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N Engl J Med.:间歇性激素剥夺疗法不会延长前列腺癌患者寿命

  1. PsA
  2. 前列腺癌
  3. 雄激素

来源:生物谷 2013-04-04 13:17

2013年4月4日讯 /生物谷BIOON/--基于前期研究,间歇性雄激素剥夺疗法或与持续性雄激素剥夺在延长前列腺癌患者寿命方面有相同的效果,因为该疗法能够减少病人在治疗手段的副作用。事实上研究人员相信间歇性疗法或许能够克服治疗耐受问题。 在最近一项研究中,研究人员治疗了1535位前列腺癌病人并跟踪长达十年时间,发现事实并非如此。

2013年4月4日讯 /生物谷BIOON/--基于前期研究,间歇性雄激素剥夺疗法或与持续性雄激素剥夺在延长前列腺癌患者寿命方面有相同的效果,因为该疗法能够减少病人在治疗手段的副作用。事实上研究人员相信间歇性疗法或许能够克服治疗耐受问题。

在最近一项研究中,研究人员治疗了1535位前列腺癌病人并跟踪长达十年时间,发现事实并非如此。结果发表在近期的New England Journal of Medicine上。

该文章的通讯作者是密歇根大学综合癌症研究中心Maha Hussain博士,Maha Hussain博士也是一位经验丰富的前列腺癌专家。Maha Hussain博士称,我们试图证明间歇性雄激素剥夺与持续性激素剥夺疗法一样的好,但是我们无法证明这一点。我们发现间歇性疗法的确不会比持续性疗法好,甚至两者根本没有可比性。

在本研究中,患有恶性激素敏感性前列腺癌患者最初给予激素剥夺疗法,这也是针对该疾病的标准疗法。当病人激素水平稳定或降到4ng/ml后,病人给予持续性或间歇性激素剥夺治疗。每月监测病人PSA水平,当间歇性组病人PSA升高至20ng/ml后,给予激素剥夺。这样接受间歇性疗法病人的PSA水平会出现起伏循环。

结果显示间歇性疗法死亡率比持续性疗法高10%,接受持续性疗法治疗病人平均存活5.8年,而接受间歇性疗法的病人平均仅5.1年。

研究人员进一步检测两组病人的生活质量,起初在前三个月中间歇性疗法病人的健康情况和情绪比持续性疗法组明显的好,但是随着时间延长两组的水平达到类似。

Hussain博士称现在标准治疗流程还是持续性雄激素剥夺,如果病人要求间歇性疗法,我们会以现有结果提醒患者。

科学家还在致力于研究新型抗激素疗法希望能够增加治疗效果。(生物谷Bioon.com)

Intermittent versus Continuous Androgen Deprivation in Prostate Cancer

Maha Hussain, M.D., Catherine M. Tangen, Dr.P.H., Donna L. Berry, Ph.D., R.N., Celestia S. Higano, M.D., E. David Crawford, M.D., Glenn Liu, M.D., George Wilding, M.D., Stephen Prescott, M.D., Subramanian Kanaga Sundaram, M.D., Eric Jay Small, M.D., Nancy Ann Dawson, M.D., Bryan J. Donnelly, M.D., Peter M. Venner, M.D., Ulka N. Vaishampayan, M.D., Paul F. Schellhammer, M.D., David I. Quinn, M.D., Ph.D., Derek Raghavan, M.D., Ph.D., Benjamin Ely, M.S., Carol M. Moinpour, Ph.D., Nicholas J. Vogelzang, M.D., and Ian M. Thompson, Jr., M.D.

Background Castration resistance occurs in most patients with metastatic hormone-sensitive prostate cancer who are receiving androgen-deprivation therapy. Replacing androgens before progression of the disease is hypothesized to prolong androgen dependence. Methods Men with newly diagnosed, metastatic, hormone-sensitive prostate cancer, a performance status of 0 to 2, and a prostate-specific antigen (PSA) level of 5 ng per milliliter or higher received a luteinizing hormone–releasing hormone analogue and an antiandrogen agent for 7 months. We then randomly assigned patients in whom the PSA level fell to 4 ng per milliliter or lower to continuous or intermittent androgen deprivation, with patients stratified according to prior or no prior hormonal therapy, performance status, and extent of disease (minimal or extensive). The coprimary objectives were to assess whether intermittent therapy was noninferior to continuous therapy with respect to survival, with a one-sided test with an upper boundary of the hazard ratio of 1.20, and whether quality of life differed between the groups 3 months after randomization. Results A total of 3040 patients were enrolled, of whom 1535 were included in the analysis: 765 randomly assigned to continuous androgen deprivation and 770 assigned to intermittent androgen deprivation. The median follow-up period was 9.8 years. Median survival was 5.8 years in the continuous-therapy groufp and 5.1 years in the intermittent-therapy group (hazard ratio for death with intermittent therapy, 1.10; 90% confidence interval, 0.99 to 1.23). Intermittent therapy was associated with better erectile function and mental health (P<0.001 and P=0.003, respectively) at month 3 but not thereafter. There were no significant differences between the groups in the number of treatment-related high-grade adverse events. Conclusions Our findings were statistically inconclusive. In patients with metastatic hormone-sensitive prostate cancer, the confidence interval for survival exceeded the upper boundary for noninferiority, suggesting that we cannot rule out a 20% greater risk of death with intermittent therapy than with continuous therapy, but too few events occurred to rule out significant inferiority of intermittent therapy. Intermittent therapy resulted in small improvements in quality of life. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00002651.)

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