Tagawa N, et al. - The safety of five docetaxel products (Taxotere, Docetaxel Hospira, Docetaxel Sandoz, Docetaxel Sawai, and Docetaxel EE) was compared. This study unveiled different adverse event profiles of injectable docetaxel products. These profiles exhibited negative associations with the amounts of polysorbate 80 (PS80) and ethyl alcohol present. There appeared additive-related pharmacokinetic and physiochemical differences among these products. It indicated a need for further pre- or post-approval testing of injectable generic products containing noticeable different levels of additives.

Methods

• This study used the medical records of operable breast cancer patients (n = 363) treated with docetaxel (75 mg/m2) in Showa University Hospital, Japan, from Jan 2013 to Mar 2016 to examine the incidence and severity of adverse events.
• Analysts graded toxicities using the Common Terminology Criteria for Adverse Events, version 4.0.

Results

• They noticed significant product-related differences in the following non-hematological adverse events: injection site reaction (P = 0.0012), hand-foot syndrome (≥grade 3) (P = 0.0003), and oral mucositis (≥grade 3) (P = 0.0080).
• Significant negative effects of PS80 and ethyl alcohol were recognized by multivariate logistic regression analyses of the associations between these adverse events and the total additive administered (g/m2).