Masaoka T
Dept. of Internal Medicine, Center for Adult Diseases, Osaka.
Gan To Kagaku Ryoho. 1989 Mar;16(3 Pt 1):316-22.
Criteria for the evaluation of chemotherapy for acute leukemia, chronic leukemia, Myelodysplastic syndrome and polycythemia vera were discussed. In leukemia patients the changes in the number of leukemic and normal cells are easily quantitatively evaluated. The criteria depends on the reduction and recovery of leukemic cells and normal cells. In acute leukemia because considerable parts of complete remissions ended with relapse, the evaluation seems necessarily to differentiate good remission from standard remission. For such purpose 5,000 leukocyte differential seemed effective. In the phase II study of anti-leukemia drugs, however, it seemed necessary to find efficacy less than remission, to avoid underestimation of drug efficacy because pretreated patients are usually studied in the phase II study. In the evaluation of chronic myelogenous leukemia, chronic myelomonocytic leukemia or polycythemia vera, short term judgment needs to be further studied about the correlation with longterm efficacy such as survival. The treatment of myelodysplastic syndrome is very hard to evaluate, reduction of blasts and increase of normal cells may be necessary for the improvement of symptoms. The relation of the efficacy and survival seemed necessary to be studied.
讨论了急性白血病、慢性白血病、骨髓增生异常综合征和真性红细胞增多症化疗的评估标准。在白血病患者中，白血病细胞和正常细胞数量的变化易于进行定量评估。评估标准取决于白血病细胞和正常细胞的减少及恢复情况。在急性白血病中，由于相当一部分完全缓解最终以复发告终，评估似乎有必要区分良好缓解和标准缓解。为此，5000个白细胞分类似乎是有效的。然而，在抗白血病药物的II期研究中，似乎有必要找到低于缓解的疗效，以避免低估药物疗效，因为II期研究通常研究的是预处理患者。在评估慢性粒细胞白血病、慢性粒单核细胞白血病或真性红细胞增多症时，关于与长期疗效（如生存）的相关性，短期判断还需要进一步研究。骨髓增生异常综合征的治疗很难评估，减少原始细胞和增加正常细胞可能是改善症状所必需的。疗效与生存的关系似乎有必要进行研究。
