A Pilot, Phase II, Randomized, Open-Label Clinical Trial Comparing the Neurotoxicity of Three Dose Regimens of Nab-Paclitaxel to That of Solvent-Based Paclitaxel as the First-Line Treatment for Patients with Human Epidermal Growth Factor Receptor Type 2-Negative Metastatic Breast Cancer.

ABSTRACT:

Background

This study aimed to characterize the neurotoxicity of three different regimens of nab-paclitaxel compared with a standard regimen of solvent-based (sb) paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer based on the Total Neurotoxicity Score (TNS), a tool specifically developed to assess chemotherapy-induced neurotoxicity.

Materials and methods

This was a randomized, open-label study testing 4-week cycles of 80 mg/m² sb-paclitaxel (PACL80/w) on days 1, 8, and 15; 100 mg/m² nab-paclitaxel on days 1, 8, and 15 (NAB100/w); 150 mg/m² nab-paclitaxel on days 1, 8, and 15 (NAB150/w); and 150 mg/m² nab-paclitaxel on days 1 and 15 (NAB150/2w). In addition to the TNS, neuropathy was assessed using th

SUBMITTER: Ciruelos E 

PROVIDER: S-EPMC6853092 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature