High-dose versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin in suboptimal ovarian cancer: a randomized study of the Gruppo Oncologico Nord-Ovest
| Autor: | G. Parodi, A. Bellini, L Iskra, Milena Bruzzone, R Algeri, Luigi M. Gallo, A Gadducci, S. Mammoliti, R. Rosso, Flavio Carnino, Nicola Ragni, Alessandra Rubagotti, G. Foglia, Silvana Chiara, S. Rugiati, E Catsafados, Isa Brunetti, Pierfranco Conte, Francesco Boccardo |
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| Jazyk: | angličtina |
| Rok vydání: | 1996 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty Neoplasm Residual Cyclophosphamide Anemia medicine.medical_treatment administration /&/ dosage/adverse effects Gastroenterology Drug Administration Schedule Nephrotoxicity Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans administration /&/ dosage Aged Epirubicin Cisplatin Ovarian Neoplasms Chemotherapy Leukopenia business.industry Adult Aged Antineoplastic Combined Chemotherapy Protocols administration /&/ dosage Cisplatin administration /&/ dosage/adverse effects Cyclophosphamide administration /&/ dosage Drug Administration Schedule Epirubicin administration /&/ dosage Female Humans Middle Aged Neoplasm Residual drug therapy Ovarian Neoplasms drug therapy Survival Rate Treatment Outcome Middle Aged medicine.disease Surgery drug therapy Survival Rate Regimen Treatment Outcome Oncology Neoplasm Female medicine.symptom business Ovarian cancer medicine.drug |
| Zdroj: | Scopus-Elsevier |
| Popis: | PURPOSE The aim of the study was to compare high-versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin as primary chemotherapy for suboptimal stage III and IV ovarian cancer. PATIENTS AND METHODS One hundred forty-five patients were randomized to receive six courses of cisplatin 50 or 100 mg/m2 plus epidoxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2. The two treatment arms were well balanced; all patients had greater than 2 cm and 37.2% had greater than 5 cm of residual disease; 29.6% had stage IV disease. RESULTS Patients in the high-dose arm received a double dose-intensity and double total dose of cisplatin. The high-dose regimen induced significantly more episodes of leukopenia (47.8% v 32.8%, P = .05), thrombocytopenia (21.7% v 3.2%, P = .003), anemia (37.6% v 12.5%, P = .002), nephrotoxicity (six v one patient), and neurotoxicity (30.4% v 6.3%, P = .002). There were no significant differences in efficacy in terms of clinical response rate (high-dose 57.5% v low-dose 61.1%), pathologic complete response (CR) (9.6% v 18.1%), median survival times (29 v 24 months), and median progression-free survival (18 v 13 months). CONCLUSION This study shows that doubling the dose-intensity and total dose of cisplatin in combination with epidoxorubicin and cyclophosphamide has significant toxic effects and does not improve clinical outcome in patients with suboptimal ovarian cancer. |
| Databáze: | OpenAIRE |
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