title: Comparison of serious adverse events between the original and a generic docetaxel in breast cancer patients.
abstract: BACKGROUND
  Generic formulations are not necessarily identical to the original in terms of efficacy and adverse events. Generic docetaxel has been available in Canada since 2011.
  
  
  OBJECTIVE
  To compare the occurrence of grade III to IV adverse events between original docetaxel and a generic formulation in breast cancer patients.
  
  
  METHODS
  A consecutive series of 400 patients were assessed retrospectively: 200 who received the original docetaxel and 200 who received a generic formulation. Patients who received both formulations or received their chemotherapy outside our center were excluded. The primary outcome was the occurrence of grade III to IV adverse events related to docetaxel (febrile neutropenia, hand and foot syndrome, intestinal perforation, thrombotic event, and death).
  
  
  RESULTS
  Three hundred-sixty-four patients were available for analysis (182/group). The use of a granulocyte colony-stimulating factor (G-CSF) was more frequent in the generic group (44.5% vs 28.8%), as well as treatment discontinuation (26.4% vs 14.8%). The occurrence of grade III to IV febrile neutropenia, hand and foot syndrome, intestinal perforation, thrombotic event, and docetaxel-related deaths were similar between the 2 formulations. However, grade IV febrile neutropenia was more frequent with the generic formulation (78.8% vs 56.3%). Limitations were the retrospective nature of the study and the variety of chemotherapy regimens.
  
  
  CONCLUSIONS
  Adverse events occurrence was similar between the 2 formulations. However, febrile neutropenia was more serious with generic docetaxel, despite increased G-CSF use. Results suggest that the studied generic formulation may be safe, but more caution during treatments might be warranted, especially concerning febrile neutropenia events.
authors: CHU de Québec, Quebec City, QC, Canada.
authors: Eric
authors: E
authors: Poirier
authors: Christine
authors: C
authors: Desbiens
authors: Brigitte
authors: B
authors: Poirier
authors: Jean-Charles
authors: JC
authors: Hogue
authors: Julie
authors: J
authors: Lemieux
authors: Catherine
authors: C
authors: Doyle
authors: Anne-France
authors: AF
authors: Leblond
authors: Isabelle
authors: I
authors: Côté
authors: Guy
authors: G
authors: Cantin
authors: Louise
authors: L
authors: Provencher
mesh_terms: D000368:Aged; D000739:Anecdotes as Topic; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000188:drug therapy / Q000209:etiology; D000077143:Docetaxel; D016568:Drugs, Generic / Q000009:adverse effects*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D012189:Retrospective Studies; D043823:Taxoids / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D016568:Drugs, Generic; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel
keywords: adverse effects; breast cancer; cancer treatment; docetaxel; generic drug