Primary Surgery with Systemic Therapy in Patients with de Novo Stage IV Breast Cancer: 10-year Follow-up; Protocol MF07-01 Randomized Clinical Trial - 22/11/21
, Vahit Ozmen, MD, FACS b, Serdar Ozbas, MD d, Hasan Karanlik, MD, FACS e, Mahmut Muslumanoglu, MD b, Abdullah Igci, MD, FACS b, Nuh Zafer Canturk, MD, FACS c, Zafer Utkan, MD c, Turkkan Evrensel, MD f, Efe Sezgin, PhD gfor the
MF07-01 Study Group
Abstract |
Background |
The aim of this randomized clinical trial was to evaluate the overall survival (OS) data of patients diagnosed with de novo stage IV breast cancer (BC) who received locoregional treatment (LRT) over a 10-year follow-up.
Study Design |
The MF07-01 is a 1:1 multicenter, randomized clinical trial comparing the LRT with systemic therapy (ST), where ST was given to all patients either immediately after randomization or after surgical resection of the intact primary tumor.
Results |
A total of 278 patients were randomized and 265 patients were in the final analysis. At 10-year follow-up, survivals were 19% (95% CI 13%–28%) and 5% (95% CI 2%–12%) in the LRT group and ST group, respectively. Median survival was 46 months for the LRT group and 35 months for the ST group, and hazard of death was 29% lower in the LRT group compared with the ST group (hazard ratio [HR] 0.71; 95% CI 0.59–0.86; p = 0.0003).
Conclusions |
Patients with a diagnosis of de novo stage IV BC who underwent LRT followed by ST had a 14% higher chance of OS by the end of the 10-year follow-up compared with the patients who received only ST. The longer study follow-up revealed that LRT should be presented to patients when discussing treatment options.
Il testo completo di questo articolo è disponibile in PDF.Visual Abstract |
Abbreviations and Acronyms : BC, ER, HR, LRP, LRT, OS, PR, QoL, ST, TN
Mappa
| CME questions for this article available at jacscme.facs.org |
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| Disclosure Information: Authors have nothing to disclose. Timothy J Eberlein, Editor-in-Chief, has nothing to disclose. Ronald J Weigel, CME Editor, has nothing to disclose. |
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| Members of the MF07-01 Study Group who coauthored this article are listed in the Appendix. |
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| Disclosure Information: Authors have nothing to disclose. Timothy J Eberlein, Editor-in-Chief, has nothing to disclose. |
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| ClinicalTrials.gov identifier number: NCT00557986 |
Vol 233 - N° 6
P. 742 - dicembre 2021 Ritorno al numero
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