Combined radiotherapy, 5-fluorouracil continuous infusion and weekly oxaliplatin in advanced rectal cancer: A phase I study

摘要: The aim of this study was to determine the maximum-tolerated dose (MTD) weekly oxaliplatin combined with 5-fluorouracil (5FU) continuous infusion administered concomitantly fractionated radiotherapy in patients presenting advanced rectal cancer. Forty-three cancer (stage T3/T4 (n = 24), metastatic 17) and 2 local recurrence), were included. delivered 45 Gy over 5 weeks (1.8 Gy/fraction/day, days per week). initial dosage 30 mg/m2 5FU 150 mg/m2/d. doses escalated. Eight levels tested. At level 8 (oxaliplatin 80 mg/m2, 225 mg/m2/d), out 4 presented dose-limiting toxicity (severe diarrhoea dehydration fatal shock, rectovesical fistula). 7, further grade 3 diarrhoea. main combination hematological neurological toxicities not severe dose-limiting. Out undergoing surgery, (13.3%) pathological complete response only microscopic residual disease. results from enabled determination recommended (60 mg/m2) (225 (45 Gy) pre-operative treatment good safety profile regimen, associated promising terms histological response, suggest that regimen could be developed future phase II/III studies.