[Treatment of 32 cervico-uterine cancer patients with 13-cis-retinoic acid and interferon alpha]

Abstract

Background: The use of chemotherapy for cervical squamous cell carcinoma has shown some positive results. Total percentage of complete plus partial responses are near 30% with the use of single cytotoxic agents. Higher percentages are achievable with combined chemotherapy including platinum but the lack of evidence that current chemotherapy can increase survival, coupled with a devastating worldwide mortality, indicates the urgent need for more effective therapies.

Objective: To further assess the role of 13-cis-Retinoic acid (13-cRA) plus interferon alfa (IFN-alfa) in a prospective phase II trial in advanced cervical cancer.

Methods: Thirty two women with untreated cervical carcinoma, with median age of 42 years (24 to 60 years) and median Zubrod performance of 1 (range 0-2) were treated for at least two months with oral 13-cRA (1 mg/kg/day) and IFN-alfa 2a (subcutaneously, 6 million units daily).

Results: Sixteen patients (50%) had major responses, including four complete clinical responses. Major response rate in regard to disease stage were 100% in the four patients with stage IVA, 36% (4/11) in stage IIIB, 50% (4/8) in stage IIB, 50% (1/2) in stage IIA, and 43% (3/7) in stage IB. Remission of the cancer in 15 patients was reached after only two months of treatment and in one patient within one month. Dose escalations after two months of therapy in nonresponding patients had no effect. Toxicity to treatment was manageable. Twenty one patients had poorly differentiated tumors.

Conclusions: These preliminary results indicate that systemic 13-cRA plus IFN-alfa 2a is a highly active, well tolerated therapy for locally advanced squamous cell carcinoma of the cervix, with potential to be used in the primary, adjuvant and salvage therapy of cervical cancer. This therapy warrants further study.