective data from 10/2014 to 7/2016 from the US Symphony Health Solutions’ Integrated Dataverse (IDV®) database were analyzed for patients receiving FTD/TPI or REG. The index date was the date of first FTD/TPI or REG prescription. Patients were included if: 1) age ≥18 years old, 2) ≥1 CRC diagnosis, 3) no diagnosis of gastric cancer or gastrointestinal stromal tumor, and 4) continuous clinical activity for ≥3 months before and after index date. The observation period spanned from index date to end of data, end of continuous clinical activity, or switch to another mCRC treatment. Adherence was assessed using medication possession ratio (MPR) ≥0.80 and proportion of days covered (PDC) ≥0.80 at 3 months. Compliance was assessed using time to discontinuation over the observation period using allowable gaps of 45, 60, or 90 days. Patients who never discontinued therapy were censored at the end of the observation period. Outcomes were compared between FTD/TPI and REG using multivariate logistic regression and Cox proportional hazards models, adjusting for demographic and clinical baseline characteristics. Results: A total of 1,630 FTD/TPI patients and 1,425 REG patients were identified. Mean ± standard deviation (SD) age of FTD/TPI patients was 61.0 ± 11.0 compared to 62.8 ± 10.9 for REG patients (p < 0.001). FTD/TPI patients were 80% more likely to have a MPR ≥0.80 compared to those on REG (Odds Ratio [OR] = 1.80, p < 0.001) and more than twice as likely to have a PDC ≥0.80 (OR = 2.66, p < 0.001) at 3 months. FTD/TPI patients were 37% less likely to discontinue their treatment compared to those on REG when using gaps of 60 days (Hazard Ratio = 0.63, p < 0.001). Similar results were found with 45 and 90 days. Conclusions: In this retrospective study of mCRC patients, patients on FTD/TPI were significantly more likely to adhere and comply with therapy compared to those on REG.

Impact of bolus versus continuous infusion of doxorubicin (DOX) on cardiotoxicity in patients with breast cancer (BC) and sarcomas: Analysis of real-world data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19123-e19123
Author(s):  
Lee D. Cranmer ◽  
Lisa M. Hess ◽  
Tomoko Sugihara ◽  
Yajun Emily Zhu
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Early Period ◽  
Cox Proportional Hazards ◽  
Test Duration ◽  
Cardiac Events ◽  
Real World Data ◽  
World Data ◽  
Middle Period ◽  
The Impact

e19123 Background: Doxorubicin continues to play a central role in management of breast cancer and sarcomas. Dose-dependent cardiomyopathy is a challenge in its use. Strategies have been proposed to mitigate this, including administration by continuous intravenous (CIV) infusion as an alternative to bolus (BOL) administration. This study used real world data to explore the impact of DOX administration mode on cardiotoxicity, duration of DOX and time to treatment failure (TTF). Methods: This study used IBM MarketScan claims to identify patients age ≥ 18 who received at least 2 DOX administrations after cancer diagnosis. Patients with history of cardiac events/toxicities were excluded. Cardiac events were compared for BOL versus CIV overall, by tumor site and by regimen during three follow-up periods, early (within 1 year), middle (>1 to 5 years) and late (>5 years), from DOX initiation using Fisher’s exact test. Duration of DOX and TTF, defined as time from initiation of DOX to subsequent systemic therapy, hospice or death, were evaluated using Kaplan-Meier method and unadjusted Cox proportional hazards models. Results: 62,597 patients were eligible, including 38,961 with BC and 1,772 with sarcoma. Most patients had codes for both modes; 1,941 and 7,094 patients had exclusive BOL and CIV codes, respectively. For these patients, mean duration of DOX was longer for BOL vs. CIV (83.9 vs. 65.4 days, p<0.001). Cardiac events for BOL vs. CIV were 6.5% vs. 5.6% (p=0.098) during the early period, 4% vs. 5.1% (p=0.046) middle period, and 0.5% vs. 0.9% (p=0.068) late period. This pattern was consistent for BC and sarcoma and among those who were pre-treated. There were no differences in cardiac events for BOL vs. CIV for the chemotherapy naïve or DOX monotherapy groups (all periods p>0.10) but statistically different for the breast during the middle period, sarcoma at any time, and pretreated subgroup middle period (all p<0.05). TTF favored CIV over BOL among patients with BC (p<0.0001) but BOL over CIV in sarcoma (p=0.002). TTF was not significantly different between BOL and CIV for BC monotherapy (p=0.067) but was significant for sarcoma monotherapy favoring BOL administration (hazard ratio 0.72, 95% confidence interval 0.54-0.95, p=0.02). Conclusions: These data suggest that cardiac events may occur at a similar rate irrespective of mode of DOX administration. Further analyses are needed to understand how these relationships are impacted by other potential risk covariates (eg, age, gender) and by protective factors (eg, dexrazoxane).

scholarly journals Multiple immune-related adverse events and anti-tumor efficacy: real-world data on various solid tumors

2020 ◽  
Author(s):  
Keitaro Shimozaki ◽  
Yasutaka Sukawa ◽  
Noriko Beppu ◽  
Isao Kurihara ◽  
Shigeaki Suzuki ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Real World ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Checkpoint Inhibitors ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
University Hospital ◽  
Real World Data

Abstract Background Immune checkpoint inhibitors have been approved for various types of cancer; however, they cause a broad spectrum of immune-related adverse events (irAEs). The association between the development of irAEs and the clinical benefit remains uncertain. We aimed to evaluate the association of irAEs and the treatment efficacy in the real-world practice. Methods We conducted a retrospective study on patients with recurrent or metastatic non-small cell lung cancer, melanoma, renal cell carcinoma, or gastric cancer who received anti-PD-1/PD-L1 antibodies (nivolumab, pembrolizumab, or atezolizumab) at the Keio University Hospital between September 2014 and January 2019. We recorded treatment-related AEs from medical records and graded them using the Common Terminology Criteria for Adverse Events version 4. We performed an overall survival (OS) analysis using a Cox proportional hazards model. Results Among 212 patients eligible for this study, 108 experienced irAEs and 42 developed multiple irAEs. OS in patients with multiple irAEs was significantly longer than that in patients with single irAE (42.3 months vs. 18.8 months; hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.25–0.93; P = 0.03). Moreover, OS from the development of a second irAE in those with multiple irAEs was longer than that from the development of the first irAE in patients with single irAEs (median OS, 26.9 months vs. 17.7 months, respectively; HR, 0.59; 95% CI, 0.30–1.14; P = 0.11). Conclusions Our single-center retrospective study revealed a remarkable tendency associating the development of multiple irAEs with favorable prognoses.

scholarly journals Real-world data: how they can help to improve quality of care

2021 ◽  
Vol 8 ◽  
pp. 134-139
Author(s):  
Giovanni Corrao ◽  
Giovanni Alquati ◽  
Giovanni Apolone ◽  
Andrea Ardizzoni ◽  
Giuliano Buzzetti ◽  
...  
Keyword(s):  
Public Health ◽  
Quality Of Care ◽  
Real World ◽  
Ethical Issues ◽  
Data Availability ◽  
Quality Data ◽  
Real World Data ◽  
World Data ◽  
Critical Issues

The current COVID pandemic crisis made it even clearer that the solutions to several questions that public health must face require the access to good quality data. Several issues of the value and potential of health data and the current critical issues that hinder access are discussed in this paper. In particular, the paper (i) focuses on “real-world data” definition; (ii) proposes a review of the real-world data availability in our country; (iii) discusses its potential, with particular focus on the possibility of improving knowledge on the quality of care provided by the health system; (iv) emphasizes that the availability of data alone is not sufficient to increase our knowledge, underlining the need that innovative analysis methods (e.g., artificial intelligence techniques) must be framed in the paradigm of clinical research; and (v) addresses some ethical issues related to their use. The proposal is to realize an alliance between organizations interested in promoting research aimed at collecting scientifically solid evidence to support the clinical governance of public health.

Analysis of real world patient compliance to everolimus-based therapy among post-menopausal women with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12546-e12546 ◽  
Author(s):  
Nicole Princic ◽  
Matthew Brouillette ◽  
Derek Tang ◽  
Chinjune Lin ◽  
Brad Lanoue ◽  
...  
Keyword(s):  
Patient Compliance ◽  
Real World ◽  
Total Duration ◽  
Medication Possession Ratio ◽  
Secondary Malignancy ◽  
Real World Data ◽  
World Data ◽  
Post Menopausal ◽  
Line Of Therapy

e12546 Background: Patient compliance, typically not captured in clinical trials, may have profound effects on treatment effectiveness. As there has been limited real-world data, the objective of this analysis was to examine compliance among HR+/HER2- mBC patients treated with everolimus as a second or later line of therapy in the US across age groups. Methods: In this retrospective cohort study, the MarketScan Commercial and Medicare Supplemental claims databases were used to select post-menopausal HR+/HER2- mBC women who initiated an everolimus-based line of therapy during 1/1/2013- 7/31/2016 study period. The first secondary malignancy diagnosis was the index date. Patients had 6 months of continuous enrollment in their health plans pre- and post- index, and were followed until the earliest of disenrollment, inpatient death, or end of study. Compliance was measured using medication possession ratio (MPR) during a second (2L), third (3L) and fourth (4L) line of therapy. MPR was defined as total days of supply of everolimus during the line of therapy divided by total duration of the line. Results: Of 645 eligible mBC patients treated with everolimus during follow-up, there were 239, 142, and 80 with a 2L, 3L, and 4L of therapy respectively. Mean age overall was 61.1 + 11.7 years and average duration of follow-up was 718.3 + 304.1 days. Across all patients the median MPR ranged during each line from 0.90-0.92 and the majority (93.8%-97.5%) were highly compliant to therapy (defined as MPR>80%). These results were consistent for patients aged <65 and 65+ years across a 2L, 3L, and 4L of therapy (Table). Conclusions: This study shows high compliance for everolimus-based therapy within a 2L, 3L, and 4L of therapy and this is consistent across ages. This real world data suggests good drug manageability and may provide valuable information for clinicians in selecting treatment for mBC. [Table: see text]

PMU71 Real World Data Availability in Latin America: Assessment and Implications for Research and Healthcare Decision Making

2021 ◽  
Vol 24 ◽  
pp. S157
Author(s):  
H. Monsanto ◽  
C. Parellada ◽  
J. Orengo ◽  
J.S. Velasco ◽  
Bavel J van ◽  
...  
Keyword(s):  
Decision Making ◽  
Latin America ◽  
Real World ◽  
Data Availability ◽  
Healthcare Decision ◽  
Real World Data ◽  
World Data ◽  
Healthcare Decision Making
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