Wirth M, Tyrrell C, Delaere K, Sánchez-Chapado M, Ramon J, Wallace D M A, Hetherington J, Pina F, Heyns C F, Navani S, Armstrong J
Department of Urology, Technical University of Dresden, Dresden, Germany.
Prostate Cancer Prostatic Dis. 2007;10(1):87-93. doi: 10.1038/sj.pcan.4500916. Epub 2006 Nov 14.
Trial 24, one of three ongoing trials in the Early Prostate Cancer programme, is evaluating the efficacy and tolerability of bicalutamide (Casodex) 150 mg following standard care (radiotherapy, radical prostatectomy or watchful waiting) in patients with early, non-metastatic prostate cancer. At 7 years' median follow-up, addition of bicalutamide significantly improved objective progression-free survival (PFS) for patients with locally advanced disease, reducing the risk of progression by 34% versus standard care alone (hazard ratio 0.66; 95% confidence interval 0.55, 0.79; P<0.001). In localized disease, a significant difference in objective PFS was not found. There was no significant difference in overall survival.
试验24是早期前列腺癌项目正在进行的三项试验之一,正在评估在早期非转移性前列腺癌患者中,标准治疗(放疗、根治性前列腺切除术或观察等待)后使用150毫克比卡鲁胺(康士得)的疗效和耐受性。在中位随访7年时,对于局部晚期疾病患者,添加比卡鲁胺显著改善了客观无进展生存期(PFS),与单独标准治疗相比,疾病进展风险降低了34%(风险比0.66;95%置信区间0.55,0.79;P<0.001)。在局限性疾病中,未发现客观PFS有显著差异。总生存期无显著差异。