Serum Prostate Specific Antigen as a Predictor of Survival in Prostate Cancer Patients Treated with Second‐Line Hormonal Therapy (CALGB 9181)

S. Halabi, M. Conaway, E. Small, N. Vogelzang, N. Dawson
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引用次数: 7

Abstract

Objectives: To explore whether serum prostate specific antigen (PSA) decline can be used as a prognostic factor for survival among patients with androgen-independent prostate cancer (AIPC) who are treated with a secondary hormonal therapy, megestrol acetate. Materials and Methods: One hundred forty-nine patients were randomized with equal probability to either low-dose (160 mg/day) or high-dose (640 mg/day) megestrol acetate. Patients were stratified on performance status (0–1, or 2) and on disease measurability (measurable, or evaluable disease). Results: Patients with high pretreatment PSA (≥95 ng/ml) had worse survival times than patients with low PSA (<95), with a hazard ratio of 1.6 (p = 0.003). The median survival times for patients with a ≥50% reduction in PSA at 8 weeks and those patients without a 50% reduction were 15 and 11 months, respectively (p = 0.763). A landmark analysis at 8 weeks showed that a PSA decline was significantly associated with survival. The survival time for patients whose PSA dropped below the pretreatment levels (median = 15 months) were significantly longer than for patients who did not have a decline in PSA (median = 9 months, p = 0.031). Similar significant results were observed between PSA reduction and survival when landmark analyses were performed at 12 and 16 weeks. PSA changes during the first 45 days after the initiation of therapy were significantly related to survival. The median survival time for patients whose PSA doubled during the first 45 days after treatment and for patients whose PSA did not double during the first 45 days were 10 and 14 months, respectively (p = 0.020). Conclusions: PSA decline is significantly associated with longer survival times in prostate patients treated with secondary hormonal manipulation. Longer survival time is observed among the following AIPC patients: 1) those whose pretreatment PSA were 0% from baseline; and 3) those whose PSA did not double during the first 45 days of therapy. If these observations are generalizeable, PSA decline as a criterion of response could be used to rapidly approve new agents in patients treated with second-line hormonal therapy.
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血清前列腺特异性抗原作为二线激素治疗前列腺癌患者生存的预测因子(CALGB 9181)
目的:探讨血清前列腺特异性抗原(PSA)下降是否可以作为雄激素非依赖型前列腺癌(AIPC)患者接受二次激素治疗醋酸甲地孕酮的预后因素。材料与方法:149例患者按等概率随机分为低剂量组(160 mg/d)和高剂量组(640 mg/d)。根据患者的表现状态(0-1或2)和疾病可测量性(可测量或可评估的疾病)对患者进行分层。结果:高预处理PSA(≥95 ng/ml)患者的生存时间较低预处理PSA(<95)患者差,风险比为1.6 (p = 0.003)。8周时PSA降低≥50%的患者和未降低50%的患者的中位生存时间分别为15和11个月(p = 0.763)。8周时的里程碑式分析显示PSA下降与生存率显著相关。PSA低于预处理水平的患者的生存时间(中位数= 15个月)明显长于PSA未下降的患者(中位数= 9个月,p = 0.031)。在12周和16周进行里程碑式分析时,在PSA降低和生存率之间观察到类似的显著结果。在开始治疗后的前45天内PSA的变化与生存率显著相关。在治疗后45天内PSA翻倍的患者和在治疗后45天内PSA未翻倍的患者的中位生存时间分别为10个月和14个月(p = 0.020)。结论:在接受二次激素调节治疗的前列腺患者中,PSA下降与更长的生存时间显著相关。在以下AIPC患者中观察到更长的生存时间:1)预处理PSA比基线为0%的患者;3)在治疗的前45天PSA没有翻倍的患者。如果这些观察结果是可推广的,PSA下降作为反应标准可用于快速批准二线激素治疗患者的新药。
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