Phase II trial of mitotane and cisplatin in patients with adrenal carcinoma: a Southwest Oncology Group study.

Abstract

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.

Combination Chemotherapy in Advanced Adrenocortical Carcinoma

“…An international network of closely collaborating investigators was the key to achieving this enrollment of patients within only 5.4 years, which is equivalent to a recruitment rate of 56 patients per year, as compared with a maximum of 7 patients per year in previous studies. 17,[25][26][27][28] This successful enrollment shows that an investigator-initiated, randomized phase 3 trial of treatment in patients with a rare tumor is feasible, despite the lack of pharmaceutical interest in sponsoring such a trial. Further strengths of the trial include its prospective, randomized design; the intentionto-treat analysis; the high percentage of patients who were evaluated for the predefined end points; and the small number of censored observations.…”

Cytotoxic therapy with etoposide and cisplatin in advanced adrenocortical carcinoma

“…Used alone, it provides a response rate around 30%. Its combination with mitotane did not increase the response rate (Tattersall et al, 1980;Chun et al, 1983;Bukowski et al, 1993).…”

Etoposide, doxorubicin and cisplatin plus mitotane in the treatment of advanced adrenocortical carcinoma: a large prospective phase II trial

“…Cisplatin is the cytotoxic agent most frequently used in this disease. Cisplatin in combination with mitotane provided a response rate close to 30% (Bukowski et al 1993). The combination of cisplatin with other cytotoxic agents such as etoposide, doxorubicin, and 5-fluorouracil did not improve this rate (Van Slooten & van Oosterom 1983, Schlumberger et al 1991, Bonacci et al 1998, Williamson et al 2000.…”

“…Only eight small phase II trials have been published up to now (Van Slooten & van Oosterom 1983, Decker et al 1991, Schlumberger et al 1991, Bukowski et al 1993, Bonacci et al 1998, Khan et al 2000, Williamson et al 2000, Abraham et al 2002. They enrolled a limited number of patients with unresectable disease and only three of them had enough power to assess a cytotoxic activity (at least 30 patients enrolled) (Bukowski et al 1993, Williamson et al 2000, Abraham et al 2002. Cisplatin is the cytotoxic agent most frequently used in this disease.…”