Elisabeth Trapp1,2, Wolfgang Janni3, Christian Schindlbeck4, Julia Jückstock1, Ulrich Andergassen1, Amelie de Gregorio3, Marianna Alunni-Fabbroni1,5, Marie Tzschaschel3, Arkadius Polasik3, Julian G Koch1, Thomas W P Friedl3, Peter A Fasching6, Lothar Haeberle6, Tanja Fehm7, Andreas Schneeweiss8, Matthias W Beckmann6, Klaus Pantel9, Volkmar Mueller10, Brigitte Rack3, Christoph Scholz3. 1. Department of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany. 2. Department of Gynecology, Medical University of Graz, Graz, Austria. 3. Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany. 4. Department of Gynecology and Obstetrics, Clinical Center Traunstein, Traunstein, Germany. 5. Ludwig-Maximilians-University of Munich Clinic and Policlinic for Radiology, Munich, Germany. 6. Department of Obstetrics and Gynecology, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-Nuremberg, Erlangen, Germany. 7. Department of Gynecology and Obstetrics, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany. 8. National Center for Tumor Diseases, Ruprecht-Karls-University Hospital Heidelberg, Heidelberg, Germany. 9. Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 10. Department of Gynecology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
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 zoledronatefor 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.
RCT Entities:
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 cancerpatients. 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.
Authors: Lorenz C Hofbauer; Aline Bozec; Martina Rauner; Franz Jakob; Sven Perner; Klaus Pantel Journal: Nat Rev Clin Oncol Date: 2021-04-19 Impact factor: 66.675
Authors: Haeyoung Kim; Yeon Jeong Kim; Donghyun Park; Woong-Yang Park; Doo Ho Choi; Won Park; Won Kyung Cho; Nalee Kim Journal: Breast Cancer Res Treat Date: 2021-06-21 Impact factor: 4.872