The negative is just as important as the positive


CURE invited Kathleen (Kat) Werner, a breast cancer survivor, to serve as a guest blogger during the 33rd annual San Antonio Breast Cancer Symposium, December 8-12.

At the end of each day of the San Antonio Breast Cancer Symposium (SABCS) the Alamo Breast Cancer Foundation hosts a "Hot Topic" review session to give advocates a day in review of some of the stand-out information from each day's presented studies. It brings together noted figures in the field of breast cancer research, including doctors and basic science researchers who provide feedback and sometimes commentary on what we have learned that day. Attended mostly by advocates, this session is a snapshot of our progress made in various areas of drug use, surgical technique, basic science research, trial data, poster review and noted findings.

There is a clear bias in reporting in this country to publish data from cancer research that presents positive results. It may be more exciting, it may be to preserve funding sources, it may be professional affirmation, but the negative findings (or where a researcher does not prove their given hypothesis) is often hidden from view or not given as much attention. This negative data reporting is just as important as positive advances made in various areas. Without this data we are not steered away from treatment that may cause harm, treatments that are simply wasting our time and resources or spinning our wheels in looking in the same places for cures that just are not present.

First, we must understand how we define success in a trial. There are several important measurements of success depending on the trial and how it is measured. Overall survival (OS) is the chance that someone will survive a disease. A five-year OS means, "What is the chance that the patient will be alive in five years?" Disease-free survival (DFS) means what are the chances that the patient will not only be alive, but will be disease-free in that time period. Progression-free survival (PFS) is often used in stage 4 measurements to indicated how long a patient's disease remains stable without indication of growing disease, spreading disease or progression of disease.

Whether five years is long enough to truly measure the success of an intervention is a growing debate, and there is more support given to studies that show results in terms of 10 year or more. However, this is difficult to fund, report on and impractical in many research situations.Today, there was data presented from the AZURE trial that a hopeful drug used traditionally for bone loss and osteoporosis issues, zoledronic acid (also known by the trade name Zometa), may not have the awesome promise of preventing breast cancer recurrence as we had hoped.

There is some small data within this study that suggests it might still be a benefit for women who have been in menopause for five or more years, but more research is needed to confirm this sub-analysis. A study looking at the drug capecitabine (trade name Xeloda) combined it with a commonly used chemotherapy, a taxane, also showed no more benefit that the current use of taxanes. It is still showing benefit in the metastatic setting, but the hope that this drug, which does not cause hair loss and can be less severe in side effects for early-stage cancers, is not the great alternative it was hoped to be.

A study examining the consistency of metastatic pathological results with the primary tumor gave a sobering result in a study that as much as 26% of metastatic tumors had a different pathology than the original primary tumor, with either loss of HER2 or hormone receptor changes. This result was particularly alarming because it is not standard of care to biopsy a metastatic lesion to make sure it matches the original tumor. Therefore, the risk of not using available treatments, or over treating a new and different tumor type, is a very real concern.

Several advocates, researchers, and physicians have made the observation that a great deal of studies being presented this week are from areas outside the United States. Some smaller countries like Finland, Austria, Norway and Spain are presenting big data and really putting the U.S. to shame in their patient accrual rates for trials. The U.S. can put a man on the moon or create the atomic bomb, but we are still trying to keep up with the ability of our smaller research counterparts to provide such great data from research. At the Hot Topics session, this question was briefly addressed with suggestions that perhaps this is because of socialized medicine in other countries, which encourage the governments to support research into cheaper and more effective treatments to get the best, "bang for their buck."

Perhaps it is the over-regulation in the U.S. that has made researchers and institutions become bogged down in 20-page waivers and lawyers hovering. It might be the government's terrible lack of funds in supplying funding for the administrative needs that come from trial oversight, registry, and maintenance. Whatever the reason, it is a clear area where advocates in the U.S. can and should demand better and push for a process and resources that can make the trial process and enrollment more accessible to patients and researchers.

Kathleen "Kat" Werner is a cancer research advocate after being diagnosed with breast cancer at age 31. She travels the country and sits at the table with private and government agencies, fighting for the best treatments for newly diagnosed women and ultimately a cure for breast cancer. She lives is Blacksburg, Virginia with her husband of 11 years, Jeff, and her three young children. Read her blog, "Next Generation Research Advocate."

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