In mid March, American Society of Clinical Oncology (ASCO) rolled out its first clinical trial. The goal of the trial is to give us access to FDA-approved targeted drugs that match a genomic abnormality, even when the drugs have not been approved to treat metastatic breast cancer (MBC).
The TAPUR (Targeted Agent and Profiling Utilization Registry) clinical trial allows us to obtain the drugs free-of-charge by cutting out the red tape when we are no longer benefiting from any standard treatment. In just taking a drug, we are considered as being enrolled in TAPUR. We can continue to use the drug as long as it is working. In addition, we are followed for treatment response and toxicities, just like in any other clinical trial. Currently, the study has eight participating pharmaceutical companies and 17 drugs, and ASCO will be adding others.
The trial's eligibility criteria are broad. For example, TAPUR allows a certain degree of abnormal liver and kidney functions that is greater than often allowed in clinical trials. Its criterion for performance status is also more inclusive, ranging from zero to two. Most clinical trials require a score of zero to one. Performance status measures how well we carry out our normal daily activities. It is often based on the ECOG (Eastern Co-operative Oncology) system. A score of zero means that we are fully active without any restrictions on activities. If we are unable to do strenuous activities but can carry out light housework, our score would be one. A score of two means that we are able to walk and manage self-care, are out of bed more than 50% of waking hours, but cannot carry on work activities of any kind. The Karnofsky Performance Status Score, which is another measure of activity, has comparable categories.
How to proceed
ASCO designed TAPUR to allow us to partner with our oncologist to decide whether a potential drug is a good match for an abnormality in our genomic profile. That profile is generated from a sample of our tumor, and TAPUR permits us to decide whether we want to use an existing sample or obtain a new biopsy.
First, you need a genomic profile, unless you already have one. But in some instances, an immunohistochemistry (IHC) test for protein expression is sufficient.
Since ASCO is aware of the high cost of sequencing a genome they have applied for a grant to cover the cost for patients who cannot afford the test or do not have medical insurance. However, often the cost of a genomic profile is not covered by insurance anyway. Sometimes a cancer facility does its own sequencing and potentially absorbs the cost. Because TAPUR is a new endeavor, we have to stay tuned for progress in the area of cost coverage.
After getting your genome sequenced, you and your oncologist can discuss which drug (if any) in TAPUR is a match for a genomic abnormality. If the drug you choose is questionable, your oncologist will receive feedback from a virtual tumor board via a conference call, which ASCO set up if your treatment facility does not have a board of its own. Tumor boards are a mainstay in large cancer facilities and hospitals to help evaluate when necessary the best approach for treating a patient, but they often do not exist at small facilities. Boards include your medical oncologist, as well as perhaps a surgeon, radiologist, interventional radiologist, pathologist, and most recently a doctor who specializes in interpreting genomic profiles.
Where to go
To date, ASCO has set up 37 sites. Most of the sites are in Michigan and North Carolina, with one site each in South Carolina and Idaho. However, ASCO is working diligently to add sites across the country as quickly as possible, and not just in large cities. But we have another option, as well. We can speak with our oncologist about getting our facility approved as a TAPUR clinical trial site. ASCO has made the process relatively easy, to continue to add treatment sites.
In order to keep up with what is happening with TAPUR and learn about newly added treatment sites, pharmaceutical companies and targeted drugs, you can sign up to receive a newsletter by visiting the TAPUR website (www.tapur.org). On the home page, first click on, For Patients. Then, under the Patient Advocates section, click on, sign up. You will not be required to complete a survey if you do not want to, in order to receive the newsletter. Just fill in your contact information and then check off, No, under volunteering (unless of course you want to volunteer your time). Your oncologist can also access information on how to add your facility as a participating treatment center by clicking on, For Researchers, on the home page. From the home page, you can also access an FAQ section for more details.
TAPUR has many benefits for the oncology community. It helps us to access approved targeted drugs that are not indicated for MBC when we are no longer benefiting from standard therapies, assists our oncologist in identifying the best drug by offering a virtual tumor board if necessary, informs the community about potential uses of already approved targeted drugs, gives pharmaceutical companies insights into new uses for drugs, and helps the FDA learn more about side effects and treatment outcomes for use of approved drugs in other cancers.
Joan is a helpline volunteer, member of SHARE Leaders, and a consumer reviewer at the Department of Defense Breast Cancer Research Program. She also facilitates SHARE's metastatic breast cancer support group, Living with Uncertainty.