The impact of radiological assessment schedules on progression-free survival in metastatic breast cancer: A systemic review and meta-analysis.
Breast cancer
Intermediate endpoints
Progression-free survival
Restaging interval
Journal
Cancer treatment reviews
ISSN: 1532-1967
Titre abrégé: Cancer Treat Rev
Pays: Netherlands
ID NLM: 7502030
Informations de publication
Date de publication:
Nov 2021
Nov 2021
Historique:
received:
26
04
2021
revised:
08
09
2021
accepted:
09
09
2021
pubmed:
21
9
2021
medline:
25
2
2023
entrez:
20
9
2021
Statut:
ppublish
Résumé
The impact of interval of restaging on the observed magnitude of benefit of progression-free survival (PFS) is undefined. Phase 3 randomized controlled trials (RCTs) investigating anti-neoplastic drugs for metastatic breast cancer which reported the restaging interval and hazard ratio (HR) for PFS were included. Data on study design and study population were collected. HRs and 95% confidence intervals for PFS and OS (overall survival) were pooled in a meta-analysis. Studies were categorized according to short (<9 weeks) or long (≥9 weeks) restaging interval. The differences in PFS and OS effect between trials employing short and long restaging intervals were assessed as subgroup analyses. Analyses were repeated for pre-specified subgroups. Eighty-nine studies comprising 95 comparisons and 44,901 patients were included. The magnitude of PFS benefit was larger in trials which employed short compared to long restaging intervals, but this difference did not reach the pre-defined threshold for statistical significance (HR = 0.79 vs. 0.86, P = 0.15). Short restaging interval was associated with significantly higher magnitude of effect on PFS in pre-specified subgroups including non-first line trials (HR = 0.78 vs. 0.92, P = 0.04), trials with drugs replacing standard treatment (HR = 0.86 vs. 1.04, P = 0.02) and studies performed in exclusively human epidermal growth factor receptor 2 (HER2) positive disease (HR = 0.72 vs. 0.90, P = 0.02). The magnitude of OS benefit was similar with short and long restaging intervals. Shorter restaging intervals are associated with a higher magnitude of effect on PFS, but not OS. Awareness of the impact of the restaging interval on quantification of PFS is important for the design and interpretation of RCTs.
Sections du résumé
BACKGROUND
BACKGROUND
The impact of interval of restaging on the observed magnitude of benefit of progression-free survival (PFS) is undefined.
MATERIALS AND METHODS
METHODS
Phase 3 randomized controlled trials (RCTs) investigating anti-neoplastic drugs for metastatic breast cancer which reported the restaging interval and hazard ratio (HR) for PFS were included. Data on study design and study population were collected. HRs and 95% confidence intervals for PFS and OS (overall survival) were pooled in a meta-analysis. Studies were categorized according to short (<9 weeks) or long (≥9 weeks) restaging interval. The differences in PFS and OS effect between trials employing short and long restaging intervals were assessed as subgroup analyses. Analyses were repeated for pre-specified subgroups.
RESULTS
RESULTS
Eighty-nine studies comprising 95 comparisons and 44,901 patients were included. The magnitude of PFS benefit was larger in trials which employed short compared to long restaging intervals, but this difference did not reach the pre-defined threshold for statistical significance (HR = 0.79 vs. 0.86, P = 0.15). Short restaging interval was associated with significantly higher magnitude of effect on PFS in pre-specified subgroups including non-first line trials (HR = 0.78 vs. 0.92, P = 0.04), trials with drugs replacing standard treatment (HR = 0.86 vs. 1.04, P = 0.02) and studies performed in exclusively human epidermal growth factor receptor 2 (HER2) positive disease (HR = 0.72 vs. 0.90, P = 0.02). The magnitude of OS benefit was similar with short and long restaging intervals.
CONCLUSIONS
CONCLUSIONS
Shorter restaging intervals are associated with a higher magnitude of effect on PFS, but not OS. Awareness of the impact of the restaging interval on quantification of PFS is important for the design and interpretation of RCTs.
Identifiants
pubmed: 34543860
pii: S0305-7372(21)00141-9
doi: 10.1016/j.ctrv.2021.102293
pii:
doi:
Types de publication
Journal Article
Meta-Analysis
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
102293Informations de copyright
Copyright © 2021 Elsevier Ltd. All rights reserved.