Amelie Schramm1, Fabienne Schochter2, Thomas W P Friedl2, Nikolaus de Gregorio2, Ulrich Andergassen3, Marianna Alunni-Fabbroni3, Elisabeth Trapp3, Bernadette Jaeger4, Georg Heinrich5, Oumar Camara6, Thomas Decker7, Angelika Ober8, Sven Mahner3, Tanja N Fehm4, Klaus Pantel9, Peter A Fasching10, Andreas Schneeweiss11, Wolfgang Janni2, Brigitte K Rack3. 1. Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany. Electronic address: Amelie.Schramm@uniklinik-ulm.de. 2. Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany. 3. Department of Obstetrics and Gynecology, Ludwig Maximilians University, Munich, Germany. 4. Department of Obstetrics and Gynecology, Heinrich Heine University, Duesseldorf, Germany. 5. Medical Office of Gynecology, Fürstenwalde, Germany. 6. Department of Obstetrics and Gynecology, Hufeland Hospital, Bad Langensalza, Germany. 7. Medical Office of Oncology, Ravensburg, Germany. 8. Department of Gynecology, St Vincenz Hospital Limburg, Limburg, Germany. 9. Institute of Tumor Biology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 10. Department of Obstetrics and Gynecology, University Hospital Erlangen, Friedrich Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany. 11. National Center for Tumor Diseases, Heidelberg, Germany.
Abstract
BACKGROUND: Use of anthracycline-based chemotherapy in patients with early breast cancer (EBC) has been well-established but is often associated with cardiotoxicity. Based on data suggesting a limited benefit of anthracyclines in human epidermal growth factor receptor 2 (HER2)-negative patients, the Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as well as Life Style Intervention Strategies (SUCCESS) C study randomized patients to either anthracycline-containing or anthracycline-free chemotherapy. Given the proven prognostic value of circulating tumor cells (CTCs) in EBC, we compared the prevalence of CTCs after chemotherapy between both treatment arms for a preliminary efficacy assessment. METHODS: The SUCCESS C trial (NCT00847444) is an open-label, phase III study randomizing 3547 patients with HER2-negative EBC to either 3 cycles ofepirubicin, 5-fluorouracil, and cyclophosphamide followed by 3 cycles of docetaxel (FEC-DOC) or 6 cycles of docetaxel and cyclophosphamide (DOC-C). CTC status was prospectively evaluated in hormone receptor-positive patients at the time of last chemotherapy cycle using the US Food and Drug Administration-approved CellSearch System (Janssen Diagnostics). RESULTS: Data on CTC status were available for 1766 patients. Overall, CTCs were found in 221 (12.5%) patients. Univariate analyses revealed that presence of CTCs at time of last chemotherapy cycle was not significantly associated with tumor or patient characteristics (all P > .1). There was no significant difference with respect to presence of CTCs between patients randomized to FEC-DOC or DOC-C (11.5% vs. 13.6%; P = .18). CONCLUSIONS: The comparable prevalence of CTCs at the time of last chemotherapy cycle may indicate that anthracycline-free chemotherapy is equally effective to anthracycline-containing chemotherapy in HER2-negative, hormone receptor-positive EBC. However, efficacy data from the final survival analysis of SUCCESS C have to be awaited to confirm these preliminary findings.
RCT Entities:
BACKGROUND: Use of anthracycline-based chemotherapy in patients with early breast cancer (EBC) has been well-established but is often associated with cardiotoxicity. Based on data suggesting a limited benefit of anthracyclines in humanepidermal growth factor receptor 2 (HER2)-negative patients, the Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as well as Life Style Intervention Strategies (SUCCESS) C study randomized patients to either anthracycline-containing or anthracycline-free chemotherapy. Given the proven prognostic value of circulating tumor cells (CTCs) in EBC, we compared the prevalence of CTCs after chemotherapy between both treatment arms for a preliminary efficacy assessment. METHODS: The SUCCESS C trial (NCT00847444) is an open-label, phase III study randomizing 3547 patients with HER2-negative EBC to either 3 cycles of epirubicin, 5-fluorouracil, and cyclophosphamide followed by 3 cycles of docetaxel (FEC-DOC) or 6 cycles of docetaxel and cyclophosphamide (DOC-C). CTC status was prospectively evaluated in hormone receptor-positive patients at the time of last chemotherapy cycle using the US Food and Drug Administration-approved CellSearch System (Janssen Diagnostics). RESULTS: Data on CTC status were available for 1766 patients. Overall, CTCs were found in 221 (12.5%) patients. Univariate analyses revealed that presence of CTCs at time of last chemotherapy cycle was not significantly associated with tumor or patient characteristics (all P > .1). There was no significant difference with respect to presence of CTCs between patients randomized to FEC-DOC or DOC-C (11.5% vs. 13.6%; P = .18). CONCLUSIONS: The comparable prevalence of CTCs at the time of last chemotherapy cycle may indicate that anthracycline-free chemotherapy is equally effective to anthracycline-containing chemotherapy in HER2-negative, hormone receptor-positive EBC. However, efficacy data from the final survival analysis of SUCCESS C have to be awaited to confirm these preliminary findings.
Authors: Amelie de Gregorio; Wolfgang Janni; Thomas W P Friedl; Ulrike Nitz; Brigitte Rack; Andreas Schneeweiss; Ronald Kates; Tanja Fehm; Hans Kreipe; Matthias Christgen; Sherko Kümmel; Elisabeth Trapp; Rachel Wuerstlein; Andreas Hartkopf; Michael Clemens; Toralf Reimer; Lothar Häberle; Peter A Fasching; Oleg Gluz; Nadia Harbeck Journal: Br J Cancer Date: 2022-02-22 Impact factor: 9.075