Real-world evidence was feasible for estimating effectiveness of chemotherapy in breast cancer: a cohort study.

Details

Serval ID
serval:BIB_62350D7787B0
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Real-world evidence was feasible for estimating effectiveness of chemotherapy in breast cancer: a cohort study.
Journal
Journal of clinical epidemiology
Author(s)
Gray E., Marti J., Brewster D.H., Wyatt J.C., Piaget-Rossel R., Hall P.S.
ISSN
1878-5921 (Electronic)
ISSN-L
0895-4356
Publication state
Published
Issued date
05/2019
Peer-reviewed
Oui
Volume
109
Pages
125-132
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
Evidence-based guidelines recommend adjuvant chemotherapy in early stage breast cancer whenever treatment benefit is considered sufficient to outweigh the associated risks. However, many groups of patients were either excluded from or underrepresented in the clinical trials that form the evidence base for this recommendation. This study aims to determine whether using administrative health care data-real world data-and econometric methods for causal analysis to provide "real world evidence" (RWE) are feasible methods for addressing this gap.
Cases of primary breast cancer in women from 2001 to 2015 were extracted from the Scottish cancer registry (SMR06) and linked to other routine health records (inpatient and outpatient visits). Four methods were used to estimate the effect of adjuvant chemotherapy on disease-specific and overall mortality: (1) regression with adjustment for covariates, (2) propensity score matching, (3) instrumental variables analysis, and (4) regression discontinuity design. Hazard ratios for breast cancer mortality and all-cause mortality were compared to those from a meta-analysis of randomized trials.
A total of 39,805 cases were included in the analyses. Regression adjustment, propensity score matching, and instrumental variables were feasible, whereas regression discontinuity was not. Effectiveness estimates were similar between RWE and randomized trials for breast cancer mortality but not for all-cause mortality.
RWE methods are a feasible means to generate estimates of effectiveness of adjuvant chemotherapy in early stage breast cancer. However, such estimates must be interpreted in the context of the available randomized evidence and the potential biases of the observational methods.
Keywords
Adult, Aged, Aged, 80 and over, Antineoplastic Agents/therapeutic use, Breast Neoplasms/drug therapy, Chemotherapy, Adjuvant/statistics & numerical data, Clinical Trials as Topic/statistics & numerical data, Cohort Studies, Female, Humans, Middle Aged, Proportional Hazards Models, Treatment Outcome, Adjuvant chemotherapy, Breast cancer, Feasibility, Instrumental variables, Meta-analysis, Propensity score, Real world evidence, Regression discontinuity
Pubmed
Web of science
Create date
24/06/2019 11:20
Last modification date
26/06/2020 6:21
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