Objectives: The efficacy and toxicity of combined therapy with irinotecan (CPT-11) plus mitomycin-C (MMC) were evaluated in patients with advanced or recurrent squamous cell carcinoma (SCC) of the uterine cervix.
Methods: CPT-11 (100 mg/m(2)) was administered on days 1, 8, and 15 by intravenous (iv) infusion over 90 min, while MMC (10 mg/m(2) iv) was given on day 1. This regimen was repeated every 28 days and at least two courses were given.
Results: Among 51 eligible patients (median age: 52 years; range: 25-72 years), 2 showed complete response (CR) and 24 showed PR, for an overall response rate (ORR) of 51.0% (95% confidence interval: 36.6-65.3%). In patients without prior chemotherapy, the ORR was 54.8% (38.7-70.2%). Twenty-five patients (Ib2:3, IIb:17, and IIIb:5) received this regimen as neoadjuvant chemotherapy and their ORR was 76% (54.9-90.6%). Twenty-two patients were able to undergo radical surgery after NAC. The major toxicity was neutropenia, which was grade 3-4 in 59% of the patients. Grade 3-4 thrombocytopenia and anemia were also seen in 26% of the patients each. The most common nonhematologic toxicity was diarrhea (grade 3-4 in 12%).
Conclusion: CPT-11 combined with MMC can be effective against advanced or recurrent SCC of the uterine cervix.