Division of Medical Oncology, Department of Medicine, Lank Center for Genitourinary Oncology, Boston, MA 02215, USA.
Urology. 2013 Mar;81(3):611-6. doi: 10.1016/j.urology.2012.12.025.
To evaluate long-term follow-up of a phase II trial of chemohormonal therapy in 62 men with prostate cancer biochemical relapse (BR).
Treatment was 4 cycles of docetaxel (70 mg/m(2)) every 3 weeks and estramustine 280 mg three times a day (days 1-5) followed by 15 months of goserelin acetate/bicalutamide. The primary endpoint was the proportion with prostate-specific antigen (PSA) <0.1 with recovered testosterone 5 years after completion of therapy. Secondary endpoints included time to progression (TTP), time to reinitiate androgen deprivation therapy (ADT), the proportion with castration-resistant prostate cancer (CRPC), and overall survival (OS).
Median follow-up was 8.6 years (range 1.3-11.1 years). At 5 year follow-up, 7 patients (11%) had PSA <0.1 (5 undetectable); 8 (13%) had PSA >0.1 but without reinitiation of ADT (median PSA 0.37). Of the 15 (24%) men without reinitiation of ADT, and 14 have recovered testosterone to normal range. Median TTP for the complete cohort was 35.0 months (95% confidence interval [CI] 31.7-39.2). Baseline PSA <3.0 ng/dL, no prior ADT, and prostatectomy (vs radiation) were associated with longer TTP (P = .0001, P = .0055, and P = .0398, respectively). At the time of analysis, 42 men (68%) had restarted ADT, 23 men had CRPC (37%), and 11 (18%) had chemotherapy. Median time to reinitiation of ADT was 32.6 months (range 0-107.6 months). Median OS has not been reached; there were 15 deaths.
Chemotherapy plus ADT for BR resulted in durable (>5 years) complete responses (<0.1 ng/mL) in 7 men (11%). Twenty-four percent of men have not re-initiated ADT 5 years from completion of protocol therapy.
评估 62 例前列腺癌生化复发（BR）患者接受化学激素治疗的 II 期试验的长期随访结果。
治疗方案为每 3 周接受 4 个周期的多西他赛（70mg/m2）和每天 3 次的雌莫司汀 280mg（第 1-5 天），随后接受 15 个月的醋酸戈舍瑞林/比卡鲁胺治疗。主要终点是治疗完成后 5 年内前列腺特异性抗原（PSA）<0.1 和恢复睾酮的患者比例。次要终点包括无进展生存期（TTP）、重新开始雄激素剥夺治疗（ADT）的时间、去势抵抗性前列腺癌（CRPC）的比例和总生存期（OS）。
中位随访时间为 8.6 年（范围 1.3-11.1 年）。在 5 年随访时，7 例（11%）患者 PSA<0.1（5 例不可检测）；8 例（13%）患者 PSA>0.1 但未重新开始 ADT（中位 PSA 0.37）。在未重新开始 ADT 的 15 例（24%）男性中，有 14 例已恢复到正常睾酮范围。全队列的中位 TTP 为 35.0 个月（95%置信区间 [CI] 31.7-39.2）。基线 PSA<3.0ng/dL、无既往 ADT 和前列腺切除术（与放疗相比）与更长的 TTP 相关（P=0.0001、P=0.0055 和 P=0.0398）。在分析时，42 例（68%）患者重新开始 ADT，23 例患者出现 CRPC（37%），11 例（18%）患者接受了化疗。重新开始 ADT 的中位时间为 32.6 个月（范围 0-107.6 个月）。中位 OS 尚未达到，共有 15 例死亡。
BR 患者接受化疗加 ADT 治疗，7 例（11%）患者获得持久（>5 年）完全缓解（<0.1ng/mL）。24%的患者在完成方案治疗 5 年后未重新开始 ADT。
