Camerini T, Mariani L, De Palo G, Marubini E, Di Mauro M G, Decensi A, Costa A, Veronesi U
Istituto Nazionale Tumori, Milan, Italy.
J Clin Oncol. 2001 Mar 15;19(6):1664-70. doi: 10.1200/JCO.2001.19.6.1664.
To describe the pattern of occurrence of adverse events commonly arising during treatment with fenretinide, a synthetic retinoid under investigation for cancer prevention.
The series includes 2,867 women accrued in a trial aimed at assessing the effect of fenretinide on the prevention of second breast malignancy. Women were randomly assigned to receive no treatment (1,435 patients) or 5-year fenretinide treatment (1,432 patients). In terms of disease recurrence in the breast, the trial showed a possible beneficial effect of the compound in premenopausal women, and an opposite trend in postmenopausal women. End points considered for safety assessment were the occurrence of diminished dark adaptation, dermatologic disorders, gastrointestinal symptoms, disorders of the ocular surface, and abnormal laboratory values.
The most common adverse events were diminished dark adaptation (cumulative incidence, 19.0%) and dermatologic disorders (18.6%). Less common events were gastrointestinal symptoms (13.0%) and disorders of the ocular surface (10.9%). In comparison, incidence figures in the control arm were 2.9% for diminished dark adaptation, 2.9% for dermatologic disorders, 5.4% for gastrointestinal symptoms, and 3.2% for disorders of the ocular surface. Symptoms occurring during fenretinide treatment tended to recover with time. No between-group difference was observed for the occurrence of laboratory data abnormalities. Overall, 63 (4.4%) treatment discontinuations were caused by adverse events.
Given the number of patients involved in the study and the prolonged intake of the drug, the experience on fenretinide tolerability can be considered sufficiently reassuring to justify further testing of the retinoid.
描述在使用阿维A酸（一种正在研究用于癌症预防的合成维甲酸）治疗过程中常见不良事件的发生模式。
该系列研究纳入了2867名女性，她们参与了一项旨在评估阿维A酸对预防第二原发性乳腺癌效果的试验。女性被随机分配接受不治疗（1435例患者）或5年阿维A酸治疗（1432例患者）。就乳腺疾病复发而言，该试验显示该化合物对绝经前女性可能有有益作用，而对绝经后女性则呈现相反趋势。安全性评估所考虑的终点包括暗适应减退、皮肤疾病、胃肠道症状、眼表疾病以及异常实验室检查值的发生情况。
最常见的不良事件是暗适应减退（累积发生率为19.0%）和皮肤疾病（18.6%）。较不常见的事件是胃肠道症状（13.0%）和眼表疾病（10.9%）。相比之下，对照组中暗适应减退的发生率为2.9%，皮肤疾病为2.9%，胃肠道症状为5.4%，眼表疾病为3.2%。阿维A酸治疗期间出现的症状往往会随时间恢复。在实验室数据异常的发生方面未观察到组间差异。总体而言，63例（4.4%）治疗中断是由不良事件导致的。
鉴于参与研究的患者数量以及药物的长期服用，阿维A酸耐受性方面的经验可被认为足以令人安心，从而有理由对该维甲酸进行进一步测试。
