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
| Autor: | Pierre Fumoleau, Yvan Krakowski, J. L. Misset, Philippe Vennin, Jacques Chauvergne, M.A. Lentz, Catherine Lhommé, B. Chevallier, Pierre Fargeot, Paul Rebattu, Anne Matthieu-Boue, Martine Van Glabbeke, H. Roche, Véronique Diéras, Dominique Mignard |
|---|---|
| Rok vydání: | 1999 |
| Předmět: |
Adult
Diarrhea Cancer Research medicine.medical_specialty Neutropenia medicine.medical_treatment Uterine Cervical Neoplasms Irinotecan Gastroenterology Internal medicine medicine Carcinoma Humans Infusions Intravenous Cervix Aged business.industry Middle Aged medicine.disease Recurrent Cervical Carcinoma Antineoplastic Agents Phytogenic Survival Analysis Surgery Radiation therapy Treatment Outcome medicine.anatomical_structure Oncology Epidermoid carcinoma Tolerability Carcinoma Squamous Cell Camptothecin Female business Progressive disease medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 17:3136-3142 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.1999.17.10.3136 |
| Popis: | 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, inoperable, progressive, metastatic or recurrent squamous cell cervical carcinoma and had received no radiotherapy in the preceding 3 months and had never received chemotherapy. The initial irinotecan dosage of 350 mg/m2 every 3 weeks was modifiable according to toxicity. Treatment continued for six cycles after complete response, or until disease progression or excessive toxicity after partial response, or for three additional cycles in the case of stable disease. Patients were stratified into group A (≥ one measurable lesion in a previously unirradiated area, with or without progressive disease in irradiated fields) or group B (measurable new lesion[s] in an irradiated field). RESULTS: Fifty-one of 55 enrolled patients were eligible for inclusion (median 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%) for group A (complete response, 2.9%), and zero for group B. The median time to progression and median survival were 4.0 and 8.2 months for group A and 2.5 and 4.2 months for group B, respectively. The major grade 3/4 toxicities 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-related deaths, three in group B. Patients with no prior external pelvic irradiation experienced fewer grade 3 and 4 adverse events. CONCLUSION: Irinotecan is effective in treating cervical squamous cell carcinoma if disease is located in an unirradiated area. Because of toxicity, a reduced dose is advised for patients previously treated with external pelvic irradiation. |
| Databáze: | OpenAIRE |
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