Annals of Oncology Advance Access originally published online on June 10, 2008
Annals of Oncology 2008 19(10):1720-1726; doi:10.1093/annonc/mdn370
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gastrointestinal tumors |
Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer: a randomized phase III noninferiority study
1 Division of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, USA
2 Department of GI Oncology Texas Oncology, PA & US Oncology Research, Dallas, TX, USA
3 Department of Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada
4 Department of Oncology, Hospital Duran I Reynals, Barcelona, Spain
5 Department of Oncology, Seoul National University Hospital, Seoul, Republic of Korea
6 Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada
7 Department of Medicine, North Wales Cancer Treatment Centre, Glan Clwyd Hospital, Rhyl, UK
8 Department of Medical Oncology, Princess Margaret Hospital, Toronto, Ontario, Canada
9 Department of Biostatistics, F. Hoffmann-La Roche, Basel, Switzerland
10 Department of Medicine, The Royal Marsden Hospital, Sutton, UK
* Correspondence to: Dr M. L. Rothenberg, Vanderbilt-Ingram Cancer Center, 777 Preston Research Building, Nashville, TN 37232-6307, USA. Tel: + 1-615-936-1796; Fax: + 1-615-343-7602; E-mail: mace.rothenberg{at}vanderbilt.edu
Background: To demonstrate the noninferiority of capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid and oxaliplatin (FOLFOX-4) as second-line therapy in patients with metastatic colorectal cancer after prior irinotecan-based chemotherapy.
Patients and methods: A total of 627 patients were randomly assigned to receive XELOX (n = 313) or FOLFOX-4 (n = 314) following disease progression/recurrence or intolerance to irinotecan-based chemotherapy. The primary end point was progression-free survival (PFS).
Results: PFS for XELOX was noninferior to FOLFOX-4 [hazard ratio (HR) = 0.97; 95% confidence interval (CI) 0.83–1.14] in the intention-to-treat (ITT) population. Median PFS was 4.7 months with XELOX versus 4.8 months with FOLFOX-4. The robustness of the primary analysis was supported by multivariate and subgroup analyses. Median overall survival in the ITT population was 11.9 months with XELOX versus 12.5 months with FOLFOX-4 (HR = 1.02; 95% CI 0.86–1.21). Treatment-related grade 3/4 adverse events occurred in 50% of XELOX- and 65% of FOLFOX-4-treated patients. Whereas grade 3/4 neutropenia (35% versus 5% with XELOX) and febrile neutropenia (4% versus < 1%) were more common with FOLFOX-4, grade 3/4 diarrhea (19% versus 5% with FOLFOX-4) and grade 3 hand–foot syndrome (4% versus < 1%) were more common with XELOX.
Conclusion: XELOX is noninferior to FOLFOX-4 when administered as second-line treatment in patients with metastatic colorectal cancer.
Key words: capecitabine, 5-fluorouracil/folinic acid, FOLFOX-4, metastatic colorectal cancer, oxaliplatin, XELOX
Received for publication March 27, 2008. Accepted for publication April 28, 2008.
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