PubMed İndeksli Yayınlar Koleksiyonu / PubMed Indexed Publications Collection

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  • Article
    Locoregional Treatment in De Novo Bone-Only Metastatic Breast Cancer: Prospective, Multi-Institutional Real-World Data, BOMETIN, Protocol MF14-1a
    (MDPI, 2025) Soran, Atilla; Demirors, Berkay; Aytac, Ozgur; Ozbas, Serdar; Dogan, Lutfi; Lucci, Anthony
    Introduction: The impact of locoregional treatment (LRT) on survival in de novo bone-only metastatic breast cancer (dnBOMBC) is controversial. This study aims to assess the effect of LRT on survival, utilizing international, prospectively acquired data in this cohort of patients. Materials and Methods: Patients with dnBOMBC were divided into two groups: those receiving systemic therapy only (ST) and those undergoing LRT. Further, patients who received LRT were divided into two subgroups: those who received ST after LRT (LRT+ST group) and those who received ST prior to LRT (ST+LRT group). Factors associated with disease progression, including solitary or multiple bone metastases, were analyzed. Results: There was a total of 744 patients with dnBOMBC treated at each of the participating institutions between 2014 and 2022, with 372 (50%) participants in each arm. Median follow-up was 48 months (32-66, 25-75%). Patients in the LRT group were significantly younger than the ST group [50 (42, 60) vs. 55 (44, 66), p = 0.0001]. There were no significant differences in grade, HER2 status, triple-negative status, receipt of hormonal therapy, or intervention to metastatic sites. During follow-up, 58% (n = 217) of patients in the ST group and 32% (n = 120) of patients in the LRT group died (p < 0.001). Local progression was observed in 20% of the patients in the ST group, whereas 9% progressed in the LRT group (p = 0.0001). Systemic progression occurred more in the ST group; 66% (n = 244) compared to 41% (n = 152) of patients in the LRT group (p < 0.001). The hazard of death was 64% lower in the LRT group than in the ST group (HR: 0.36, 95% CI: 0.29-0.45, p < 0.0001). The burden of metastatic disease differed significantly between the two groups, with a higher rate of solitary bone metastases in the LRT group compared to the ST group (50% vs. 24%, p < 0.001). However, the LRT group had better overall survival (OS) for both solitary (HR: 0.38, 95% Cl: 0.26-0.55) and multiple (HR: 0.38, 95% Cl: 0.29-0.51) bone metastasis patients. Within the LRT group, survival rates were similar whether the breast surgery was performed before or after ST. Multivariate Cox analysis showed that LRT and ER/PR positivity significantly decrease the hazard of death (p < 0.05). Conclusions: Analysis of this large multi-institutional patient cohort provides further evidence that LRT is associated with longer OS and lower locoregional recurrence rates in patients with dnBOMBC. In breast cancer patients with bone-only metastases at presentation, the decision for LRT should be made through a multidisciplinary approach with consideration of surgical therapy at the primary tumor.
  • Article
    Citation - WoS: 1
    Citation - Scopus: 1
    A Pragmatic Grouping Model for Bone-Only De Novo Metastatic Breast Cancer (MetS Protocol MF22-03)
    (MDPI, 2025) Goktepe, Berk; Demirors, Berkay; Senol, Kazim; Ozbas, Serdar; Sezgin, Efe; Lucci, Anthony; Soran, Atilla
    De novo metastatic breast cancer (dnMBC) accounts for 3-10% of newly diagnosed cases, with 20-40% presenting as a bone-only metastatic disease, which can achieve survival outcomes exceeding 10 years with multimodal therapy. However, the role of multimodal therapy remains controversial in the guidelines. Objective: This study aims to identify dnBOMBC subgroups to develop a pragmatic staging system for guiding locoregional therapy decisions. Materials and Methods: Data from the MF07-01 phase III randomized trial (2021, median follow-up time (mFT): 40 months (range 1-131)) and the BOMET prospective multi-institutional registry trial (2021, mFT: 34 months (range 25-45)) were combined for analysis, including only patients who presented with bone-only metastases. Exclusion criteria were patients under 18 and those with a history of prior cancer or cancer metastases. Patients with missing data and positive surgical margins were excluded. Out of 770 patients, 589 were included. Survival analyses were first conducted according to molecular subgroups, after which patients were further stratified by hormone receptor status, human epidermal human epidermal growth factor receptor 2 (HER2) status, tumor grade, and clinical T (cT) stage. Group A (GrA) included hormone receptor (HR)-positive, low- or intermediate-grade tumors at any cT; HR-positive, high-grade tumors with cT0-3; or any HER2-positive tumors. Group B (GrB) included HR-positive, high-grade tumors with cT4 disease or any triple-negative (TN) tumors. Results: The hazard of death (HoD) was 43% lower in GrA than in GrB. Median OS was 65 months (39-104) for GrA patients and 44 months (28-72) for GrB patients (HR 0.57, 95% CI 0.41-0.78, p = 0.0003). Primary tumor surgery (PTS) significantly improved OS in GrA patients, regardless of the number of metastases (solitary: HR, 0.375, 95% CI 0.259-0.543, p < 0.001; multiple: HR 0.435, 95% CI 0.334-0.615, p < 0.001). Conversely, GrB patients did not experience a significant benefit from PTS. Conclusions: This study demonstrates that GrA patients have better OS than GrB patients, and PTS reduces the HoD in GrA patients compared to systemic therapy alone. These findings support using a modified staging system in dnBOBMC to identify patients who may benefit from multimodal therapy including PTS.
  • Article
    Biologically Informed Decision-Making for PMRT in PT3N0M0 Luminal Breast Cancers (Protocol MF22-02): International Multicenter Real-World Data
    (Cig Media Group, Lp, 2025) Soran, Atilla; Gultekin, Melis Bahadir; Venkatesulu, Bhanu Prasad; Barry, Parul Nafees; King, Caleb; Bhargava, Rohit; Vargo, John Austin
    Two hundred and 2 women from 16 centers with pT3N0M0 hormone receptor (HR) positive, HER2 negative BC who underwent mastectomy were retrospectively analyzed. Patients were divided into 2 groups: PMRT (n = 130) and no PMRT (n = 69). Groups were compared in terms of overall survival (OS), loco-regional recurrence (LRR) rate, and distant metastases (DM) in light of Magee Equations Score (MS). At a median follow-up of 51.3 months for the no PMRT group and 65.9 months for the PMRT group (P =.041), 9% (n = 6) of patients from the no PMRT group and 2% (n = 3) from the PMRT group developed LRR (P = 0.047). There was no difference in local recurrence (1% in no PMRT group vs. 2% in PMRT group; P =.7) and distant recurrence (7% in no PMRT group vs. 3% in PMRT group; P =.16) in patients who received PMRT and no PMRT. Further comparison of the LRR in the no PMRT and PMRT groups in patients with an MS < 18 did not show a significant difference (3% vs. 4%; P =.64). However, among patients with an MS >= 18, no PMRT group had a higher LRR rate compared to the PMRT group (11% vs. 2%; P =.01). In patients with an MS >= 18, the administration of PMRT correlates with statistically significantly better LRR-free survival (HR 0.19; 95% CI 0.05-0.79; P =.02). Patients with MS <18 experience a comparable rate of recurrence irrespective of PMRT, while those with MS >= 18 have higher rates of LRR and thus should not omit PMRT. Background: Current guidelines do not list definitive recommendations for postmastectomy radiation therapy (PMRT) in patients with luminal pT3N0M0 breast cancer (BC). Increased data suggests de-escalation of radiation therapy (RT) in genomically defined biologically favorable luminal BCs. The goal of this study is to determine whether PMRT can be safely omitted for this specific subgroup of patients. Methods and materials: Two hundred and 2 women from 16 centers with pT3N0M0 hormone receptor (HR) positive, HER2 negative BC who underwent mastectomy were retrospectively analyzed. No patients received neoadjuvant chemotherapy. Three patients were excluded because of positive surgical margins. Patients were divided into 2 groups: PMRT (n = 130) and no PMRT (n = 69). Groups were compared in terms of overall survival (OS), loco-regional recurrence (LRR) rate, and distant metastases (DM) in light of the Magee Equations Score (MS), menopausal status/age, axillary surgery, pathology, lymphovascular invasion (LVI), adjuvant chemotherapy, and adjuvant endocrine therapy. Results: The majority of the patients had invasive ductal carcinoma (49%, n = 98). There was no significant difference regarding tumor size, axillary surgery, and adjuvant endocrine therapy between the 2 groups (P =.82, P =.28, P =.12, respectively). LVI was 19% (n = 39), and it was greater in the PMRT group (25% vs. 10%; P =.01). Patients in the PMRT group received more chemotherapy (66% vs. 30%; P <.001), had more grade 3 tumors (28% vs. 9%, P =.005), and were more premenopausal (49% vs. 22%; P =.0001). At a median follow-up of 51.3 months for the no PMRT group and 65.9 months for the PMRT group (P =.041), 9% (n = 6) of patients from the no PMRT group and 2% (n = 3) from the PMRT group developed LRR (P =.047). There was no difference in local recurrence (1% in no PMRT group vs. 2% in PMRT group; P =.7) and distant recurrence (7% in no PMRT group vs. 3% in PMRT group; P =.16) in patients who received PMRT and no PMRT. Further comparison of the LRR in the no PMRT and PMRT groups in patients with an MS < 18 did not show a significant difference (3% vs. 4%; P =.64). However, among patients with an MS >= 18, no PMRT group had a higher LRR rate compared to the PMRT group (11% vs. 2%; P =.01). In patients with an MS >= 18, the administration of PMRT correlates with statistically significantly better LRR-free survival (HR 0.19; 95% CI 0.05-0.79; P =.02). Conclusions: Our findings imply that when considering PMRT for patients with pT3N0M0, HR-positive, and HER2-negative BC, clinicians can benefit from a combination of pathological risk factors and recurrence prediction models. Patients with MS < 18 experience a comparable rate of recurrence irrespective of PMRT, while those with MS >= 18 have higher rates of LRR and thus should not omit PMRT. (c) 2025 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
  • Article
    Citation - WoS: 6
    Citation - Scopus: 4
    Early Detection of Breast Cancer-Related Lymphedema: Accuracy of Indocyanine Green Lymphography Compared With Bioimpedance Spectroscopy and Subclinical Lymphedema Symptoms
    (Mary Ann Liebert, 2023) Soran, Atilla; Bengur, Fuat Barış; Rodriguez, Wendy; Chroneos, Maria Z.; Sezgin, Efe
    Introduction: The reported incidences of breast cancer-related lymphedema (LE) affecting the arms vary greatly. Reason for this variability includes different diagnostic techniques used across studies. In the current study, we compared the accuracy of indocyanine green lymphography (ICG_L) and bioimpedance spectroscopy (BIS) in detecting LE before presentation of clinical signs.Methods and Results: Patients with no initial detectable signs of clinical LE of their arms after axillary lymph node dissection or removal of >5 lymph nodes on sentinel lymph node biopsy were included. Subclinical LE was defined as BIS values outside the normal range [(>= 7 units (or >10 units)] or a 7-unit (or 10 unit) change between two measurements. We tracked ICG_L and BIS measurements for 133 potentially affected arms (n = 123). ICG_L detected signs of lymphatic flow disruption in 63 arms (47%). Based on the BIS value of 7 units, 60 arms (45%) had values outside the normal range. When using ICG_L-identified LE cases as true positives, BIS had a 54% accuracy (area under the curve [AUC] = 0.54) in detecting LE. Accuracy was 61% for subclinical LE symptoms when compared with ICG_L (AUC = 0.62). Both BIS and subclinical LE symptoms had <0.70 AUC-receiver characteristic operator curve, suggesting that BIS and development of subclinical LE symptoms are not adequate for identifying patients with subclinical LE.Conclusion: ICG_L is a reliable diagnostic tool for detecting early signs of lymphatic flow disruption in subclinical LE. Utilizing ICG_L to diagnose subclinical LE followed by a personalized treatment plan may provide patients the best chance of preventing disease progression.
  • Erratum
    Correction: Intervention for Hepatic and Pulmonary Metastases in Breast Cancer Patients: Prospective, Multi-Institutional Registry Study–imet, Protocol Mf 14-02
    (Springer, 2023) Soran, Atilla; Özbaş, Serdar; Özçınar, Beyza; Işık, Arda; Doğan, Lütfi; Şenol, Kazım; Sezgin, Efe
    The authors‘ given names are correct as reflected here. © Society of Surgical Oncology 2022.
  • Article
    Citation - WoS: 1
    Aso Visual Abstract: Intervention for Hepatic and Pulmonary Metastases in Breast Cancer Patients-Prospective, Multi-Institutional Registry Study: Imet; Protocol Mf 14-02
    (Springer, 2022) Soran, Atilla; Özbaş, Serdar; Özçınar, Beyza; Işık, Arda; Doğan, L.; Şenol, Kazım; Dağ, Ahmet; Karanlık, Hasan; Aytaç, Özgür; Karadeniz Çakmak, Güldeniz; Dalcı, Kubilay; Doğan, Mutlu; Sezer, Atakan Y.; Gökgöz, Şehsuvar; Özyar, Enis; Sezgin, Efe
    The aim of our prospective, multicenter registry study was to investigate the importance of interventions for operable lung and/or liver metastasis for breast cancer (BC) survival (https://doi.org/10.1245/s10434-022-12239-z). The results reveal that surgical resection or ablative interventions may contribute to survival in patients with BC with limited number and operable metachronous hepatic/pulmonary metastases. Ultimately, randomized studies will determine whether intervention on lung and liver metastatic sites should be performed. In the meantime, such interventions can be considered on select patients.
  • Article
    Citation - WoS: 6
    Citation - Scopus: 8
    Intervention for Hepatic and Pulmonary Metastases in Breast Cancer Patients: Prospective, Multi-Institutional Registry Study-Imet, Protocol Mf 14-02
    (Springer, 2022) Soran, Atilla; Özbaş, Serdar; Özçınar, Beyza; Işık, Arda; Doğan, Lütfi; Şenol, Kazım; Dağ, Ahmet; Karanlık, Hasan; Aytaç, Özgür; Karadeniz Çakmak, Güldeniz; Dalcı, Kubilay; Doğan, Mutlu; Sezer, Atakan Y.; Gökgöz, Şehsuvar; Özyar, Enis; Sezgin, Efe
    Background: One fourth of early-stage breast cancer cases become metastatic during the follow-up period. Limited metastasis is a metastatic disease condition in which the number of metastatic sites and the extent of the disease both are limited, and the disease is amenable to metastatic intervention. This prospective study aimed to evaluate intervention for limited metastases in the lung, liver, or both. Methods: The study enrolled luminal A/B and/or human epidermal growth factor receptor 2 (HER2)-neu+ patients with operable lung and/or liver metastases in the follow-up assessment after completion of primary breast cancer treatment and patients with a diagnosis of metastasis after 2014. Demographic, clinical, tumor-specific, and metastasis detection-free interval (MDFI) data were collected. Bone metastasis in addition to lung and liver metastases also was included in the analysis. The patients were divided into two groups according to the method of treatment for metastases: systemic therapy alone (ST) group or intervention (IT) group.
  • Article
    Citation - WoS: 4
    Citation - Scopus: 7
    Adding Pneumatic Compression Therapy in Lower Extremity Lymphedema Increases Compliance of Treatment, While Decreasing the Infection Rate
    (Mary Ann Liebert, Inc, 2022) Soran, Atilla; Toktaş, Osman; Grassi, Ariel; Sezgin, Efe
    Background: Lymphedema (LE) is a chronic condition that requires lifelong treatment. Although pneumatic compression therapy (PCT) is one treatment option, current algorithms consider it as an adjunct to standard LE. The purpose of this study is to evaluate the importance of adapting PCT for lower extremity LE (LEL) in relation to patient compliance and rate of infection.</p> Materials and Methods: Patients diagnosed with LEL were followed prospectively. Patient demographics, comorbidities, treatment modality, compliance, infection due to LE, and hospitalization were recorded. LEL patients with no-PCT were also recorded in the same time period to evaluate the treatment compliance and the need for physical therapy visits. The no-PCT group received the standard LE care, whereas the PCT group received the standard LE care plus a new-generation pneumatic compression device.</p> Results: A total of 69 patients were enrolled in this study. The PCT group had 50 patients and no-PCT group had 19 patients. The PCT group had median 58.5 months of LE symptoms, while non-PCT patients had median 23 months of LE symptoms (p = 0.11). Infection rates decreased by 32% and hospitalizations due to infection decreased by 14% after PCT treatment had been initiated. Physical therapy needs decreased by 24% after PCT use. At median 18 months, follow-up compliance for PCT was 84%, but compliance for manual lymphatic drainage was almost half (53%) in no-PCT group.</p> Conclusions: PCT leads to a decrease in infection rate, hospital admissions, and physical therapy (PT) visits in clinically significant LEL. Although there is no cost calculation in this study, it can be correlated to significant cost savings due to a reduction of infection and hospitalization and the need for PT visits. Adoption of PCT offers a superior value proposition to not only patients but also the health care system. Cost analysis should be followed.</p>
  • Article
    Citation - WoS: 34
    Citation - Scopus: 32
    Lymphedema After Sentinel Lymph Node Biopsy: Who Is at Risk?
    (Mary Ann Liebert, Inc., 2021) Işık, Arda; Soran, Atilla; Grasi, Ariel; Barry, Noran; Sezgin, Efe
    Aim: Sentinel lymph node biopsy (SLNB) is the accepted approach to stage the clinically negative axilla. The incidence of lymphedema (LE) after SLNB is about 5%. We hypothesize that patients undergoing axillary excision of >5 lymph nodes (LNs) are at increased risk of developing LE. Methods and Results: A single institution prospective breast cancer database was retrospectively reviewed from January 2013 to December 2017, to identify patients who underwent SLNB and were diagnosed with LE. Inclusion criteria was (1) de novo breast cancer, (2) SLNB in clinically node negative patients, and (3) no preoperative diagnosis LE of an extremity. Exclusion criteria was history of axillary lymph node dissection. Age, body mass index, tumor-node-metastasis status, surgery type, neoadjuvant or adjuvant chemotherapy, radiotherapy, and hormone therapy were analyzed. Of the 3325 patients identified, 2940 patients met the inclusion criteria and were included in the final analysis. Median follow-up time was 24 months. Forty-seven (2%) patients were diagnosed with LE, and nine patients (19%) had >5 LNs excised. LE was diagnosed in 3.7% of patients who had >5 LNs excised versus 1.4% of patients with <= 5 LNs excised. Incidence of LE was higher in patients with >5 LNs excision (p = 0.006). Conclusion: Our study showed that patients have a higher likelihood of developing LE when >5 LNs are excised.
  • Article
    Citation - WoS: 63
    Citation - Scopus: 63
    The Effect of Primary Surgery in Patients With De Novo Stage Iv Breast Cancer With Bone Metastasis Only (protocol Bomet Mf 14-01): a Multi-Center, Prospective Registry Study
    (Springer, 2021) Soran, Atilla; Doğan, Lütfi; Işık, Arda; Özbaş, Serdar; Trabulus, Didem Can; Demirci, Umut; Sezgin, Efe
    Background More evidence shows that primary surgery for de novo metastatic breast cancer (BC) prolongs overall survival (OS) in selected cases. The aim of this study was to evaluate the role of locoregional treatment (LRT) in BC patients with de novo stage IV bone only metastasis (BOM). Methods The prospective, multicenter registry study BOMET MF14-01 was initiated in May 2014. Patients with de novo stage IV BOM BC were divided into two groups: those receiving systemic treatment (ST group) and those receiving LRT (LRT group). Patients who received LRT were further divided into two groups: ST after LRT (LRT + ST group) and ST before LRT (ST + LRT group). Results We included 505 patients in this study; 240 (47.5%) patients in the ST group and 265 (52.5%) in the LRT group. One hundred and thirteen patients (26.3%) died in the 34-month median follow-up, 85 (35.4%) in the ST group and 28 (10.5%) in LRT group. Local progression was observed in 39 (16.2%) of the patients in the ST group and 18 (6.7%) in the LRT group (p = 0.001). Hazard of death was 60% lower in the LRT group compared with the ST group (HR 0.40, 95% CI 0.30-0.54, p < 0.0001). Conclusion In this prospectively maintained registry study, we found that LRT prolonged survival and decreased locoregional recurrence in the median 3-year follow-up. Timing of primary breast surgery either at diagnosis or after ST provided a survival benefit similar to ST alone in de novo stage IV BOM BC patients.