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Challenges to Hereditary Cancer Research

September 06, 2013

Challenges to Hereditary Cancer Research

by Sue Friedman

Much progress has been made in cancer research in the 15 years since I learned about my mutation and founded FORCE. Most exciting are advances in "personalized medicine" that focus on the unique traits of a subset of the general population, such as people with HBOC. HBOC cancers behave differently than other cancers: they are younger-onset, more aggressive, bestow greater lifetime risk for diagnosis and multiple cancers, and HBOC risk can be passed to our children. The biology that makes HBOC cancers different also offers researchers an opportunity to develop strategies to better prevent or treat hereditary cancers.

After years of advocacy, HBOC research is getting well-deserved attention, with studies moving towards personalized medicine as the best ways to prevent, detect, and treat hereditary cancers and improve quality of life. PARP inhibitors, new drugs designed to target cancers caused by BRCA mutations, are a significant example. These drugs will not be widely available until these studies are completed, yet open clinical trials of PARP inhibitors desperately need participants. Our community understands that research is the key to better options, and is willing to participate in the research to benefit them and future generations. So what is delaying progress? Here are some of the barriers we have identified.

  • Limited patient population. With one million Americans affected by HBOC, plenty of study participants should be available, but only about 10% of people with BRCA mutations are aware of their status. Among people diagnosed with cancer who meet expert guidelines, only about one-third receive genetic counseling and testing for mutations.
  • Competition from less-specific clinical trials. Up to 10% of cancers are hereditary, a small subset of a larger disease state. HBOC-specific clinical trials compete for participants with more numerous, larger studies that are not limited to people with mutations. For example, a recent search of — a National Institutes of Health database that lists research studies with human participants — for U.S. treatment trials enrolling people with metastatic breast cancer returned 220 open studies, yet only eight studies that will treat people with BRCA mutations. Of 60 advanced ovarian cancer treatment studies listed, just eight are specifically for patients with BRCA mutations. Therefore, a mutation carrier with advanced breast or ovarian cancer has a higher likelihood of finding and enrolling in a less-specific clinical trial than one of the few studies open to someone with their specific cancer and mutation type.
  • Doctor referral of patients to clinical trials. Doctors may be unaware of clinical trials beyond their own facility. Sometimes institutional barriers or personal biases keep physicians from informing patients with BRCA mutations about HBOC clinical trials elsewhere if research or treatment options are available at their own institution, even if those options are not HBOCspecific and may not be as good a "fit" for the patient. Some patients are not referred until their doctors have exhausted all other treatments, when patients may no longer qualify for a clinical trial.
  • Clinical trial eligibility. Clinical trials are carefully designed to determine whether new medications or interventions work better than standard care. All research must outline eligibility requirements or limitations regarding who can or cannot participate. Sometimes certain treatment affects a patient's eligibility. Neoadjuvant breast cancer studies, for example, determine whether a specific treatment causes breast tumors to shrink, grow, disappear, or has no effect. However, only people who have their original breast tumor are eligible: once the tumor is removed by lumpectomy or mastectomy, patients are ineligible. Receiving certain chemotherapies may also lead to ineligibility. For these reasons, patients should be aware of clinical trial options before starting treatment or resuming treatment after a recurrence.
  • Consumer knowledge about clinical trials. Many people have concerns about safety, medical care, use of placebos, cost, and the ability to withdraw from clinical trial participation. Efforts to educate people about clinical trial design, safety, and oversight are ongoing, but more awareness is needed. Navigating sites like clinicaltrials. gov and enrolling in a study can be confusing, even for patients who are motivated to participate.
  • Time, effort, or cost required to participate. Some participation requires travel to a different hospital, city or state, and requires that patients consult with a new team of doctors at a time when they are already under considerable stress. Transportation, lodging, time off from work, and childcare costs can add to the financial burden that keeps some patients from participating in trials.

FORCE is focusing on the following actions to overcome these barriers.

Raise awareness and educate consumers

  • Increase public awareness about national expert guidelines that identify qualifications for and potential benefits of genetic counseling and genetic testing.
  • Educate the community about the importance of participating in HBOC-specific research.
  • Empower patients to proactively seek out or ask their oncologist about clinical trials.

Engage stakeholders

  • Unite and educate HBOC stakeholders to advocate for community involvement in every aspect of HBOC research development.
  • Motivate and train the HBOC community to participate in panels, research peer review, and on advisory boards to represent community perspective in setting research priorities and developing and conducting studies.

Help patients find clinical trials

  • Inform people about promising new, targeted agents and HBOC-specific research opportunities.
  • Develop a user-friendly tool to help people find and filter clinical trial opportunities based on their specific information and situation.
  • Train volunteers to help people navigate the search for clinical trials.
  • Work with researchers and industry partners to develop and distribute patientfriendly websites and materials that can be shared with the HBOC community.

Educate health care providers

  • Survey the health care community to better understand the barriers to clinical trial referral.
  • Educate providers about challenges facing the HBOC community; our urgent need for better prevention, detection, and treatment options; and how they can help with our efforts to improve HBOC research enrollment.
  • Educate providers about open clinical trials enrolling people with HBOC.

Inform health care policy

  • Educate policymakers and regulatory agencies about challenges facing the HBOC community, and the need for expedited drug development, research, and approval.
  • Activate the community to speak out on key policy issues that affect HBOC research.

Visit the FORCE website and follow our blog to learn more about how you can help advance HBOC research.

Posted in: Research
Tags: Hereditary Cancer Research , Clinical Trials , Patient Engagement , Patient Centered Research

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