Background: To assess the frequency and severity of gastrointestinal adverse effects in advanced colorectalcarcinoma patients treated with four different schedules of FOLFOX. Materials and
Methods: Patients(median age 61 years) who underwent surgery were included in the study. All had measureable disease at CTscan, ultrasonography or clinical examination. Toxicity was graded on a scale of 1-5 according to the generalgrade definition of CTC v2.0. The severity of adverse effects (Grade 3 and 4) assessed in each treatment armwas compared.
Results: Differences between the incidence rates of 3 and 4 toxicity and all grades of toxicityfor all parameters in GI toxicity were very highly significant (p<0.001). Severe gastrointestinal symptoms oftoxicity were noted with FOLFOX7 (oxaliplatin 130 mg/m2). Grade 3 diarrhea was reported in 25% patientsand grade 4 diarrhea in 4% in the FOLFOX7 treatment arm. Grade 2 vomiting was very frequently reported inthe FOLFOX4 treatment arm (oxaliplatin 85mg/m2). Grade 2 stomatitis was reported in 42% patients treatedwith mFOLFOX6 (oxaliplatin 100mg/m2). Differences in the incidence rate of nausea, diarrhea and stomatitisamong all treatment arms of FOLFOX were significant (p<0.05) .
Conclusions: Severe diarrhea is associatedwith FOLFOX7 treatment. No grade 3 or 4 GI toxicity was reported in patients of the mFOLFOX6 arm.