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Phase II Clinical Trial of GM-CSF Treatment in Patients with Hormone-Refractory or Hormone-Naïve Adenocarcinoma of the Prostate

机译:GM-CSF治疗前列腺癌激素难治性或初治性腺癌的II期临床试验

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摘要

The objective of this Phase II clinical trial was to determine the effects of chronic GM-CSF dosing on PSA levels in men with hormone-refractory or hormone-naïve prostate cancer. Six hormone-refractory and 10 hormone-naïve patients were recruited from an institutional practice and were treated with 250 and 125 μg/m2 of GM-CSF, respectively, 3 times per week for continuous 12-week treatment cycles until evidence of disease progression, as indicated by 2 consecutive rising PSA levels. PSA levels were measured every 6 weeks. Of the 6 hormone-refractory patients, 2 were classified with progressive disease after 4 months and 1 after 1.75 months. The best PSA responses for the remaining 3 patients were 3%, 12%, and 32% declines which lasted from 1.75 to 8.5 months. Of the 10 hormone-naïve patients, 2 were classified with progressive disease after 3 and 12 months, and 1 patient met the criteria for stable disease after 7.75 months. The best PSA response for the remaining 7 patients ranged from 7% to 42% declines which lasted from 0.5 to 10 months. These results indicate that further study of GM-CSF administration is not warranted for hormone-refractory patients but is recommended for hormone-naïve patients using a chronic dosing regimen.
机译:这项II期临床试验的目的是确定长期GM-CSF剂量对患有激素难治性或未经激素治疗的前列腺癌男性的PSA水平的影响。从机构实践中招募了6名激素难治性患者和10名未接受激素的患者,分别接受250和125μg/ m 2 GM-CSF的治疗,每周3次,连续12周如2个连续升高的PSA水平所示,治疗周期一直到疾病进展的迹象为止。每6周测量一次PSA水平。在6名激素难治性患者中,有2名在4个月后被分类为进行性疾病,而1名在1.75个月后被分类为疾病。其余3例患者的最佳PSA缓解率分别为1.75到8.5个月,分别下降了3%,12%和32%。在10名未使用过激素的患者中,有2名在3和12个月后被分类为进行性疾病,而1名患者在7.75个月后达到了稳定疾病的标准。其余7例患者的PSA最佳反应为下降7%至42%,持续0.5到10个月。这些结果表明,对于激素难治性患者,尚无必要对GM-CSF进行进一步研究,但建议使用长期给药方案的未接受激素的患者进行进一步研究。

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