A phase II study of 4'-epi-doxorubicin plus cis-platinum in advanced solid tumors.

ABSTRACT

4'-Epi-doxorubicin (4'-epi-DX) is a new doxorubicin derivative that in phase II human studies has been demonstrated to be less toxic than doxorubicin. Sixty-four patients with advanced solid tumors were treated with the drug combination of 4'-epi-DX and cis-dichlorodiammineplatinum (CDDP) at the doses of 40-60 and 50 mg/m2, respectively, every 21-28 days. Out of 52 evaluable patients, complete remission (CR) was recorded in 5, partial remission (PR) in 12, minor remission (MR) in 7, no change (NC) in 16 and progression (P) in 12. The median duration of remission in patients who achieved a CR and PR was 9+ months. In particular, out of 19 patients with ovarian cancer, 2 CR (second look) and 7 PR have been documented. One CR and 3 PR also have been observed in 21 patients with lung carcinoma. Complete and partial responses also have been documented in breast cancer (1 CR/1), in bladder carcinoma (1 CR/2), in renal cancer (1 PR/5) and in testicular cancer (1 PR/1). Hematologic toxicity was generally mild to moderate (leukopenia less than or equal to 1500 cells/mm3 in 3% of the patients; thrombocytopenia less than or equal to 120,000 cells/mm3 in 2% of the patients). Vomiting was present in almost all patients while alopecia has been recorded in 63% of the patients. No case of cardiac toxicity had been observed up to now (median cumulative dose of 4'-epi-DX240 mg/m2, range 40-650 mg/m2). The combination of 4'-epi-DX with CDDP appears to be an active and well-tolerated regimen in ovarian cancer and lung cancer.