【摘要翻译】康士德150mg：不再适合治疗局限性前列腺癌
发布于 2004-07-16 · 浏览 1007 · IP 浙江浙江
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康士德150mg：不再适合治疗局限性前列腺癌
英国和加拿大已经不在批准用单一的康士德50mg tid来治疗前列腺癌。在欧洲和斯堪的纳维亚的超过5年的随访证实使用康士德的患者的死亡率高于使用安慰剂组（25.2％：20.5％，文章中没有提及总病例数，不知道那个dxy对这个研究有所了解的？？），在美国也有相似的报道。
目前康士德主要被批准用于
1。150mg的剂量用于不适合或者不同意进行手术去势的局限进展期的患者
2. 50mg用于和其它治疗一起的联合治疗。
Casodex 150 Mg (Bicalutamide): No Longer Indicated for Treatment of Localised Prostate Cancer
G. Duff, Committee on Safety of Medicines, London, United Kingdom
http://www.mca.gov.uk/ourwork/monitorsafequalmed/safetymessages/casodex_281003.htm
Editorial Comment: I have just learned that both England and Canada have determined that Casodex (bicalutamide, AstraZeneca, United Kingdom, Ltd., Bedfordshire, United Kingdom) as monotherapy at a dose of 50 mg 3 times a day (150 mg) is no longer licensed for the treatment of localized prostate cancer. The drug was withdrawn because in the international randomized trial of men managed by watchful waiting in Europe and Scandinavia at a mean followup of more than 5 years there was a trend for an increase in the number of deaths in patients receiving Casodex 150 mg when compared with patients who received placebo (25.2% deaths versus 20.5% deaths, hazard ratio = 1.23, 95% confidence interval 1.0 to 1.50). I was unaware of this important announcement, as I’m sure many of the readers in the United States are as well. Although the drug was never licensed at this dose for this purpose in the United States, there were a number of articles supporting its use published in American journals and I am personally aware of patients who were placed on this formulation. It is interesting that even our own AstraZeneca representative was unaware of this outcome. As you may recall, the international study (where men on watchful waiting or following radical prostatectomy or radiation were randomized to placebo vs Casodex 150 mg) came under severe criticism when it was prematurely terminated because the men on early hormonal therapy, as one would expect, experienced a reduction in progression of disease versus men on placebo.1It was hoped by many of us that this study would be carried out to an end point that had true significance—a difference in survival. Now we know the answer. It appears that the Food and Drug Administration in the United States demonstrated great judgment in withholding approval. This outcome is similar to the long-term followup of men with M0 disease in the Medical Research Council study of immediate vs delayed hormonal therapy. Once again, with time, the improvement in overall survival disappeared suggesting an adverse effect of prolonged hormonal therapy in increasing mortality from other causes.
英国和加拿大已经不在批准用单一的康士德50mg tid来治疗前列腺癌。在欧洲和斯堪的纳维亚的超过5年的随访证实使用康士德的患者的死亡率高于使用安慰剂组（25.2％：20.5％，文章中没有提及总病例数，不知道那个dxy对这个研究有所了解的？？），在美国也有相似的报道。
目前康士德主要被批准用于
1。150mg的剂量用于不适合或者不同意进行手术去势的局限进展期的患者
2. 50mg用于和其它治疗一起的联合治疗。
Casodex 150 Mg (Bicalutamide): No Longer Indicated for Treatment of Localised Prostate Cancer
G. Duff, Committee on Safety of Medicines, London, United Kingdom
http://www.mca.gov.uk/ourwork/monitorsafequalmed/safetymessages/casodex_281003.htm
Editorial Comment: I have just learned that both England and Canada have determined that Casodex (bicalutamide, AstraZeneca, United Kingdom, Ltd., Bedfordshire, United Kingdom) as monotherapy at a dose of 50 mg 3 times a day (150 mg) is no longer licensed for the treatment of localized prostate cancer. The drug was withdrawn because in the international randomized trial of men managed by watchful waiting in Europe and Scandinavia at a mean followup of more than 5 years there was a trend for an increase in the number of deaths in patients receiving Casodex 150 mg when compared with patients who received placebo (25.2% deaths versus 20.5% deaths, hazard ratio = 1.23, 95% confidence interval 1.0 to 1.50). I was unaware of this important announcement, as I’m sure many of the readers in the United States are as well. Although the drug was never licensed at this dose for this purpose in the United States, there were a number of articles supporting its use published in American journals and I am personally aware of patients who were placed on this formulation. It is interesting that even our own AstraZeneca representative was unaware of this outcome. As you may recall, the international study (where men on watchful waiting or following radical prostatectomy or radiation were randomized to placebo vs Casodex 150 mg) came under severe criticism when it was prematurely terminated because the men on early hormonal therapy, as one would expect, experienced a reduction in progression of disease versus men on placebo.1It was hoped by many of us that this study would be carried out to an end point that had true significance—a difference in survival. Now we know the answer. It appears that the Food and Drug Administration in the United States demonstrated great judgment in withholding approval. This outcome is similar to the long-term followup of men with M0 disease in the Medical Research Council study of immediate vs delayed hormonal therapy. Once again, with time, the improvement in overall survival disappeared suggesting an adverse effect of prolonged hormonal therapy in increasing mortality from other causes.
最后编辑于 2004-07-17 · 浏览 1007
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