The impact of radiological assessment schedules on progression-free survival in metastatic breast cancer: A systemic review and meta-analysis
Por:
Dabush, DR, Shepshelovich, D, Shochat, T, Tibau, A, Amir, E, Goldvaser, H
Publicada:
1 nov 2021
Ahead of Print:
1 sep 2021
Resumen:
Background: The impact of interval of restaging on the observed magnitude of benefit of progression-free survival (PFS) is undefined.
Materials and 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: 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: 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.
Filiaciones:
Dabush, DR:
Rabin Med Ctr, Davidoff Canc Ctr, Petah Tiqwa, Israel
Shepshelovich, D:
Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel
Tel Aviv Sourasky Med Ctr, Internal Med D, Tel Aviv, Israel
Shochat, T:
Rabin Med Ctr, Stat Consulting Unit, Petah Tiqwa, Israel
Tibau, A:
Hosp Santa Cruz & San Pau, Inst Invest Biomed Sant Pau, Dept Oncol, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Amir, E:
Univ Toronto, Div Med Oncol, Toronto, ON, Canada
Princess Margaret Canc Ctr, Toronto, ON, Canada
Goldvaser, H:
Shaare Zedek Med Ctr, Oncol Inst, 12 Shmuel Bait St, IL-9103102 Jerusalem, Israel
Hebrew Univ Jerusalem, Fac Med, Jerusalem, Israel
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