This multicenter phase IV study was designed to evaluate the safety, toxicity and quality of life (QoL) of a nanoparticle docetaxel formulation in Breast Cancer Nanoxel®M (Docetaxel-loaded polymeric micelles) were prepared from poly(N-vinylpyrrolidone)-block-poly(D,L-lactide) (PVP-b-PDLLA) using different incorporation methods, additives and drug-loading levels. Taxotere has used polysorbate 80 as unloaded vehicles, which produces hypersensitivitrty and edema. Nanoxel®M could be expected to be improved solubility, reduced toxicity, and reduced hypersensitivity than Taxotere.
Fifty-five patients with pathological stage II-III breast cancer were enrolled for this trial. Luminal A breast cancer patients were received adjuvant TC (Nanoxel®M 75 mg/m2 plus cyclophosphamide 600 mg/m2) (N = 11). Breast cancer patients with Luminal B, HER2 and triple negative subtype were treated with the adjuvant AC (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2) followed by Nanoxel®M 75-100 mg/m2 in node positive breast cancer (N = 35). The primary endpoint was safety and toxicity of Nanoxel®M. The secondary endpoints included QoL.
Dose reductions were required for 17 of the 18 patients (94.46%) in Nanoxel®M single 100 mg/m2, 11 of the 27 patients (40.7%) in Nanoxel®M single 75 mg/m2, 9 of the 11 patients (81.8%) in Nanoxel®M 75 mg/m2 combined with cyclophosphamide. Neutropenia was observed in 16 of the 18 patients (88.9%) with grade 4 and in 2 of 18 (11.1%) with grade 3 in Nanoxel®M single 100 mg/m2; in 14 of the 27 patients (51.9%) with grade 4 and in 4 of 27 (14.8%) with grade 3 in Nanoxel®M single 75 mg/m2; and in 7 of the 10 patients (70.08%) with grade 4 and in 1 of 10 (10.0%) with grade 3 in Nanoxel®M 75 mg/m2 combined with cyclophosphamide. The nonhematological toxicities was similar with those of taxotere, which included mucositis, anorexia, nausea, vomiting, diarrhea, and pain. Fluid retention was less than 30%, which was as grade 1-2. Hypersensitivity was developed in one case (1.8%) of Nanoxel®M single 100 mg/m2.
The hematological and nonhematological toxicities of Nanoxel®M were similar with those of taxotere. However solubilizer related toxicities such as fluid retention, hypersensitivity were less frequent than taxotere.
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All authors have declared no conflicts of interest.