1. Randomized trial comparing resection of primary tumor with no surgery in stage IV breast cancer at presentation: Protocol MF07-01
- Author
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Nalan Ulufi, Haluk Alagol, Ronald Johnson, Bahadir M. Gulluoglu, Betül Bozkurt, Serdar Özbaş, Neslihan Cabioglu, Emin Yildirim, Erol Aksaz, Cavit Col, Cihangir Ozaslan, G Gurleyik, Ali Uzunkoy, Mustafa Dulger, Neset Koksal, Ergun Erdem, Vahit Ozmen, Ayhan Koyuncu, Zafer Canturk, Semra Salimoglu, Atilla Soran, Mahmut Muslumanoglu, Bülent Ünal, U Berberoglu, Aykut Soyder, Zafer Utkan, Umit Ugurlu, Turkkan Evrensel, Abdullah Igci, Efe Sezgin, Atakan Sezer, Hasan Karanlik, Can Atalay, Cihan Uras, Omer Cengiz, Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı., Evrensel, Türkkan, AAJ-1027-2021, Tıp Fakültesi, and Hitit Üniversitesi, Tıp Fakültesi, Cerrahi Tıp Bilimleri Bölümü
- Subjects
0301 basic medicine ,Survival rate ,Secondary ,Antineoplastic Combined Chemotherapy Protocols/therapeutic use ,Biomarkers, Tumor/metabolism ,Breast Neoplasms/pathology/surgery/*therapy ,Carcinoma, Ductal, Breast/secondary/surgery/*therapy ,Carcinoma, Lobular/secondary/surgery/*therapy ,Combined Modality Therapy/*mortality ,Female ,Follow-Up Studies ,Humans ,Mastectomy/*mortality ,Middle Aged ,Neoplasm Invasiveness ,Neoplasm Metastasis ,Prognosis ,Radiotherapy/*mortality ,Receptor, ErbB-2/metabolism ,Receptors, Estrogen/metabolism ,Receptors ,Survival ,Receptor, ErbB-2 ,medicine.medical_treatment ,Neoplasm invasiveness ,Receptors, progesterone ,Cancer staging ,Receptors, estrogen ,law.invention ,Progesterone receptor ,Metastasis ,Cancer growth ,0302 clinical medicine ,Breast cancer ,Randomized controlled trial ,Metastatic-disease ,law ,Phase 3 clinical trial ,Pathology ,Estrogen receptor ,Overall survival ,Relapse ,Middle aged ,Mastectomy ,Improves ,Systemic therapy ,Lobular carcinoma ,Hazard ratio ,[Belirlenecek] ,Metastatic Breast Cancer ,Combined modality therapy ,Metaanalysis ,Primary tumor ,Multicenter study ,Management ,Clinical trial ,Oncology ,Antineoplastic agent ,030220 oncology & carcinogenesis ,Surgical resection ,Locoregional Treatment ,Paget nipple disease ,Human ,Adult ,medicine.medical_specialty ,Randomization ,Breast surgery ,Neoplasm metastasis ,Tumor invasion ,Breast tumor ,Breast Neoplasms ,Follow-up studies ,Major clinical study ,Carcinoma, ductal, breast ,Lymph node dissection ,Article ,Epidermal growth factor receptor 2 ,03 medical and health sciences ,Antineoplastic combined chemotherapy protocols ,medicine ,Tumor marker ,Mortality ,Multimodality cancer therapy ,Cancer recurrence ,Performance status ,Surgical Resection ,Radiotherapy ,business.industry ,Locoregional treatment ,ERBB2 protein, human ,Bone metastasis ,Follow up ,medicine.disease ,Carcinoma, lobular ,Surgery ,030104 developmental biology ,Metabolism ,Biomarkers, tumor ,Hormone Receptors ,Metastatic-Disease ,Therapy ,Comparative study ,business ,Axillary lymph node ,Removal ,Controlled study - 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. © 2018, Society of Surgical Oncology.
- Published
- 2018