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Erschienen in: Cancer Chemotherapy and Pharmacology 4/2017

01.09.2017 | Original Article

Comparison of adverse events following injection of original or generic docetaxel for the treatment of breast cancer

verfasst von: Nao Tagawa, Erika Sugiyama, Masataka Tajima, Yasutsuna Sasaki, Seigo Nakamura, Hiromi Okuyama, Hisanori Shimizu, Vilasinee Hirunpanich Sato, Tadanori Sasaki, Hitoshi Sato

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 4/2017

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Abstract

Purpose

The approval of injectable generic drugs does not require bioequivalence testing. However, although generic products contain the same level of the active compound, the levels and types of additives present can differ from those used in the original product. Since docetaxel is highly lipophilic, polysorbate 80 (PS80), polyethylene glycol (PEG), and ethyl alcohol are employed to solubilize this anticancer agent. This retrospective study compared the safety of five docetaxel products (Taxotere®, Docetaxel Hospira, Docetaxel Sandoz, Docetaxel Sawai, and Docetaxel EE).

Methods

The incidence and severity of adverse events were analyzed using 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. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0.

Results

Significant product-related differences were observed 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). Multivariate logistic regression analyses of the associations between these adverse events and the total additive administered (g/m2) identified significant negative effects of PS80 and ethyl alcohol.

Conclusions

Injectable docetaxel products had different adverse event profiles, which showed negative associations with the amounts of PS80 and ethyl alcohol present. This finding indicated that there might be additive-related pharmacokinetic and physiochemical differences among these products, suggesting a need for further pre- or post-approval testing of injectable generic products containing noticeable different levels of additives.
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Metadaten
Titel
Comparison of adverse events following injection of original or generic docetaxel for the treatment of breast cancer
verfasst von
Nao Tagawa
Erika Sugiyama
Masataka Tajima
Yasutsuna Sasaki
Seigo Nakamura
Hiromi Okuyama
Hisanori Shimizu
Vilasinee Hirunpanich Sato
Tadanori Sasaki
Hitoshi Sato
Publikationsdatum
01.09.2017
Verlag
Springer Berlin Heidelberg
Erschienen in
Cancer Chemotherapy and Pharmacology / Ausgabe 4/2017
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-017-3425-3

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