Dr Bennouna and colleagues from France evaluated the efficacy and tolerability of a new combination of uracil/ftorafur/leucovorin and oxaliplatin for colorectal cancer.
The investigative team evaluated 64 patients with metastatic colorectal cancer who had not received prior chemotherapy for metastatic disease.
The team performed a phase 2 trial in 2002.
The patients received uracil/ftorafur 300 mg m2 per day.
Leucovorin was given as 90 mg per day from day 1 to day 14 combined with oxaliplatin 130 mg m2 on day 1, every 3 weeks.
All patients were evaluable for safety analysis and 58 of 64 patients were eligible for efficacy.
| Grade 3 diarrhea occurred in only 11% of the patients|
|British Journal of Cancer|
The investigators were reviewed by an independent review committee.
Of the 58 per-protocol defined assessable patients, 1 complete response and 20 partial responses were observed yielding a response rate of 34%.
The median response duration was 9 months.
The median time to progression and the median survival were 6 months, and 18 months, respectively.
The investigative team found that diarrhea and peripheral neuropathy were the most frequent and predictable toxicities.
The team noted that these events were reversible, noncumulative and manageable.
Grade 3 diarrhea occurred in only 11% of the patients.
The investigators observed no grade 4 gastrointestinal toxicity.
The incidence of grade 3 or 4 peripheral neuropathy, according to the National Cancer Institute Common Toxicity Criteria, was 15%.
Hematological toxicity was of mild to moderate intensity with 10% of the patients with Grade 3 or 4 neutropenia without any episode of complication.
Dr Bennounal's team concluded, “The TEGAFOX regimen, a new combination using uracil/ftorafur/leucovorin and oxaliplatin every 3 weeks is feasible on an outpatient basis.”
“The combination is safe and active and may offer a promising alternative to the intravenous route.”
“Nevertheless this efficacy results should be confirmed by randomized phase 3 trials.”