Efficacy and safety evaluation of albumin-bound paclitaxel chemotherapy in East Asian patients with gynecological tumors based on the degree of paclitaxel binding to patient plasma.

Nab-PTX is a special dosage form of antitumor drug that is different from other injections. In order to explore the efficacy and safety of albumin-bound paclitaxel, we developed an analytical method with UPLC-MS/MS to quantify the total and free paclitaxel in plasma, and prospectively evaluate the impact of unbound fraction fu (%) on the prognosis and adverse reactions of patients with gynecological tumors. From 2020.10 to 2021.10, a total of 116 patients with gynecological tumors were included, application of albumin-bound paclitaxel combined with platinum chemotherapy drugs, the blood collection time is 18-30 h after nab-PTX intravenous infusion. The collection time and the start (end) time of intravenous drip are recorded correctly, and a high-precision and sensitive UPLC-MS/MS method for the simultaneous determination of total and free paclitaxel was established. With fu (%) = Cunbound/Ctotal as the evaluation index, the concentration of total paclitaxel and free paclitaxel were determined by UPLC-MS/MS. The value of fu (%) was closely related to clinical adverse reactions, neutropenia, thrombocytopenia, leukopenia and bone marrow suppression. Neurotoxicity was statistically remarkable ( P  up0.001), and fu (%) has a significant correlation with clinical efficacy ( P  up0.001). We have developed a highly precise, highly sensitive and specific UPLC-MS/MS method for the simultaneous determination of binding and free albumin-bound paclitaxel concentrations in patients' serum. In addition, we found that fu (%) could be used as the detection index. The higher the fu (%) was, the more taxol could be free, the more adverse reactions related to toxic events occurred in patients.