The impact of previous therapy on overall-survival in registration clinical trials for 1st line metastatic breast cancer a systemic review Journal Article
| Authors: | Remilah, A. A.; Krayim, B.; Amir, E.; Tibau, A.; Robson, M. E.; Abuhadra, N.; Chen, Y.; Shepshelovich, D.; Goldvaser, H. |
| Article Title: | The impact of previous therapy on overall-survival in registration clinical trials for 1st line metastatic breast cancer a systemic review |
| Abstract: | Aim: To explore the impact of previous treatment on the efficacy of investigational new drugs in registration trials for 1st line metastatic breast cancer (MBC). Methods: Thirteen US Food and Drug Administration (FDA) approved indications for 1st line MBC between 1/2000–12/2023 were identified and their supporting publications were searched in the ClinicalTrials.gov and Google Scholar. Where available, hazard ratios (HRs) and 95 % confidence intervals (CI) for overall-survival (OS) were pooled into meta-analysis and the difference in the magnitude of OS benefit between treatment naïve and previously treated patients was analyzed. Results: There was no difference in the magnitude of OS benefit between treatment-naïve and previously treated patients (HR=0.72 versus 0.80,p for difference=0.25). In indications for triple-negative BC, treatment-naïve patients had higher magnitude of OS benefit compared to previously treated patients (HR=0.53 versus 0.81,p=0.03). In indications for luminal disease, the magnitude of benefit was comparable between the subgroups. Conclusions: In trials supporting 1st line therapy for TNBC the magnitude of benefit is significantly higher in treatment naïve compared to previously treated patients. Our findings may represent a previously unrecognized bias, potentially over-estimating the benefit of triple-negative BC new drugs. © 2024 Elsevier B.V. |
| Keywords: | cancer chemotherapy; overall survival; review; bevacizumab; drug efficacy; drug approval; united states; gemcitabine; paclitaxel; comparative study; carboplatin; aromatase inhibitor; publication; docetaxel; systematic review; tamoxifen; letrozole; trastuzumab; anastrozole; metastatic breast cancer; lapatinib; fulvestrant; pertuzumab; clinical trial (topic); triple negative breast cancer; de-novo; first-line treatment; human; palbociclib; pembrolizumab; abemaciclib; ribociclib; atezolizumab; treatment-naïve; registration trials |
| Journal Title: | Critical Reviews in Oncology/Hematology |
| Volume: | 202 |
| ISSN: | 1040-8428 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2024-10-01 |
| Start Page: | 104455 |
| Language: | English |
| DOI: | 10.1016/j.critrevonc.2024.104455 |
| PUBMED: | 39067779 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Review -- Source: Scopus |
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