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Multicenter Phase II/III Study of Oxaliplatin Plus Cyclophosphamide (C) [OXC] Versus Cisplatin (P) Plus
Cyclophosphamide [CPC] in Advanced Chemonaive Ovarian Cancer (AOC) Patients (Pts): Final Results. Multicenter Phase II/III Study of Oxaliplatin Plus C
Ivor Benjamin, MD
OncoLink Assistant Editor
Ultima Vez Modificado: 21 de mayo del 2000
Presenter: Jean Louis Misset
Affiliation: Htpital Paul Brousse, Villejuif, France; Ctr Oscar Lambret, Lille, France; Ctr Jean Perrin, Clermont-Ferrand, France; Inst Curie, Paris, France; Ctr Hospitalier, Bourg en Bresse, France; Clin St Pierre, Perpignan, France; Ctr Val d'Aurelle, Montpellier, France; Policlinico Umberto, Rome, Italy; Ctr Paul Papin, Angers, France; Sanofi-Synthilabo, Gentilly, France; CAC, Kremlin-Bicjtre, France; Neoplasicas, INEN, Lima, Peru
Oxaliplatin (OXA) has been previously shown to have activity in the second-line treatment of epithelial ovarian cancer. The aim of this study was to compare the safety and efficacy of Oxaliplatin-cyclophosphamide vs. cisplatin- cyclophosphamide for pretreated ovarian cancer patients.
Materials and Methods:
- FIGO stages IIC through IV were included
- Patients were treated between 4/92 and 1/96
- Treatment regimen:
- Oxaliplatin-cyclophophamide: OXA:130 mg/m2 iv + C:1000 mg/m2 iv , q 3 weeks x 6 (85 pts)
- Cisplatin-cyclophosphamide: P: 100 mg/m2 iv + C: 1000 mg/m2 iv, q3w x 6) (92 pts)
- Anemia: fewer grade 3-4 on OXC (5) vs. CPC (31)arm p<0.0001
- Red cell transfusions: fewer for OXC (7 vs. 20) p<0.0001
- Grade 3-4 leukopenia: fewer for OXC (32 vs. 51) p<0.042
- Peripheral Neuropathy: mild
- No significant difference in efficacy between the two arms.
- The authors' suggest that the lower toxicity of the OXC arm may increase interest in using OXA in second-line combination therapies
- Since the CPC arm uses a higher dose of cis- platin (100 mg/m2 rather than the more standard 75 mg/m2) the high grade toxicities observed are not surprising.
- Further studies with OXA containing combinations should be compared in a Phase II/III setting with paclitaxel-carboplatin and paclitaxel-cis-platin containg regimens.
- Unfortunately, the accrual period for this study predated the taxane era.