Antibody-drug conjugate monotherapy refines the oncological efficacy as compared to therapy of physicians' choices in advanced breast cancers: a systematic review and meta-analysis.
Transl Breast Cancer Res
; 4: 11, 2023.
Article
in En
| MEDLINE
| ID: mdl-38751489
ABSTRACT
Background:
Antibody-drug conjugate (ADC) is an emerging therapy that bestows advanced breast tumors with encouraging clinical activity and manageable toxicity; however, the outcomes of phase 2/3 randomized controlled trials (RCTs) are heterogeneous. Our study aims to assess the clinical utilities [i.e., objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS)], and treatment-related adverse events (AEs) of ADC monotherapy (defined as the study cohort) versus the therapy of physician's choice (TPC) (defined as the control cohort) in participants with advanced breast tumors.Methods:
We conducted a computerized retrieval to identify RCTs from MEDLINE, Web of Science, Cochrane Library, Embase databases, and ClinicalTrials.gov until April 4th, 2023. Screening, data extraction, and quality assessment were performed in duplicate.Results:
A total of 10 RCTs were involved, with 5,089 unique patients. A binary random-effect model Mantel-Haenszel method was employed to pool data due to the considerable heterogeneity. The primary outcome measure was odds ratio (OR) with the corresponding 95% confidential interval (CI) of ORR and CBR. The secondary outcome measure represented hazard ratio (HR) of PFS and OS and OR of the frequency of any grade/grade ≥3 AEs. The pooled results showed an insignificant difference of ORR (OR =1.64; 95% CI 0.86-3.13; P=0.136) and CBR (OR =1.43; 95% CI 0.89-2.31; P=0.142) in the study cohort than the control cohort. The pooled effect on PFS (HR =0.62; 95% CI 0.50-0.74; P<0.001) and on OS (HR =0.70; 95% CI 0.57-0.83; P<0.001) both indicated a significant superiority of the study cohort. The frequency of any grade AEs (OR =1.03; 95% CI 0.75-1.41; P=0.849) and that of grade ≥3 AEs (OR =0.83; 95% CI 0.57-1.21; P=0.342) were both observed a nonsignificant difference between the cohorts. These domains, i.e., allocation concealment, blinding of participants and personnel, and blinding of outcome assessment, had the high risk of bias over 50%.Conclusions:
Compared to physician's choice, ADC monotherapy overall confirms a considerable refinement in survival benefits plus a similar safety profile in advanced breast tumors.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Language:
En
Journal:
Transl Breast Cancer Res
Year:
2023
Document type:
Article
Affiliation country:
China