Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Sahlgrenska University Hospital, Göteborg, Sweden.
Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Göteborg, Sweden.
Eur Urol. 2016 Nov;70(5):760-766. doi: 10.1016/j.eururo.2016.03.048. Epub 2016 Apr 16.
Active surveillance (AS) has become a well-accepted and widely used treatment strategy.
To assess the long-term safety of AS for men with screen-detected prostate cancer (PCa).
DESIGN, SETTING, AND PARTICIPANTS: All men with screen-detected PCa who had very low-, low-, or intermediate-risk PCa and were managed with AS (January 1, 1995 to December 31, 2014) in the Göteborg screening trial.
Prostate-specific antigen tests every 3-12 mo, rebiopsies in cases of clinical progression, and every 2-3 yr in men with stable disease. Triggers for intervention were disease progression (prostate-specific antigen, grade, and/or stage) or patient initiative.
Treatment-free, failure-free, PCa-specific, and overall survival. The Kaplan-Meier method and Cox proportional hazards models were used.
Four-hundred and seventy-four men were managed with AS (median age at diagnosis 66.0 yr, median follow-up 8.0 yr). Two-hundred and two men discontinued AS and initiated treatment. The 10-yr and 15-yr treatment-free survival was 47% and 34%, respectively. The hazard ratio for the treatment for low- and intermediate-risk PCa, compared with very low risk, was 1.4 (95% confidence interval [CI] 1.01-1.94) and 1.6 (95% CI 1.13-2.25). Fifty-four men failed AS. The 10-yr and 15-year failure-free survival was 87% and 72%, respectively. These estimates were 94% and 88% for the very low-risk group, 85% and 77% for the low-risk group, and 73% and 40% for the intermediate-risk group. The hazard ratio for failure for low- and intermediate-risk PCa, compared with very low-risk, was 2.2 (95% CI 1.05-4.47) and 4.8 (95% CI 2.44-9.33). Six men died from PCa and none had very low-risk PCa. The 10-yr and 15-yr PCa-specific survival was 99.5% and 96%, respectively. These estimates were 100% for the very low-risk group, 100% and 94% for the low-risk group, and 98% and 90% for the intermediate-risk group. No predefined protocol was used.
AS is safe for men with very low-risk PCa, but for men with low- and intermediate-risk PCa, AS carries a risk of missing the possibility of being able to cure the cancer. It is questionable whether men who are not in the lowest tumor risk group and who have a long remaining life expectancy are suitable candidates for this strategy.
Long-term results from this study indicate that some men will miss their chance of cure with active surveillance and it is questionable whether active surveillance is a suitable strategy for men who are not in the lowest tumor risk group and who have a very long remaining life expectancy.
主动监测（AS）已成为一种广泛接受和广泛使用的治疗策略。
评估 AS 治疗经筛查发现的前列腺癌（PCa）患者的长期安全性。
设计、地点和参与者：所有在哥德堡筛查试验中接受 AS 治疗（1995 年 1 月 1 日至 2014 年 12 月 31 日）的经筛查发现的具有极低、低或中危 PCa 的男性。
每隔 3-12 个月进行前列腺特异性抗原检测，在临床进展时进行再次活检，在疾病稳定的男性中每 2-3 年进行一次。干预的触发因素是疾病进展（前列腺特异性抗原、分级和/或分期）或患者主动要求。
无治疗、无失败、前列腺癌特异性和总体生存。使用 Kaplan-Meier 方法和 Cox 比例风险模型进行分析。
474 名男性接受 AS 治疗（诊断时中位年龄 66.0 岁，中位随访 8.0 年）。202 名男性停止 AS 并开始治疗。低危和中危 PCa 的 10 年和 15 年无治疗生存率分别为 47%和 34%。与极低危相比，低危和中危的治疗风险比分别为 1.4（95%置信区间 [CI]1.01-1.94）和 1.6（95% CI 1.13-2.25）。54 名男性 AS 失败。10 年和 15 年无失败生存率分别为 87%和 72%。极低危组的这些估计值为 94%和 88%，低危组为 85%和 77%，中危组为 73%和 40%。与极低危相比，低危和中危的失败风险比分别为 2.2（95% CI 1.05-4.47）和 4.8（95% CI 2.44-9.33）。6 名男性死于前列腺癌，且均无极低危 PCa。10 年和 15 年前列腺癌特异性生存率分别为 99.5%和 96%。极低危组的这些估计值为 100%，低危组为 100%和 94%，中危组为 98%和 90%。没有使用预定义的方案。
AS 对极低危 PCa 男性是安全的，但对于低危和中危 PCa 男性，AS 存在错过治愈癌症的可能性的风险。对于那些不属于最低肿瘤风险组且预期寿命较长的男性，是否适合采用这种策略值得怀疑。
这项研究的长期结果表明，一些男性将错过治愈的机会，对于那些不属于最低肿瘤风险组且预期寿命很长的男性，主动监测是否是一种合适的策略值得怀疑。
