Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients.

Abstract

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.

• Authors: Hans-Joachim Schmoll, Thomas Cartwright, Josep Tabernero, Marek P Nowacki, Arie Figer, Jean Maroun, Timothy Price, Robert Lim, Eric Van Cutsem, Young-Suk Park, Joseph McKendrick, Claire Topham, Gemma Soler-Gonzalez, Filipo de Braud, Mark Hill, Florin Sirzén, Daniel G Haller
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 25 Issue 1 Pg. 102-9 (Jan 01 2007) ISSN: 1527-7755 [Electronic] United States
• PMID: 17194911 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Deoxycytidine
• Capecitabine
• Leucovorin
• Fluorouracil

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Capecitabine
• Chemotherapy, Adjuvant (methods)
• Colonic Neoplasms (drug therapy, mortality)
• Deoxycytidine (administration & dosage, analogs & derivatives, therapeutic use)
• Disease-Free Survival
• Fluorouracil (administration & dosage, analogs & derivatives, therapeutic use)
• Humans
• Leucovorin (administration & dosage)
• Middle Aged
• Organoplatinum Compounds (administration & dosage, therapeutic use)
• Oxaliplatin
• Research Design
• Safety
• Treatment Outcome