Bukowski R M, Wolfe M, Levine H S, Crawford D E, Stephens R L, Gaynor E, Harker W G
Cleveland Clinic Foundation, OH.
J Clin Oncol. 1993 Jan;11(1):161-5. doi: 10.1200/JCO.1993.11.1.161.
Previous reports of chemotherapy in patients with adrenal cancer have described responses to cisplatin (CDDP). Because of these reports of good results, a phase II trial that used CDDP with and without mitotane (o,p'DDD) was initiated.
Patients with metastatic or residual adrenocortical carcinoma with objectively measurable disease or biochemical abnormalities were divided into good-risk and poor-risk categories. The latter received CDDP 100 mg/m2 intravenously, and the former received 75 mg/m2. o,p'DDD was administered at a 1,000-mg dose orally four times a day along with cortisone acetate and Florinef (fludrocortisone acetate; Bristol-Myers Squibb Co, Princeton, NJ).
Of a total of 42 patients entered onto the study, 37 were eligible. Twenty-nine patients received good-risk and eight received poor-risk doses of CDDP. Functioning tumors were present in 45% of patients. Objective responses were noted in 30% (11 of 37) patients (95% confidence interval, 16% to 50%). Response duration was 7.9 months, and the median time to response was 76 days. The median survival of the 37 eligible patients was 11.8 months, and a significant survival advantage was found for patients who underwent prior surgical removal of their primary tumor or bulky disease, who had a performance status of 0 or 1, or who had synchronous metastatic disease. Toxicity of the CDDP and o,p'DDD combination was moderate to severe, and the most common side effects were gastrointestinal, renal, and neurologic.
The regimen of CDDP and o,p'DDD has activity in patients with adrenocortical carcinoma; however, the toxicity of this treatment was moderate to severe.
既往关于肾上腺癌患者化疗的报告描述了对顺铂（CDDP）的反应。鉴于这些报告显示出良好的结果，启动了一项II期试验，该试验使用了含或不含米托坦（邻对滴滴滴，o,p'DDD）的CDDP。
患有转移性或残留肾上腺皮质癌且具有客观可测量疾病或生化异常的患者被分为低风险和高风险类别。后者静脉注射CDDP 100 mg/m²，前者静脉注射75 mg/m²。o,p'DDD以每日4次、每次1000 mg的剂量口服，同时服用醋酸可的松和氟氢可的松（醋酸氟氢可的松；百时美施贵宝公司，新泽西州普林斯顿）。
共有42例患者进入该研究，其中37例符合条件。29例患者接受了低风险剂量的CDDP，8例接受了高风险剂量的CDDP。45%的患者存在功能性肿瘤。30%（37例中的11例）的患者出现客观反应（95%置信区间，16%至50%）。反应持续时间为7.9个月，中位反应时间为76天。37例符合条件的患者的中位生存期为11.8个月，对于那些先前接受过原发性肿瘤或大块病变手术切除、体能状态为0或1或患有同步转移性疾病的患者，发现了显著的生存优势。CDDP与o,p'DDD联合使用的毒性为中度至重度，最常见的副作用是胃肠道、肾脏和神经系统方面的。
CDDP与o,p'DDD方案对肾上腺皮质癌患者有活性；然而，这种治疗的毒性为中度至重度。
