Bicalutamide as immediate therapy either alone or as adjuvant to standard care of patients with localized or locally advanced prostate cancer: First analysis of the early prostate cancer program
Bicalutamide as immediate therapy either alone or as adjuvant to standard care of patients with localized or locally advanced prostate cancer: First analysis of the early prostate cancer program
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DOI：
10.1016/s0022-5347(05)64652-6
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发表时间：
2002-08-01
影响因子：
6.6
通讯作者：
Kolvenbag, GJCM
中科院分区：
文献类型：
--
作者：
See, WA;Wirth, MP;Kolvenbag, GJCM
目的：我们确定比卡鲁胺在临床局部或局部晚期前列腺癌患者中作为直接疗法的有效性和耐受性，无论是单独治疗还是作为治疗意图的辅助治疗。材料和方法：这项国际计划包括3个正在进行的随机、双盲、安慰剂对照临床试验(试验23、24和25)。患有局部或局部晚期(T1-T4，NX/N0，M0)前列腺癌的男性随机接受150 mg的治疗。每天服用比卡鲁胺或服用安慰剂，除了接受根治性前列腺切除术、放射治疗或警惕等待的标准护理外。主要终点是达到目标进展和总体生存的时间。结果：共有8,113名患者(4,052名患者随机接受比卡鲁胺治疗，4,061名患者接受标准治疗)，平均随访时间为3.0年。比卡鲁胺治疗与单独使用标准治疗相比，客观进展的风险降低了42%(9.0%比13.8%，危险比0.58；95%可信区间0.51，0.66；p<0.0001)。总体结果反映在3个试验中的2个(试验24和25)，试验3(试验23)此时显示无显著差异。无论初级治疗或疾病阶段如何，在整个患者群体中，疾病进展的风险都有所降低。总体生存数据目前还不成熟，更长时间的随访将确定比卡鲁胺是否也有生存益处。比卡鲁胺最常见的副作用是女性乳房发育症和乳房疼痛。比卡鲁胺每天单独或作为治疗意图的辅助治疗，显著降低局部或局部晚期前列腺癌患者的疾病进展风险。这一益处必须与长期激素治疗相关的发病率相平衡。追踪正在进行中，以确定这种治疗方法的潜在生存益处。
Purpose: We determine the efficacy and tolerability of bicalutamide as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with clinically localized or locally advanced prostate cancer.Materials and Methods: This international program consists of 3 ongoing, randomized, double-blind, placebo controlled clinical trials (trials 23, 24, and 25). Men with localized or locally advanced (T1-T4, Nx/N0, M0) prostate cancer were randomized to receive 150 mg. bicalutamide daily or placebo, in addition to standard care with radical prostatectomy, radiotherapy or watchful waiting. Primary end points are time to objective progression and overall survival. In this first analysis data from the trials were combined in a single overview analysis according to protocol.Results: Data are available for 8,113 patients (4,052 randomized to bicalutamide, 4,061 to standard care alone) at a median followup of 3.0 years. Treatment with bicalutamide provided a highly significant reduction of 42% in the risk of objective progression compared with standard care alone (9.0% versus 13.8%, hazards ratio 0.58; 95% confidence interval 0.51, 0.66; p much less than0.0001). The overall result was reflected in 2 of the 3 trials (trials 24 and 25) with trial 3 (trial 23) showing a nonsignificant difference at this time. Reductions in the risk of disease progression were seen across the entire patient population, irrespective of primary treatment or disease stage. Overall survival data are currently immature and longer followup will determine if there is also a survival benefit with bicalutamide. The most frequently reported side effects of bicalutamide were gynecomastia and breast pain.Conclusions: Immediate treatment with 150 mg. bicalutamide daily, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with localized or locally advanced prostate cancer. This benefit must be balanced with the morbidity associated with long-term hormonal therapy. Followup is ongoing to determine potential survival benefits of this treatment approach.