Topics:
Breast CancerMedical Oncology
Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer
About this trial
S1703, the first disease monitoring study in SWOG, is a randomized non-inferiority trial to assess whether patients with HR+, HER2- patients with MBC who are monitored with STMDDM have non-inferior overall survival compared to patients monitored with usual care. Cumulative direct health care costs, and patient reported outcomes of anxiety and quality of life will also be compared among patients monitored with STMDDM vs. those monitored with usual care.
STMDDM consists of serum tumor marker (STM) (CEA, CA 15-3, and CA 27.29) evaluation every 6 weeks (+/- 2 weeks) without imaging until an elevation of at least one STM. In the usual care arm, patients will have imaging studies (frequency and modality per treating physician) alone or in conjunction with STMs (frequency determined by the treating physician). Patients will continue disease monitoring on their assigned arm until disease progression.
Why this trial is important
We hypothesize that STMDDM will not alter survival outcomes and may be associated with lower healthcare costs and improved quality of life. The results of this study will provide context for cost-comparison of the different disease monitoring strategies, possibly leading to practice altering changes in how cancer care is delivered, and reduction of expensive imaging testing.Who qualifies
Step 1
- Patients eligible for STEP 1 include patients with ER+ and/or PR+, HER-2- metastatic breast cancer, who have ≥1 STM (CEA, CA 15-3, and/or CA 27.29) that is ≥2x the institutional upper limit of normal.
- Patients cannot enroll or plan to enroll on a first-line treatment trial with a defined monitoring schedule.
Step 2
- Patients eligible for STEP 2 must have a decrease of least 25% of ≥1 STM that was previously elevated. Patients with known CNS disease are not eligible.
Frequently asked questions (FAQ) about this trial:
What if my patient on the STMDDM arm develops a new symptom but their STMs have remained stable?
If a patient develops new signs or symptoms concerning for disease progression, imaging may be performed at any time regardless of STM trend.
How will progression be determined?
Progression will be determined based on the clinical judgement of the treating physician.
Can a patient enroll if only one STM is elevated?
Yes, a patient can enroll if at least one breast cancer STM (CEA, CA 15-3, and/or CA 27.29) is elevated +/- 2 weeks from the start of first-line systemic therapy. For step 2 registration, there must be a decrease in value of an elevated STM by at least 25%.
Do I need to test all 3 tumor markers (CEA, CA 15-3, and CA 27.29) and every time point?
Yes, to the best analysis possible, all 3 markers (CEA, CA 15-3, and CA 27.29) will be drawn at each time point. In our clinical experience, these 3 markers are routinely covered by insurance. Furthermore, this has been reviewed with a private insurer who has determined there were no impediments to insurance reimbursement. Other insurance representatives have reassured us that there shouldn’t be limitations to insurance coverage of these markers, as insurers are not interested in limiting these blood tests and don’t have the resources to track these tests (they cost ~$25-60 each) and their focus is on limiting more expensive testing such as imaging.
Is there credit for participating in this trial?
Yes, for every patient who registers to STEP 1 you will receive 0.2 DCP Cancer Control Credits, and for every patient who registers to STEP 2 you will receive 0.8 DCP Cancer Control Credits.
How do I talk to patients about this trial?
It is important to monitor patients who are receiving systemic therapy, but we currently don’t know the “right” way to do this. Currently, we use imaging tests at “random” frequencies and sometimes combine those imaging tests with blood tests called tumor markers. There is no evidence that frequent disease monitoring with either imaging tests or tumor markers are associated with longer survival. However, frequent disease monitoring may be associated with higher levels of anxiety and higher costs of care. Anxiety surrounding scans, sometimes called “scanxiety” can be overwhelming for cancer patients. The goal of this study is to see if a different monitoring approach, called serum tumor marker directed disease monitoring, where we use the trend of patients’ tumor marker values to figure out the best time to do imaging tests, is as effective as usual care, and if it is associated with less anxiety, better quality of life, and lower costs of care.
About the PI (Melissa K. Accordino, MD, MS)
Dr. Accordino’s research involves improving the quality and delivery of cancer care, and cancer survivorship. Dr. Accordino participates in clinical trials at the local and national level, and participates in multicenter cancer trials through SWOG. The overall goal of this research is to improve quality and outcomes within oncology.
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