主页 > 医药科学 >
【medical-news】大剂量骨化三醇联合多烯紫衫醇与
Study Of High-Dose Calcitriol Plus Docetaxel Compared With Placebo Plus Docetaxel In Androgen-Independent Prostate Cancer
UroToday.com- Calcitriol (1, 25-dihydroxycholecalciferol), the natural ligand of the vitamin D receptor, has been shown to possess antitumor activity in preclinical prostate cancer models. It is believed to exert its effect by inducing apoptosis and inhibiting proliferation, angiogenesis, and tumor invasiveness. While a phase II trial has previously shown that calcitriol may enhance the cytotoxicity of traditional chemotherapy, this had not been previously studied in a placebo-controlled fashion.
In the February 20th issue of the Journal of Clinical Oncology, Beer and colleagues from the ASCENT group (AIPC Study of Calcitriol Enhancing Taxotere) report the results of a prospective, placebo-controlled, randomized trial designed to determine whether calcitriol enhances the efficacy of docetaxel in men with androgen independent prostate cancer.
The cohort consisted of 250 men with progressive, metastatic androgen independent prostate cancer who were randomized to receive weekly docetaxel with or without DN-101, a high-dose oral formulation of calcitriol. The primary endpoint was a 50 percent reduction in PSA after 6 months; the secondary endpoint was survival.
After 6 months, only a trend was observed for an improvement in overall PSA response between the calcitriol ( 63%) and placebo groups (52%), p = 0.07. Interestingly, however, in multivariate analysis patients in the calcitriol group exhibited an improvement in overall survival after adjusting for hemoglobin and ECOG performance status, with a hazard ratio of 0.67 (95% CI 0.45 to 0.97). The estimated median survival for the calcitriol group was 24.5 months, compared with 16.4 months for the placebo group. There were no differences in the incidence of grade 3 or 4 toxicities between the treatment and placebo arms.
While this exciting industry-sponsored study was primarily designed to evaluate if adding calcitriol to docetaxel would result in a favorable PSA response, it surprisingly showed that the calcitriol/docetaxel combination was associated with a mortality risk reduction of approximately 33%. We anxiously await the results of ASCENT-2 to confirm these findings, another phase III trial comparing the efficacy of calcitriol using weekly docetaxel versus the traditional 3-weekly regimen.
本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Study Of High-Dose Calcitriol Plus Docetaxel Compared With Placebo Plus Docetaxel In Androgen-Independent Prostate Cancer
大剂量骨化三醇联合多烯紫杉醇对比安慰剂联合多烯紫杉醇在治疗雄激素非依赖性前列腺癌中的研究
UroToday.com- Calcitriol (1, 25-dihydroxycholecalciferol), the natural ligand of the vitamin D receptor, has been shown to possess antitumor activity in preclinical prostate cancer models. It is believed to exert its effect by inducing apoptosis and inhibiting proliferation, angiogenesis, and tumor invasiveness. While a phase II trial has previously shown that calcitriol may enhance the cytotoxicity of traditional chemotherapy, this had not been previously studied in a placebo-controlled fashion.
UroToday.com-骨化三醇（1，25-二羟维生素D3），维生素D受体的天然配体，在临床前期前列腺癌模型中已被证实具有抗肿瘤活性。据认为其发挥效应是由于诱导凋亡并抑制增殖、血管形成、以及肿瘤浸润。虽然既往一项II期临床试验表明骨化三醇可以提高传统化疗的细胞毒性，还没有进行安慰剂对照的研究。
In the February 20th issue of the Journal of Clinical Oncology, Beer and colleagues from the ASCENT group (AIPC Study of Calcitriol Enhancing Taxotere) report the results of a prospective, placebo-controlled, randomized trial designed to determine whether calcitriol enhances the efficacy of docetaxel in men with androgen independent prostate cancer.
《临床肿瘤学杂志》2月20号一期杂志中，ASCENT 研究组（AIPC中骨化三醇提高泰素帝疗效）的Beer及其同事报告了这项旨在明确骨化三醇是否能增加多烯紫杉醇对雄激素非依赖性前列腺癌治疗效果的前瞻性、安慰剂对照、随机试验的结果。
The cohort consisted of 250 men with progressive, metastatic androgen independent prostate cancer who were randomized to receive weekly docetaxel with or without DN-101, a high-dose oral formulation of calcitriol. The primary endpoint was a 50 percent reduction in PSA after 6 months; the secondary endpoint was survival.
队列中包括250例进展期、转移性雄激素非依赖性前列腺癌患者，随机接受每周多烯紫杉醇＋DN101——一种高剂量的骨化三醇口服剂型。一级终点是6个月后PSA下降50％，二级终点是存活期。
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-01-23 17:14
医学,生命科学网