PURPOSE: Capecitabine has shown similar efficacy to 5-fluorouracil (5-FU); a regimen containing 2 weeks of capecitabine/oxaliplatin (CapOx) has demonstrated noninferiority to infusional 5-FU/oxaliplatin/leucovorin (FOLFOX) for the treatment of metastatic colorectal cancer (mCRC). This phase II study explores the efficacy and safety of a 2-day course of oxaliplatin/capecitabine (2DOC), with oxaliplatin given on day 1 and capecitabine given orally every 8 hours in high doses over 6 doses, mimicking FOLFOX6. PATIENTS AND METHODS: This phase II study was conducted by the University of Wisconsin Carbone Cancer Center. Eligible patients with mCRC received oxaliplatin 100 mg/m2 intravenously (I.V.) over 2 hours followed by leucovorin 20 mg/m2 I.V. bolus and 5-FU 400 mg/m2 I.V. bolus on day 1 and day 15. Capecitabine was administered at 1500 mg/m2 orally every 8 hours over 6 doses starting on day 1 and day 15. RESULTS: A total of 45 patients were enrolled; 44 were evaluated for response. Seventeen patients (39%) had objective responses. Median time to progression was 6.8 months, and median overall survival (OS) was 17.5 months. The most common side effects were grade 1/2 neuropathy, fatigue, and nausea. Severe hand-foot syndrome (HFS) was rare. CONCLUSION: The overall response rate with the 2DOC regimen is similar to published CapOx regimens, and time to progression and OS are similar. The incidence of HFS, diarrhea, and mucositis were lower compared with published results of 2-week schedules of capecitabine. The 2DOC regimen merits further study as a more convenient regimen than infusional 5-FU with less HFS when compared with a 2-week administration of capecitabine.
PURPOSE:Capecitabine has shown similar efficacy to 5-fluorouracil (5-FU); a regimen containing 2 weeks of capecitabine/oxaliplatin (CapOx) has demonstrated noninferiority to infusional 5-FU/oxaliplatin/leucovorin (FOLFOX) for the treatment of metastatic colorectal cancer (mCRC). This phase II study explores the efficacy and safety of a 2-day course of oxaliplatin/capecitabine (2DOC), with oxaliplatin given on day 1 and capecitabine given orally every 8 hours in high doses over 6 doses, mimicking FOLFOX6. PATIENTS AND METHODS: This phase II study was conducted by the University of Wisconsin Carbone Cancer Center. Eligible patients with mCRC received oxaliplatin 100 mg/m2 intravenously (I.V.) over 2 hours followed by leucovorin 20 mg/m2 I.V. bolus and 5-FU 400 mg/m2 I.V. bolus on day 1 and day 15. Capecitabine was administered at 1500 mg/m2 orally every 8 hours over 6 doses starting on day 1 and day 15. RESULTS: A total of 45 patients were enrolled; 44 were evaluated for response. Seventeen patients (39%) had objective responses. Median time to progression was 6.8 months, and median overall survival (OS) was 17.5 months. The most common side effects were grade 1/2 neuropathy, fatigue, and nausea. Severe hand-foot syndrome (HFS) was rare. CONCLUSION: The overall response rate with the 2DOC regimen is similar to published CapOx regimens, and time to progression and OS are similar. The incidence of HFS, diarrhea, and mucositis were lower compared with published results of 2-week schedules of capecitabine. The 2DOC regimen merits further study as a more convenient regimen than infusional 5-FU with less HFS when compared with a 2-week administration of capecitabine.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: E Van Cutsem; C Twelves; J Cassidy; D Allman; E Bajetta; M Boyer; R Bugat; M Findlay; S Frings; M Jahn; J McKendrick; B Osterwalder; G Perez-Manga; R Rosso; P Rougier; W H Schmiegel; J F Seitz; P Thompson; J M Vieitez; C Weitzel; P Harper Journal: J Clin Oncol Date: 2001-11-01 Impact factor: 44.544
Authors: J Schüller; J Cassidy; E Dumont; B Roos; S Durston; L Banken; M Utoh; K Mori; E Weidekamm; B Reigner Journal: Cancer Chemother Pharmacol Date: 2000 Impact factor: 3.333
Authors: D Mulkerin; N K LoConte; K D Holen; J P Thomas; D Alberti; R Marnocha; J Kolesar; J Eickhoff; K Oliver; C Feierabend; G Wilding Journal: Invest New Drugs Date: 2009-01-08 Impact factor: 3.850
Authors: Jim Cassidy; Josep Tabernero; Chris Twelves; René Brunet; Charles Butts; Thierry Conroy; Filippo Debraud; Arie Figer; Johannes Grossmann; Noriaki Sawada; Patrick Schöffski; Alberto Sobrero; Eric Van Cutsem; Eduardo Díaz-Rubio Journal: J Clin Oncol Date: 2004-06-01 Impact factor: 44.544
Authors: T Aparicio; J Desramé; T Lecomte; E Mitry; J Belloc; I Etienney; S Montembault; L Vayre; C Locher; J Ezenfis; P Artru; M Mabro; S Dominguez Journal: Br J Cancer Date: 2003-10-20 Impact factor: 7.640