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Open Access Research article

Weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF) as first-line chemotherapy for elderly patients with advanced gastric cancer: results of a phase II trial

D Santini1*, F Graziano2, V Catalano3, M Di Seri4, E Testa2, AM Baldelli3, P Giordani3, A La Cesa1, B Spalletta4, B Vincenzi1, A Russo5, M Caraglia6, V Virzi1, S Cascinu7 and G Tonini1

Author Affiliations

1 Medical Oncology, University Campus Bio-Medico, Rome, Italy

2 Medical Oncology, Civic Hospital, Urbino, Italy

3 Medical Oncology, Civic Hospital, Pesaro, Italy

4 Medical Oncology, University La Sapienza, Rome, Italy

5 Medical Oncology, University of Palermo, Italy

6 National Cancer Institute Fondazione "G. Pascale", Experimental Oncology, Department, Experimental Pharmacology Unit, Naples, Italy

7 Division of Medical Oncology, University of Ancona, Ancona, Italy

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BMC Cancer 2006, 6:125  doi:10.1186/1471-2407-6-125

Published: 10 May 2006

Abstract

Background

Elderly patients have been often excluded from or underrepresented in the study populations of combination chemotherapy trials. The primary end point of this study was to determine the response rate and the toxicity of the weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF) regimen in elderly patients with advanced gastric cancer. The secondary objective was to measure the time to disease progression and the survival time.

Methods

Chemotherapy-naive patients with advanced gastric cancer aged 70 or older were considered eligible for study entry. Patients received weekly oxaliplatin 40 mg/m2, fluorouracil 500 mg/m2 and folinic acid 250 mg/m2. All drugs were given intravenously on a day-1 schedule.

Results

A total of 42 elderly patients were enrolled. Median age was 73 years and all patients had metastatic disease. The response rate according to RECIST criteria was 45.2% (95% CIs: 30%–56%) with two complete responses, 17 partial responses, 13 stable diseases and 10 progressions, for an overall tumor rate control of 76.2% (32 patients). Toxicity was generally mild and only three patients discontinued treatment because of treatment related adverse events. The most common treatment-related grade 3/4 adverse events were fatigue (7.1%), diarrhoea (4.8%), mucositis (2.4%), neurotoxicity (2.4%) and neutropenia (4.8%). The median response duration was 5.3 months (95% CIs: 2.13 – 7.34), the median time to disease progression was 5.0 months (95% CIs: 3.75 – 6.25) and the median survival time was 9.0 months (95% CIs: 6.18 – 11.82).

Conclusion

OXALF represents an active and well-tolerated treatment modality for elderly patients with locally advanced and metastatic gastric cancer.