Schellhammer P, Cockett A, Boccon-Gibod L, Gospodarowicz M, Krongrad A, Thompson I M, Scardino P, Soloway M, Adolfsson J
Department of Urology, Eastern Virginia Medical School, Norfolk, USA.
Urology. 1997 Apr;49(4A Suppl):27-38. doi: 10.1016/s0090-4295(99)80321-5.
The AUA Practice Guidelines Panel convened to address the issue of appropriate endpoints for assessment of treatment modalities for localized carcinoma of the prostate.
A review of the literature and the design of existing clinical trials produced a consensus, which was presented to and critiqued by the members of the general conference.
The pitfalls associated with identification of local failure endpoints were discussed, and the more accurate endpoints of freedom from metastatic progression and overall survival were recognized. The strict definition that must be fulfilled for intermediate endpoints to become surrogates for metastasis free and/or survival endpoints was stressed. For more efficient and rapid conduct of future clinical trials, the urgent need to validate such surrogate endpoints by evaluation in randomized control trials is obvious. PSA, while an indicator of disease activity and a critical marker for estimating disease progression or regression in response to therapy, is not a surrogate for metastasis free or overall survival.
Until surrogate endpoints are validated, the committee has evaluated the endpoints in current use, reviewed their limitations, and stressed the importance of quality-of-life assessment together with the traditional endpoint assessment.
美国泌尿外科学会（AUA）实践指南小组召开会议，以探讨评估前列腺局限性癌治疗方式的合适终点问题。
对文献进行回顾并设计现有临床试验，形成了一项共识，并提交给全体会议成员进行讨论和批评。
讨论了与确定局部失败终点相关的陷阱，并认识到无转移进展和总生存期这两个更准确的终点。强调了中间终点要成为无转移和/或生存终点替代指标必须满足的严格定义。为了更高效、快速地开展未来的临床试验，通过在随机对照试验中进行评估来验证此类替代终点的迫切需求显而易见。前列腺特异性抗原（PSA）虽然是疾病活动的指标，也是评估治疗反应中疾病进展或消退的关键标志物，但它不是无转移或总生存期的替代指标。
在替代终点得到验证之前，委员会已评估了当前使用的终点，审查了其局限性，并强调了生活质量评估与传统终点评估同样重要。
