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CM regimen
Abstract: Phase II trial of mitotane and cisplatin in patients
with adrenal carcinoma: a Southwest Oncology Group study.
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.
References
Bukowski RM, Wolfe M, Levine HS, Crawford DE, Stephens RL, Gaynor E, Harker
WG. Phase II trial of mitotane and cisplatin in patients with adrenal carcinoma:
a Southwest Oncology Group study. J Clin Oncol 1993; 11:161 - 165.
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| Regimen |
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Cisplatin....... 100 mg / M2 IV day
1
- dose reduced to 75 mg / M2 in poor risk patients
Mitotane....... 1000 mg PO QID daily
- advance dose as tolerated |
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Summary |
Metastatic and
residual adrenal cancer randomized to cisplatin with or without
mitotane |
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Overall Response Rate |
30% |
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Medican Survival |
11.8 months |
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Toxicity |
Toxicity of the CDDP and o,p'DDD combination was moderate to severe, and the
most common side effects were gastrointestinal, renal, and neurologic. |
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