TY - JOUR
T1 - Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer
T2 - A planned safety analysis in 1,864 patients
AU - Schmoll, Hans Joachim
AU - Cartwright, Thomas
AU - Tabernero, Josep
AU - Nowacki, Marek P.
AU - Figer, Arie
AU - Maroun, Jean
AU - Price, Timothy
AU - Lim, Robert
AU - Van Cutsem, Eric
AU - Park, Young Suk
AU - McKendrick, Joseph
AU - Topham, Claire
AU - Soler-Gonzalez, Gemma
AU - De Braud, Filipo
AU - Hill, Mark
AU - Sirzén, Florin
AU - Haller, Daniel G.
PY - 2007/1/1
Y1 - 2007/1/1
N2 - Purpose: To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer. Patients and Methods: Patients with stage III colon carcinoma were randomly assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) regimen for a similar length of time. A total of 1,886 patients were randomly assigned. Results: The safety population comprised 1,864 patients, of whom 938 received XELOX and 926 received FU/LV. Most treatment-related adverse events (AEs) occurred at similar rates in both treatment arms. However, patients receiving XELOX experienced less all-grade diarrhea, alopecia, and more neurosensory toxicity, vomiting, and hand-foot syndrome than those patients receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. Treatment-related mortality within 28 days from the last study dose was 0.6% in the XELOX group and 0.6% in the FU/LV group. Conclusion: XELOX has a manageable tolerability profile in the adjuvant setting. Efficacy data will be available within the next 24 months.
AB - Purpose: To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer. Patients and Methods: Patients with stage III colon carcinoma were randomly assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) regimen for a similar length of time. A total of 1,886 patients were randomly assigned. Results: The safety population comprised 1,864 patients, of whom 938 received XELOX and 926 received FU/LV. Most treatment-related adverse events (AEs) occurred at similar rates in both treatment arms. However, patients receiving XELOX experienced less all-grade diarrhea, alopecia, and more neurosensory toxicity, vomiting, and hand-foot syndrome than those patients receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. Treatment-related mortality within 28 days from the last study dose was 0.6% in the XELOX group and 0.6% in the FU/LV group. Conclusion: XELOX has a manageable tolerability profile in the adjuvant setting. Efficacy data will be available within the next 24 months.
UR - https://www.scopus.com/pages/publications/33847722573
U2 - 10.1200/JCO.2006.08.1075
DO - 10.1200/JCO.2006.08.1075
M3 - Article
C2 - 17194911
AN - SCOPUS:33847722573
SN - 0732-183X
VL - 25
SP - 102
EP - 109
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 1
ER -
