Phase II study of 5-fluorouracil/leucovorin in combination with paclitaxel and oxaliplatin (POF) in patients with primary refractory or relapsed advanced oesophageal and gastric carcinoma.

Abstract

4157 Background: Primary results of POF as 1st-line treatment for AGC have been presented at ASCO 2008. The purpose of this study was to assess the efficacy and toxicity of POF in primary refractory or relapsed locally advanced or metastatic oesophageal and gastric carcinoma. Methods: From February 2006 to May 2009, 34 eligible patients were enrolled in this study. All had received one line of chemotherapy, and 4 had received at least two lines of chemotherapy. The median treatment-free interval was 40.0 days, and twenty-five patients (73.5%) had suffered cancer progression within 90 days after the withdrawal of previous chemotherapy. Twenty-eight patients (82.4%) had previously received a fluoropyrimidine agent. Twenty-six patients (76.5%) had previously received a platinum agent. Thirteen patients (38.2%) had previously received a taxane agent. Seven patients (20.6%) had previously received an irinotecan agent. The POF regimen was comprised of a 3-hour infusion of 135 mg/m2 of paclitaxel followed by oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2, administered simultaneously as a 2-hour infusion, then continued a 46-hour infusion of FU 2.4 g/m2 using an ambulatory pump. Results: A total of 183 cycles of POF were administered with a median of 4 (range 1- 15) cycles. The median patient age was 53 years (range, 37 to 74 years), 25 were males and 9 were females. Twenty-four patients had measurable lesions. Four CRs, nine PRs and nine SDs were observed. At a median follow-up of 623 days, the median survival was 236 days. Frequent grade 3 to 4 toxicities were: neutropenia (38.2%), anaemia (23.5%), thrombocytopenia (17.6%), hepatic dysfunction (8.8%), stomatitis (5.9%), peripheral neuropathy (2.9%), lethargy (2.9%). No treatment-related death occurred. Conclusions: POF regimen is active as second-line chemotherapy in chemotherapy-resistant advanced or metastatic oesophageal and gastric carcinoma. The toxicity profile is moderate. No significant financial relationships to disclose.