title: A Difference in the Incidences of Hypersensitivity Reactions to Original and Generic Taxanes.
abstract: OBJECTIVE
  To compare incidences of hypersensitivity reaction (HSR) between original and generic taxanes including paclitaxel and docetaxel.
  
  
  METHODS
  We conducted a prospective study enrolling all patients receiving taxanes at King Chulalongkorn Memorial Hospital. Taxanes were infused accordingly to the step-wise rate escalation protocol at this hospital. Active surveillance for HSRs was performed. During the study period, there was only 1 generic brand used for each taxane. We primarily compared the incidences of HSR between original and generic drugs for each taxane.
  
  
  RESULTS
  During the period from January 1 to December 31, 2013, a total of 258 consecutive patients receiving taxanes were enrolled; 128 received paclitaxel, i.e. 65 and 63 in the original (Taxol) and generic arms, respectively, and 130 received docetaxel, i.e. 66 and 64 in the original (Taxotere) and generic arms, respectively. Premedication, including antihistamines and dexamethasone, was administered to all patients 30 min before taxane infusion. There were 26 (10.0%) HSR events including 24 grade 2 and 2 grade 3 HSRs. In the paclitaxel group, there were 9 (13.8%) and 7 (11.1%) HSRs in the original and generic arms, respectively (p = 0.791). In the docetaxel group, there were 9 (13.6%) and 1 (1.6%) HSRs in the original and generic arms, respectively (p = 0.017). No life-threatening symptoms or permanent discontinuation of taxanes occurred.
  
  
  CONCLUSIONS
  In this prospective study, the incidences of HSR were similar with generic and original paclitaxel but significantly different with generic and original docetaxel.
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
authors.forename: Tanchanok
authors.initials: T
authors.lastname: Ratanajarusiri
authors.forename: Virote
authors.initials: V
authors.lastname: Sriuranpong
authors.forename: Piyada
authors.initials: P
authors.lastname: Sitthideatphaiboon
authors.forename: Nattaya
authors.initials: N
authors.lastname: Poovoravan
authors.forename: Chanida
authors.initials: C
authors.lastname: Vinayanuwat
authors.forename: Napa
authors.initials: N
authors.lastname: Parinyanitikul
authors.forename: Pattama
authors.initials: P
authors.lastname: Angspatt
authors.forename: Wilai
authors.initials: W
authors.lastname: Thawinwisan
authors.forename: Suebpong
authors.initials: S
authors.lastname: Tanasanvimon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects*; D016568:Drugs, Generic / Q000009:adverse effects*; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis* / Q000453:epidemiology*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D011446:Prospective Studies; D043823:Taxoids / Q000009:adverse effects*; D013785:Thailand / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D016568:Drugs, Generic; D043823:Taxoids