Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 1993
Phase II trial of mitotane and cisplatin in patients with adrenal carcinoma: a Southwest Oncology Group study.
Клиническое исследованиеКлиническое исследование II фазыСтатьяПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод пока не подготовлен
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Bukowski R M, Wolfe M, Levine H S, Crawford D E, Stephens R L, Gaynor E, Harker W G
Аннотация
PURPOSE: 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 AND METHODS: 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).
RESULTS: 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.
CONCLUSION: 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.
PATIENTS AND METHODS: 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).
RESULTS: 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.
CONCLUSION: 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.