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

Schmid, P, Kühnhardt, D, Kiewe, P, Lehenbauer-Dehm, S, Schippinger, W, Greil, R, Lange, W, Preiss, J, Niederle, N, Brossart, P, Freier, W, Kümmel, S, Van de Velde, H, Regierer, A and Possinger, K (2008) A phase I/II study of bortezomib and capecitabine in patients with metastatic breast cancer previously treated with taxanes and/or anthracyclines. Annals of Oncology, 19 (5). pp. 871-876. ISSN 1569-8041

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Abstract

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/m(2) on days 1, 4, 8 and 11) and capecitabine (1500-2500 mg/m(2) on days 1-14) in 3-week intervals for up to eight cycles.

RESULTS

The maximum tolerated doses (MTDs) were bortezomib 1.3 mg/m(2) and capecitabine 2500 mg/m(2). 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.

Item Type: Article
Schools and Departments: Brighton and Sussex Medical School > Clinical Medicine
Subjects: R Medicine
R Medicine > RC Internal medicine
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
Depositing User: Tracey O'Gorman
Date Deposited: 14 Nov 2012 09:55
Last Modified: 14 May 2015 09:34
URI: http://sro.sussex.ac.uk/id/eprint/41977
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