Treatment Choices and Clinical Trials

May 1, 2013 7:48 pm

The following article is provided by The Clearity Foundation to support women with ovarian cancer and their families. Learn more about The Clearity Foundation and the services we provide directly to women as they make treatment decisions and navigate emotional impacts of their diagnosis.

Treatment Choices and Clinical Trials

By: Cory Bentley, PhD & Teresa Gallagher, PhD

A study presented at the Society of Gynecological Oncology meeting found that most women diagnosed with ovarian cancer are not receiving medical care that meets the guidelines of the National Comprehensive Cancer Network (NCCN). The study was presented in April by Dr. Robert Bristow of the University of California, Irvine and reviewed the medical records of more than 13,000 women with ovarian cancer. Surprisingly, the study found that only 37 percent of women were receiving the recommended standard of care. Importantly, the advanced stage patients who received the standard of care recommended by the NCCN guidelines lived longer than those who did not. Women treated by physicians with less experience treating ovarian cancer (those treating fewer than 10 cases per year) and women treated at “low-volume” hospitals (those treating fewer than 20 patients with ovarian cancer each year) were less likely to receive the standard of care.

Faced with such a challenging environment, it is no wonder that many patients can be overwhelmed and even skeptical. At Clearity, we believe that one way to inform treatment selection is to use the results of tumor molecular profiling to help prioritize drugs among those recommended in the NCCN guidelines for recurrent ovarian cancer. Tumor profile reports can also be used to help select a drug or drug combination from among those that are currently in clinical trials.

When it comes to clinical trials, patients can have many reservations. Dr. Teresa Gallagher has studied how patients consider clinical trial options. She explains that there are several important barriers that may deter women from deciding to participate in a clinical trial:

  1. Concern about being used as a “human guinea pig” to test potentially unsafe drugs;
  2. Mistrust of the drug companies and their motives;
  3. Fear of being assigned to a group where you will not receive the experimental treatment;
  4. Belief that you will not benefit from the trial drug — that currently available treatments are more effective than “experimental” treatments;
  5. Lack of awareness of appropriate trials that fit your molecular profile and other circumstances such as no available trials nearby and eligibility criteria.

With all these questions and concerns, why would a patient consider a clinical trial? This question was put to Clearity’s scientific director, Deb Zajchowski, PhD. According to Dr. Zajchowski, one compelling reason for participation in a clinical trial is the possibility of receiving a drug that could be a very effective treatment. “Many of the drugs that are now in clinical trials are predicted to work only in certain patients who can be identified by tumor molecular profiling approaches similar to those used by Clearity. It is hoped that by such selection, these new drugs will work in more patients than in the past when there was no selection process.”

To those patients whose top concern is whether or not they receive the trial drug, Dr Zajchowski points out that randomized clinical trials compare a standard treatment with the same treatment with a new study drug added on top. Therefore, the patient who is in the placebo arm will still receive the standard treatment that is appropriate for her cancer. The clinical trial drug is in addition to the standard of care. A clinical trial makes a lot of sense for a patient when her molecular profile has matched her to the standard of care drug used in the trial as well as the new drug being tested.

Another factor keeping women from participating in clinical trials is a concern about safety. Safety issues are most pertinent for a phase I study, which is designed to evaluate the safety of a drug being used in human beings for the first time. Several aspects of a phase I study design help keep patients safe. First, substantial data is available on the safety of the drug in animal models; second, patients are very closely monitored; third, the study starts with a very low dose and only increases to a higher dose after the lower dose proves tolerable; and lastly, a patient can withdraw from a trial at any time. There is always a risk of experiencing side effects with a clinical trial drug, but Dr. Zajchowski explains, “The decision is a personal one where every patient must balance the risks with the possible benefits– the chance of receiving a new drug that could work better than any other drug to treat your cancer and the risk for a severe adverse reaction.” Both drug effectiveness and safety are critical to the success of any drug.

Suspicion of drug companies’ motivations dissuades some patients from participating in clinical trials. Dr. Teresa Gallagher explains that unfortunately the pharmaceutical industry is being portrayed negatively in the media, which can cause patients to mistrust the drug companies and drug trials. Cory Bentley, PhD, the author of this article, currently works in drug discovery and development for a biotechnology company, where real people are interested in making a real difference. In Dr. Bentley’s experience, people in drug companies and physicians running clinical trials are working to make a drug that will truly give something valuable to patients: extended life and quality of life.

As patients look at clinical trials, there are so many issues to consider. Perhaps the most critical considerations are how well a trial drug matches her tumor molecular profile and practical concerns such as eligibility and distance from home. Clearity will help patients find their way to a treatment that best fits their molecular profile, whether that includes a trial drug or approved drug.

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