Maeda Takahiro, Kosaka Takeo, Honda Aki, Okata Utako, Hayakawa Nozomi, Ito Yujiro, Nagata Hirohiko, Chen Ko-Ron, Nakamura So, Oya Mototsugu
Department of Urology, Saiseikai Central Hospital, Tokyo, Japan,
Support Care Cancer. 2015 May;23(5):1377-81. doi: 10.1007/s00520-014-2483-x. Epub 2014 Oct 31.
The aims of the present study were to investigate the incidence of injection site reactions (ISRs) following administration of 240 mg degarelix and identify the risk factors for ISRs.
This study was conducted in 50 consecutive men treated with degarelix for the first time. ISRs after an initial degarelix dose of 240 mg (administered subcutaneously as two 3 ml subcutaneous injection) were evaluated using the five categories of the Common Terminology Criteria for Adverse Events Version 4 of the National Cancer Institute. We also assessed the differences in patient background between patients with and without an ISR.
The mean age of patients and prostate-specific antigen (PSA) level just before degarelix administration were 75.6 and 198.4 ng/ml, respectively. Hormonal therapy with degarelix was administered for the first time to 33 patients; 11 of the 50 patients were receiving an oral steroid, 6 for prostate cancer, 1 for hematological disease, and 4 for allergic conditions. ISRs were observed in 25 patients, and all of the ISRs were categorized as grade 1 or 2; however, 2 patients discontinued this procedure due to the ISR. Significant differences in the first experience with subcutaneous therapy (p = 0.007) and rate of combination with a steroid (p = 0.017) were observed between patients with and without ISRs.
The incidences of ISRs in patients receiving subcutaneous therapy for the first time and in patients also receiving an oral steroid were 64 and 18 %, respectively. Patients should be provided with information concerning the possible occurrence of ISR due to degarelix prior to the administration, particularly patients who are not receiving steroids and patients who have no experience with subcutaneous injections.
本研究旨在调查给予240mg地加瑞克后注射部位反应（ISR）的发生率，并确定ISR的风险因素。
本研究对50例首次接受地加瑞克治疗的男性患者进行。使用美国国立癌症研究所不良事件通用术语标准第4版的五个类别，评估首次给予240mg地加瑞克剂量（以两个3ml皮下注射的方式皮下给药）后的ISR。我们还评估了发生和未发生ISR的患者在患者背景方面的差异。
患者的平均年龄以及地加瑞克给药前的前列腺特异性抗原（PSA）水平分别为75.6岁和198.4ng/ml。33例患者首次接受地加瑞克激素治疗；50例患者中有11例正在接受口服类固醇治疗，其中6例用于前列腺癌，1例用于血液系统疾病，4例用于过敏情况。25例患者观察到ISR，所有ISR均归类为1级或2级；然而，2例患者因ISR而停止该治疗。发生和未发生ISR的患者在首次皮下治疗经历（p = 0.007）和类固醇联合使用率（p = 0.017）方面存在显著差异。
首次接受皮下治疗的患者和同时接受口服类固醇治疗的患者中，ISR的发生率分别为64%和18%。在给药前，应向患者提供有关地加瑞克可能导致ISR的信息，特别是未接受类固醇治疗的患者和没有皮下注射经验的患者。
