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Annals of Oncology Advance Access originally published online on January 21, 2008
Annals of Oncology 2008 19(5):871-876; doi:10.1093/annonc/mdm569
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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 email: journals.permissions@oxfordjournals.org

breast cancer

A phase I/II study of bortezomib and capecitabine in patients with metastatic breast cancer previously treated with taxanes and/or anthracyclines

P. Schmid1,*, D. Kühnhardt2, P. Kiewe3, S. Lehenbauer-Dehm2, W. Schippinger4, R. Greil5, W. Lange6, J. Preiss7, N. Niederle8, P. Brossart9, W. Freier10, S. Kümmel11, H. Van de Velde12, A. Regierer2 and K. Possinger2

1 Medical Oncology, Imperial College London, Charing Cross Hospital, London, UK
2 Department of Oncology and Haematology, Charite Campus Mitte, Berlin
3 Department of Haematology, Oncology and Transfusion Medicine, Charite Campus Benjamin Franklin, Berlin, Germany
4 Department of Oncology and Haematology, Universitaetsklinikum, Graz
5 3rd Medical Department of Oncology and Haematology, Private Medical University Hospital Salzburg, Salzburg, Austria
6 Department of Oncology and Haematology, Johanniter-Krankenhaus Rheinhausen, Duisburg
7 Department of Oncology and Haematology, Caritasklinik St Theresia, Saarbrücken
8 Department of Oncology and Haematology, Klinikum Leverkusen, Leverkusen
9 Department of Oncology and Haematology, Universitätsklinikum, Tübingen
10 Practice for Oncology and Haematology, Hildesheim
11 Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg, Germany
12 Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium

* Correspondence to: Dr P. Schmid, Charing Cross and Hammersmith Hospital, Imperial College London, Fulham Palace Road, London W6 8RF, UK. Tel: +44-20-8846-1418; Fax: +44-20-8846-1433; E-mail: p.schmid{at}imperial.ac.uk

Background: Proteasome inhibitors are a novel class of compounds entering clinical trials as a method to increase tumour sensitivity to standard chemotherapy. This phase I/II trial was carried out to evaluate the combination of capecitabine and the proteasome inhibitor bortezomib in anthracycline and/or taxane-pretreated patients with metastatic breast cancer.

Patients and methods: A total of 35 patients were treated with bortezomib (1.0–1.3 mg/m2 on days 1, 4, 8 and 11) and capecitabine (1500–2500 mg/m2 on days 1–14) in 3-week intervals for up to eight cycles.

Results: The maximum tolerated doses (MTDs) were bortezomib 1.3 mg/m2 and capecitabine 2500 mg/m2. The treatment was generally well tolerated and associated with toxic effects that were consistent with the known side-effects of the individual agents. The intent-to-treat overall response rate was 15% and an additional 27% of patients had stable disease (SD). In the 20 patients treated at the MTD, the response rate was 15% and 40% had SD. Median time to progression and overall survival were 3.5 months [95% confidence interval (CI) 1.9–4.4] and 7.5 months (95% CI 5.6–14.6), respectively. Median duration of response was 4.4 months.

Conclusion: The combination of bortezomib and capecitabine is well tolerated and has moderate antitumour activity in heavily pretreated patients.

Key words: bortezomib, capecitabine, chemotherapy, metastatic breast cancer, phase I study, proteasome inhibition

Received for publication November 20, 2007. Accepted for publication November 26, 2007.


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