Support Care Cancer DOI 10.1007/s00520-014-2499-2
ORIGINAL ARTICLE
New cutaneous toxicities with generic docetaxel: are the excipients guilty? Margarita Garrido-Siles & Jose Javier Arenas-Villafranca & Elísabeth Pérez-Ruiz & M. Francisca de Linares Fernández & Begoña Tortajada & Francisco Rivas-Ruiz & Vicente Faus & Antonio Rueda
Received: 16 June 2014 / Accepted: 24 October 2014 # Springer-Verlag Berlin Heidelberg 2014
Abstract Purpose Docetaxel is one of the most widely used anticancer drugs and an ideal candidate for the development of generic formulations to reduce the economic cost. However, the use of generic drugs is an issue of debate because studies of their safety and efficacy in comparison with the original drug are not required for approval. The aim of this study is to determine whether the change in the formulation of the original drug is responsible for the toxicity changes observed. Methods A retrospective study contrasts the incidence of acute infusion reactions and skin reactions to four different presentations of docetaxel including the original drug. These drugs differ in the amounts of excipients. Results 1.031 doses of docetaxel were administered to 268 patients. A total of 26 grade 3/4 infusion reactions were detected. Compared to the original formulation, the relative risk of acute infusion reaction was 3.74 (1.52–9.18, p=0.002), 0.57 (0.19–1.64, p=0.288) and 0.37 (0.1–1.34, p=0.117) for the patients treated with drugs 2, 3 and 4. For the dermal toxicity, 9 % of patients suffered a clinically significant skin reaction. The relative risks of clinically significant dermal toxicity for the different M. Garrido-Siles : J. J. Arenas-Villafranca : B. Tortajada : V. Faus Department of Pharmacy, Hospital Costa del Sol, Marbella, Spain E. Pérez-Ruiz (*) : A. Rueda Department of Medical Oncology (REDISSEC), Hospital Costa del Sol, Marbella, Spain e-mail: [email protected] M. F. de Linares Fernández Department of Oncology’s Nurse, Hospital Costa del Sol, Marbella, Spain F. Rivas-Ruiz Technical Research Unit (REDISSEC), Hospital Costa del Sol, Marbella, Spain
formulations of docetaxel versus the original formulation were as follows: 6.15 (2.78–13.58) and 7.13 (3.24–15.69) for drugs 3 and 4 (p
ORIGINAL ARTICLE
New cutaneous toxicities with generic docetaxel: are the excipients guilty? Margarita Garrido-Siles & Jose Javier Arenas-Villafranca & Elísabeth Pérez-Ruiz & M. Francisca de Linares Fernández & Begoña Tortajada & Francisco Rivas-Ruiz & Vicente Faus & Antonio Rueda
Received: 16 June 2014 / Accepted: 24 October 2014 # Springer-Verlag Berlin Heidelberg 2014
Abstract Purpose Docetaxel is one of the most widely used anticancer drugs and an ideal candidate for the development of generic formulations to reduce the economic cost. However, the use of generic drugs is an issue of debate because studies of their safety and efficacy in comparison with the original drug are not required for approval. The aim of this study is to determine whether the change in the formulation of the original drug is responsible for the toxicity changes observed. Methods A retrospective study contrasts the incidence of acute infusion reactions and skin reactions to four different presentations of docetaxel including the original drug. These drugs differ in the amounts of excipients. Results 1.031 doses of docetaxel were administered to 268 patients. A total of 26 grade 3/4 infusion reactions were detected. Compared to the original formulation, the relative risk of acute infusion reaction was 3.74 (1.52–9.18, p=0.002), 0.57 (0.19–1.64, p=0.288) and 0.37 (0.1–1.34, p=0.117) for the patients treated with drugs 2, 3 and 4. For the dermal toxicity, 9 % of patients suffered a clinically significant skin reaction. The relative risks of clinically significant dermal toxicity for the different M. Garrido-Siles : J. J. Arenas-Villafranca : B. Tortajada : V. Faus Department of Pharmacy, Hospital Costa del Sol, Marbella, Spain E. Pérez-Ruiz (*) : A. Rueda Department of Medical Oncology (REDISSEC), Hospital Costa del Sol, Marbella, Spain e-mail: [email protected] M. F. de Linares Fernández Department of Oncology’s Nurse, Hospital Costa del Sol, Marbella, Spain F. Rivas-Ruiz Technical Research Unit (REDISSEC), Hospital Costa del Sol, Marbella, Spain
formulations of docetaxel versus the original formulation were as follows: 6.15 (2.78–13.58) and 7.13 (3.24–15.69) for drugs 3 and 4 (p
