Background

Abiraterone acetate (abiraterone) combined with prednisone is a standard of care in metastatic castration-resistant prostate cancer. Recently, benefit in overall survival was reported in metastatic castration-sensitive prostate cancer also, and an extension of indication has been granted. Abiraterone is seldom associated with liver toxicity. The clinical management and the outcome of patients with transaminase increase while on abiraterone have not been described.

Patients and method

We identified 25 men with metastatic prostate cancer and liver function test disorders occurring while on abiraterone treatment from December 2009 to September 2017 in three oncology centres in France.

Results

Forty-six liver disorder events occurred in 25 patients while on abiraterone treatment. The median age at liver function test increase was 67 (55–85) years. The incidence of aspartate aminotransférase (AST) (24 events) and that of alanine aminotransférase (ALT) (22 events) increases were similar. Liver toxicity was of grade 1, 2 and 3 (Common Terminology Criteria for Adverse Events. version 4) in 7 (32%), 6 (27%) and 9 (41%) patients for ALT, and in 12 (50%), 6 (25%) and 6 (25%) for AST, respectively. The median time from abiraterone initiation to the detection of liver toxicity was 7.1 (4–95) weeks. The median time from highest ALT/AST increase to normalisation was 6.2 [[2], [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14]] weeks. In 13 patients (52%), liver tests spontaneously returned to baseline values, while abiraterone was continued at full dose.

Conclusion

Liver function test increase is a rare event that typically occurs within the first two months on abiraterone. Most patients experience normalisation of the tests, either spontaneously or after dose reduction/discontinuation.

中文翻译：

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转移性前列腺癌男性的肝脏测试增加醋酸阿比特龙的治疗：自然病史，治疗和结局

背景

醋酸阿比特龙（阿比特龙）与泼尼松联用是转移性去势抵抗性前列腺癌的治疗标准。最近，据报道在转移性去势敏感性前列腺癌中也有改善总体生存的趋势，并且已经扩大了适应症的范围。阿比特龙很少与肝毒性相关。尚未对使用阿比特龙治疗期间转氨酶升高的患者的临床管理和结果进行描述。

患者和方法

我们确定了2009年12月至2017年9月在法国三个肿瘤学中心接受阿比特龙治疗期间发生转移性前列腺癌和肝功能测试疾病的25名男性。

结果

25例阿比特龙治疗期间发生了46例肝脏疾病。肝功能检查增加的中位年龄为67（55-85）岁。天冬氨酸转氨酶（AST）（24个事件）的发生率和丙氨酸转氨酶（ALT）（22个事件）的发生率相似。肝毒性分别为1级，2级和3级（不良事件通用术语标准，第4版），其中7（32％），6（27％）和9（41％）的ALT患者以及12（50％）的患者，AST分别为6（25％）和6（25％）。从阿比特龙开始治疗到检测到肝毒性的中位时间为7.1（4–95）周。从最高ALT / AST升高到恢复正常的中位时间为6.2 [[2]，[3]，[4]，[5]，[6]，[7]，[8]，[9]，[10]， [11]，[12]，[13]，[14]]周。在13例患者（52％）中，肝脏检查自发恢复到基线值，

结论

肝功能检查增加是罕见的事件，通常在阿比特龙治疗的头两个月内发生。大多数患者会自发地或在减少剂量/中止剂量后经历测试的正常化。