Annals of Oncology 14:1735-1743, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial
1 Vienna University Medical School, Vienna, Austria; 2 Box Hill Hospital, Melbourne; 3 Port Macquarie Hospital, Port Macquarie, Australia; 4 Institute of Medical Oncology, Berne, Switzerland; 5 St Vincent’s Hospital, Melbourne, Australia; 6 Sarah Cannon Cancer Center, Nashville, TN, USA; 7 University of Aberdeen, Aberdeen; 8 University of Edinburgh, Western General Hospital, Edinburgh, UK; 9 Rydygier Memorial Hospital, Krakow, Poland; 10 The Christie Hospital and Holt Radium Institute, Manchester, UK; 11 Outpatient Cancer Centre, Freiburg, Germany; 12 Ottawa Regional Cancer Centre, Ottawa, Canada; 13 Hospital Gregorio Marañón, Madrid, Spain; 14 Regional Center of Oncology, Bydgoszcz, Poland; 15 The Mount Hospital, Perth, and Sir Charles Gairdner Hospital, Nedlands, Australia; 16 Tom Baker Cancer Centre, Calgary, Canada; 17 Great Poland Cancer Center, Poznan, Poland; 18 Beatson Oncology Centre, Glasgow; 19 University of Leeds, Leeds, UK
Received 23 September 2003; accepted 26 September 2003
Background:
Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil–leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV (Mayo Clinic regimen) in Dukes’ C colon cancer.
Patients and methods:
Patients aged 18–75 years with resected Dukes’ C colon carcinoma were randomized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m2 twice daily, days 1–14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m2 with i.v. leucovorin 20 mg/m2 on days 1–5, repeated every 28 days (n = 974).
Results:
Patients receiving capecitabine experienced significantly (P <0.001) less diarrhea, stomatitis, nausea/vomiting, alopecia and neutropenia, but more hand–foot syndrome than those receiving 5-FU/LV. Fewer patients receiving capecitabine experienced grade 3 or 4 neutropenia, febrile neutropenia/sepsis and stomatitis (P <0.001), although more experienced grade 3 hand–foot syndrome than those treated with 5-FU/LV (P <0.001). Capecitabine demonstrates a similar, favorable safety profile in patients aged <65 years or 
65 years old.
Conclusions:
Based on its improved safety profile, capecitabine has the potential to replace 5-FU/LV as standard adjuvant treatment for patients with colon cancer. Efficacy results are expected to be available in 2004.
Keywords: Adjuvant treatment, capecitabine, chemotherapy, colorectal cancer
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