Oxaliplatin and 5-fluorouracil in heavily pretreated patients with ovarian carcinoma: A well tolerated and efficient treatment

Abstract

16028 Background: Recurrent ovarian cancer is an incurable disease. The prognosis of patients with platinum refractory disease is dismal. We present data from heavily pretreated patients with recurrent ovarian cancer to whom the Folfox regimen was administered. Methods: Patients with recurrent, resistant or refractory, pretreated ovarian carcinoma were eligible for this compassionate use program of oxaliplatin (85 mg/m2 in 2 hours) and leucovorin (200 mg/m2 in 1 hour) on day 1, followed by a continuous infusion of 5FU (2,600 mg/m2 in 48 hours), every 2 weeks. The objectives of the study were primarily to assess response rate and secondarily to evaluate the safety profile. Results: Fourteen patients were treated. Median age: 56 years (49–70). Performance status: 0 (n=4) and 1 (n=10). Median number of previous chemotherapy regimens: 5 (3–10) and previous platinum-based regimens: 2 (1–3). Median chemotherapy-free interval: 9.5 weeks (1–39). Median administered cycles of Folfox/patient: 8 (2–11 cycles). Responses according to RECIST criteria: 2 CR (14.5%), 2 PR (14.5%), 4 SD (29%) and 6 PD (43%). Responses according to CA125 Rustin's criteria: 4 CR (29%), 2 PR (14.5%), 5 SD (35.5%) and 3 PD (21%). Grade 1/2 and 3 peripheral neuropathy: 10 (71%) and 2 (14.5%), respectively. There were no grade 4 adverse events or deaths due to the treatment. Conclusions: Folfox is a valuable option for heavily pre-treated patients with ovarian cancer, with an overall response rate of 29% (95% CI 15.2% to 41.8%), disease stabilization in an additional 29%, and a manageable toxicity profile. These results support the use of Folfox as salvage treatment for patients with ovarian carcinoma. No significant financial relationships to disclose.