Abstract | BACKGROUND: The prognostic relevance of circulating tumor cells (CTCs) at the time of primary diagnosis has been well established. However, little information is available regarding their prognostic relevance to follow-up care. METHODS: The multicenter, open-label, phase III SUCCESS A trial compared two adjuvant chemotherapy regimens followed by 2 vs 5 years of zoledronate for early-stage, high-risk breast cancer patients. The presence of CTCs was assessed before and 2 years after chemotherapy using the FDA-approved CellSearch System. Overall survival (OS) and disease-free survival (DFS) were analyzed using univariate log-rank tests and multivariable Cox regressions. OS and DFS were measured starting from an assessment of CTCs 2 years after the completion of chemotherapy. All statistical tests were two-sided. RESULTS: The sample included 1087 patients who participated in the translational research program of the SUCCESS A trial and for whom sufficient translational data were available regarding CTC status at baseline and at the 2-year follow-up visit. Two years after chemotherapy, 198 (18.2%) patients were CTC-positive. The median follow-up after this timepoint was 37 months. Cox regressions that included CTC status at baseline revealed that CTC status 2 years after chemotherapy had statistically significant and independent prognostic relevance for OS (hazard ratio [HR] = 3.91, 95% confidence interval [CI] = 2.04 to 7.52, P < .001) and DFS (HR = 2.31, 95% CI = 1.50 to 3.55, P < .001). CONCLUSION: The presence of CTCs 2 years after chemotherapy was associated with decreased OS and DFS. Based on these results, active individualized surveillance strategies for breast cancer survivors based on biomarkers should be reconsidered.
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Authors | Elisabeth Trapp, Wolfgang Janni, Christian Schindlbeck, Julia Jückstock, Ulrich Andergassen, Amelie de Gregorio, Marianna Alunni-Fabbroni, Marie Tzschaschel, Arkadius Polasik, Julian G Koch, Thomas W P Friedl, Peter A Fasching, Lothar Haeberle, Tanja Fehm, Andreas Schneeweiss, Matthias W Beckmann, Klaus Pantel, Volkmar Mueller, Brigitte Rack, Christoph Scholz, SUCCESS Study Group |
Journal | Journal of the National Cancer Institute
(J Natl Cancer Inst)
Vol. 111
Issue 4
Pg. 380-387
(04 01 2019)
ISSN: 1460-2105 [Electronic] United States |
PMID | 30312434
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please email: [email protected]. |
Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Breast Neoplasms
(blood, drug therapy, pathology)
- Carcinoma, Ductal, Breast
(blood, drug therapy, pathology)
- Carcinoma, Lobular
(blood, drug therapy, pathology)
- Female
- Follow-Up Studies
- Humans
- Middle Aged
- Neoplastic Cells, Circulating
(drug effects, pathology)
- Prognosis
- Prospective Studies
- Risk Factors
- Survival Rate
- Young Adult
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