ADVERSE REACTIONS
Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following the administration of both oral and parenteral leucovorin. No other adverse reactions have been attributed to the use of leucovorin per se.
The following table summarizes significant adverse events occurring in 316 patients treated with the leucovorin/5-fluorouracil combinations compared against 70 patients treated with 5-fluorouracil alone for advanced colorectal carcinoma. These data are taken from the Mayo/NCCTG large multicenter prospective trial evaluating the efficacy and safety of the combination regimen.
PERCENTAGE OF PATIENTS TREATED WITH LEUCOVORIN/FLUOROURACIL FOR ADVANCED COLORECTAL CARCINOMA REPORTING ADVERSE EXPERIENCES OR HOSPITALIZED FOR TOXICITY | (High LVHigh LV = Leucovorin 200 mg/m2) /5-FU | (Low LVLow LV = Leucovorin 20 mg/m2) /5-FU | 5-FU Alone |
| (N=155) | (N=161) | (N=70) |
| AnyAny = percentage of patients reporting toxicity of any severity | Grade 3+ Grade 3+ = percentage of patients reporting toxicity of Grade 3 or higher | Any | Grade 3+ | Any | Grade 3+ |
| (%) | (%) | (%) | (%) | (%) | (%) |
| Leukopenia | 69 | 14 | 83 | 23 | 93 | 48 |
| Thrombocytopenia | 8 | 2 | 8 | 1 | 18 | 3 |
| Infection | 8 | 1 | 3 | 1 | 7 | 2 |
| Nausea | 74 | 10 | 80 | 9 | 60 | 6 |
| Vomiting | 46 | 8 | 44 | 9 | 40 | 7 |
| Diarrhea | 66 | 18 | 67 | 14 | 43 | 11 |
| Stomatitis | 75 | 27 | 84 | 29 | 59 | 16 |
| Constipation | 3 | 0 | 4 | 0 | 1 | - |
| Lethargy/Malaise/Fatigue | 13 | 3 | 12 | 2 | 6 | 3 |
| Alopecia | 42 | 5 | 43 | 6 | 37 | 7 |
| Dermatitis | 21 | 2 | 25 | 1 | 13 | - |
| Anorexia | 14 | 1 | 22 | 4 | 14 | - |
| Hospitalization for Toxicity | 5% | 15% | 7% |
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