Akaza H, Usami M, Kotake T, Matsumura Y, Moriyama N, Imai K, Fuse H, Isaka S, Yamanaka H, Matsumoto K
Hinyokika Kiyo. 1987 Jun;33(6):894-904.
The efficacy of cytotoxic agents in the treatment of prostatic cancer is difficult to evaluate because objective, measurable lesions, such as lung, liver, skin, subcutaneous and nodal metastasis are often not found. However, most of the patients with advanced prostatic cancer have bone involvement and elevated serum acid-phosphatase in addition to the primary tumor. Exact clinical trials on such cases, especially phase II studies can not be performed without appropriate evaluations of these three parameters. The criteria of these three parameters offered by various study groups are reviewed and the relevant response criteria are proposed. A stable category was thought to be useful to evaluate the efficacy on the patients with progressing disease. In our proposal, overall assessment of response involves all objective parameters including these three parameters as well as both measurable and unmeasurable disease described in the WHO handbook for reporting results of cancer treatment.
细胞毒性药物治疗前列腺癌的疗效难以评估，因为通常找不到如肺、肝、皮肤、皮下及淋巴结转移等客观、可测量的病灶。然而，大多数晚期前列腺癌患者除原发性肿瘤外，还伴有骨转移和血清酸性磷酸酶升高。对于此类病例，尤其是II期研究，如果不对这三个参数进行适当评估，就无法进行确切的临床试验。本文综述了各研究组提供的这三个参数的标准，并提出了相关的反应标准。认为稳定类别有助于评估疾病进展患者的疗效。在我们的提议中，反应的总体评估涉及所有客观参数，包括这三个参数以及世界卫生组织癌症治疗结果报告手册中描述的可测量和不可测量疾病。
