A phase II trial of isotretinoin and alpha interferon in patients with recurrent squamous cell carcinoma of the cervix - A Gynecologic Oncology GroupStudy

From January 1993 through January 1996, 37 patients with unresectable squam ous carcinoma of the cervix were entered on study and scheduled to receive oral isotretinoin 1 mg/kg per day with subcutaneous alpha interferon 6,000, 000 units/day. A course was defined as 4 continuous weeks of therapy. The m ean number of four-course cycles delivered was 1.8. One patient was ineligi ble because of wrong cell type and two were never treated. Thus, 34 patient s were evaluable for toxicity. Eight patients were inevaluable for response . Five did not receive a complete 4-week course and three did not have addi tional tumor measurements; thus 26 were evaluable for response. Prior radio therapy had been given to 25 patients and prior chemotherapy to 23 patients . There was no grade 4 neutropenia. The incidence of Gynecologic Oncology G roup (GOG) grade 3 granulocytopenia and thrombocytopenia was 8.8% and 5.8%, respectively. Six patients (17.6%) developed grade 3 or worse nausea and v omiting. Four(11.7%) patients developed grade 3 neurologic symptoms. There were no complete responses and one partial response. The overall response r ate was 3.8% (95% confidence interval, 0.1-19.6%). In this pretreated popul ation, isotretinoin and alpha interferon in the dose and schedule employed exhibit minimal activity.