Chemotherapy effectiveness in trial-underrepresented groups with early breast cancer: A retrospective cohort study.

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License: CC BY 4.0
Serval ID
serval:BIB_64A29716E18C
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Chemotherapy effectiveness in trial-underrepresented groups with early breast cancer: A retrospective cohort study.
Journal
PLoS medicine
Author(s)
Gray E., Marti J., Wyatt J.C., Brewster D.H., Hall P.S.
Working group(s)
SATURNE advisory group
ISSN
1549-1676 (Electronic)
ISSN-L
1549-1277
Publication state
Published
Issued date
12/2019
Peer-reviewed
Oui
Volume
16
Number
12
Pages
e1003006
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
Adjuvant chemotherapy in early stage breast cancer has been shown to reduce mortality in a large meta-analysis of over 100 randomised trials. However, these trials largely excluded patients aged 70 years and over or with higher levels of comorbidity. There is therefore uncertainty about whether the effectiveness of adjuvant chemotherapy generalises to these groups, hindering patient and clinician decision-making. This study utilises administrative healthcare data-real world data (RWD)-and econometric methods for causal analysis to estimate treatment effectiveness in these trial-underrepresented groups.
Women with early breast cancer aged 70 years and over and those under 70 years with a high level of comorbidity were identified and their records extracted from Scottish Cancer Registry (2001-2015) data linked to other routine health records. A high level of comorbidity was defined as scoring 1 or more on the Charlson comorbidity index, being in the top decile of inpatient stays, and/or having 5 or more visits to specific outpatient clinics, all within the 5 years preceding breast cancer diagnosis. Propensity score matching (PSM) and instrumental variable (IV) analysis, previously identified as feasible and valid in this setting, were used in conjunction with Cox regression to estimate hazard ratios for death from breast cancer and death from all causes. The analysis adjusts for age, clinical prognostic factors, and socioeconomic deprivation; the IV method may also adjust for unmeasured confounding factors. Cohorts of 9,653 and 7,965 were identified for women aged 70 years and over and those with high comorbidity, respectively. In the ≥70/high comorbidity cohorts, median follow-up was 5.17/6.53 years and there were 1,935/740 deaths from breast cancer. For women aged 70 years and over, the PSM-estimated HR was 0.73 (95% CI 0.64-0.95), while for women with high comorbidity it was 0.67 (95% CI 0.51-0.86). This translates to a mean predicted benefit in terms of overall survival at 10 years of approximately3% (percentage points) and 4%, respectively. A limitation of this analysis is that use of observational data means uncertainty remains both from sampling uncertainty and from potential bias from residual confounding.
The results of this study, as RWD, should be interpreted with caution and in the context of existing and emerging randomised data. The relative effectiveness of adjuvant chemotherapy in reducing mortality in patients with early stage breast cancer appears to be generalisable to the selected trial-underrepresented groups.
Pubmed
Web of science
Open Access
Yes
Create date
03/01/2020 21:18
Last modification date
12/01/2022 7:10
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