GM-CSF significantly enhanced ANC recovery after FAC chemotherapy; it decreased the incidence and duration of associated neutropenia and moderately increased the dose-intensity of adjuvant chemotherapy. Whether these effects will ultimately translate into improved long-term outcome remains to be determined.

Biobanks provide a window of opportunity to store and add value to material from rare cases allowing their future use in biomedical research. One such example is the opportunityto obtain good quality tissue from patients undergoing gender re-assignment. Following patient agreement to donate tissue samples to our biobank we catalogued the histological appearance, defined the expression of the hormone receptors ERα, PR, AR and the proliferation marker Ki67, and generated and characterised primary cell cultures in a female to male (FTM) transgender patient referred to our unit for surgery. Immunohistochemistry was performed for ERα, PR and AR and the proliferation marker Ki67. Hormone receptor expression was confined to epithelial cells lining the breast ducts. Ki67 immunoreactivity was sparse indicating little proliferation of luminal epithelium, consistent with normal mammary gland. Cultures of epithelial cells and fibroblasts were derived from surplus tissue. The latter lacked expression of epithelial markers and hormone receptors but exhibited expression of vimentin. Culture of the former on Matrigel saw an outgrowth of more rounded "epithelial-like" cells. Immunofluoresence characterisation showed a mixed phenotype with expression of vimentin and both myoepithelial and luminal epithelial markers. Sporadic weak ERα expression and moderate PR expression was seen. In summary, as well as routinely collecting tissue and blood samples, we have characterised and stored tissue and cells from a FTM transgender patient, adding value to this resource which,available from the Breast Cancer Campaign Tissue Bank for those interested in further studying the biology of FTM transgender tissue.

The need for a specialist breast cancer biobank was recognised through a Gap Analysis conducted by the UK charity, Breast Cancer Campaign (Thompson AM et al., Breast Cancer Res 2008: 10(2); R26). As a result The Breast Cancer Campaign Tissue Bank (www.breastcancertissuebank.org) was launched in 2010 as a coalition of 4 centres of excellence for breast cancer research in the UK. Breast cancer patients presenting to these centres are offered the opportunity to donate surplus tissue and bloods to The Breast Cancer Campaign Tissue Bank. Researchers can apply for these samples by completing a simple on line application form. Here we describe our early experience of patient donation to The Breast Cancer Campaign Tissue Bank and outline the sample requests received from researchers to date. Most of the first year of operation (2010) was spent developing SOPs and ensuring collection protocols were robust, with some limited prospective collection. The collection was pump-primed from existing resources. By 2011 all sites were operational and working to the same standards. Over a 2 year period (Jan 2011 - Dec 2012), over 90% of suitable patients (1803) consented to tissue donation. From these we derived 3951 frozen tissue aliquots, 1517 formalin-fixed paraffin-embedded cases and 2012 blood derivatives (serum, plasma and whole blood). Asian patients were less likely to consent while younger patients tended not to donate blood, but were happy to donate tissue. All male patients consented to tissue and blood donation. At Dec 2012, the total numbers of sample aliquots derived from these donated tissue and blood samples was 22, 127. This includes frozen and formalin-fixed paraffin-embedded tissues, serum, plasma and whole blood. At present, application for tissue samples is restricted to the UK and Ireland but we aim to open to international applications in the near future. All applications are reviewed by an international Tissue Access Committee which includes appropriate clinical and scientific expertise plus representation by patient advocates. At 1st June 2013, seventeen applications had been received, of which 14 were approved. Three applications were rejected, made on the basis that the applicants were not making the best use of the donated material. Thus far, tissues have been dispatched to 9 researchers with 5 in preparation. These include 465 formalin-fixed paraffin-embedded cases and 158 frozen samples, all provided with a basic minimum dataset. Early experience of patient consent was encouraging with patients overall very enthusiastic and willing to donate to our biobanking programme. More research is needed to help understand the barriers in preventing ethnic minorities to donate and the reluctance in some young people to donate blood samples. Interest by the breast cancer research community in accessing samples is steadily rising as the resource becomes more widely known and increased website traffic is translating into applications for tissues. This has been an ambitious multidisciplinary endeavour but we are building a valuable resource to service the needs of the breast cancer research community with the goal of helping translate laboratory results into clinical benefit. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-19-02.

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