Results from a randomized, multicenter, phase III clinical trial indicate that Eloxatin (oxaliplatin)-based chemotherapy improves responses and time to treatment failure compared to Platinol® (cisplatin)-based chemotherapy in the treatment of stages III-IV gastric cancer. These results were reported as a late-breaking abstract at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO).

The majority of gastric cancers are diagnosed at a late stage, with combination chemotherapy remaining a cornerstone of therapy. The combination of Platinol and 5-fluorouracil (5-FU) is a standard treatment for gastric cancer, however, long-term efficacy of this regimen is disappointing and tends to be associated with significant toxicity.

A multi-center phase III trial was recently conducted to compare Eloxatin in addition to 5-FU to Platinol/5-FU in the treatment of locally advanced or metastatic gastric or esophogastric junction adenocarcinoma. Patients were randomized to the FLO arm (n=112) consisting of Eloxatin (85 mg/m2 IV days 1, 15, 29), 5-FU (2600 mg/m2 24-hour infusion every 2 weeks), leucovorin (200 mg/m2 every 2 weeks) on a 57 day cycle, or the FLP arm (n=108) consisting of Platinol (50 mg/m2 days 1, 15, 29), 5-FU (2000 mg/m2 24-hour infusion every week), leucovorin (200 mg/m2 every week) on a 50-day cycle. Approximately 80% of patients had gastric carcinoma and approximately 70% of patients had a new diagnosis in both arms. Patients were assessed every 6 weeks.

Results were as follows:

• Overall response rates were 38% in the FLO arm, and 27% in the FLP arm.
• Disease progression occurred in 15% of patients in the FLO arm, compared with 30% of patients in the FLP arm.
• Median time to treatment failure was 5.3 months in the FLO arm, compared with 3.1 months in the FLP arm (p=0.0.29).
• Median time to progression was 5.7 months in the FLO arm, compared with 3.8 months in the FLP arm (p=0.081).
• There was significantly less toxicity associated with FLO compared to FLP with the exception of neurotoxicity.

The researchers concluded that Eloxatin/5-FU/leucovorin has significantly improved efficacy and fewer toxicities than Platinol/5-FU/leucovorin in the treatment of advanced gastric cancer. Longer follow-up will help reveal longer-term outcomes of these treatment regimens.

Reference: Al-Batran SE, Hartmann JT, Probst S. A randomized phase III trial in patients with advanced adenocarcinoma of the stomach receiving first-line chemotherapy with fluorouracil, leucovorine and oxaliplatin (FLO) versus fluorouracil, leucovorine and cisplatin (FLP). Proceedings of the 42nd annual meeting of the American Society of Clinical Oncology. Atlanta, Ga. June 2006; Abstract # LBA4016.

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