title: Incidence of and risk factors associated with nedaplatin-related hypersensitivity reactions.
abstract: BACKGROUND
  Nedaplatin (NDP)-related hypersensitivity reactions (HSRs) trigger adverse clinical events. Prediction and prevention of NDP-HSRs are thus essential to minimize the risk and maximize the benefit of NDP therapy. However, the incidence of NDP-HSRs and the associated risk factors remain unclear.
  
  
  METHODS
  We retrospectively examined patients who received NDP monotherapy between April 2011 and July 2015 in Nagoya University Hospital. HSRs severity was defined according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE ver.4). Risk factors for NDP-HSRs were determined using multivariate logistic regression.
  
  
  RESULTS
  Of 111 patients who received NDP monotherapy, 90 (81%) were female; median age was 59 years (range, 29-78 years). Eighty-eight patients had gynecological cancer and 20 suffered from head and neck cancer. Eight of 111 patients (7.2%) experienced NDP-HSRs, six of which developed in the second NDP cycle. However, all patients with NDP-HSRs were treated with carboplatin (CBDCA) for more than three cycles. Grade 3 and 4 HSRs developed in 2 patients. NDP-HSRs were significantly associated with a history of CBDCA-HSRs (odds ratio 37.5, 95% confidence interval 5.38-262, p < 0.001) and with the interval between NDP administration and the previous platinum treatment (odds ratio 13.9, 95% confidence interval 1.23-158, p = 0.034).
  
  
  CONCLUSIONS
  The risk of NDP-HSRs increases in patients with a history of CBDCA-HSRs and in those administered NDP for more than 6 months after previous platinum treatment. Such individuals must be closely monitored if given NDP, even if they are expected to benefit from the treatment.
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan. y.kawarada@med.nagoya-u.ac.jp.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Kawarada
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Miyazaki
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Ayaka
authors.initials: A
authors.lastname: Itoh
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Risa
authors.initials: R
authors.lastname: Araki
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Hidetaka
authors.initials: H
authors.lastname: Iwamizu
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Tomomi
authors.initials: T
authors.lastname: Kataoka
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Kumakura
authors.affiliation: Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Ota
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Taku
authors.initials: T
authors.lastname: Nagai
authors.affiliation: Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
authors.forename: Kiyofumi
authors.initials: K
authors.lastname: Yamada
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D016190:Carboplatin / Q000627:therapeutic use; D004342:Drug Hypersensitivity / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy; D006258:Head and Neck Neoplasms / Q000188:drug therapy; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects*; D012189:Retrospective Studies; D012307:Risk Factors
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C053989:nedaplatin; D016190:Carboplatin
keywords: Cross-reactivity; Hypersensitivity reactions; Nedaplatin; Risk factors