Atilla Soran1, Vahit Ozmen2, Serdar Ozbas3, Hasan Karanlik4, Mahmut Muslumanoglu2, Abdullah Igci2, Nuh Zafer Canturk5, Zafer Utkan5, Turkkan Evrensel6, Efe Sezgin7. 1. Department of Surgery, University of Pittsburgh Medical Center, Magee-Womens Hospital, Pittsburgh, PA. Electronic address: asoran@upmc.edu. 2. Istanbul University Istanbul School of Medicine, Istanbul, Turkey. 3. Breast and Endocrine Surgeon, Ankara, Turkey. 4. Surgical Oncology Unit, Istanbul University Institute of Oncology, Capa, Istanbul, Turkey. 5. Kocaeli University School of Medicine, Kocaeli, Turkey. 6. Department of Medical Oncology, Uludag University School of Medicine, Bursa, Turkey. 7. Department of Food Engineering, Laboratory of Nutrigenomics and Epidemiology, Izmir Institute of Technology, Izmir, Turkey.
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.
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.
Authors: Michael Untch; Peter A Fasching; Renate Haidinger; Nadia Harbeck; Christian Jackisch; Diana Lüftner; Volkmar Müller; Eva Schumacher-Wulf; Rachel Würstlein; Christoph Thomssen Journal: Geburtshilfe Frauenheilkd Date: 2022-09-30 Impact factor: 2.754