進行・再発大腸がんに対する FOLFOX 4 療法の安全性評価

The FOLFOX 4 regimen,a combination of oxaliplatin (L-OHP) plus fluorouracil (5-FU)/levofolinate calcium (l-LV) which is administered bimonthly,has become standard therapy for advanced and recurrent colorectal cancer.We evaluated the safety of this regimen in 22 patients with advanced and recurrent colorectal cancer.The average relative dose intensities of bolus 5-FU (400 mg/m2),infusional 5-FU (600 mg/m2),and L-OHP (85 mg/m2)were 91.5,90.0 and 90.0%,respectively.The most frequent adverse events were hematologic toxicity,gastrointestinal tract toxicity,and peripheral neuropathy.Neutropenia occurred in 17 patients (77.3%),in whom the incidence of grade 3/4 was 36.4% and thrombocytopenia of grade 1/2 occurred in 8 patients.Peripheral neuropathy occurred in 16 patients (72.7%) including one case of grade 3.Other non-hematologic adverse events included nausea (68.2%),vomiting (27.3%),fatigue (45.5%),stomatitis (22.7%),anorexia (54.5%),vision dysfunction (27.3%),dysgeusia (9.1%),alopecia (18.2%),phlebitis (27.3%),diarrhea (18.2%).Allergic reactions were observed in 3 patients and one of them experienced anaphylactic shock of grade 4 during the 7 th course.Our results suggest that adverse effects are relatively frequent events during systemic chemotherapy with the FOLFOX 4 regimen.Patients should therefore be carefully monitored for adverse events and rapid intervention with supportive care is important in ensuring that chemotherapy with this regimen is conducted safely.