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Annals of Oncology Advance Access published online on November 15, 2005
Annals of Oncology, doi:10.1093/annonc/mdj060
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© 2005 European Society for Medical Oncology
Received November 23, 2004
Revised September 21, 2005
Accepted September 29, 2005

original article

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. Pfeiffer 1 *, H. Sørbye 2, H. Ehrsson 3, T. Fokstuen 4, J. P. Mortensen 5, L. Baltesgard 6, K. M. Tveit 7, D. Øgreid 8, H. Starkhammar 9, I. Wallin 3, C. Qvortrup 1, and B. Glimelius 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 and Pathology, Karolinska Hospital, Stockholm, Sweden; Department of Oncology, Radiology and Clinical Immunology, University Hospital, Uppsala, Sweden

* To whom correspondence should be addressed.
P. Pfeiffer, E-mail: per.pfeiffer{at}ouh.fyns-amt.dk


  Abstract

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.

Keywords: colorectal cancer; short-time infusion; pharmacokinetics; oxaliplatin; capecitabine.
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