Kawarada Yuki, Miyazaki Masayuki, Itoh Ayaka, Araki Risa, Iwamizu Hidetaka, Kataoka Tomomi, Kumakura Yasuo, Ota Akiko, Nagai Taku, Yamada Kiyofumi
Department of Hospital Pharmacy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.
Int J Clin Oncol. 2017 Jun;22(3):593-599. doi: 10.1007/s10147-017-1091-4. Epub 2017 Jan 25.
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.
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.
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).
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.
奈达铂（NDP）相关的超敏反应（HSR）会引发不良临床事件。因此，预测和预防NDP-HSR对于将NDP治疗的风险降至最低并使获益最大化至关重要。然而，NDP-HSR的发生率及相关危险因素仍不明确。
我们回顾性研究了2011年4月至2015年7月在名古屋大学医院接受NDP单药治疗的患者。HSR严重程度根据《不良事件通用术语标准》第4版（CTCAE ver.4）进行定义。使用多因素逻辑回归确定NDP-HSR的危险因素。
在111例接受NDP单药治疗的患者中，90例（81%）为女性；中位年龄为59岁（范围29 - 78岁）。88例患者患有妇科癌症，20例患有头颈癌。111例患者中有8例（7.2%）发生NDP-HSR，其中6例在第二个NDP周期出现。然而，所有发生NDP-HSR的患者均接受了超过三个周期的卡铂（CBDCA）治疗。2例患者出现3级和4级HSR。NDP-HSR与CBDCA-HSR病史显著相关（比值比37.5，95%置信区间5.38 - 262，p < 0.001），且与NDP给药和上一次铂类治疗之间的间隔相关（比值比13.9，95%置信区间1.23 - 158，p = 0.034）。
有CBDCA-HSR病史的患者以及在上一次铂类治疗后6个月以上接受NDP治疗的患者发生NDP-HSR的风险增加。如果给予这些个体NDP治疗，即使预计他们会从治疗中获益，也必须密切监测。
