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Ann Surg Oncol. 2018 Oct;25(11):3141-3149. doi: 10.1245/s10434-018-6494-6. Epub 2018 May 17.

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

Author information

1
Division of Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Magee-Womens Hospital, Pittsburgh, PA, USA. asoran@upmc.edu.
2
Department of Surgery, Istanbul University Istanbul Faculty of Medicine, Istanbul, Turkey.
3
Breast and Endocrine Surgery Unit, Ankara Guven Hospital, Ankara, Turkey.
4
Surgical Oncology Unit, Istanbul University Institute of Oncology, Capa, Istanbul, Turkey.
5
Department of Surgery, Istanbul University Istanbul School of Medicine, Istanbul, Turkey.
6
Department of Surgery, Kocaeli University School of Medicine, Kocaeli, Turkey.
7
Department of General Surgery, Kocaeli University School of Medicine, Kocaeli, Turkey.
8
Department of Surgery, Ankara Oncology Teaching and Research Hospital, Ankara, Turkey.
9
Department of Medical Oncology, Uludag University School of Medicine, Bursa, Turkey.
10
Department of Surgery, Acibadem University School of Medicine, Istanbul, Turkey.
11
Mamer Medical Center, Bursa, Turkey.
12
Department of Surgery, Adnan Menderes University School of Medicine, Aydin, Turkey.
13
Department of Surgery, Marmara University School of Medicine, Istanbul, Turkey.
14
Department of Surgery, Etimed Hospital, Etimesgut, Ankara, Turkey.
15
Department of Surgery, Hitit University School of Medicine, Corum, Turkey.
16
Department of Surgery, Harran University School of Medicine, Urfa, Turkey.
17
Department of Surgery, SBU Umraniye Teaching and Research Hospital, Istanbul, Turkey.
18
Department of Surgery, School of Medicine, Osmangazi University, Eskisehir, Turkey.
19
Bozok University Medical School, Yozgat, Turkey.
20
Department of Surgery, Pamukkale University School of Medicine, Denizli, Turkey.
21
Department of Surgery, Tepecik Teaching and Research Hospital, Izmir, Turkey.
22
Department of Surgery, Trakya University School of Medicine, Edirne, Turkey.
23
Department of Surgery, Medicana Sivas Hospital, Sivas, Turkey.
24
Department of Surgery, Haydarpaşa Numune Teaching and Research Hospital, Istanbul, Turkey.
25
Department of Surgery, Ozel Bolge Pendik Hospital, Pendik, Istanbul, Turkey.
26
Department of Surgery, Cihan Hospital, Kocaeli, Turkey.
27
Department of Surgery, Koru Ankara Hospital, Ankara, Turkey.
28
Department of Food Engineering, Laboratory of Nutrigenomics and Epidemiology, Izmir Institute of Technology, Izmir, Turkey.
29
Division of Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Magee-Womens Hospital, Pittsburgh, PA, USA.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00557986.

PMID:
29777404
DOI:
10.1245/s10434-018-6494-6
[Indexed for MEDLINE]

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