Journal
BRITISH JOURNAL OF CANCER
Volume 103, Issue 5, Pages 607-612Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.bjc.6605812
Keywords
metastatic breast cancer; phase I trials; drug resistance
Categories
Funding
- National Institute for Health Research
- Institute of Cancer Research
- Cancer Research UK
- Experimental Cancer Medicine Centre
- National Institute for Health Research Biomedical Research Centre
- Drug Development Unit of the Royal Marsden NHS Foundation Trust
- MRC [G0701935] Funding Source: UKRI
- Medical Research Council [G0701935] Funding Source: researchfish
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BACKGROUND AND METHODS: Novel approaches to treat chemo-refractory metastatic breast cancer (MBC) are currently under investigation. This retrospective series reviews the outcome of 70 MBC patients who have participated in 30 phase I trials at the Royal Marsden Hospital from 2002 to 2009. RESULTS: The median treatment lines before phase I trial entry for MBC was 5 (range: 1-12 lines). The overall response rate was 11.4% (95% CI: 4.0-18.9%) and the clinical benefit rate at 4 months was 20% (95% CI: 10.6-29.3). The median time to progression was 7.0 weeks (95% CI: 6.4-7.5) and median overall survival was 8.7 months (95% CI: 7.6-9.8) from start of first phase I treatment. No patients discontinued trial because of treatment-related toxicities. Abnormal lactate dehydrogenase, serum albumin <35 mg per 100 ml, >= 5 previous treatment lines, liver metastases and Eastern Cooperative Group performance status >= 2 at study entry were significantly associated with poor overall survival in multivariate analysis. CONCLUSION: This retrospective analysis provides evidence that patients with MBC tolerate phase I clinical trials and a significant proportion of patients with chemo-refractory disease, particularly those with triple-negative or Her2-positive breast cancer, may benefit from treatment. British Journal of Cancer (2010) 103, 607-612. doi:10.1038/sj.bjc.6605812 www.bjcancer.com Published online 27 July 2010 (C) 2010 Cancer Research UK
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