Klin Onkol 2003; 16(6): 265-271.
Summary: The primary endpoint of the study was to evaluate the efficacy of the combined chemotherapy raltitrexed + oxaliplatin as second-line treatment in patient with metastatic colorectal cancer. The secondary end points were overall survival, time to progression and evaluation of the toxicity. The target population included patients with metastatic colorectal adenocarcinoma, who progressed after first line chemotherapy regimen with 5-fluorouracil/leucovorin ± irinotecan. Totaly
58 patients were included, WHO PS 0 – 2. Treatment consisted of raltitrexed 3mg/m2 i.v. infusion 15 min. and oxaliplatin 130 mg/m2 i.v. infusion 2 hours, both given on day 1 every three weeks until progression of disease, unacceptable toxicities or decision of the patient. The overall objective response rate was 26 % for 54 evaluable patients, stable disease occured in 65 % of the treated patients. The median time to progression was 5,9 months, after median follow-up 8 months 32 patients are still alive. The treatment was well-tolerated, grade 3 or 4 toxicity (NCI-CTC criteria ) appeared in 8 patient only. The most common toxicity recorded were sensory neuropathy, nausea, vomiting and hematological toxicity grade 1, 2. The combination of oxaliplatin and raltitrexed appears to be effective and well tolerated as second line therapy in patients with disseminated colorectal cancer.
