Human lymphoblastoid interferon (IFN-alpha-N1) plus doxorubicin, cyclophosphamide, and cisplatin in the treatment of advanced epithelial ovarian malignancies. A phase I-II study of the Gynecologic Oncology Group.

This is a phase I-II study of lymphoblastoid interferon (IFN-alpha-N1) combined with primary chemotherapy after cytoreductive surgery in patients with suboptimal stage III and stage IV epithelial ovarian carcinoma. Fourteen patients were treated initially with cyclophosphamide, doxorubicin, and cisplatin (CAP regimen) for two cycles, and IFN (alpha-N1) was added to this combination on day 2 of the third cycle. Patients then were divided into four groups, each group receiving differing doses of IFN ranging from 3 to 10 MU/m2 on each of days 2-5. A total of eight courses of chemotherapy was administered, six of which included interferon. Severe fatigue and malaise were the greatest dose-limiting toxicities associated with the interferon. However, severe bone marrow suppression also limited the administration of interferon. The results of this study suggest that the addition of interferon to the multiagent chemotherapy regimen of CAP is both unacceptable to patients and excessively toxic to the bone marrow. Because of the small patient sample and poor tolerance of the treatment, an accurate evaluation of therapeutic response could not be performed.