Treatment of Granulomatous Mastitis With Steroids: Should the Decision to End the Treatment be Made Radiologically?

Objective: Idiopathic granulomatous mastitis (IGM) is a benign inflammatory breast disease of unknown etiology that affects women in their reproductive period. The most commonly preferred option as first-line treatment is steroids, but the lack of a standard treatment protocol and high recurrence rate after treatment constitutes a recurring challenge during its management. The aim of this study was to investigate whether the decision to end the treatment should be made radiologically or clinically. Materials and Methods: This retrospective cohort study included IGM patients who had complete clinical recovery with steroids and were followed for a minimum of 30 months. Patient demographics, disease severity and findings, treatment regimens and duration, and magnetic resonance imaging (MRI) findings at clinical recovery were assessed for their relation to recurrence. Results: Eighty-nine patients who were clinically completely healed after steroid treatment for IGM were included in the study. At the time of clinical healing, 51 (57.3%) patients had a complete radiological response and 38 (42.7%) had a partial radiological response (PRR) on MRI. Overall, recurrence developed in 22 (24.7%) patients after a median 38.6-month follow-up. Patients who experienced recurrence were significantly older and had PRR when their treatment was stopped upon clinical healing. Conclusion: During the process of clinical healing, the imaging findings revealed that the remaining disease seems to be a significant predictor for recurrence in IGM patients. In patients with PRR, extending the treatment with either prolonged steroid therapy or by surgical excision of the occult residual disease may prevent recurrences in IGM patients.

New Media Platforms for Teaching and Networking: Emerging Global Opportunities for Breast Surgeons.

Background: The framework of breast care is changing rapidly due to the increasing success of systemic therapies for breast cancer, and consequently, surgeons need to adapt themselves to the changing role of surgery in its management. Real-world evidence indicates that breast cancer patient-related outcomes are better if they are managed by specialized physicians and surgeons. On the other hand, the curriculum for the training of breast surgeons is expanding and includes skills that involve newer surgical techniques and nonsurgical technologies. De-escalation of surgery and also the fact that quality of life is becoming one of the priorities in breast cancer management require breast surgeons to be competent in all aspects of multidisciplinary management. Classical teaching including master-apprentice relation-based training is no more sufficient to satisfy the expectations of the trainees. However, on the other hand, the sources for contemporary postgraduate education are relatively scarce when considering these fast changes in the field. Therefore, there is a continuing quest among breast surgeons for finding ways to maintain their professional development. Summary: Classrooms and operating theaters without walls that came with the internet boom brought substantial opportunities for breast surgeons. Platforms such as BreastGlobal, Breastics24 h, Global Breast Hub, Oncoplastic Academy-Brazil, ibreastbook, Virtual Breast Oncoplastic Surgical Simulator, and CluBreast helped surgeons who needed to get contemporary training and interaction for their professional continuous development. Networking sites such as YouTube, Facebook, and Twitter are also among the social media platforms for professional groups to interact. National and global breast surgery societies also provide periodical online meetings and congresses for their members in order to satisfy the ongoing demand for training, interaction, and networking. Therefore, web-based platforms helped many surgeons from different parts of the world who could not afford to travel or did not have time to attend the necessary meetings due to their limited time and resources. Moreover, these online programs may have also encouraged surgeons to pursue specialized training in breast surgery which in turn should be expected to increase the quality of breast care in their countries. Key Messages: The platforms have downsides such as practical training and role modeling are limited and the opportunity of receiving real-time feedback on skills requirements lacks and networking would not be productive as expected. Nevertheless, web-based platforms require certain technology and infrastructure which still could not be provided everywhere.

Prediction of nipple involvement in breast cancer after neoadjuvant chemotherapy: Should we rely on breast MRI to preserve the nipple?

BACKGROUND: Indications for nipple sparing mastectomy (NSM) is extending to post-neoadjuvant chemotherapy (NAC) setting. Eligibility for NSM with an optimum tumor-nipple distance (TND) after NAC is unclear. We examined predictive factors for nipple tumor involvement in patients undergoing total mastectomy following NAC. METHODS: Clinical and pathological data from prospectively collected medical records of women with invasive breast carcinoma, who were undergone NAC and total mastectomy with sentinel lymph node biopsy and/or axillary lymph node dissection were analyzed. PreNAC and postNAC magnetic resonance imaging (MRI) views were examined and a cut-off TND value for predicting the negative nipple tumor status was determined. RESULTS: Among 180 women, the final mastectomy specimen analysis revealed that 12 (7%) had nipple involvement as invasive carcinoma. Patients with nipple involvement had more postNAC multifocal/multicentric tumors (p: 0.03), larger tumors on preNAC and postNAC images (p: 0.002 and p < 0.001), shorter median TNDs on preNAC and postNAC images (7 mm-IQR 1.5-14, p: 0.005 and 8.5 mm-IQR 3-15.5, p < 0.001, respectively), more nipple retraction on preNAC and postNAC images (p: 0.007 and p: 0.006) and more nipple areola complex skin thickening (> 2mm) on preNAC and postNAC images (p < 0.001 and p: 0.01). The best likelihood ratios (LR) belonged to the postNAC positivity of the < 20 mm TND, with a + LR of 3.40, and - LR of 0.11 for nipple involvement. PreNAC positivity of the < 20 mm TND also had a similar - LR of 0.14. CONCLUSION: A TND-cut-off  ≥ 2 cm on preNAC and postNAC MRI was shown to be highly predictive of negative nipple tumor involvement.

Uncertainties and controversies in axillary management of patients with breast cancer.

The aims of this Oncoplastic Breast Consortium and European Breast Cancer Research Association of Surgical Trialists initiative were to identify uncertainties and controversies in axillary management of early breast cancer and to recommend appropriate strategies to address them. By use of Delphi methods, 15 questions were prioritized by more than 250 breast surgeons, patient advocates and radiation oncologists from 60 countries. Subsequently, a global virtual consensus panel considered available data, ongoing studies and resource utilization. It agreed that research should no longer be prioritized for standardization of axillary imaging, de-escalation of axillary surgery in node-positive cancer and risk evaluation of modern surgery and radiotherapy. Instead, expert consensus recommendations for clinical practice should be based on current evidence and updated once results from ongoing studies become available. Research on de-escalation of radiotherapy and identification of the most relevant endpoints in axillary management should encompass a meta-analysis to identify knowledge gaps, followed by a Delphi process to prioritize and a consensus conference to refine recommendations for specific trial designs. Finally, treatment of residual nodal disease after surgery was recommended to be assessed in a prospective register.

Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411).

BACKGROUND: Surgical excision of a non-palpable breast lesion requires a localization step. Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have been developed in the last two decades with the aim of improving outcomes and logistics. METHODS: We performed a systematic review on localization techniques for non-palpable breast cancer. RESULTS: For most techniques, oncological outcomes such as lesion identification and clear margin rate seem either comparable with or better than for WGL, but evidence is limited to small cohort studies for some of the devices. Intraoperative ultrasound is associated with significantly higher negative margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons' and radiologists' attitudes towards these techniques. CONCLUSIONS: Large studies with an additional focus on patient, surgeon, and radiologist preference are necessary. This review aims to present the rationale for the MELODY (NCT05559411) study and to enable standardization of outcome measures for future studies.

Oncoplastic breast consortium recommendations for mastectomy and whole breast reconstruction in the setting of post-mastectomy radiation therapy.

AIM: Demand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario. METHODS: A large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology. RESULTS: The panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR. CONCLUSIONS: The panel endorsed the need for prospective, ideally randomised phase III studies and for surgical and radiation oncology teams to work together for determination of optimal sequencing and techniques for PMRT for each patient in the context of BR.

Association of biochemical and clinical parameters with parathyroid adenoma weight. Turkish-Bulgarian endocrine and breast surgery study group, hyperparathyroidism registry study.

BACKGROUND: Primary hyperparathyroidism (pHPT) caused by a single benign parathyroid adenoma is a common endocrine disorder that is affected by regional differences. Living in different geographical regions reveals differences in the laboratory results and pathological findings, but studies on this subject are not sufficient. The article focuses on biochemical and pathological effects of geographical differences in parathyroid adenoma. In addition, the present study seeks to elaborate on treatment methods and effectiveness of screening in geographical area of Bulgaria and Turkey. METHOD: In this prospective study, 159 patients were included from 16 centres. Demographic characteristics, symptoms, biochemical markers and pathologic characteristics were analysed and compared between 8 different regions. RESULTS: Patients from Turkish Black Sea had the highest median serum calcium (Ca) level, whereas patients from Eastern Turkey had the lowest median serum phosphorus (P) level. On the other hand, there was no significant difference between Ca, parathormone (PTH) and P levels according to regions. Patients from Eastern Turkey had the highest adenoma weight, while patients from Bulgaria had the lowest adenoma weight. The weight of adenoma showed statistically significant differences between regions (p < 0.001). There was a correlation between adenoma weight and serum PTH level (p = 0.05) and Ca level (p = 0.035). CONCLUSION: This study has provided a deeper insight into the effect of the regional differences upon clinicopathological changing and biochemical values of pHTP patients with adenoma. Awareness of regional differences will assist in biochemical screening and treatment of this patient group.

The relative importance of factors influencing the surgeons' choice between mastectomy and breast-conserving surgery for women with breast cancer.

The authors' aim is to provide breast surgeons' perspectives on the relative importance of the criteria for choosing an appropriate surgery method between mastectomy (total removal of a breast) and breast-conserving surgery (removal of a breast cancer tumor and some of the normal tissue that surrounds it) for women with breast cancer by using the multicriteria decision-making method (MCDM). The Analytic Hierarchy Process (AHP), the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS), and Vise Kriterijumska Optimizacija I Kompromisno Resenje (VIKOR) methods are utilized. A decision hierarchy is set with a goal, criteria, and alternatives. We developed our model based on three main criteria, tumor-related, patient-related, and post-operative process-related factors and nineteen sub-criteria, as well as two alternatives, mastectomy and breast-conserving surgery (BCS). An online questionnaire was sent to the breast surgeons; we showed that the most important criteria are post-operative process-related factors, especially the demand for esthetic appearance based on 39 breast surgeons. Conversely, the least significant criteria are tumor-related factors. Furthermore, breast-conserving surgery is selected as the most appropriate surgery method for breast cancer patients using the AHP, TOPSIS, and VIKOR.

Sentinel Lymph Node Biopsy May Prevent Unnecessary Axillary Dissection in Patients with Inflammatory Breast Cancer Who Respond to Systemic Treatment.

BACKGROUND AND OBJECTIVES: Inflammatory breast cancer (IBC) is a rare and aggressive breast cancer treated up-front with systemic treatment. Both breast-conserving surgery and sentinel lymph node biopsy (SLNB) are controversial issues in the management of IBC. In this study, we aimed to assess the feasibility of SLNB in pathologically proven node-positive IBC patients. METHODS: All patients with a histopathological diagnosis of IBC and biopsy-proven metastatic axillary lymph nodes underwent systemic treatment. Patients with a complete clinical response in the axilla who underwent SLNB followed by standard axillary dissection were analyzed. RESULTS: The study consisted of 25 female patients. The identification rate (IR) and the false negativity rate (FNR) were 17/25 and 2/10, respectively. Overall, 9/25 and 7/25 of patients had a complete pathological response (pCR) in the breast and axilla after systemic treatment, respectively. Although the pCR in the axilla was 2/4 in nonluminal HER2-positive patients, the highest IR 4/4 and the lowest FNR 0/2 were determined in these patients. In triple-negative patients, however, the IR was 2/4 and the FNR was found to be 0/2. CONCLUSIONS: SLNB may be considered in selected axilla-downstaged IBC patients including patients with a pCR with HER2-positive and triple-negative tumors. Axillary dissection may be, therefore, omitted in those with negative SLNs.

Value-Based Quality Care for Breast Cancer: More Than Guidelines.

Although guidelines recommend some of the most expensive diagnostic methods and therapies, some patients do have the opportunity to use them, but some others have overused or misused such methods. The cost of cancer care is increasing, but the satisfaction levels of patients and healthcare workers have not increased in line with this rise. Value-based care for cancer, especially breast cancer, should be implemented. For this reason, all unnecessary screening, tests, treatments, and follow-up parameters should be avoided.

Breast-Gynaecological & Immuno-Oncology International Cancer Conference (BGICC) Consensus and Recommendations for the Management of Triple-Negative Breast Cancer.

Background: The management of patients with triple-negative breast cancer (TNBC) is challenging with several controversies and unmet needs. During the 12th Breast-Gynaecological & Immuno-oncology International Cancer Conference (BGICC) Egypt, 2020, a panel of 35 breast cancer experts from 13 countries voted on consensus guidelines for the clinical management of TNBC. The consensus was subsequently updated based on the most recent data evolved lately. Methods: A consensus conference approach adapted from the American Society of Clinical Oncology (ASCO) was utilized. The panellists voted anonymously on each question, and a consensus was achieved when ≥75% of voters selected an answer. The final consensus was later circulated to the panellists for critical revision of important intellectual content. Results and conclusion: These recommendations represent the available clinical evidence and expert opinion when evidence is scarce. The percentage of the consensus votes, levels of evidence and grades of recommendation are presented for each statement. The consensus covered all the aspects of TNBC management starting from defining TNBC to the management of metastatic disease and highlighted the rapidly evolving landscape in this field. Consensus was reached in 70% of the statements (35/50). In addition, areas of warranted research were identified to guide future prospective clinical trials.

The role of loco-regional treatment in long-term quality of life in de novo stage IV breast cancer patients: protocol MF07-01Q.

BACKGROUND/OBJECTIVE: Since more solid evidence has emerged supporting the effectiveness of loco-regional treatment (LRT), clinicians consider LRT a treatment option for selected de novo stage IV breast cancer (BC) patients. This is the first report on long-term quality of life (QoL) in a cohort of patients who were randomized to receive either LRT and then systemic treatment (ST) or ST alone in the protocol MF07-01. We aimed to evaluate QoL in patients living at least 3 years since randomization using scores from the SF-12 health survey. METHODS: SF-12 (V2) forms were completed during visits of patients who were living 36 months after the randomization. We first calculated PCS-12 (Physical Health Composite Scale) and MCS-12 (Mental Health Composite Scale) scores from de novo stage IV BC patients and compared them with the scores of patients diagnosed with stage I-III BC who lived more than 3 years. Further, PCS-12 and MCS-12 scores were compared between the LRT and ST groups with de novo stage IV BC. Additionally, general health, physical functioning, role functioning, bodily pain, vitality, mental health, and social functioning were evaluated and compared between the groups. Considering age-related changes in QoL, we also compared PCS-12 and MCS-12 scores of patients below or above 55 and 65 years of age. Responses to four additional questions (compare your physical health, mental health, daily activities, and energy currently vs. at diagnosis of BC) were recorded, considering cultural differences. RESULTS: There were 81 patients in this analysis; 68% of patients (n = 55) had LRT, and 32% (n = 26) received ST. General health was good or very good in 62% (n = 34) in the LRT group and 66% (n = 17) in the ST-only group (p = 0.63). Mean PCS-12 score was 40.8 + 1.6, and mean MCS-12 score was 43.4 + 2.0 (p = 0.34 and p = 0.54, respectively). PCS-12 and MCS-12 score difference was lower than that of the general Turkish population (PCS-12 = 49.3 + 12.8 and MCS-12 = 46.8 + 13.0) and stage I-III BC patients (PCS-12 = 51.1 ± 0.5, MCS-12 = 45.7 ± 0.6). PCS-12 and MCS-12 scores were similar between the LRT and ST-only groups in patients younger and older than 55 and 65, but QoL scores were much better in stage I-III BC patients younger than 65 when compared to the scores of those with de novo stage IV BC. Although treatment with or without LRT did not affect physical health, mental health, daily activities, and energy at 3 years vs. at diagnosis of BC in de novo stage IV BC patients (p > 0.05), these variables were significantly better in stage I-III BC patients (p < 0.001). CONCLUSION: The current MF07-01Q study demonstrates that patient who had LRT has similar physical and mental health outcomes compared to ST only in a cohort of patients who lived longer than 3 years. Trial registration This study is registered on clinicaltrials.gov with identifier number NCT00557986.

Turkish national consensus on breast cancer management during temporary state of emergency due to COVID-19 outbreak.

OBJECTIVES: Cancer care is excessively influenced by the COVID-19 outbreak for various reasons. One of the major concerns is the tendency for delayed surgical treatment of breast cancer patients. The outbreak has urged clinicians to find alternative treatments until surgery is deemed to be feasible and safe. Here in this paper, we report the results of a consensus procedure which aimed to provide an expert opinion-led guideline for breast cancer management during the COVID-19 outbreak in Turkey. MATERIAL AND METHODS: We used the Delphi method with a 9-scale Likert scale on two rounds of voting from 51 experienced surgeons and medical oncologists who had the necessary skills and experience in breast cancer management. Voting was done electronically in which a questionnaire-formatted form was used. RESULTS: Overall, 46 statements on 28 different case scenarios were voted. In the first round, 37 statements reached a consensus as either endorsement or rejection, nine were put into voting in the second round since they did not reach the necessary decision threshold. At the end of two rounds, for 14 cases scenarios, a statement was endorsed as a recommendation for each. Thirty-two statements for the remaining 14 were rejected. CONCLUSION: There was a general consensus for administering neoadjuvant systemic therapy in patients with node-negative, small-size triple negative, HER2-positive and luminal A-like tumors until conditions are improved for due surgical treatment. Panelists also reached a consensus to extend the systemic treatment for patients with HER2-positive and luminal B-like tumors who had clinical complete response after neoadjuvant systemic therapy.

Idiopathic granulomatous mastitis with erythema nodosum: Is it a variant of clinical presentation indicating treatment resistance? A retrospective cohort study.

Idiopathic granulomatous mastitis (IGM) rarely occurs with erythema nodosum (EN) as a systemic finding. However, the impact of their coexistence on disease severity and response to steroids has not been investigated yet. Patients diagnosed with IGM between September 2014 and October 2018 were divided into two groups according to the presence or absence of EN during the first admission retrospectively. The IGM was more severe in patients with EN as it was presented more often as bilateral and diffuse involvement of the breast. Findings of mastitis did not resolve with steroids in 50% of this group. Repetitive excisions and mastectomy with reconstructions were required to control the disease. Coexistence of EN and IGM was found to be related to bilateral and aggressive involvement, which could be associated with insufficient response to steroids. Associated patients should be informed in terms of the aggressive course, and surgery can be highlighted as a first-line treatment.

National Consensus on Oncoplastic Breast Conserving Surgery in Turkey: Position Paper for the Standardization of Surgical Practice.

OBJECTIVES: The algorithms that define most of the application of oncoplastic breast conserving surgery (OBCS) in breast cancer patients are not clearly defined. Therefore, a consensus survey was conducted between the leading and experienced breast surgeons and oncoplastic breast surgeons in Turkey on the controversial areas of oncoplastic breast surgery. MATERIAL AND METHODS: This consensus survey was carried out on-line through the Consensus software program (www.consensuss.com) under the roof of Turkish Federation of National Societies for Breast Diseases (TFNSBD). After finalizing each proposition, web-based remote access consensus process was performed on the Likert scale using Delphi method with the Consensus (www.consensuss.com) software program. Through the related software, an invitation was sent to 111 people who had at least 5 years of general surgery expertise in Turkey, and who devoted more than 50% of their daily clinical practice to the treatment and surgery of breast diseases. RESULTS: Sixty-two out of 111 people accepted to participate in the panel and made an on-line evaluation. According to the consensus results; Lumpectomy area should be done by placing the clips on at least four walls of the cavity, if the margin of the tumor is clear in central tumors, the distance between the tumor and the nipple is not significantly important, oncoplastic techniques may be used in patients with locally advanced breast cancer after neoadjuvant chemotherapy, in patients who have macromastia with ductal carcinoma in situ or breast cancer, OBCS techniques can be performed, and OBCS should be evaluated in terms of breast aesthetics. After OBCS, re-excision can be performed at a re-do setting in cases with involved surgical margins. CONCLUSION: Our consensus results may provide a basis for the development of some standards in OBCS.

Impact of older age on local treatment decisionss.

Managing elderly breast cancer patients brings challenges both to physicians and patients themselves. There are certain controversial issues regarding local treatment of early breast cancer in this population. Since elderly patients are more likely to have comorbidities and functional limitations, they are more prone to undertreatment. Although surgical treatment in elderly patients were reported to be safe, severity and number of comorbidities are shown to be related with increased complications, hence may lead to higher mortality and lower life quality. Therefore, frailty is one of the concerns which prevents elderly patients to receive standard-of-care local treatment. Nevertheless, breast cancers developing in elderly are more likely to be low grade and luminal type. Until now, primary endocrine treatment without surgical resection, omitting whole breast irradiation after partial mastectomy and avoiding sentinel lymph node biopsy, which are otherwise accepted as standard-of-care, were questionned in healthy, low-risk, elderly fit patients. Two main issues were suggested to be considered when assessing the impact of local treatment options in this patient group; the clinical significance of treatments' effects, and the patients' expectations. Due to their vulnerability, baseline geriatric assessment should be the initial step for management in elderly breast cancer patients. Even in those who are healthy and fit with long life-expectancy, de-escalation in management might be an option in low-risk patients after considering patients' individual expectations and limited clinical benefits of standard local treatment options.

Comparison of Topical, Systemic, and Combined Therapy with Steroids on Idiopathic Granulomatous Mastitis: A Prospective Randomized Study.

BACKGROUND: Idiopathic granulomatous mastitis (IGM) is a benign disorder of the breast, for which the optimal treatment modality remains missing. METHODS: A total of 124 patients with a histopathologically proven diagnosis of IGM were enrolled in a prospective, randomized parallel arm study. Patients were treated with topical steroids in Group T (n: 42), systemic steroids (0.8 mg/kg/day peroral) in Group S (n: 42), and combined steroids (0.4 mg/kg/day peroral + topical) in Group C (n: 40). Compliance with the therapy, response to the therapy, the duration of therapy, side effects and the recurrence rates were compared. RESULTS: Sixteen patients did not comply with the treatment, and the highest ratio of compliance with therapy was seen in Group T (p < 0.05). Complete clinical regression (CCR) was observed in 90 (83.3%) patients. Response to the treatment (RT) was evaluated radiologically and observed in 89.8% of the patients. There was no statistically significant difference between groups regarding CCR, RT and the recurrence rate. The longest duration of therapy was observed in Group T (22 ± 9.1-week), whereas the shortest was observed in Group S (11.7 ± 5.5-week) (p < 0.001). The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively) (p < 0.001). CONCLUSIONS: The efficiency of the treatment was similar for all groups, both clinically and radiologically. Although the duration of therapy was longer in Group T, the lack of systemic side effects increased the compliance of the patients with the therapy. Therefore, topical steroids would be among first-line treatment options of IGM.

Complications Associated with Loco-Regional Treatment of Breast Cancer and Their Impact on Quality-of-Life.

OBJECTIVE: Aim of this prospective study was to determine the complications of different treatment modalities for breast cancer and assess their impact on patients' quality-of-life and psychological status. MATERIALS AND METHODS: Patients surgically treated for early-stage breast cancer were enrolled in the study. Complications after treatment and quality-of-life parameters were measured and recorded. RESULTS: 218 patients, all female with a median age of 48 (19-82) years, were included in the study. In early period, significant limitation of shoulder movements, increased pain and decreased in functional capacity were observed, whereas in mid-term, all shoulder movements, as well as pain and functional capacity returned normal. In both early period and mid-terms, anxiety scores were significantly decreased, whereas depression scores were significantly increased. In early period, there was a significant decrease in physical and mental area scores. Social area scores were significantly increased, whereas environmental, mental and physical area scores were significantly decreased in mid-term and late period. CONCLUSION: Overall, patients' quality-of-life was found to be significantly deteriorated in both early period and mid-term and returned to pre-treatment period at long term follow up.

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 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.