A Multicenter Retrospective Study to Evaluate Safety and Efficacy of Tocopheryl Polyethylene Glycol Succinate Docetaxel in Various Cancers

Abstract Introduction In order to overcome the polysorbate induced hypersensitivity reactions with chemotherapy drugs, novel drug-delivery mechanisms have been developed in the last decade. D-alpha-tocopheryl polyethylene glycol succinate (TPGS) is formed by esterification of alpha-tocopheryl succinate and polyethylene glycol 1000. Materials and Methods This was a real-world retrospective analysis designed to evaluate safety and efficacy of TPGS-docetaxel in various cancers. Patients hospitalized between June 2018 and May 2019 were included in the data set. While the efficacy was assessed by the Response Evaluation Criteria in Solid Tumors criteria, safety was assessed by the National Cancer Institute Common Terminology Criteria-adverse event (AE) criteria. Results A total of 61 patients who received at least one dose of TPGS-docetaxel were incorporated into the analysis set. The dose of TPGS docetaxel ranged from 20 mg/m 2 to 120 mg/m 2 , commonly prescribed dose being 75 mg/m 2 . While 25 (40.98%) patients had a partial response, 17 (27.86%) patients had stable disease. Five (8.19%) patients progressed and 4 (6.55%) patients died during the chemotherapy, which was adjudicated to be unrelated to the drug as opined by the treating clinician. AE were reported in 42 patients in the safety data set. There were no AEs pertaining to hypersensitivity reported during the study. One AE of Grade 3 hand foot syndrome was encountered. Conclusion The preliminary evidence suggests that the novel TPGS-based docetaxel formulation is efficacious in various cancers, and importantly, it has an enhanced safety profile, as it is devoid of polysorbate 80 induced hypersensitivity reactions.