Henney J E, Devita V T
Cancer. 1980 Aug 15;46(4 Suppl):999-1008. doi: 10.1002/1097-0142(19800815)46:4+<999::aid-cncr2820461325>3.0.co;2-e.
Based on both laboratory and clinical data, two major prospective randomized clinical trials were initiated in 1972 and 1973 by the NSABP and the Instituto Nazionale Tumori, of Milano, Italy, under the sponsorship of the National Cancer Institute, to test the value of administering chemotherapy to patients with Stage II breast cancer in the postoperative period. With a follow-up time of nearly five years, both studies continue to demonstrate a significantly prolonged disease-free interval for treated premenopausal women. The Milano trial also indicates an increase in survival from 74% to 90% in the treated group of premenopausal women. A recent analysis of the postmenopausal women treated in the Milano study show that those treated patients who received 75% of the calculated drug dose have significantly prolonged disease-free intervals. These positive results from these trials and byproducts of other basic and clinical research, particularly the value of the estrogen receptor as a prognostic factor of disease-free interval survival and possible treatment selector, have stimulated the scientific community to undertake additional adjuvant therapy studies. The design and rationale for these subsequent studies are discussed. Preliminary indications exist that these trials will lead to a reduction in the national mortality and the overall economic impact from this disease will be lessened within the next five years. Based on the positive results of these studies, rationale currently exists for designing clinical trials that have the potential to extend similar benefit to the 60,000 patients with Stage I disease.
基于实验室和临床数据，1972年和1973年，美国国家乳腺癌和肠道外科辅助治疗计划（NSABP）以及意大利米兰国家肿瘤研究所，在美国国立癌症研究所的资助下，发起了两项主要的前瞻性随机临床试验，以测试对II期乳腺癌患者术后进行化疗的价值。经过近五年的随访，两项研究均继续表明，接受治疗的绝经前女性的无病生存期显著延长。米兰的试验还表明，绝经前女性治疗组的生存率从74%提高到了90%。最近对米兰研究中接受治疗的绝经后女性的分析表明，那些接受了计算出的药物剂量75%的治疗患者，其无病生存期显著延长。这些试验的积极结果以及其他基础和临床研究的副产品，特别是雌激素受体作为无病生存期预后因素和可能的治疗选择指标的价值，促使科学界开展更多的辅助治疗研究。本文讨论了这些后续研究的设计和基本原理。初步迹象表明，这些试验将导致全国死亡率降低，并且在未来五年内，这种疾病的总体经济影响将得到减轻。基于这些研究的积极结果，目前有理由设计有可能将类似益处扩展到60000例I期疾病患者的临床试验。
