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Many of the expert faculty of the 3rd Annual Symposium on Personalized Therapies and Best Clinical Practices, the expert faculty of this forthcoming 4th annual symposium to be held on January 22, 2011 in La Jolla, CA, and several additional key opinion leader breast cancer experts provided us with the IDEAL or "best practices" for treating breast cancer with personalized therapies. The previous symposium's audience of learners, and numerous additional community-based, non-academic oncologists and hematologist/oncologists and allied healthcare professionals who treat patients with breast cancer helped to provide us with the BASELINE or "current practices." From the differences between the IDEAL and BASELINE practices we developed the Practice Gaps for this Needs Assessment.

For these two CME activities (January 2011 live symposium and corresponding Internet-based enduring materials) numerous focus groups and personal interviews were conducted during the past several months, beginning in February 2010, in June 2010 during the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, and subsequently with more than thirty academic experts and also with more than forty community-based, non-academic oncologists and hematologist/oncologists and allied healthcare professionals involved in the treatment, care and management of patients with breast cancer.

The community-based practitioners helped us identify a overal Practice Gap: There is simply too much new information now available for molecular testing of breast cancer patients, and for the new drugs and indications of existing drugs. Moreover, the rate at which this new information is becoming available is constantly increasing. Much of the important new scientific and clinical data for breast cancer includes clinical trials' results that are helping facilitate the identification of and the improved treatment of three major breast cancer patient sub groups and personalized therapies for them. The academic experts pointed out that there were several abstracts and sessions at the 2010 ASCO meeting including new data on existing and emerging biomarker tests that can further help identify these breast cancer subtypes and the optimal use of corresponding personalized therapies.

The large amount of new testing information for HER2 breast cancer patients is critical for patients who either fail to respond or who have relapsed on current therapies, especially with the emergence of new and multiple therapies for treating this breast cancer subtype. The academic experts also mentioned that there were several abstracts and sessions at the 2010 ASCO meeting on the subjects of the existing and also of the new gene-based assays that help with the identification of hormone-receptor positive patients who might better respond to endocrine therapy and to chemotherapy. One 2010 ASCO abstract was actually designed to review the role of personalized therapy with a drug that is approximately 40 years old, tamoxifen.

New data regarding BRCA1 and BRCA2 testing was also revealed at the 2010 ASCO meeting. The academic experts indicated that this is important for developing optimal and personalized systemic regimens involving PARP inhibitors and also for identifying breast cancer patient subgroups who may better benefit from platinum-based therapies. And there were several abstracts and posters on the biomarker, SPARC (Secreted Protein acidic Rich in Cysteine) that were presented along with several clinical studies for which SPARC was used for nab paclitaxel for breast cancer therapy in various treatment settings. Subsequently, there have been data with circulating tumor cells, and the availability of a cytoplasmic PARP assay, and further usage of both the commercially available 70-gene DNA micro array-based in vitro test, and the 21-gene assay all help determine therapy selection and disease recurrence in some patients.

In addition, just prior to the June 2010 annual ASCO meeting, the College of American Pathologists and the American Society of Clinical Oncology issued "game-changing' new joint guidelines (April 19, 2010) for immunohistochemistry (IHC) testing for the expression status of estrogen and progesterone receptors in breast cancer. The main goal of the new ASCO/CAP ER/PgR guidelines is to improve the accuracy of IHC test results and ensure that patients receive appropriate care with endocrine therapy, as it has the potential to improve survival and save more lives. Widespread access to accurate ER/PgR testing is critical. IHC is commonly used to measure the amount of ER and PgR proteins in breast cancer cells, which can help guide treatment with endocrine therapies, such as tamoxifen, that have shown to improve survival. However, between 10 and 20 percent of IHC test results may be inaccurate, yielding false-positive or false-negative results, according to an ASCO/CAP joint statement announcing the new published guidelines. Hormone-receptor positive is the most common breast cancer phenotype worldwide. Therefore, access to accurate and reliable ER/PgR testing and established and relatively affordable endocrine therapies could have a profound impact on breast cancer outcomes in high- and low-/middle-income countries around the globe. This new ASCO/CAP guideline information has an impact on the treatment of ER-positive disease but also, as the experts pointed out to us, it importantly, impacts the number of patients who are classified as, and consequently treated as having triple-negative breast cancer.

This increasing number of diagnostic tests and molecular classification data and biomarkers, prompted the experts to raise the following additional "questions in practice" that remain components of the overall key Practice Gap for biomarkers and testing of breast cancer patients: For which patients with breast cancer are these various tests such as tests for HER2 status, IHC, FISH, CYP2D6, and others most appropriate and useful? What are the appropriate clinical applications of gene-based testing? What are the clinical applications of the quantitative mRNA genetic test? What are the molecular predictors of response to adjuvant endocrine therapy? Is there a patient subtype, for whom we should test for cytoplasmic PARP? And perhaps, most importantly, how does each test help oncologists with improved decision making as they decide how to treat their patients with breast cancer?

The Biomedical Learning Institute designates this enduring material for a maximum of 8 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

All faculty and BMLI staff participating in the content, planning or implementation of an educational CME activity are required to disclose to the audience of the educational activity any relevant financial relationships or interests and to assist in the resolution of any conflict of interest that may arise from the relationship(s) or interest(s). It is also the policy of the BMLI to require all faculty presenters to make a meaningful disclosure to the audience of their discussions of unlabeled or FDA unapproved drugs, products, tests or devices. This information will be available as part of the educational activity and related material.

The following faculty and BMLI staff have reported real or potential relevant conflicts of interest and these conflicts have been resolved, prior to this educational activity through a peer-review process by two medical oncologists who have had no affiliation with this educational activity other than the peer review process.  This is documented on this page immediately following the financial disclosures below.

Sincere appreciation is extended to the following companies for their generous support of this educational meeting: