Toxicity profile of adjuvant treatment according to Mayo protocol in colorectal cancer patients

Introduction: We analyzed the tolerability of Mayo protocol in a prospective study.

Patients and study design: 103 stage II/III CRC patients who previously had undergone colon resection with curative intent were treated according to Mayo protocol at our department between May 2003 and September 2004. The average age was 62 ys (37–81), 49 men and 54 women were treated. On days 1.-5. of each cycle 20mg/m2 Leucovorin, 425mg/m2 5-FU bolus infusion was administered in 28 days cycle. 6 cycles were to administer starting the treatment. Results: Regarding gastrointestinal side effects in 37 patients stomatitis, in 47 patients diarrhoea, in 58 patients nausea/vomitus, in 22 patients flatulance/abdominal dyscomfort, in 20 patients constipation were assessed. Concerning hematological adverse events in 14 patients grade 2–4 neutropenia (5 neutropenia with fever, one life-threatening) occurred, in 10 patients transfusion was needed to administer due to anemia. Five patients developed hand-and-foot syndrome. In 10 patients dyspnea, in 12 patients angina-like chest pain occurred relating to the treatment. In 2 patients deep-vein thrombosis was diagnosed, in one case associated with pulmonal embolisation. Despite supporting treatment with G-CSF and antibiotics one patient developed sepsis and died. Due to severe side effects in 2 cases we had to interrupt the treatment permanently, in 8 patients dose reduction was performed. Conclusions: Analyzing our results the administration of 5-fluorouracil/leucovorin according to Mayo protocol is characterized by an inconvenient toxicity profile. In the light of the state of the art and our results as well, the 5-fluorouracil/leucovorin combination should be administered according to the more convenient de Gramont protocol.