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

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... Full description

Journal Title: Annals of surgical oncology 2018, Vol.25 (11), p.3141-3149
Main Author: Soran, Atilla
Other Authors: Ozmen, Vahit , Ozbas, Serdar , Karanlik, Hasan , Muslumanoglu, Mahmut , Igci, Abdullah , Canturk, Zafer , Utkan, Zafer , Ozaslan, Cihangir , Evrensel, Turkkan , Uras, Cihan , Aksaz, Erol , Soyder, Aykut , Ugurlu, Umit , Col, Cavit , Cabioglu, Neslihan , Bozkurt, Betül , Uzunkoy, Ali , Koksal, Neset , Gulluoglu, Bahadir M , Unal, Bulent , Atalay, Can , Yıldırım, Emin , Erdem, Ergun , Salimoglu, Semra , Sezer, Atakan , Koyuncu, Ayhan , Gurleyik, Gunay , Alagol, Haluk , Ulufi, Nalan , Berberoglu, Uğur , Dulger, Mustafa , Cengiz, Omer , Sezgin, Efe , Johnson, Ronald
Format: Electronic Article Electronic Article
Language: English
Subjects:
NCT
Publisher: Cham: Springer International Publishing
ID: ISSN: 1068-9265
Link: https://www.ncbi.nlm.nih.gov/pubmed/29777404
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title: Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01
format: Article
creator:
  • Soran, Atilla
  • Ozmen, Vahit
  • Ozbas, Serdar
  • Karanlik, Hasan
  • Muslumanoglu, Mahmut
  • Igci, Abdullah
  • Canturk, Zafer
  • Utkan, Zafer
  • Ozaslan, Cihangir
  • Evrensel, Turkkan
  • Uras, Cihan
  • Aksaz, Erol
  • Soyder, Aykut
  • Ugurlu, Umit
  • Col, Cavit
  • Cabioglu, Neslihan
  • Bozkurt, Betül
  • Uzunkoy, Ali
  • Koksal, Neset
  • Gulluoglu, Bahadir M
  • Unal, Bulent
  • Atalay, Can
  • Yıldırım, Emin
  • Erdem, Ergun
  • Salimoglu, Semra
  • Sezer, Atakan
  • Koyuncu, Ayhan
  • Gurleyik, Gunay
  • Alagol, Haluk
  • Ulufi, Nalan
  • Berberoglu, Uğur
  • Dulger, Mustafa
  • Cengiz, Omer
  • Sezgin, Efe
  • Johnson, Ronald
subjects:
  • Antineoplastic Combined Chemotherapy Protocols - therapeutic use
  • Biomarkers, Tumor - metabolism
  • Breast cancer
  • Breast Neoplasms - pathology
  • Breast Neoplasms - surgery
  • Breast Neoplasms - therapy
  • Breast Oncology
  • Carcinoma, Ductal, Breast - secondary
  • Carcinoma, Ductal, Breast - surgery
  • Carcinoma, Ductal, Breast - therapy
  • Carcinoma, Lobular - secondary
  • Carcinoma, Lobular - surgery
  • Carcinoma, Lobular - therapy
  • Combined Modality Therapy - mortality
  • Epidermal growth factor
  • ErbB-2 protein
  • Estrogen receptors
  • Female
  • Follow-Up Studies
  • Humans
  • Mastectomy - mortality
  • Medicine
  • Medicine & Public Health
  • Metastases
  • Middle Aged
  • NCT
  • NCT00557986
  • Neoplasm Invasiveness
  • Neoplasm Metastasis
  • Oncology
  • Patients
  • Progesterone
  • Prognosis
  • Radiotherapy - mortality
  • Receptor, ErbB-2 - metabolism
  • Receptors, Estrogen - metabolism
  • Receptors, Progesterone - metabolism
  • Statistical analysis
  • Surgery
  • Surgical Oncology
  • Survival
  • Survival Rate
ispartof: Annals of surgical oncology, 2018, Vol.25 (11), p.3141-3149
description: 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.
language: eng
source:
identifier: ISSN: 1068-9265
fulltext: no_fulltext
issn:
  • 1068-9265
  • 1534-4681
url: Link


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titleRandomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01
creatorSoran, Atilla ; Ozmen, Vahit ; Ozbas, Serdar ; Karanlik, Hasan ; Muslumanoglu, Mahmut ; Igci, Abdullah ; Canturk, Zafer ; Utkan, Zafer ; Ozaslan, Cihangir ; Evrensel, Turkkan ; Uras, Cihan ; Aksaz, Erol ; Soyder, Aykut ; Ugurlu, Umit ; Col, Cavit ; Cabioglu, Neslihan ; Bozkurt, Betül ; Uzunkoy, Ali ; Koksal, Neset ; Gulluoglu, Bahadir M ; Unal, Bulent ; Atalay, Can ; Yıldırım, Emin ; Erdem, Ergun ; Salimoglu, Semra ; Sezer, Atakan ; Koyuncu, Ayhan ; Gurleyik, Gunay ; Alagol, Haluk ; Ulufi, Nalan ; Berberoglu, Uğur ; Dulger, Mustafa ; Cengiz, Omer ; Sezgin, Efe ; Johnson, Ronald
creatorcontribSoran, Atilla ; Ozmen, Vahit ; Ozbas, Serdar ; Karanlik, Hasan ; Muslumanoglu, Mahmut ; Igci, Abdullah ; Canturk, Zafer ; Utkan, Zafer ; Ozaslan, Cihangir ; Evrensel, Turkkan ; Uras, Cihan ; Aksaz, Erol ; Soyder, Aykut ; Ugurlu, Umit ; Col, Cavit ; Cabioglu, Neslihan ; Bozkurt, Betül ; Uzunkoy, Ali ; Koksal, Neset ; Gulluoglu, Bahadir M ; Unal, Bulent ; Atalay, Can ; Yıldırım, Emin ; Erdem, Ergun ; Salimoglu, Semra ; Sezer, Atakan ; Koyuncu, Ayhan ; Gurleyik, Gunay ; Alagol, Haluk ; Ulufi, Nalan ; Berberoglu, Uğur ; Dulger, Mustafa ; Cengiz, Omer ; Sezgin, Efe ; Johnson, Ronald
descriptionBackground 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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1EISSN: 1534-4681
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3PMID: 29777404
languageeng
publisherCham: Springer International Publishing
subjectAntineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biomarkers, Tumor - metabolism ; Breast cancer ; Breast Neoplasms - pathology ; Breast Neoplasms - surgery ; Breast Neoplasms - therapy ; Breast Oncology ; Carcinoma, Ductal, Breast - secondary ; Carcinoma, Ductal, Breast - surgery ; Carcinoma, Ductal, Breast - therapy ; Carcinoma, Lobular - secondary ; Carcinoma, Lobular - surgery ; Carcinoma, Lobular - therapy ; Combined Modality Therapy - mortality ; Epidermal growth factor ; ErbB-2 protein ; Estrogen receptors ; Female ; Follow-Up Studies ; Humans ; Mastectomy - mortality ; Medicine ; Medicine & Public Health ; Metastases ; Middle Aged ; NCT ; NCT00557986 ; Neoplasm Invasiveness ; Neoplasm Metastasis ; Oncology ; Patients ; Progesterone ; Prognosis ; Radiotherapy - mortality ; Receptor, ErbB-2 - metabolism ; Receptors, Estrogen - metabolism ; Receptors, Progesterone - metabolism ; Statistical analysis ; Surgery ; Surgical Oncology ; Survival ; Survival Rate
ispartofAnnals of surgical oncology, 2018, Vol.25 (11), p.3141-3149
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0Soran, Atilla
1Ozmen, Vahit
2Ozbas, Serdar
3Karanlik, Hasan
4Muslumanoglu, Mahmut
5Igci, Abdullah
6Canturk, Zafer
7Utkan, Zafer
8Ozaslan, Cihangir
9Evrensel, Turkkan
10Uras, Cihan
11Aksaz, Erol
12Soyder, Aykut
13Ugurlu, Umit
14Col, Cavit
15Cabioglu, Neslihan
16Bozkurt, Betül
17Uzunkoy, Ali
18Koksal, Neset
19Gulluoglu, Bahadir M
20Unal, Bulent
21Atalay, Can
22Yıldırım, Emin
23Erdem, Ergun
24Salimoglu, Semra
25Sezer, Atakan
26Koyuncu, Ayhan
27Gurleyik, Gunay
28Alagol, Haluk
29Ulufi, Nalan
30Berberoglu, Uğur
31Dulger, Mustafa
32Cengiz, Omer
33Sezgin, Efe
34Johnson, Ronald
title
0Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01
1Annals of surgical oncology
addtitle
0Ann Surg Oncol
1Ann Surg Oncol
descriptionBackground 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.
subject
0Antineoplastic Combined Chemotherapy Protocols - therapeutic use
1Biomarkers, Tumor - metabolism
2Breast cancer
3Breast Neoplasms - pathology
4Breast Neoplasms - surgery
5Breast Neoplasms - therapy
6Breast Oncology
7Carcinoma, Ductal, Breast - secondary
8Carcinoma, Ductal, Breast - surgery
9Carcinoma, Ductal, Breast - therapy
10Carcinoma, Lobular - secondary
11Carcinoma, Lobular - surgery
12Carcinoma, Lobular - therapy
13Combined Modality Therapy - mortality
14Epidermal growth factor
15ErbB-2 protein
16Estrogen receptors
17Female
18Follow-Up Studies
19Humans
20Mastectomy - mortality
21Medicine
22Medicine & Public Health
23Metastases
24Middle Aged
25NCT
26NCT00557986
27Neoplasm Invasiveness
28Neoplasm Metastasis
29Oncology
30Patients
31Progesterone
32Prognosis
33Radiotherapy - mortality
34Receptor, ErbB-2 - metabolism
35Receptors, Estrogen - metabolism
36Receptors, Progesterone - metabolism
37Statistical analysis
38Surgery
39Surgical Oncology
40Survival
41Survival Rate
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1Ozmen, Vahit
2Ozbas, Serdar
3Karanlik, Hasan
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5Igci, Abdullah
6Canturk, Zafer
7Utkan, Zafer
8Ozaslan, Cihangir
9Evrensel, Turkkan
10Uras, Cihan
11Aksaz, Erol
12Soyder, Aykut
13Ugurlu, Umit
14Col, Cavit
15Cabioglu, Neslihan
16Bozkurt, Betül
17Uzunkoy, Ali
18Koksal, Neset
19Gulluoglu, Bahadir M
20Unal, Bulent
21Atalay, Can
22Yıldırım, Emin
23Erdem, Ergun
24Salimoglu, Semra
25Sezer, Atakan
26Koyuncu, Ayhan
27Gurleyik, Gunay
28Alagol, Haluk
29Ulufi, Nalan
30Berberoglu, Uğur
31Dulger, Mustafa
32Cengiz, Omer
33Sezgin, Efe
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titleRandomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01
authorSoran, Atilla ; Ozmen, Vahit ; Ozbas, Serdar ; Karanlik, Hasan ; Muslumanoglu, Mahmut ; Igci, Abdullah ; Canturk, Zafer ; Utkan, Zafer ; Ozaslan, Cihangir ; Evrensel, Turkkan ; Uras, Cihan ; Aksaz, Erol ; Soyder, Aykut ; Ugurlu, Umit ; Col, Cavit ; Cabioglu, Neslihan ; Bozkurt, Betül ; Uzunkoy, Ali ; Koksal, Neset ; Gulluoglu, Bahadir M ; Unal, Bulent ; Atalay, Can ; Yıldırım, Emin ; Erdem, Ergun ; Salimoglu, Semra ; Sezer, Atakan ; Koyuncu, Ayhan ; Gurleyik, Gunay ; Alagol, Haluk ; Ulufi, Nalan ; Berberoglu, Uğur ; Dulger, Mustafa ; Cengiz, Omer ; Sezgin, Efe ; Johnson, Ronald
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0Antineoplastic Combined Chemotherapy Protocols - therapeutic use
1Biomarkers, Tumor - metabolism
2Breast cancer
3Breast Neoplasms - pathology
4Breast Neoplasms - surgery
5Breast Neoplasms - therapy
6Breast Oncology
7Carcinoma, Ductal, Breast - secondary
8Carcinoma, Ductal, Breast - surgery
9Carcinoma, Ductal, Breast - therapy
10Carcinoma, Lobular - secondary
11Carcinoma, Lobular - surgery
12Carcinoma, Lobular - therapy
13Combined Modality Therapy - mortality
14Epidermal growth factor
15ErbB-2 protein
16Estrogen receptors
17Female
18Follow-Up Studies
19Humans
20Mastectomy - mortality
21Medicine
22Medicine & Public Health
23Metastases
24Middle Aged
25NCT
26NCT00557986
27Neoplasm Invasiveness
28Neoplasm Metastasis
29Oncology
30Patients
31Progesterone
32Prognosis
33Radiotherapy - mortality
34Receptor, ErbB-2 - metabolism
35Receptors, Estrogen - metabolism
36Receptors, Progesterone - metabolism
37Statistical analysis
38Surgery
39Surgical Oncology
40Survival
41Survival Rate
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1Ozmen, Vahit
2Ozbas, Serdar
3Karanlik, Hasan
4Muslumanoglu, Mahmut
5Igci, Abdullah
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8Ozaslan, Cihangir
9Evrensel, Turkkan
10Uras, Cihan
11Aksaz, Erol
12Soyder, Aykut
13Ugurlu, Umit
14Col, Cavit
15Cabioglu, Neslihan
16Bozkurt, Betül
17Uzunkoy, Ali
18Koksal, Neset
19Gulluoglu, Bahadir M
20Unal, Bulent
21Atalay, Can
22Yıldırım, Emin
23Erdem, Ergun
24Salimoglu, Semra
25Sezer, Atakan
26Koyuncu, Ayhan
27Gurleyik, Gunay
28Alagol, Haluk
29Ulufi, Nalan
30Berberoglu, Uğur
31Dulger, Mustafa
32Cengiz, Omer
33Sezgin, Efe
34Johnson, Ronald
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issn1068-9265
eissn1534-4681
abstractBackground 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.
copCham
pubSpringer International Publishing
pmid29777404
doi10.1245/s10434-018-6494-6