A clinical study on regional lymphatic chemotherapy using an activated carbon nanoparticle-epirubicin in patients with breast cancer.

The purpose of this study was to understand the short-term therapeutic effects of an activated carbon nanoparticle-epirubicin suspension for regional lymphatic chemotherapy in patients with breast cancer. One hundred and twenty patients with stage I, II, or III primary breast cancer were randomly divided into three groups: the lymphatic chemotherapy group using the activated carbon nanoparticle-epirubicin suspension, the epirubicin control group, and the activated carbon control group. Each group of 40 patients was further divided into two subgroups with the drug injected either 24 or 48 h before surgery. The terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end labeling (TUNEL) assay was used to determine cancer cell apoptotic indices in metastatic lymph nodes. The epirubicin concentration in the black-stained lymph nodes in the lymphatic chemotherapy treatment group was 4,144.64 ± 2,426.44 ng/g, which is significantly higher than in the epirubicin control group (335.87 ± 212.82 ng/g, P < 0.001). The plasma epirubicin concentrations at 0.5, 1.5, and 24 h postinjection in the regional lymphatic chemotherapy treatment group were significantly lower than in the epirubicin control group (P < 0.001). Tolerable mild pain was observed at the injection area after administration of the epirubicin-activated carbon nanoparticle suspension. No regional necrosis or adverse effects were found. The TUNEL assay demonstrated that there was no significant difference in the apoptotic indices in the metastatic lymph nodes from the three groups. Performing lymphatic chemotherapy by regionally injecting the epirubicin-activated carbon nanoparticle suspension could significantly enhance the drug concentration in the stained lymph nodes and lower the plasma drug concentration. The epirubicin-activated carbon nanoparticle suspension has the ability to release the drug slowly in the lymph nodes and, as a result, can prolong the chemotherapeutic effects.