Poon Darren M C, Chan Kuen, Lee S H, Chan T W, Sze Henry, Lee Eric K C, Lam Daisy, Chan Michelle F T
Department of Clinical Oncology, State Key Laboratory in Oncology in South China, Sir YK Pao Centre for Cancer, Hong Kong Cancer Institute and Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Hong Kong Society of Uro-Oncology (HKSUO), Hong Kong, Hong Kong.
BMC Urol. 2016 Mar 22;16:12. doi: 10.1186/s12894-016-0132-z.
There is much interest in confirming whether the efficacy of abiraterone acetate (AA) demonstrated within the trial setting is reproducible in routine clinical practice. We report the clinical outcome of metastatic castration-resistant prostate cancer (mCRPC) patients treated with AA in real-life clinical practice.
The clinical records of mCRPC patients treated with AA from all 6 public oncology centers in Hong Kong between August 2011 and December 2014 were reviewed. The treatment efficacy and its determinants, and toxicities were determined.
A total of 110 patients with mCRPC were treated with AA in the review period, of whom 58 were chemo-naive and 52 had received prior chemotherapy (post-chemo). The median follow-up time was 7.5/11.4 months for chemo-naive/post-chemo patients. 6.9/15.4 % of chemo-naive/post-chemo patients had visceral metastases. The median overall survival (OS) and progression-free survival (PFS) were 18.1/15.5 months and 6.7/6.4 months for chemo-naive/post-chemo patients, respectively. Among chemo-naive patients, those with visceral diseases had significantly inferior OS (2.8 vs 18.0 p = 0.0007) and PFS (2.8 vs 6.8 months, p = 0.0088) than those without. Pain control was comparable in both groups of patients. The most common grade 3 or above toxicities were hypertension (6.9/5.8 %) and hypokalemia (3.4/3.8 %) in chemo-naive/post-chemo patients. In multivariate analysis, the presence of prostate-specific antigen (PSA) response (≥50 % drop of PSA from baseline) within the first 3 months of therapy was associated with favorable OS and PFS in both chemo-naive and post-chemo group.
In clinical practice outside the trial setting, OS after AA in our chemo-naive patient cohort (18.1 months) was considerably shorter than that reported in the COU-AA-302 trial (34.7 months), and the OS was particularly short in those with visceral metastases (2.8 months). Conversely, AA was efficacious in post-chemo patients. AA resulted in comparable pain control in both groups of patients. The presence of PSA response within the first 3 months of treatment was a significant determinant of survival.
人们对确认醋酸阿比特龙（AA）在试验环境中所展现的疗效在常规临床实践中是否可重复存在浓厚兴趣。我们报告了在现实临床实践中接受AA治疗的转移性去势抵抗性前列腺癌（mCRPC）患者的临床结局。
回顾了2011年8月至2014年12月期间香港所有6家公立肿瘤中心接受AA治疗的mCRPC患者的临床记录。确定了治疗疗效及其决定因素以及毒性。
在回顾期间，共有110例mCRPC患者接受了AA治疗，其中58例未接受过化疗，52例曾接受过化疗（化疗后）。未接受过化疗/化疗后的患者中位随访时间分别为7.5/11.4个月。未接受过化疗/化疗后的患者中分别有6.9/15.4%发生内脏转移。未接受过化疗/化疗后的患者中位总生存期（OS）和无进展生存期（PFS）分别为18.1/15.5个月和6.7/6.4个月。在未接受过化疗的患者中，有内脏疾病的患者的OS（2.8个月对18.0个月，p = 0.0007）和PFS（2.8个月对6.8个月，p = 0.0088）明显低于无内脏疾病的患者。两组患者的疼痛控制情况相当。未接受过化疗/化疗后的患者中最常见的3级及以上毒性反应为高血压（6.9/5.8%）和低钾血症（3.4/3.8%）。在多变量分析中，治疗前3个月内前列腺特异性抗原（PSA）有反应（PSA从基线下降≥50%）与未接受过化疗组和化疗后组的良好OS和PFS相关。
在试验环境之外的临床实践中，我们未接受过化疗的患者队列中AA治疗后的OS（18.1个月）明显短于COU - AA - 302试验中报告的（34.7个月），且有内脏转移的患者OS尤其短（2.8个月）。相反，AA在化疗后的患者中有效。AA在两组患者中产生了相当的疼痛控制效果。治疗前3个月内PSA有反应是生存的一个重要决定因素。
