Phase II trial of intraperitoneal carboplatin in ovarian carcinoma patients with macroscopic residual disease at second-look laparotomy
| Autor: | Catherine Lhommé, Moïse Namer, Jean-Paul Guastalla, F. Chauvin, P. Goupil, J.F. Héron, P. Charrot, P. Kerbrat, M. Chazard, I. Richard, F. Mayer |
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| Rok vydání: | 1994 |
| Předmět: |
Cisplatin
medicine.medical_specialty Chemotherapy Leukopenia business.industry medicine.medical_treatment Phases of clinical research Hematology medicine.disease Chemotherapy regimen Carboplatin Surgery chemistry.chemical_compound Oncology chemistry Laparotomy medicine medicine.symptom business Ovarian cancer medicine.drug |
| Zdroj: | Annals of Oncology. 5:127-132 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/oxfordjournals.annonc.a058763 |
| Popis: | Summary Background Because of its antitumour activity and its pharmacological advantage when administered by the intraperitoneal route, carboplatin was studied in a phase II multicen-tric trial. The aim of the study was to determine the response rate and the toxicity of carboplatin administered intraperito-neally and to determine if pathological complete response could be attained in women with macroscopic residual ovarian cancer at second-look laparotomy after intravenous cis-platin chemotherapy. Patients and methods Twenty-nine patients with macroscopical residual disease after intravenous cisplatin-based chemotherapy at second-look laparotomy, were treated at that time with 300 mg/m2 of carboplatin administered in the abdominal cavity every four weeks for six cycles. In instances of negative findings at physical and CT scan examination, laparotomy evaluation was performed and the catheter was removed. The dose of carboplatin was increased or decreased according to hematological toxicity. Results Efficacy is evaluable in 25 pts: 2 pts had pathological complete responses and 1 pt had microscopic disease (12% response rate of evaluable patients). Toxicity is evaluable for 135 cycles in 29 patients. No grade 4 hematological toxicity was observed, 2 pts had grade 3 leukopenia and 3 pts had grade 3 thrombocytopenia; grade 3 vomiting was observed in 11% of cycles. No peritoneal complication was observed; catheter dysfunction occurred after the first cycle in one patient who refused a surgical procedure to remove the catheter and to pursue treatment. Conclusions Intraperitoneal carboplatin demonstrates efficacy in patients with macroscopical residual disease at second-look laparotomy after first-line cisplatin chemotherapy. The recommended dose for further studies is 300 mg/m2 administered every 4 weeks. A low response rate does not favour a randomised study. |
| Databáze: | OpenAIRE |
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