Dear Editor,
We would like to comment on the paper published by Garrido-Siles et al. about the new cutaneous toxicities of generics docetaxel [1]. We had a similar but undocumented experience with docetaxel. We used the original molecule until 2012; then, we switched to generics. Having successively used three different generics of docetaxel, we noted an increase in docetaxel-induced skin toxicities, especially grades 3–4.
We would also refer to the paper published by Vial et al. who evaluated the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH, versus those of the original docetaxel. Their study demonstrated that 90 % of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both with potential impact on efficacy and safety of docetaxel [2].
These two articles involve ethical considerations:
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Should we inform the patient about the increasing risk of skin toxicities?
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One of the generics studied increased the relative risk of skin toxicities nine times compared to the original docetaxel. What cut-off of cutaneous toxicity should we accept?
In our opinion, the burden of cancer on patients is sufficiently high in terms of quality of life. We should not accept any increase of toxicity by the use of generics.
References
Garrido-Siles M, Arenas-Villafranca JJ, Pérez-Ruiz E, de Linares Fernández MF, Tortajada B, Rivas-Ruiz F, Faus V, Rueda A (2014) New cutaneous toxicities with generic docetaxel: are the excipients guilty? Support Care Cancer
Vial J, Cohen M, Sassiat P, Thiébaut D (2008) Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis. Curr Med Res Opin 24:2019–2033
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Boutayeb, S., El ghissassi, I., Naceri, S. et al. Letter to the editor. Support Care Cancer 23, 2861 (2015). https://doi.org/10.1007/s00520-015-2790-x
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DOI: https://doi.org/10.1007/s00520-015-2790-x