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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 11/2018

01-10-2018 | Breast Oncology

Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01

Authors: Atilla Soran, MD, MPH, FNCBC, FACS, Vahit Ozmen, MD, FACS, Serdar Ozbas, MD, Hasan Karanlik, MD, Mahmut Muslumanoglu, MD, Abdullah Igci, MD, Zafer Canturk, MD, Zafer Utkan, MD, Cihangir Ozaslan, MD, Turkkan Evrensel, MD, Cihan Uras, MD, Erol Aksaz, MD, Aykut Soyder, MD, Umit Ugurlu, MD, Cavit Col, MD, Neslihan Cabioglu, MD, Betül Bozkurt, MD, Ali Uzunkoy, MD, Neset Koksal, MD, Bahadir M. Gulluoglu, MD, FACS, Bulent Unal, MD, Can Atalay, MD, Emin Yıldırım, MD, Ergun Erdem, MD, Semra Salimoglu, MD, Atakan Sezer, MD, Ayhan Koyuncu, MD, Gunay Gurleyik, MD, Haluk Alagol, MD, Nalan Ulufi, MD, Uğur Berberoglu, MD, Mustafa Dulger, MD, Omer Cengiz, MD, Efe Sezgin, PhD, Ronald Johnson, MD, FACS

Published in: Annals of Surgical Oncology | Issue 11/2018

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Abstract

Background

The MF07-01 trial is a multicenter, phase III, randomized, controlled study comparing locoregional treatment (LRT) followed by systemic therapy (ST) with ST alone for treatment-naïve stage IV breast cancer (BC) patients.

Methods

At initial diagnosis, patients were randomized 1:1 to either the LRT or ST group. All the patients were given ST either immediately after randomization or after surgical resection of the intact primary tumor.

Results

The trial enrolled 274 patients: 138 in the LRT group and 136 in the ST group. Hazard of death was 34% lower in the LRT group than in the ST group (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.49–0.88; p = 0.005). Unplanned subgroup analyses showed that the risk of death was statistically lower in the LRT group than in the ST group with respect to estrogen receptor (ER)/progesterone receptor (PR)(+) (HR 0.64; 95% CI 0.46–0.91; p = 0.01), human epidermal growth factor 2 (HER2)/neu(–) (HR 0.64; 95% CI 0.45–0.91; p = 0.01), patients younger than 55 years (HR 0.57; 95% CI 0.38–0.86; p = 0.007), and patients with solitary bone-only metastases (HR 0.47; 95% CI 0.23–0.98; p = 0.04).

Conclusion

In the current trial, improvement in 36-month survival was not observed with upfront surgery for stage IV breast cancer patients. However, a longer follow-up study (median, 40 months) showed statistically significant improvement in median survival. When locoregional treatment in de novo stage IV BC is discussed with the patient as an option, practitioners must consider age, performance status, comorbidities, tumor type, and metastatic disease burden.
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Metadata
Title
Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01
Authors
Atilla Soran, MD, MPH, FNCBC, FACS
Vahit Ozmen, MD, FACS
Serdar Ozbas, MD
Hasan Karanlik, MD
Mahmut Muslumanoglu, MD
Abdullah Igci, MD
Zafer Canturk, MD
Zafer Utkan, MD
Cihangir Ozaslan, MD
Turkkan Evrensel, MD
Cihan Uras, MD
Erol Aksaz, MD
Aykut Soyder, MD
Umit Ugurlu, MD
Cavit Col, MD
Neslihan Cabioglu, MD
Betül Bozkurt, MD
Ali Uzunkoy, MD
Neset Koksal, MD
Bahadir M. Gulluoglu, MD, FACS
Bulent Unal, MD
Can Atalay, MD
Emin Yıldırım, MD
Ergun Erdem, MD
Semra Salimoglu, MD
Atakan Sezer, MD
Ayhan Koyuncu, MD
Gunay Gurleyik, MD
Haluk Alagol, MD
Nalan Ulufi, MD
Uğur Berberoglu, MD
Mustafa Dulger, MD
Omer Cengiz, MD
Efe Sezgin, PhD
Ronald Johnson, MD, FACS
Publication date
01-10-2018
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 11/2018
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-018-6494-6

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