Apples and oranges: building a consensus for standardized eligibility criteria and end points in prostate cancer clinical trials.
Apples and oranges: building a consensus for standardized eligibility criteria and end points in prostate cancer clinical trials.
复制标题
苹果和橙子：就前列腺癌临床试验的标准化资格标准和终点建立共识。
DOI：
--
复制
发表时间：
1998
影响因子：
45.3
通讯作者：
Nancy A. Dawson
中科院分区：
文献类型：
--
作者：
Nancy A. Dawson
目的
调查激素难治性前列腺癌 (HRPC) 临床试验的资格和反应标准。
方法
HRPC 的 35 名固定调查员完成了 125 个问题的调查。
结果
人们普遍认为，临床试验的进入标准包括基于前列腺特异性抗原 (PSA) 水平升高的进展（94% 的研究人员）、可测量疾病的增加 (91%) 和/或骨扫描中出现新骨病变 (83%)。大多数人认为，应在研究入组前记录睾酮的去势水平（77%）和抗雄激素撤药后的进展（97%）。 82% 的人需要继续抑制睾丸雄激素。 77% 的人赞成单独报告骨骼反应率、可测量疾病、症状和生化标志物（主要是 PSA 水平），而不是综合反应。 94% 的研究人员接受 PSA 水平的变化作为替代反应终点。然而，这些研究人员对 PSA 数据集的解释与临床试验中可能观察到的情况类似，显示出明显的不一致。对于 94% 的研究人员来说，生存是最重要的终点。基于可测量疾病变化、进展时间、反应持续时间、PSA水平降低或生活质量改善的反应与临床试验终点具有相似的加权值，并且对这些研究者来说不如生存重要（P < 10(-8)）。
结论
这项调查表明对于 HRPC 临床研究的资格和伴随治疗达成了一些共识。使用多参数评估反应和 PSA 水平作为替代终点已被广泛采用。
PURPOSE
To survey eligibility and response criteria for clinical trials in hormone-refractory prostate cancer (HRPC).
METHODS
Thirty-five established investigators of HRPC completed a 125-question survey.
RESULTS
There was a general consensus that criteria for clinical trial entry would include progression based on an increasing prostate-specific antigen (PSA) level (94% of investigators), an increase in measurable disease (91%), and/or appearance of new bone lesions on bone scan (83%). Most believed that castrate levels of testosterone (77%) and progression after antiandrogen withdrawal (97%) should be documented before study enrollment. Continuation of testicular androgen suppression would be required by 82%. Seventy-seven percent favored separate reports on response rates in bone, measurable disease, symptoms, and biochemical markers (primarily PSA levels), rather than a composite response. Ninety-four percent of the investigators accepted changes in PSA level as a surrogate end point of response. However, interpretation by these investigators of a PSA data set similar to what might be observed in a clinical trial showed marked discordance. Survival is the end point of most importance to 94% of these investigators. Response based on changes in measurable disease, time to progression, response duration, PSA level decrease, or quality-of-life improvement were of similar weighted value as a clinical trial end point and were rated as less important to these investigators than survival (P < 10(-8)).
CONCLUSION
This survey indicates some consensus on eligibility and concomitant treatments for clinical studies in HRPC. The use of multiparameter assessment of response and PSA level as a surrogate end point have been widely adopted.
登录
查看更多内容
影响因子：
45.3
作者：
Scher, HI;Liebertz, C;Schwartz, M
通讯作者：
Schwartz, M
甲基乙二醛-双（脒腙）在激素抵抗性前列腺腺癌中的应用。
DOI：
10.1200/jco.1985.3.2.224
发表时间：
1985
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Scher,HI;Yagoda,A;Ahmed,T;Watson,RC
通讯作者：
Watson,RC
口服雌莫司汀和口服依托泊苷治疗激素难治性前列腺癌的 II 期评估。
DOI：
10.1200/jco.1994.12.10.2005
发表时间：
1994
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Pienta,KJ;Redman,B;Hussain,M;Cummings,G;Esper,PS;Appel,C;Flaherty,LE
通讯作者：
Flaherty,LE
复发性前列腺癌的临床试验：确定目标。
DOI：
10.1093/jnci/88.22.1623
发表时间：
1996
期刊：
Journal of the National Cancer Institute
影响因子：
--
作者：
Scher,HI;Mazumdar,M;Kelly,WK
通讯作者：
Kelly,WK
影响因子：
45.3
作者：
KELLY, WK;SCHER, HI;FOSSA, SD
通讯作者：
FOSSA, SD