Purpose: To determine the therapeutic efficacy of cisplatin plus gemcitabine in the treatment of patients with metastatic cervical cancer.
Methods and materials: A total of 51 patients were enrolled in this study. The median age was 46 years (34-67). Thirty-five patients were previously treated to the pelvis by radical radiotherapy, one patient was treated by surgery and one by surgery and postoperative radiotherapy. There were 14 patients with stage IVB cervical cancer who were previously untreated. The sites of metastases were 10 in the lungs, 5 in the supraclavicular nodes, 9 in the paraaortic nodes, 4 in the liver, 3 in the inguinal nodes, 5 in both supraclavicular nodes and lungs, 9 in both supraclavicular and paraaortic nodes, 1 in both supraclavicular and inguinal nodes, 1 in both lung and inguinal nodes, 2 in both lung and paraaortic nodes and 2 in both liver and lungs. Fine needle biopsies were done in all metastatic sites except for multiple lung and multiple liver metastases. Cisplatin was administered as an i.v. infusion on day 1 (70 mg/m2). Gemcitabine was administered as an i.v. infusion for over 30 minutes on day 1 and 8 (1,250 mg/m2) in a 21 day cycle.
Results: Forty patients were available for evaluation, with 3/40 (7.5%) achieving a complete response, 27/40 (67.5%) achieving a partial response (OR=30/40, 75%), 5/40 (12.5%) having a stable disease, and 5/40 (12.5%) a progressive one. Eleven patients were not assessable because of patient refusal for further treatment and loss of follow up. Myelosuppression was the major toxicity. Grade 3 or 4 anemia and granulocytopenia occurred at a frequency of 25.5% and 29.4%, respectively. Grade 3-4 thrombocytopenia was found in 3.8%. There were 3 (5.8%) patients who developed grade 4 neutropenia and fever. No other major side effects were found other than alopecia and usual gastrointestinal toxicities such as anorexia, nausea and vomiting. There were no treatment related deaths. The median time to progression was 8.3 months and the median survival was 9.6 months. With a median follow up of 7.7 months (range, 0.3 to 22.1), 30% of the patients were alive at 12 months.
Conclusion: In this study of patients with metastatic cervical cancer, the combination of cisplatin and gemcitabine treatment induced a high response rate.