Results of a European organization for research and treatment of cancer/early clinical studies group phase II trial of first-line irinotecan in patients with advanced or recurrent squamous cell carcinoma of the cervix

Purpose: To determine the efficacy and tolerability of irinotecan (CPT-11) in advanced or recurrent cervical carcinoma. Patients and Methods: Eligible patients had histologically confirmed, inope rable, progressive, metastatic or recurrent squamous cell cervical carcinom a and had received no radiotherapy in the preceding 3 months and had never received chemotherapy. The initial irinotecan dosage of 350 mg/m(2) every 3 weeks was modifiable according to toxicity. Treatment continued for six cy cles after complete response, or until disease progression or excessive tox icity after partial response, or for three additional cycles in the case of stable disease. patients were stratified into group A (greater than or equ al to one measurable lesion in a previously unirradiated area, with or with out progressive disease in irradiated fields) or group B (measurable new le sion[s] in an irradiated field). Results: Fifty-one of 55 enrolled patients were eligible for inclusion (med ian age, 47 years; range, 30 to 71 years). The response rate was 15.7% (95% confidence interval [CI], 7.0% to 28.6%) overall, 23.5% (95% CI, 10.7% to 41.2%) far group A (complete response, 2.9%), and zero for group B. The med ian time to progression and median survival were 4.0 and 8.2 months for gro up A and 2.5 and 4.2 months for group 8, respectively The major grade 3/4 t oxicities for groups A and B were diarrhea (24.3% and 55.5%, respectively) and neutropenia (24.3% and 33.3%, respectively). There were four toxicity-r elated deaths, three in group 8. patients with no prior external pelvic irr adiation experienced fewer grade 3 and 4 adverse events. Conclusion: Irinotecan is effective in treating cervical squamous cell carc inoma if disease is located in an unirradiated area. Because of toxicity, a reduced dose is advised for patients previously treated with external pelv ic irradiation. (C) 1999 by American Society of Clinical Oncology.