122P - Efficacy and safety of mFOLFOX-6 in advanced gastric cancer: A prospective observational study

Background

The widespread use of oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX) in advanced gastric cancers is mainly based on clinical trials conducted at Western/European countries. The prospective data on efficacy and safety of FOLFOX in advanced gastric cancer is lacking from the developing countries. In this prospective observational study, we evaluated the efficacy and toxicity of mFOLFOX-6 in patients with advanced gastric or gastro-esophageal junction (GEJ) adenocarcinomas, as first-line palliative chemotherapy.

Methods

Patients with previously untreated metastatic adenocarcinoma of stomach/GEJ, received mFOLFOX-6(2 hours infusion of oxaliplatin (85 mg/m2) and folinic acid (400mg/m2), followed by fluorouracil 400 mg/m2 IV push, then a 46-hour continuous infusion of 5-FU (2,400 mg/m2). Cycles were repeated every 2 weeks. The patients were prospectively followed up for response rates and toxicity.

Results

Sixty six patients were included in the study with a median age of 57 years. Sixty two patients were evaluable for response. The overall response rate was 53%, with a disease control rate (overall response and stable disease) of 81.8%. The median progression-free survival was 6 months (95% CI 5.2-6.7 months) and the median overall survival was 11.5 months (95% CI 9.0-13.9 months). Ascites at presentation, and more than one site of metastasis are associated with significantly lower survival on the log-rank test. Gastrointestinal and hematological toxicities were predominant, with rates of Grade3-4 Nausea/Vomiting (13.6%), anemia (15.1%) and neutropenia (13.6%). Amongst other toxicities, neuro-sensory toxicities were common. Four (6%) patients had grade 3 peripheral neuropathy. In one patient chemotherapy had to be discontinued before response evaluation due to grade 3 cardiotoxicity.

Conclusions

mFOLFOX-6 is an active and well-tolerated chemotherapy regimen in advanced adenocarcinoma of stomach/GEJ. This regimen has similar response rates and treatment outcomes with lesser grade 3 or 4 toxicities than that of triplet regimens compared to historical studies.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.