Here is a unique opportunity for patients to have their voices heard, BEFORE a clinical trial gets approved. Many thanks to Dr. Julie Gralow (@jrgralow) from the University of Washington for asking for advice from our community. 

Patient Survey Regarding Follow-up of Early Stage Breast Cancer

We are seeking patient input through this survey to help in planning a national clinical trial designed to determine how to optimally screen for breast cancer recurrence.

One goal in the long-term follow-up of breast cancer patients is the early recognition and treatment of potentially curable disease recurrence. Most of the time, the first indication that breast cancer has returned is that a woman develops new symptoms, such as pain.  There are blood tests, called tumor markers, that can be performed that may indicate that cancer has returned before symptoms develop. However, sometimes these tests can increase for completely unrelated, non-cancer reasons. Some examples of these tests are CEA, CA27.29, and CA15-3.

The large organizations of cancer doctors in the U.S. do not recommend that tumor markers be tested on a regular basis to see if a patient’s cancer has returned, because no study has ever shown that earlier detection of breast cancer recurrence prolongs survival or improves outcome. National guidelines for follow-up and management of early stage breast cancer recommend that patients undergo regular history and physical examination along with annual mammography, but they state that blood and other imaging tests should not be done routinely (including tumor markers). Trials evaluating more intensive follow-up of breast cancer patients done in the 1990s, when we had different ways of looking for cancer recurrence and different treatment options, did not show a benefit for including blood or imaging tests in breast cancer follow-up. These trials did not include blood tumor markers. Today, some physicians check tumor markers in their breast cancer patients on a regular basis hoping that early detection of recurrence might help, but there is no evidence to support this practice. There could be harm to the patient from routinely checking tumor markers if an elevation due to a non-cancer cause occurs (a false positive value) and it leads to unnecessary scans and biopsies. Additionally, not all breast cancer recurrences are associated with an elevation in blood tumor markers, so a normal tumor marker result might not mean that there is no cancer recurrence (a false negative result). The fact is that we do not know what the true benefits and harms of using tumor markers to screen for breast cancer recurrence are, or if a patient’s outcome and survival would be better if treatment is started at the time the tumor marker increases instead of waiting until symptoms develop.  Research is necessary to develop optimal breast cancer follow-up strategies.

SWOG, in partnership with members of the National Cancer Institute’s Clinical Trials Network, is currently designing a clinical trial evaluating the testing of tumor markers (CEA, CA15-3, CA 27.29) in patients with stage II and III breast cancer.  The primary goal of the study will be to determine whether early initiation of treatment at the time of tumor marker-detected breast cancer relapse can improve survival.  Patients who have recently completed surgery, chemotherapy, and/or radiation therapy would be invited to participate. Approximately 10,000 patients would be involved. All patients would be asked to have their blood drawn every 3 months for 5 years. The blood would be sent to a central laboratory for testing and storage. Serum tumor marker assays would be performed at the central laboratory, with patients and physicians blinded to the results. To study a question like this in a sound scientific manner, we need to compare two groups of patients – one receiving “standard” follow-up and one receiving “experimental” follow-up.  “Standard” follow-up would use currently accepted guidelines … that is, ordering imaging and blood tests only if a new symptom that could be due to breast cancer develops, with treatment starting at that time. The “experimental” follow-up group would be informed of elevated tumor marker levels, if this occurs. This would result in undergoing imaging tests such as CT, PET, or bone scans to evaluate for recurrence with treatment being started at the time of tumor marker elevation. Decisions about the actual treatment in either case would be up to the patient and her physician.

Dr. Lynn Henry from the University of Michigan is the Principal Investigator on the study.  Dr. Julie Gralow is the  the senior PI for this study and SWOG Executive Officer.

We are asking for your help at this time, to better understand patient attitudes and acceptance of such a trial, and get input as to what would be important to patients related to long-term follow-up.

TAKE THE SURVEY!

[SURVEYS 1]