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Medline ® Abstract for Reference 46

of 'Systemic chemotherapy for metastatic colorectal cancer: Completed clinical trials'

Activity and toxicity of oxaliplatin plus raltitrexed in 5-fluorouracil refractory metastatic colorectal adeno-carcinoma.
Laudani A, Gebbia V, Leonardi V, Savio G, Borsellino N, Cusimano MP, Calabria C, Stefano R, Agostara B
Anticancer Res. 2004;24(2C):1139.
BACKGROUND: This study evaluated the antitumor efficacy and safety of a novel oxaliplatin/raltitrexed combination in pretreated advanced colorectal cancer patients.
PATIENTS AND METHODS: Forty-five patients with 5-fluorouracil-refractory metastatic colorectal cancer received raltitrexed 3.0 mg/m2 as a 15-minute intravenous (i.v.) infusion, followed 45 min later by l-OHP 130 mg/m2 i.v. as 2-h venous infusion on 1 day every 3 weeks. All patients had histologically proven metastatic colorectal cancer, age 18-75, measurable disease and normal baseline biological values. Most patients (60%) had>2 disease sites. All patients were assessed for safety and also for response according to an intent-to-treat fashion.
RESULTS: The overall response rate was 29% (95% CL 16%-44%) including one CR (2%) and 12 PR (27%). Six patients (16%) showed a stabilization of disease for a tumor growth control rate of 45%. The median time to progression was 4 months (range 1-12+) and median overall survival was 9 months (range 1-29+).
CONCLUSION: These data confirm that this oxaliplatin/raltitrexed combination is effective against metastatic colorectal carcinoma, well tolerated with low grade toxicity and easy to administer. Further evaluation of this regimen seems warranted as an alternative to fluoropyrimidine-based combinations.
Division of Medical Oncology, Oncological Hospital M. Ascoli, Palermo, Italy.