Bonneterre J, Coppens H, Mauriac L, Metz M, Rouesse J, Armand J P, Fargeot P, Mathieu M, Tubiana M, Cappelaere P
Eur J Cancer Clin Oncol. 1985 Oct;21(10):1153-8. doi: 10.1016/0277-5379(85)90007-0.
We have conducted a multicenter randomized clinical trial comparing in advanced post-menopausal breast cancer patients 500 mg vs 1 g AG/day. The hydrocortisone dose was 40 mg/day in both groups. One hundred and seventy patients have been randomized; 161 were evaluable for tolerability, 149 for effectiveness. Response rates were similar in both groups, 19 and 24% respectively for the 500 mg and 1 g groups. No difference was observed according to tumor site. Duration of response was the same in both groups (14 months), as was mean time to response (about 3 months). Survival (studies in 125 patients) was similar in both groups (responders and non-responders). No response could be obtained with 1 g after relapse or failure with 500 mg (n = 17). Tolerability was good in 91% of the 500 mg group patients and 78% of the 1 g group patients (P less than 0.03). It was poor in 4 and 15% respectively (P less than 0.03). Side-effects were the same in both groups but less frequent and less severe in the 500 mg group; however, these patients more frequently had 'moon face'.
我们开展了一项多中心随机临床试验，比较晚期绝经后乳腺癌患者每日服用500毫克与1克AG的效果。两组患者的氢化可的松剂量均为每日40毫克。170例患者已被随机分组；161例可评估耐受性，149例可评估有效性。两组的缓解率相似，500毫克组和1克组分别为19%和24%。未观察到肿瘤部位存在差异。两组的缓解持续时间相同（14个月），平均缓解时间也相同（约3个月）。两组（应答者和无应答者）的生存率（125例患者的研究）相似。500毫克剂量复发或治疗失败后使用1克剂量未获得缓解（n = 17）。500毫克组91%的患者和1克组78%的患者耐受性良好（P < 0.03）。两组分别有4%和15%的患者耐受性较差（P < 0.03）。两组的副作用相同，但500毫克组的副作用频率更低、严重程度更低；然而，这些患者出现“满月脸”的频率更高。
