Browsing by Author "Aksaz, Erol"

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Primary surgery in patients with de novo stage IV BC; finalizing the protocol MF07-01 randomized clinical trial
(American Association for Cancer Research, 2020-02-15) Soran, Atilla; Özmen, Vahit; Özbaş, Serdar; Karanlık, Hasan; Müslümanoğlu, Mahmut; İğci, Abdullah; Cantürk, Zafer; Utkan, Zafer; Özaslan, Cihangir; Uras, Cihan; Aksaz, Erol; Soyder, Aykut; Uğurlu, Ümit; Çöl, Cavit; Cabıoğlu, Neslihan; Erdem, Ergün; Gürleyik, Günay; Sezgin, Efe; Evrensel, Türkkan; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Dahili Tıp Bilimleri/İç Hastalıkları.; 0000-0002-9732-5340; AAJ-1027-2021
Background. The MF07-01 trial is a multicenter randomized study comparing locoregional treatment (LRT) followed by systemic therapy (ST) with ST alone in de novo Stage IV breast cancer (BC) patients. Aim: To evaluate and finalize the survival data of LRT in patients with the diagnosis of de novo Stage IV BC. 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. Continuous and categorical variable differences between LRT and ST groups were analyzed using t-test and Chi-square test, respectively. Overall survival (OS) and 5-year survival rates were compared using Kaplan-Meier log-rank tests. Univariate and multivariate Cox models were used to estimate hazard ratios, and logistic regession model used to estimate odds ratio. Results. During more than 10 years follow-up, 23% of patients in LRT group and 8% of patients in ST group were alive. Median survival was 46 months for LRT (n=134) and 35 months for ST (n=131) [HR:0.71, 95%CI;0.59-0.86, p=0.0004]. Solitary bone metastasis patients’ median survival was 14 months longer in LRT group comparing ST group [HR:0.55, 95%CI; 0.35-0.86, p=0.008]; 16% of solitary bone metastasis patients in the LRT group were alive, but all patients died in the ST group. Patients younger than 55 lived longer compared the patients older than 55 [HR:0.67, 95%CI; 0.52-0.87, p=0.002], and 26% of hormone receptor positive patients were still alive in the LRT group comparing 10% in the ST group [HR:0.71, 95%CI; 0.58-0.88, p=0.002]. Regarding the patients who lived at least 5 years since randomization, LRT (p=0.003), hormone receptor positivity (p=0.004), Triple negative status (p=0.02), hormonotherapy (p=0.0001), bisphosphonates usage (p=0.03), and 2 or more organ metastases (p=0.004) were associated with OS in univariant analyses. However, in the multivariate model with significant baseline and clinical characteristics only LRT [OR= 1.58, p=0.03] was found to be significantly related with over 5 years of survival. Conclusion. In the current analysis, patients at the diagnosis of de novo stage IV BC who underwent LRT followed by ST had a 58% higher chance to live at least 5 years compared to the patients who received only ST. Longer follow-up of the study discloses that LRT should be presented to patients when discussing treatment options.
Primary surgery with systemic therapy in patients with de novo stage IV breast cancer: 10-year follow-up; protocol MF07-01 randomized clinical trial
(Elsevier Inc., 2021-12) Soran, Atilla; Özmen, Vahit; Özbaş, Serdar; Karanlık, Hasan; Müslümanoğlu, Mahmut; İğci, Abdullah; Cantürk, Nuh Zafer; Utkan, Zafer; Sezgin, Efe; Özaslan, Cihangir; Uras, Cihan; Aksaz, Erol; Soyder, Aykut; Çöl, Cavit; Cabioğlu, Neslihan; Güllüoğlu, Bahadır M.; Erdem, Ergün; Evrensel, Türkkan; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Bölümü.; EXZ-0745-2022; 6603942124
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.
Randomized trial comparing resection of primary tumor with no surgery in stage IV breast cancer at presentation: Protocol MF07-01
(Springer, 2018-10-24) Soran, Atilla; Ozmen, Vahit; Ozbas, Serdar; Karanlık, Hasan; Muslumanoglu, Mahmut; Igci, Abdullah; Canturk, Zafer; Utkan, Zafer; Ozaslan, Cihangir; Uras, Cihan; Aksaz, Erol; Soyder, Aykut; Ugurlu, Umit; Col, Cavit; Cabioglu, Neslihan; Bozkurt, Betül; Uzunkoy, Ali; Koksal, Neset; Gulluoglu, Bahadir M.; Ünal, Bülent; Atalay, Can; Yildirim, Emin; Erdem, Ergun; Salimoglu, Semra; Sezer, Atakan; Koyuncu, Ayhan; Gurleyik, Gunay; Alagol, Haluk; Ulufi, Nalan; Berberoglu, Ugur; Dulger, Mustafa; Cengiz, Omer; Sezgin, Efe; Johnson, Ronald; Evrensel, Türkkan; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı.; 0000-0002-9732-5340; AAJ-1027-2021; 6603942124
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-na < ve stage IV breast cancer (BC) patients. 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. 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). 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.
Validation of breast cancer nomograms for predicting the non-sentinel lymph node metastases after a positive sentinel lymph node biopsy in a multi-center study
(Elsevier, 2010-01) Gür, Serhat; Ünal, Bülent; Özbek, Umut; Özmen, Vahit; Aydoğan, Fatih; Güllüoğlu, Bahadır Mahmut; Aksaz, Erol; Özbaş, Serdar Mustafa; Başkan, Semih; Koyuncu, Ayhan; Soran, Atilla; Gökgöz, Şehsuvar; Uludağ Üniversitesi/Tıp Fakültesi/Genel Cerrahi Anabilim Dalı.; 6603238737
Objective: In the study, our aim was to evaluate the predictability of four different nomograms on non-sentinel lymph node metastases (NSLNM) in breast cancer (BC) patients with positive sentinel lymph node (SLN) biopsy in a multi-center study. Methods: We identified 607 patients who had a positive SLN biopsy and completion axillary lymph node dissection (CALND) at seven different BC treatment centers in Turkey. The BC nomograms developed by the Memorial Sloan Kettering Cancer Center (MSKCC), Tenon Hospital, Cambridge University, and Stanford University were used to calculate the probability of NSLNM. Area under (AUC) Receiver Operating Characteristics Curve (ROC) was calculated for each nomogram and values greater than 0.70 were accepted as demonstrating good discrimination. Results: Two hundred and eighty-seven patients (287) of 607 patients (47.2%) had a positive axillary NSLNM. The AUC values were 0.705, 0.711, 0.730, and 0.582 for the MSKCC, Cambridge, Stanford, and Tenon models, respectively. On the multivariate analysis; overall metastasis size (OMS), lymphovascular invasion (LVI), and proportion of positive SLN to total SLN were found statistically significant. We created a formula to predict the NSLNM in our patient population and the AUC value of this formula was 0.8023. Conclusions: The MSKCC, Cambridge, and Stanford nomograms were good discriminators of NSLNM in SLN positive BC patients in this study. A newly created formula in this Study needs to be validated in prospective studies in different patient populations. A nomogram to predict NSLNM in patients with positive SLN biopsy developed at one institution should be used with caution.
Validation of breast cancer nomograms for predicting the non-sentinel lymph node metastases after a positive sentinel lymph node biopsy in a multi-center study (vol 36, pg 30, 2010)
(Elsevier, 2011-05) Gür, Serhat; Ünal, Bülent; Özbek, Umut; Özmen, Vahit; Aydoǧan, Fatih; Güllüoǧlü, Bahadır Mahmut; Aksaz, Erol; Özbaş, Serdar Mustafa; Başkan, Semih; Koyuncu, Ayhan; Soran, Atilla; Gökgöz, Şehsuvar; Uludağ Üniversitesi/Tıp Fakültesi/Genel Cerrahi Anabilim Dalı.; 6603238737