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Annals of Oncology Advance Access originally published online on November 15, 2005
Annals of Oncology 2006 17(2):252-258; doi:10.1093/annonc/mdj060
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© 2005 European Society for Medical Oncology

Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil

P. Pfeiffer1,*, H. Sørbye2, H. Ehrsson3, T. Fokstuen4, J. P. Mortensen5, L. Baltesgard6, K. M. Tveit7, D. Øgreid8, H. Starkhammar9, I. Wallin3, C. Qvortrup1 and B. Glimelius4,10

1 Department of Oncology, Odense University Hospital, Odense, Denmark; 2 Department of Oncology, Haukeland University Hospital, Bergen, Norway; 3 Karolinska Pharmacy, Karolinska Hospital and Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden; 4 Department of Oncology and Pathology, Karolinska Hospital, Stockholm, Sweden; 5 Department of Oncology, Vejle Hospital, Vejle, Denmark; 6 Department of Oncology, Tromso University Hospital, Tromso, Norway; 7 Department of Oncology, Ullevaal University Hospital, Oslo, Norway; 8 Department of Oncology, Rogaland Central Hospital, Stavanger, Norway; 9 Department of Oncology, Linkoping University Hospital, Linkoping, Sweden; 10 Department of Oncology, Radiology and Clinical Immunology, University Hospital, Uppsala, Sweden

* Correspondence to: Dr P. Pfeiffer, Department of Oncology, Odense University Hospital, Sdr Boulevard 29, DK – 5000 Odense C, Denmark. Tel: +45-65-41-15-90; Fax: +45-65-41-29-57; E-mail: per.pfeiffer{at}ouh.fyns-amt.dk

Background: The efficacy of oxaliplatin combined with capecitabine (XELOX) as second-line therapy in patients with advanced colorectal cancer (ACRC) resistant to irinotecan is not well established. Oxaliplatin induces acute, cold-induced neuropathy in most patients. The incidence is claimed to be infusion rate-dependent and therefore a 2-h infusion is recommended.

Patients and methods: For practical and economic reasons, but also for patient's convenience, we performed a phase II study to examine XELOX30 (capecitabine 1000 mg/m2 orally twice daily on days 1–14 and oxaliplatin 130 mg/m2 as a 30 min infusion on day 1) in patients with ACRC resistant to irinotecan. In addition the pharmacokinetics of oxaliplatin was studied.

Results: From November 2002 to September 2003, 70 patients with ACRC were treated with XELOX30. Median age was 62 (range 33–74 years) years and median performance status was 1 (range 0–2). The median number of courses was four (range 1–12) and median cumulative dose of oxaliplatin was 530 (range 125–1560 ) mg/m2. The response rate was 17% (95% CI 10–23), median time to progression (TTP) was 5.4 months (95% CI 4.6–6.4) and median survival 9.5 months (95% CI 8.5–11.2). White blood cell count (WBC) and performance status were significantly correlated to TTP. Neurotoxicity was moderate: grade 1 56%, grade 2 17% and grade 3 6%. Other grade 3 toxicities were nausea/vomiting 9%, diarrhoea 14% and PPE 8%. The maximum blood concentration and total body clearance of oxaliplatin was higher than previously reported in studies examining 2-h infusions, but the volume of distribution and terminal half-life was in close agreement with previous results.

Conclusion: XELOX30 is a very convenient second-line regimen in ACRC with an activity and safety profile similar to other oxaliplatin schedules.

Key words: colorectal cancer, short-time infusion, pharmacokinetics, oxaliplatin, capecitabine


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