Ryan Charles J, Kheoh Thian, Li Jinhui, Molina Arturo, De Porre Peter, Carles Joan, Efstathiou Eleni, Kantoff Philip W, Mulders Peter F A, Saad Fred, Chi Kim N
Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA.
Janssen Research & Development, San Diego, CA.
Clin Genitourin Cancer. 2017 Jul 25. doi: 10.1016/j.clgc.2017.07.014.
Radiographic progression-free survival (rPFS) is associated with overall survival (OS) in chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) patients. Using readily assessable baseline clinical and laboratory parameters, we developed a prognostic index model for rPFS in chemotherapy-naïve mCRPC patients without visceral disease who were treated with abiraterone acetate plus prednisone.
Data from the abiraterone acetate plus prednisone arm of COU-AA-302 were used. rPFS was defined based on modified Prostate Cancer Working Group 2 criteria. Baseline variables were assessed for association with rPFS through univariate Cox modeling. The lower (LLN) and upper (ULN) limits of laboratory normal were used to dichotomize most laboratory parameters; baseline median was used to dichotomize prostate-specific antigen (PSA). Prognostic factors for rPFS were identified by multivariate Cox modeling. Model accuracy was estimated by the C-index.
Presence of lymph node metastasis (hazard ratio [HR] = 1.76, P < .0001), lactate dehydrogenase > ULN (234 IU/L) (HR = 1.71, P = .0001), ≥ 10 bone metastases (HR = 1.71, P = .0015), hemoglobin ≤ LLN (12.7 g/dL) (HR = 1.47, P = .0030) and PSA > 39.5 ng/mL (HR = 1.42, P = .0078) were associated with poor outcome. Patients were categorized into 3 prognostic groups (good, n = 230; intermediate, n = 152; poor, n = 164) based on number of risk factors. Median rPFS was calculated (27.6, 16.6, and 8.3 months for good, intermediate, and poor, respectively). The C-index was 0.83 (95% confidence interval = 0.73-0.91).
The prognostic index model for rPFS reveals differential outcomes based on factors readily available in clinical practice. If validated, this model can be integrated into clinical practice and design of risk-stratified trials.
在未经化疗的转移性去势抵抗性前列腺癌（mCRPC）患者中，影像学无进展生存期（rPFS）与总生存期（OS）相关。我们利用易于评估的基线临床和实验室参数，为接受醋酸阿比特龙加泼尼松治疗、无内脏疾病的未经化疗的mCRPC患者开发了一种rPFS预后指数模型。
使用COU-AA-302研究中醋酸阿比特龙加泼尼松治疗组的数据。rPFS根据改良的前列腺癌工作组2标准进行定义。通过单变量Cox模型评估基线变量与rPFS的相关性。大多数实验室参数采用实验室正常范围的下限（LLN）和上限（ULN）进行二分法划分；前列腺特异性抗原（PSA）采用基线中位数进行二分法划分。通过多变量Cox模型确定rPFS的预后因素。模型准确性通过C指数进行估计。
存在淋巴结转移（风险比[HR]=1.76，P<.0001）、乳酸脱氢酶>ULN（234 IU/L）（HR=1.71，P=.0001）、≥10处骨转移（HR=1.71，P=.0015）、血红蛋白≤LLN（12.7 g/dL）（HR=1.47，P=.0030）以及PSA>39.5 ng/mL（HR=1.42，P=.0078）与不良预后相关。根据风险因素数量，将患者分为3个预后组（良好组，n=230；中等组，n=152；不良组，n=164）。计算出各组的中位rPFS（良好组、中等组和不良组分别为27.6、16.6和8.3个月）。C指数为0.83（95%置信区间=0.73-0.91）。
rPFS预后指数模型根据临床实践中易于获得的因素揭示了不同的预后情况。如果得到验证，该模型可纳入临床实践和风险分层试验的设计中。
