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 Cyclophosphamide (C) [OXC] Versus Cisplatin (P) Plus Cyclophosphamide [CPC] in Advanced Chemonaive Ovarian Cancer (AOC) Patients (Pts): Final Results (Abstract 1502)

English

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

Background:
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)

Results:

Toxicity:
- 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

Authors' Conclusions

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

Clinical/Scientific Implications:

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.

ASCO Abstract 1502