前列腺癌新药频出让患者翘首以待
前列腺癌药物研发进入了黄金期，两年内有四种前列腺癌药物的临床试验结果显示能够显著延长前列腺癌患者生命。新英格兰医学杂志8月15日发表的一篇文章提到，药物enzalutamide可显著延长晚期前列腺癌患者生命，提高患者生活质量，研究结果可以更加拓宽晚期前列腺癌治疗方法的选择。
英国癌症研究院及其合作医院皇家马世登医院、NHS联合基金共同组织了新药enzalutamide的3期临床试验，同时对另外两种药物卡巴它赛（cabazitaxel）和阿比特龙（abiraterone）也进行了3期临床试验。阿比特龙也曾在英国癌症研究院研发，最近获得NHS认可。另外一种药物sipuleucel-T也被认为可以大幅延长患者生命。
英国癌症研究院主任AlanAshworth教授说，英国癌症研究院为晚期前列腺癌患者提供了一种新的治疗选择，在这之前很长一段时间，晚期前列腺癌的治疗方法是有限的。Ashworth教授说：“晚期前列腺癌非常难处理，通过大规模的协作努力，才使新药开发得以实现，十年前，一旦激素治疗没有效果，就没有其他的治疗方法了。”
“我们现在所看到的是前列腺癌研究空前的成功时期，四种新药在大型临床试验中均显示能显著延长患者生命，而且另外几种新药也展现出希望。这确实是前列腺癌药物研发和发展的黄金时期。”皇家马世登医院主任MartinGore教授说：“我们欣喜地看到在晚期前列腺癌治疗中所取得的进步，同时也欣喜地看到患者的治疗效果，他们中的很多人能够以较好的生活质量生活更长时间，这都是这些新药研发的结果。
Enzalutamide治疗是一种新型激素治疗方法，Medivation和 Astellas制药公司资助了这项多中心、随机、安慰剂对照临床试验，有1,199例曾经接受过化学药物治疗的转移性雄激素抵抗性前列腺癌患者参与了临床评估。接受enzalutamide治疗的患者的中位生存数是18.4个月，而接受安慰剂治疗者为13.6个月。大约43% 接受enzalutamide治疗的患者的生活质量有所提高，而服用安慰剂者只有18%。去年11月，该临床试验的独立数据监测委员会建议本临床试验应该提前结束，并向接受安慰剂治疗的患者提供enzalutamide治疗。
Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
Howard I. Scher, M.D., Karim Fizazi, M.D., Ph.D., Fred Saad, M.D., Mary-Ellen Taplin, M.D., Cora N. Sternberg, M.D. Kurt Miller, M.D., Ronald de Wit, M.D., Peter Mulders, M.D., Ph.D., Kim N. Chi, M.D., Neal D. Shore, M.D., Andrew J. Armstrong, M.D., Thomas W. Flaig, M.D., Aude Fléchon, M.D., Ph.D., Paul Mainwaring, M.D., Mark Fleming, M.D., John D. Hainsworth, M.D., Mohammad Hirmand, M.D., Bryan Selby, M.S., Lynn Seely, M.D., and Johann S. de Bono, M.B., Ch.B., Ph.D. for the AFFIRM Investigators
Background
Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor–signaling pathway, the major driver of prostate-cancer growth. We aimed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy.
Methods
In our phase 3, double-blind, placebo-controlled trial, we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity. We randomly assigned them, in a 2:1 ratio, to receive oral enzalutamide at a dose of 160 mg per day (800 patients) or placebo (399 patients). The primary end point was overall survival.
Results
The study was stopped after a planned interim analysis at the time of 520 deaths. The median overall survival was 18.4 months (95% confidence interval [CI], 17.3 to not yet reached) in the enzalutamide group versus 13.6 months (95% CI, 11.3 to 15.8) in the placebo group (hazard ratio for death in the enzalutamide group, 0.63; 95% CI, 0.53 to 0.75; P<0.001). The superiority of enzalutamide over placebo was shown with respect to all secondary end points: the proportion of patients with a reduction in the prostate-specific antigen (PSA) level by 50% or more (54% vs. 2%, P<0.001), the soft-tissue response rate (29% vs. 4%, P<0.001), the quality-of-life response rate (43% vs. 18%, P<0.001), the time to PSA progression (8.3 vs. 3.0 months; hazard ratio, 0.25; P<0.001), radiographic progression-free survival (8.3 vs. 2.9 months; hazard ratio, 0.40; P<0.001), and the time to the first skeletal-related event (16.7 vs. 13.3 months; hazard ratio, 0.69; P<0.001). Rates of fatigue, diarrhea, and hot flashes were higher in the enzalutamide group. Seizures were reported in five patients (0.6%) receiving enzalutamide.
文献链接： /Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
