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Annals of Oncology Advance Access originally published online on February 14, 2008
Annals of Oncology 2008 19(6):1154-1159; doi:10.1093/annonc/mdn002
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org

gastrointestinal tumors

Chronomodulated capecitabine in combination with short-time oxaliplatin: a Nordic phase II study of second-line therapy in patients with metastatic colorectal cancer after failure to irinotecan and 5-flourouracil

C. Qvortrup1,2,*, M. Yilmaz3, D. Ogreid4, A. Berglund5, L. Balteskard6, J. Ploen7, T. Fokstuen8, H. Starkhammar9, H. Sørbye10, K. Tveit11 and P. Pfeiffer1

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

* Correspondence to: Dr C. Qvortrup, Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, Odense C 5000, Denmark. Tel: +45 65413147; Fax: +45 66135477; E-mail: camilla.qvortrup{at}ouh.regionsyddanmark.dk

Background: Oxaliplatin in combination with capecitabine prolongs survival in patients with metastatic colorectal cancer (mCRC). Chronomodulation might reduce toxicity and improve efficacy.

Patients and methods: A phase II study examining chronomodulated XELOX30 (XELOX30chron): oxaliplatin: 130 mg/m2 on day 1, as a 30-min infusion between 1 and 3 p.m. Capecitabine: total daily dose of 2000 mg/m2, 20% of the dose between 7 and 9 a.m. and 80% of the dose between 6 and 8 p.m. in patients with mCRC resistant to irinotecan. Seventy-one patients were enrolled. Response rate was 18%; median progression-free survival 5.1 months and median overall survival (OS) 10.2 months. Platelet count and performance status were significantly correlated to OS in multivariate analyses. Neurotoxicity grade 2 and 3 was seen in 25% and 2% of patients, respectively, other grade 3 toxic effects were as follows: nausea 6%, vomiting 3%, diarrhoea 12% (3% experienced grade 4) and palmoplantart erytem 9%.

Conclusion: XELOX30chron is a convenient second-line regimen with efficacy and safety profile similar to other oxaliplatin schedules. To further investigate chronomodulated XELOX, we have started a Nordic randomised phase II study comparing XELOX30 and XELOX30chron as first-line therapy in patients with mCRC.

Key words: capecitabine, chronotherapy, metastatic colorectal cancer, oxaliplatin, short-time infusion, XELOX

Received for publication October 24, 2007. Revision received December 28, 2007. Accepted for publication December 31, 2007.


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