Ten-year survival rates by PSA nadir in patients with metastatic hormone-sensitive prostate cancer: long-term survival analysis from the ECOG-ACRIN 3805 (CHAARTED) trial.

This analysis focuses on 10-year overall survival(OS) stratified by disease volume and on-therapy prostate-specific antigen (PSA) levels at 6 months.

本分析关注的是根据疾病体积和治疗6个月时的前列腺特异性抗原（PSA）水平分层的10年总生存期（OS）。

patients_and_methods

OS was calculated using the Kaplan-Meier method from randomization to death or last known alive date.

总生存期（OS）使用Kaplan-Meier方法从随机化开始计算，直至死亡或最后已知存活日期。

Patients were grouped based on baseline disease characteristics [high-volume (HV) or low-volume (LV)] and PSA levels at 6 months (<0.2 ng/ml versus ≥0.2 ng/ml).

患者根据基线疾病特征[高体积（HV）或低体积（LV）]以及6个月时的PSA水平（<0.2 ng/ml与≥0.2 ng/ml）进行分组。

Multivariable Cox regression analysis was used to evaluate correlation of PSA nadir with OS adjusted for treatment arm, disease volume, Gleason score, and prior local therapy.

使用多变量Cox回归分析评估PSA最低值与总生存期的相关性，调整了治疗组、疾病体积、Gleason评分和既往局部治疗等因素。

Results

Of 790 patients, 225 were without recorded death after a median follow-up of 10 years.

在790名患者中，经过中位随访10年后，有225名患者没有记录到死亡。

The 10-year OS was 25.9% (ADT + docetaxel) versus 22.5% [ADT; hazard ratio(HR) 0.78, P = 0.004].

10年总生存率为25.9%（ADT + 多西他赛）对比22.5%（ADT；风险比（HR）0.78，P = 0.004）。

HV patients treated with docetaxel had significantly higher OS (20.9% versus 11.4%, P < 0.0001).

接受多西他赛治疗的HV患者总生存率显著更高（20.9%对比11.4%，P < 0.0001）。

PSA <0.2 ng/ml at 6 months was associated with improved median OS in both ADT + docetaxel (100.3 versus 45.4 months, P < 0.0001) and ADT (116.8 versus 31.8 months, P < 0.0001) arms.

在ADT + 多西他赛（100.3 vs 45.4个月，P < 0.0001）和ADT（116.8 vs 31.8个月，P < 0.0001）组中，6个月时PSA <0.2 ng/ml与总生存期（OS）的改善相关。

PSA nadir <0.2 ng/l at 6 months was an independent predictor of improved OS (HR 0.41, P < 0.0001) adjusting for disease volume, prior local therapy, Gleason score and treatment arm.

在调整疾病体积、先前的局部治疗、Gleason评分和治疗组后，6个月时PSA最低值<0.2 ng/l是改善总生存期（OS）的独立预测因子（HR 0.41，P < 0.0001）。

Conclusions

Long-term follow-up confirms that ADT + docetaxel significantly improves OS in metastatic HSPC patients with HV disease.

长期随访确认，ADT + 多西他赛显著改善了转移性高危前列腺癌患者的总生存。

PSA nadir <0.2 ng/ml at 6 months is a strong prognostic marker for OS, supporting its use in response-adapted de-escalation strategies.

6个月内PSA最低值<0.2 ng/ml是总生存的一个强有力的预后标志，支持其在反应适应性降级策略中的使用。