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INTRODUCTION Extreme hypofractionation in patients with early-stage breast cancer has been studied in randomized phase III non-inferiority trials. There is scarce data on this strategy in Latin American patients. OBJECTIVES To describe the profile of patients diagnosed with breast cancer treated with radiotherapy with an ultra-hypofractionated regimen (5 fractions of 5.2 Gy, in one week), as well as the dosimetric aspects and acute toxicity related to the treatment. METHOD Retrospective cohort through a Brazilian uni-institutional series, with analysis of pathological, dosimetric, and toxicity variables. RESULTS Between May 2020 and March 2022, 67 patients were included, with a median age at diagnosis of 71 years (41-93). Regarding staging, 25.8% had in situ tumors, 60.6% of patients were IA, and only 3% were stage IIA. Nineteen percent of patients had histological grade 3; 24.6%, had nuclear grade 3. Hormone receptors were positive in 92.1% of patients. The mean ki67 was 19%, and HER2 was negative at 84.5%. All patients underwent conservative surgery, and 5 underwent reconstruction with autologous flaps. Fifty-one patients underwent hormone therapy and only 2 underwent adjuvant chemotherapy. All but two patients were treated with the conformal technique (VMAT was used due to unfavorable anatomy). The mean volume of the irradiated breast was 926 cm3 (ranging from 920 to 932 cm3). Regarding the constraints of the organs at risk, the average V8Gy of the ipsilateral lung was 11.4%, ranging from 0 to 24%. In the heart, the average volumes receiving 1.5Gy and 7Gy were, respectively, 9.2% and 0.7%. No patient had acute toxicity greater than grade 2. The effects on the skin appeared on average 20 days after the end of treatment, with resolution in a maximum of 3 months. The median follow-up time was 10 months (3 - 26). We did not observe any case of local-recurrence, of breast-cancer-related death. CONCLUSION Although our follow-up time is premature, we have found that ultra-hypofractionated radiotherapy was feasible, tolerable, and safe, for patients with early breast cancer. Also, the constraints on the organs at risk were respected. There were no high-grade acute toxicities. Besides convenience, ultra-hypofractionation can improve access to radiotherapy in resource-scarce settings. Citation Format: Leticia Hernandes de Brito, Felipe Cicci Farinha Restini, Maria Thereza Mansur Starling, Gabriela Silva Moreira de Siqueira, Gustavo Nader Marta, Heloisa de Andrade Carvalho, Samir Abdallah Hanna. Ultra-hypofractionated Radiotherapy for Breast Cancer: A Brazilian Single-Institutional Series [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-10-03.

IntroductionMale breast cancer (MBC) is uncommon tumor that represents only 0,5% of all tumor diagnoses in men. In general, the age of incidence of MBC is, on average, 5-10 years later than women and have more advanced stage at diagnosis and worse prognosis. International recommendations for staging and treatment for MBC are the same as female breast cancer. Due to the rarity of the tumor, few data are available related to MBC. The aim of this study was to evaluate the clinicopathological characteristics, treatment trends and survival outcomes in MBC in Sao Paulo State of Brazil.MethodsThis population-based study had included men diagnosed with invasive breast cancer between January 2000 and June 2020 from Fundação Oncocentro de Sao Paulo. Patients were described according to age, education level, treatment modalities and medical practice. Categorical variables are described as percentages and frequencies. The association between demographic and treatment factors and overall survival was evaluated using a Cox Proportional Hazard (PH) regression model while accounting for different lengths of participant follow-up. Uni- and multivariable Cox proportional-hazards model were used to estimate hazard ratios with corresponding 95% confidence intervals for OS. The Kaplan-Meier (KM) curves were used to visually display survival curves, and the log-rank test were used to compare the estimated KM curves. ResultsA total of 907 MBC patients were included (825 patients had invasive ductal carcinoma; 64, had invasive lobular carcinoma;18, had especial subtypes). The age at diagnosis were 70y in 12.2%, 51.5% and 27.1% of patients, respectively. The proportion of stage I, II, III and IV were 19.5%, 36.6%, 31,5% and 12.3%, respectively (Table 1). OS by stage at diagnosis was presented in the Figure 1. For each stage I, II, III and IV, 5- and 10-years OS were, respectively, 87.9% and 77.8%, 79.9% and 58.9%, 51.6% and 24.5%, 20.0% and 5.6%. In the multivariable analyses adjusted for practice (public or private), education (low or medium/high), age, stage at diagnosis and treatment. modalities, the significant independent predictor for OS was stage at diagnosis only Figure 2. ConclusionMBC tends to be diagnosed at a more advanced stage and older age at the time of diagnosis. Type of practice, age, treatment modalities and educational level did not influence survival outcomes. Stage at diagnosis was the most important factor related to the OS. Citation Format: Ridânia de Oliveira Frederice, Allan AndressonLima Pereira, Felipe EduardoMartins de Andrade, Samir Abdallah Hanna, Heloisa de Andrade Carvalho, Gustavo Nader Marta. Characteristics and survival outcomes of male breast cancer in Sao Paulo state of Brazil: A population-based study [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-12-27.

Aim To show three patients with soft tissue sarcomas of distal extremities conservatively treated after tumor-board discussion, involving margin-free surgery, exclusive intraoperative radiotherapy, and immediate reconstruction. Background Current guidelines show clear and robust recommendations regarding the composition of the treatment of sarcomas of extremities. However, little evidence exists regarding the application of these treatments depending on the location of the primary neoplasia. Tumors that affect the distal extremities present different challenges and make multidisciplinary discussions desirable. Methods/Results We reported 3 patients who were approached with a conservative intention, after tumor board recomendation. The goals from the treatment performed were aesthetic and functional preservation, while enruring locoregional control. We had wound healing complications in 2 of the cases, requiring additional reconstruction measures. Patients are followed up for 24, 20 and 10 months; local control is 100%, and functional preservation is 100%. Conclusions Despite being a small series, it was sufficient to illustrate successful multidisciplinary planning, generating a therapeutic result with improved quality of life for patients who had an initial indication for extremity amputation.

Background: Recent medical literature reports that mastectomy rates are increasing in early breast cancer. The reasons for this have not yet been elucidated and appear to be complex and can be related to: availability of immediate reconstruction, expertise of the surgeon, increment of genetic tests and beliefs, unwillingness or impossibility of receipting radiotherapy, and information of the patients themselves. The present study aimed to demonstrate mastectomy rates throughout the years from a single Brazilian institution and to correlate it with age, neoadjuvant therapies and tumor staging. Methods: A retrospective analysis of breast cancer surgeries from patients treated at Hospital Sírio-Libanês cancer center from 2005 to 2018 was performed. The institutional database electronically of physically registered in this period included pathology, radiology, and clinical information. Chi-squared coefficient of correlation was applied for categorical variables analysis of association, and for significant findings a multivariate regression analysis was performed. All statistical analyses were performed in STATA version 15.1C. Results: Medical records from 2,942 patients treated were analyzed. 1,798 mastectomies (including nipple-sparing mastectomies and skin-sparing mastectomies) were performed against 1,144 conservative surgeries (61.11% x 38.89%). The range of mastectomy rates varied from 73.04% (2007) to 48.8% (2018) and mastectomy rates showed a slight decrease (53.84% in 2005 and 48.14% in 2018). Type of surgery (conservative, mastectomy, skin-sparing mastectomy) was associated with neoadjuvant treatment (p Conclusions: These results demonstrate that our mastectomy rates, differently from global trends, did not increase through the past 15 years. These findings are probably related to impossibility of genetic tests in this population, accurate diagnostic techniques and the achievement of higher response rates with neoadjuvant treatment. Interestingly, breast-conserving surgery rates were inversely correlated with older age, which can reflect an individualized therapeutic approach among a subgroup of patients potentially vulnerable to chemo-related toxicity. Citation Format: Thatyane EspósitoGallo Cunha, Thamyse FernandaSá Dassie, Julianne MariaSilva Lima, Max Senna Mano, Lincon Jo Mori, Samir Abdallah Hanna, Sandro ViniciusMachado Melo, Gustavo Nader Marta, Felipe EduardoMartins Andrade. Mastectomy rates in a single Brazilian institution through the past 15 years: Are we following the global trend? [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-20-29.

Objective: The Brazilian health system can be divided into public and private sectors. In the public sector, insurance is provided by the state to all Brazilian citizens (municipal, state, and federal levels). The private sector is comprised of the private health insurance area, with various schemes of health plans or with out-of-pocket expenses. This study proposed to evaluate the breast cancer population characteristics and treatments according to public and private health care systems. Methods: This retrospective cohort study included patients diagnosed with invasive breast cancer, with health insurance information, between January 2000 and June 2020, from the Fundação Oncocentro de Sao Paulo database. Patients were described according to age, gender, level of education, histology of neoplasm, stage at diagnosis, and type of treatment. Categorical variables are described as percentages and frequencies. The association between demographic and treatment factors and overall survival (OS) was evaluated using a Cox proportional hazard (PH) regression model while accounting for different lengths of participant follow-up. Uni- and multivariable Cox PH models were used to estimate hazard ratios with corresponding 95% confidence intervals for OS. The Kaplan-Meier (KM) curves were used to visually display survival curves, and the log-rank test was used to compare the estimated KM curves. Results: A total of 65,543 patients were included. The distribution by age, gender, and histology was the same for public and private systems. The majority of patients were diagnosed on stages I and II (77.8%) in the private system. However, in the public system, it was found more advanced stage disease (67.8% in stages II and III). Patients with metastatic tumor were more common in the public system (11.1% versus 5.3%). Treatment with surgery and, at least, two types of adjuvant therapy as trimodal therapy were the same in both groups (46.6% private versus 46.2% public). KM plot shows 5- and 10-years OS differences in all stages; 10-year OS in stages I, II, III, and IV in private and public systems were, respectively, 81.6 versus 77.5%, 74 versus 63.3%, 55.6% versus 39.6%, and 7.6 versus 6.4%. In the multivariable analyses, the significant independent predictors for OS were private system, age and stage at diagnosis, high-level education, and trimodal therapy. Conclusion: Older patients, less intensive treatment, and lower educational levels were independent predictors for worse OS. Public health system presented a more advanced stage at diagnosis than private care and was associated with worse survival outcomes in Brazilian breast cancer patients.

Background: This study aims to assess the clinical outcomes of patients with spine metastases who underwent stereotactic ablative radiation therapy (SABR) as part of their treatment. SABR has arisen as a contemporary treatment option for spinal metastasis patients with good prognoses. Materials and methods: Between November 2010 and September 2018, Spinal SABR was performed in patients with metastatic disease in different settings: radical (SABR only), postoperative (after decompression and/or fixation surgery), and reirradiation. Local control (LC), pain control, overall survival (OS) and toxicities were reported. Results: Eighty-five patients (corresponding to 96 treatments) with spine metastases were included. The median age was 59 years (range, 23–91). In most SABR (82.3%, n = 79) was performed as the first local spine treatment, while in 12 settings (12.5%), fixation and/or decompression surgery was performed prior to SABR. Two-year overall survival rate was 74.1%, and median survival was 19 months. The LC rate at 2 years was 72.3%. With regard to pain control, among 67 patients presenting with pain before SABR, 83.3% had a complete response, 12.1% had a partial response, and 4.6% had progression. Vertebral compression fractures occurred in 10 patients (11.7%), of which 5 cases occurred in the reirradiation setting. Radiculopathy and myelopathy were not observed. No grade III or IV toxicities were seen. Conclusion: This is the first study presenting a Brazilian experience with spinal SABR, and the results confirm its feasibility and safety. SABR was shown to produce good local and pain control rates with low rates of adverse events.

Because of the strong prognostic value of pathologic complete response (pCR) in early breast cancer (EBC), patients who fail to achieve this outcome have increasingly been eligible to a new treatment modality, namely post-neoadjuvant systemic therapy (PNT). However, adjuvant radiation therapy (RT) retains a crucial role in EBC, and also needs to be timely administered to patients. To address how modern PNT optimally integrates with adjuvant RT is therefore the purpose of this review. How PNT administration optimally integrates with adjuvant RT has varied depending on the type of systemic therapy employed. The introduction of novel “targeted” agents has created new challenges, as for many of them limited information is available on the feasibility of concurrent systemic and RT administration or their optimal sequencing. PNT and RT are both of utmost importance to the management of EBC and need to be timely and safely administered to patients. The optimal strategy to integrate these modalities may vary according to the type of PNT agent and other factors.

Background: The majority of patients diagnosed with glioblastoma develop recurrent disease resulting in poor prognoses. The current study aimed to determine the survival rates of patients diagnosed with glioblastoma in Brazil accounting for the influence of age, treatment modalities, public and private practices, and educational level using a population-based national database. Methods" Patients diagnosed with glioblastoma from 1999-2020 were identified from The Fundacao Oncocentro de Sao Paulo database to create a retrospective cohort. Patients were described according to age, education level treatment modalities and medical practice. In a Cox proportional hazards model, controlled for confounding factors for overall survival, the hazard ratio and 95% CI of overall survival in adults with and without glioblastoma was evaluated. Results: A total of 4,511 patients were included. The median lengths of survival for patients treated in the public and private settings were 8 and 17 months (p

e23533 Background: The accurate classification of sarcomas remains a major challenge due to the diversity and rarity of this group of mesenchymal tumors. In addition to standard microscopy and immunohistochemical techniques, molecular analyses are often required to achieve an appropriate diagnosis. The limited availability of specialized pathology centers, multidisciplinary teams, and diagnostic tools may directly affect the initial evaluation and subsequent treatment plan. Therefore, we sought to characterize the impact of diagnostic review by reference pathologists and molecular assessments in a reference center in Brazil. Methods: We conducted a retrospective analysis of sarcoma samples initially analyzed at outside laboratories and subsequently revised in a reference center by two dedicated pathologists between 01/2014-12/2020. After extracting demographic and tumor characteristics, we assessed the presence of complete discordance (benign versus malignant, sarcoma versus other malignancy), partial concordance (similar diagnosis of connective tumor, but different grade/histological subtype/differentiation), and complete concordance. The concordance for histology or grade, as well as the role of molecular assessments supporting the diagnosis, were also independently determined. Statistical analyses were conducted through the kappa coefficient of agreement, adherence by χ2 test, χ2 test by Person, and Fisher's exact test. Results: A total of 197 cases were included, with a predominance of male patients (57.9%), localized tumors (86.8%), and the median age at diagnosis of 46.3 years. The most common primary sites were lower extremities (34.6%) and retroperitoneum (11.3%). Following the revision, the most frequent histologies were undifferentiated pleomorphic sarcoma (20.3%), liposarcomas (13.1%), and leiomyosarcoma (6.6%). Complete discordance was present in 13.2%, partial discordance in 45.2%, and complete concordance in 41.6% of reviews (p < 0.001). We found a concordance for histology or grade of 53.5% (p < 0.001) and 51.8% (p < 0.001) respectively. Molecular assessments, comprising NGS panels (79.5%) and FISH (20.5%), were performed in 44 (22.3%) cases, with findings of diagnostic relevance in 31.8% of those. Conclusions: In almost 60% of the cases, the initial diagnosis was at least partially modified when revised in a reference center, with a relevant impact of molecular assessments. These findings highlight the importance of managing sarcoma patients in reference centers and justify the assembly of referral networks in countries with limited healthcare resources.

Background: The majority of patients diagnosed with glioblastoma develop recurrent disease resulting in poor prognoses. The current study aimed to determine the survival rates of patients diagnosed with glioblastoma in Brazil accounting for the influence of age, treatment modalities, public and private practices, and educational level using a population-based national database. Methods: Patients diagnosed with glioblastoma from 1999-2020 were identified from The Fundação Oncocentro de São Paulo database to create a retrospective cohort. Patients were described according to age, education level treatment modalities and medical practice. In a Cox proportional hazards model, controlled for confounding factors for overall survival, the hazard ratio and 95% CI of overall survival in adults was evaluated. Findings: A total of 4,511 patients were included. The median lengths of survival for patients treated in the public and private settings were 8 and 17 months (p

Introduction Soft tissue sarcomas (STSs) are rare tumors and constitute only 1% of all tumors in adults. Indeed, due to their rarity, most cases in Brazil are not treated according to primary international guidelines. Methods This consensus addresses the treatment of STSs in the extremities. It was made by workgroups from Brazilian Societies of Surgical Oncology, Orthopaedics, Clinical Oncology, Pathology, Radiology and Diagnostic Imaging, and Radiation Oncology. The workgroups based their arguments on the best level of evidence in the literature and recommendations were made according to diagnosis, staging, and treatment of STSs. A meeting was held with all the invited experts and the topics were presented individually with the definition of the degree of recommendation, based on the levels of evidence in the literature. Results Risk factors and epidemiology were described as well as the pathological aspects and imaging. All recommendations are described with the degree of recommendation and levels of evidence. Conclusion Recommendations based on the best literature regional aspects were made to guide professionals who treat STS. Separate consensus on specific treatments for retroperitoneal, visceral, trunk, head and neck sarcomas, and gastrointestinal stromal tumor, are not contemplated into this consensus.

e12595 Background: Preoperative breast MRI can provide important clinical information on the surgical management of BC patients (pts). However, there is no evidence that it can produce a statistical impact on surgical outcomes in the early BC setting. This retrospective study sought to evaluate whether preoperative MRI was significantly correlated with CSur among early BC pts. Methods: Digital and physical records from 532 pts treated in a specialized BC center in Brazil from 2005 to 2018 were analyzed. The institutional database registered pathological, radiological and clinical information. The categorical variables CSur and MRI were analyzed by Chi-squared coefficient of correlation, whereas significant correlations were included in a multivariate logistic regression model. All statistical analysis were performed in STATA version 15.1C. Results: The present analysis included 532 pts. The diagnosis was suspected through suspicious self-exam in 380 pts (71%), while 129 pts (24%) had altered mammary screening tests. Clinical T and N stages were: T0-1=154pts (29%); T2=179 pts (33%); T3=135 pts (25%); T4=49 pts (9%); N0=267 pts (50%); N1=172 pts (32%); N2=80 pts (15%). Neoadjuvant treatment was performed in 223 pts (42%). MRI was indicated in 248 pts (46%). CSur was performed in 149 pts (28%). Margins were positive in 15 cases. This study found a statistically significant correlation between CSur and MRI ( X2 = 8.07; p=0.018). Although, when controlled for neoadjuvant treatment, T, N, and age, the independent variable MRI was not a statistical predictor of CSur (R=0.008; t=0.25; p=0.8; 95%CI -0.57 – 0.74). Advanced T and neoadjuvant treatment were inversely correlated with CSur in the multivariate analysis (R= -0.11; t= -7.8; p

SUMMARY OBJECTIVE: To assess the cosmetic satisfaction of patients diagnosed with breast cancer submitted to the hypofractionated radiotherapy with IMRT (hIMRT) technique and its correlation with dosimetric data of the radiotherapy planning. MATERIALS AND METHODS: The retrospective cohort study that assessed women with a diagnosis of malignant breast neoplasia submitted to the conservative treatment or radical mastectomy and treated with hIMRT. In the period between August 2007 to December 2014, in a philanthropic / private institution, 170 records were selected. The cosmetic assessment was carried out by means of the Harvard/RTOG/NSABP scale with one-year minimum range after treatment. The collected dosimetric data were: breast / chest wall volume, volume that received 95% (V95%) and 107% (V107%) of the prescribed dose. RESULTS: The volume of the treated breasts ranged from 169 to 2.103 ml (median = 702; IQR: 535 to 914 ml). Median V95% was 86.7% (54.6-96.6%; IQR: 80.0% to 90.6%); eight (5.7%) patients had V95% higher than 95%. Median V107% was 0% (0%-16.3%; IQR: 0.0% to 0.3% and 13); 9.3% patients had V107% higher than 2%. One hundred and thirty-three (78.2%) patients responded to the cosmetic assessment: 99 (74.4%) considered the cosmetic results excellent. Significant associations between cosmetic assessment and breast volume (p=0.875), V95% (p=0.294) e V107% (p=0.301) were not found. CONCLUSION: The cosmetic results showed favorable when using hIMRT, and the lack of correlation with usual the dosimetric data illustrates the capacity of hIMRT to minimize the heterogeneity of the dose in this endpoint, even in voluminous breasts. RESUMO OBJETIVO: Avaliar a satisfação cosmética de pacientes diagnosticadas com câncer de mama submetidas à radioterapia hipofracionada com técnica IMRT (hIMRT) e sua correlação com dados dosimétricos do planejamento radioterápico. MATERIAIS E MÉTODOS: Estudo de coorte retrospectivo que avaliou mulheres com diagnóstico de neoplasia maligna de mama submetidas a tratamento conservador ou mastectomia radical e tratadas com hIMRT. No período de agosto de 2007 a dezembro de 2014, em uma instituição filantrópica/particular, foram selecionados 170 prontuários. A avaliação cosmética foi feita por meio da escala de Harvard/RTOG/NSABP com um intervalo mínimo de um ano após o tratamento. Dados dosimétricos coletados foram: volume da mama/plastrão, volume que recebeu 95% (V95%) e 107% (V107%) da dose prescrita. RESULTADOS: O volume das mamas tratadas variou de 169 a 2.103 ml (mediana = 702; IQR: 535 a 914 ml). O V95% mediano foi 86,7% (54,6-96,6%; IQR: 80,0% a 90,6%); oito (5,7%) pacientes tiveram o V95% superior a 95%. O V107% mediano foi 0% (0%-16,3%; IQR: 0,0% a 0,3% e 13); 9,3% pacientes tiveram o V107% superior a 2%. Cento e trinta e três (78,2%) pacientes responderam à avaliação cosmética: 99 (74,4%) consideraram o resultado cosmético excelente. Não foram encontradas associações significativas entre a avaliação cosmética e o volume da mama (p=0,875), V95% (p=0,294) e V107% (p=0,301). CONCLUSÕES: Os resultados cosméticos mostraram-se favoráveis com o uso de hIMRT, e a ausência de correlação com os dados dosimétricos usuais ilustra a capacidade do hIMRT em minimizar a heterogeneidade da dose neste desfecho, mesmo em mamas volumosas.

Background and purpose: Accelerated partial breast irradiation (APBI) is the strategy that allows adjuvant treatment delivery in a shorter period of time in smaller volumes. This study was undertaken to assess the effectiveness and outcomes of APBI in breast cancer compared with whole-breast irradiation (WBI). Material and methods: Systematic review and meta-analysis of randomized controlled trials of WBI versus APBI. Two authors independently selected and assessed the studies regarding eligibility criteria. Results: Eight studies were selected. A total of 8653 patients were randomly assigned for WBI versus APBI. Six studies reported local recurrence outcomes. Two studies were matched in 5years and only one study for different time of follow-up. Meta-analysis of two trials assessing 1407 participants showed significant difference in the WBI versus APBI group regarding the 5-year local recurrence rate (HR=4.54, 95% CI: 1.78–11.61, p =0.002). Significant difference in favor of WBI for different follow-up times was also found. No differences in nodal recurrence, systemic recurrence, overall survival and mortality rates were observed. Conclusions: APBI is associated with higher local recurrence compared to WBI without compromising other clinical outcomes.

Prostate cancer is the most frequently diagnosed malignancy in men and its incidence has been increasing in the last decades. Diagnosis and treatment of prostate cancer were radically improved after the discovery of prostatic-specific antigen. Early detection rates increased, especially in asymptomatic individuals, confirmed by recent published randomized trials. The impact of screening in overdiagnosis and overtreatments is discussed, since benefits in overall mortality rates were not clearly demonstrated. Perhaps younger patients with a longer life expectancy would be the ones with the most benefits from screening. This study presents an update of the most important screening methods for prostate cancer as well as the recent recommendations for screening.

Purpose We aim to assess any association between study and self-reported conflict of interest (COI) or trial sponsorship in breast cancer radiation clinical trials. Materials and methods We searched PubMed for all clinical trials (CTs) published between 09/2004 and 09/2014 related to breast cancer. We included only radiotherapy CTs with primary clinical endpoints. We classified eligible trials according to the funding source, presence or absence of conflict of interest, study conclusion and impact factor (IF). Results 1,603 CTs were retrieved. 72 randomized clinical trials were included for analysis. For-profit (PO), not for profit organization (nPO), none and not reported sponsorship rates were 9/72 (12.5%), 35/72 (48.6%), 1/72 (1.4%), 27/72 (37.5%), respectively. Present, absent or not reported COI were found in 6/72 (8.3%), 43/72 (59.7%) and 23/72 (32%) of the CTs, respectively. Conclusion was positive, neutral and negative in 57/72 (79.1%), 9/72 (12.5%) and 6/72 (8.4%) of the trials, respectively. Positive conclusion was reported in 33/44 (75%) funded trials (PO and nPO) and 5/6 (83.3%) CTs with reported COI. On univariate analysis no association with funding source (P=0.178), COI (P=0.678) or trial region (P=0.567) and trial positive conclusion was found. Sponsored trials (HR 4.50, 95CI-0.1.23-16.53;P=0.0023) and positive trials (HR 4.78, 95CI- 1.16-19.63;P=0.030) were more likely to be published in higher impact factor journals in the multivariate analysis. Conclusions nPO funding was reported in almost 50% of the evaluated CTs. No significant association between study conclusion and funding source, COI or trial region was identified. Sponsored trials and positive trials were more likely to be published in higher impact factor journals.

Purpose Image-guided radiotherapy (IGRT) allows more precise localization of the prostate, thus minimizing errors resulting from organ motion and set-up during treatment of prostate cancer. Using megavoltage cone-beam computed tomography (MVCBCT), references such as bones, the prostate itself or implanted fiducial markers can be used as surrogates to correct patient positioning immediately before each treatment fraction. However, the use of fiducials requires an invasive procedure and may increase costs. We aimed to assess whether intra- or periprostatic calcifications (IPC) could be used as natural fiducials. Methods and Materials Data on patients treated with IGRT for prostate cancer with clearly visible IPC and implanted fiducials in both planning CT and MVCBCT images were reviewed. IPC were classified as central when inside the prostate and peripheral when within the planning target volume. Daily deviations in lateral, longitudinal, and vertical directions from baseline positioning using fiducials and using IPC were compared. Results A total of 287 MVCBCT images were obtained and analyzed from 10 patients. The mean ± standard deviation daily deviation (mm) in the lateral, longitudinal, and vertical coordinates were 0.55 ± 3.11, 0.58 ± 3.45, and −0.54 ± 4.03, respectively, for fiducials, and 0.72 ± 3.22, 0.63 ± 3.58, and −0.69 ± 4.26, for IPC. The p values for comparisons (fiducials vs. IPC) were 0.003, 0.653, and 0.078 for lateral, longitudinal, and vertical coordinates, respectively. When cases with central IPC were analyzed ( n = 7), no significant difference was found in such comparisons. Central IPC and fiducials exhibited a similar pattern of displacement during treatment, with equal values for daily displacements in the three directions for more than 90% of measurements. Conclusions Our data suggest that centrally located IPC may be used as natural fiducials for treatment positioning during IGRT for prostate cancer, with potential reductions in the risks and costs associated with fiducial implantation.

SummaryBreast cancer (BC) is the most common malignancy among women. Therapeutic options are based on disease staging, histopathological characteristics, age, and others. The objective of the present study is to carry out an update of the concepts and definitions of radiotherapy (RT) in conservative treatment of early-stage breast cancer, with emphasis on indications, contraindications, RT dose fractionation schedules (classic, hypofractionated and partial breast irradiation), adjuvant RT in ductal carcinoma in situ (DCIS) and molecular predictors of recurrence. MEDLINE, SciELO and Cochrane databases were used for article selection. Adjuvant RT is indicated for patients with BC who underwent conservative breast surgery. In selected patients, hypofractionated or partial breast irradiation can be used. Adjuvant RT should be provided for all patients with DCIS. The correlation of RT and molecular predictors of local and systemic recurrence are not yet well-known.

OBJECTIVES To examine the association between trial sponsorship and conflicts of interest (COI) with clinical trial conclusions for prostate cancer trials related to radiotherapy. MATERIALS AND METHODS The MEDLINE database was searched for all prostate cancer clinical trials published between 2004 and 2013 and identified 1396 studies. Two investigators independently identified trials published in the English language of ≥30 patients, and extracted relevant data. Clinical trials were classified according to trial characteristics, sponsorship source and type, COI, and study conclusion, and analyzed by univariable and multivariable logistic regression. RESULTS Of 240 eligible trials, 160 (67.5%) evaluated drugs without radiotherapy, 60 (25%) involved radiotherapy, and 18 (7.5%) involved procedures without radiotherapy. Of the 60 radiotherapy trials eligible for analysis, positive sponsorship and potential COI were present in 58.3% and 20% of trials, respectively. Study conclusions were positive, negative, or neutral in 78.3%, 5%, and 16.7% of trials, respectively. No association was found between positive conclusions and either industry support of potential COI. Positive conclusions were reported in 86.7% and 83.3% of trials with sponsorship and COI, respectively, as compared with 75.6% and 77.1% of those without sponsorship (P=0.37) and COI (P=0.64). Sponsorship was significantly associated with radiotherapy trials combined with drugs (odds ratio 5.5, P=0.01) and higher-risk disease (odds ratio 4.71, P=0.01). CONCLUSIONS The presence of sponsorship was associated with radiotherapy trials involving drugs or studying higher-risk prostate cancer. However, there were no identified associations between study conclusion and sponsorship type or COI.

INTRODUÇÃO: A razão para a radioterapia parcial da mama em comparação ao tratamento convencional da mama inteira baseia-se em 3 pontos: a) cerca de 90% das recidivas locais ocorre na adjacência do tumor primário; b) é possível estabelecer a equivalência de efetividade entre a dose única e o tratamento fracionado convencional; e c) existem dificuldades logísticas, financeiras e emocionais no tratamento fracionado convencional (falta da disponibilidade do aparelho de radioterapia em muitos municípios e desistência de tratamento das mulheres que iniciam a radioterapia convencional). Em maio de 2004 iniciou-se um estudo prospectivo com a eletronterapia intraoperatória adjuvante no carcinoma inicial invasor de mama, porém com sistemática de tratamento diferente de outras técnicas: ao invés de se usar um acelerador linear portátil e dedicado, utilizou-se o acelerador linear estático convencional. Neste trabalho, buscou-se analisar a frequência de complicações imediatas e tardias; o grau de satisfação estética das pacientes com as mamas após o tratamento; e as taxas de sobrevida livre de doença e sobrevida livre de falha local. MÉTODOS: Coletaram-se dados dos prontuários, buscando informações demográficas, do estadiamento inicial, da avaliação histopatológica intraoperatória (margens cirúrgicas e linfonodo sentinela), dados técnicos da eletronterapia e os achados finais em exame de parafina. Além disso, a frequência de complicações imediatas (até um mês de cirurgia) e tardias (depois de um mês), a estética (um ano da cirurgia, usando a escala de Harvard/NSABP/RTOG) e finalmente os índices de sobrevida global e livre de evento. RESULTADOS: Foram incluídas 169 pacientes e destas 35 foram excluídas devido a critérios intraoperatórios (linfonodo sentinela positivo ou margens positivas). Assim, 134 foram analisadas com idade mediana de 57,9 (40-85,4) anos, em um seguimento mediano de 50,6 (1-97,2) meses. Quatro pacientes desenvolveram recidiva local e três tiveram recorrência regional. As estimativas actuariais em 5 anos de sobrevida global, livre de eventos e livre de falha local foram respectivamente 97, 90,5 e 93,6%. A incidência cumulativa de falha local em 5 anos foi de 3,7%. A incidência global de toxicidade aguda foi de 8,2% e tardia de 26,2%. Os resultados estéticos excelentes, bons, regulares e ruins observados foram respectivamente 70,9%, 14,2%, 3,7% e 3,0%. Os tamanhos de colimador utilizados foram 4 cm em 18,7%, 5 cm em 80,6% e 7 cm de 0,7% dos casos. A energia de elétrons escolhida para tratamento foi de 6 MeV em 7,4%, 9 MeV em 52,2%, 12 MeV em 35,8%, 15 MeV em 3,7%, e 18 MeV em 0,7%. Os aceleradores lineares dedicados apresentam opção de energia de elétron variando até 9 MeV. Sendo assim, 40,29% dessa amostra provavelmente seria sub-tratada em equipamentos dedicados, pois foram necessários valores maiores de energia de elétrons para um tratamento adequado. Todas as pacientes fizeram portal-filme para checagem antes do tratamento e em 72,4% o alinhamento entre o disco de proteção e o colimador foi suficiente. No entanto, 27,6% das pacientes tiveram que ter os discos reposicionados. Nenhum caso de infecção no período perihospitalar fora observado. CONCLUSÕES: A eletronterapia intraoperatória com acelerador linear convencional apresentou baixa frequência de complicações e resultados estéticos desfavoráveis, e foi oncologicamente efetiva INTRODUCTION: The rationale for partial breast radiation therapy when compared to conventional whole breast treatment is based on three points: a) about 90% of local recurrences occur in the adjacent area of the primary tumor, b) it is possible to establish equivalence between the effectiveness of single dose and fractionated conventional treatment, and c) there are logistical, financial and emotional difficulties related to conventional fractionated treatment (lack of availability of radiotherapy facilities in many cities and the high dropout rate of women who start conventional radiotherapy). In May 2004 we started a prospective trial using adjuvant intraoperative electron-beam therapy in early invasive breast cancer, but instead of a dedicated linear accelerator, we used the static conventional linear accelerator. In this study, we aimed to analyze the frequency of early and late complications, the cosmetic satisfaction of patients after treatment, and freedom from disease and local recurrence rates. METHODS: Data were collected from medical records, looking for demographic information, the initial stage, intraoperative and definitive histopathological evaluation of surgical margins and sentinel lymph node, technical data and pathologic staging, and follow-up data. In addition, the frequency of immediate (up to one month of surgery) and late (after one month) complications, aesthetics (one year of surgery, using the scale of Harvard/NSABP/RTOG), and finally the event-free and overal survival were obtained. RESULTS: We included 169 patients and 35 of these were excluded due to intraoperative criteria (positive sentinel lymph nodes or margins). Thus, 134 were analyzed. The median age was 57.9 (40 to 85.4) years and the median follow-up was 50.6 (1 to 97.2) months. Four patients developed local recurrence and three had regional recurrence. The actuarial estimates for overall, event-free, and local failure-free survivals were respectively 97, 90.5, and 93.6%. The crude incidence of local failure at 5 years was 3.7%. The overall incidences of acute and late toxicities were respectively 8.2% and 26.2%. The cosmetic results as excellent, good, fair and bad respectively were observed in 70.9%, 14.2%, 3.7% and 3.0%. Collimator sizes were 4 cm in 18.7%, 5 cm in 80.6%, and 7 cm in 0.7% of cases. The electron energy chosen for treatment was 6 MeV in 7.4%, 9 MeV in 52.2%, 12 MeV in 35.8%, 15 MeV in 3.7% and 18 MeV in 0.7%. The dedicated linear accelerators have electron beam energy ranging up to 9 MeV. Thus, 40.29% of these patients probably would not be treated adequately in dedicated equipment due to the need for higher values of electron energy. All patients underwent portal-film and in 72.4% the alignment between the shielding disc and the collimator was enough. However, in 27.6% of patients it had to be repositioned. No case of infection was observed during perihospitalar time. CONCLUSIONS: Intraoperative electrontherapy using conventional linear accelerator has shown low complications and worsening aesthetics rates, and oncologic efficacy

Purpose. To assess feasibility, efficacy, toxicity, and cosmetic results of intraoperative radiotherapy (IORT) with electrons delivered by standard linear accelerators (Linacs) during breast conserving surgeries for early infiltrating breast cancer (BC) treatment.Materials and Methods. A total of 152 patients with invasive ductal carcinoma (T≤3.0 cm) at low risk for local relapses were treated. All had unicentric lesions by imaging methods and negative sentinel node. After a wide local excision, 21 Gy were delivered on the parenchyma target volume with electron beams. Local recurrences (LR), survival, toxicity, and cosmetic outcomes were analyzed.Results. The median age was 58.3 years (range 40–85); median follow-up was 50.7 months (range 12–101.5). There were 5 cases with LR, 2 cases with distant metastases, and 2 cases with deaths related to BC. The cumulative incidence rates of LR, distant metastases, and BC death were 3.2%, 1.5%, and 1.5%, respectively. Complications were rare, and the cosmetic results were excellent or good in most of the patients.Conclusions. IORT with electrons delivered by standard Linacs is feasible, efficient, and well tolerated and seems to be beneficial for selected patients with early infiltrating BC.

To present local control, complications, and cosmetic outcomes of intraoperative radiation therapy (IORT) for early breast cancer, as well as technical aspects related to the use of a nondedicated linear accelerator.This prospective trial began in May of 2004. Eligibility criteria were biopsy-proven breast-infiltrating ductal carcinoma, age40 years, tumor3 cm, and cN0. Exclusion criteria were in situ or lobular types, multicentricity, skin invasion, any contraindication for surgery and/or radiation therapy, sentinel lymph node involvement, metastasis, or another malignancy. Patients underwent classic quadrantectomy with intraoperative sentinel lymph node and margins evaluation. If both free, the patient was transferred from operative suite to linear accelerator room, and IORT was delivered (21 Gy). Primary endpoint: local recurrence (LR); secondary endpoints: toxicities and aesthetics. Quality assurance involved using a customized shield for chest wall protection, applying procedures to minimize infection caused by patient transportation, and using portal films to check collimator-shield alignment.A total of 152 patients were included, with at least 1 year follow-up. Median age (range) was 58.3 (40-85.4) years, and median follow-up time was 50.7 (12-110.5) months. The likelihood of 5-year local recurrence was 3.7%. There were 3 deaths, 2 of which were cancer related. The Kaplan-Meier 5-year actuarial estimates of overall, disease-free, and local recurrence-free survivals were 97.8%, 92.5%, and 96.3%, respectively. The overall incidences of acute and late toxicities were 12.5% and 29.6%, respectively. Excellent, good, fair, and bad cosmetic results were observed in 76.9%, 15.8%, 4.3%, and 2.8% of patients, respectively. Most treatments were performed with a 5-cm collimator, and in 39.8% of the patients the electron-beam energy used was ≥12 MeV. All patients underwent portal film evaluation, and the shielding was repositioned in 39.9% of cases. No infection or anesthesia complications were observed.Local control with IORT was adequate, with low complication rates and good cosmetic outcomes. More than one-third of patients benefited from the "image-guidance" approach, and almost 40% benefited from the option of higher electron beam energies.

Background Clinically localized prostate cancer may be treated by different approaches of radiation therapy. The aim of this study was to report the results of disease control and toxicity in patients with clinically localized prostate cancer treated with high dose IMRT alone with 1 cm PTV posterior margin. Methods From September 2001 to April 2008, 140 patients with localized prostate cancer were treated with definitive IMRT (dose ≥ 74 Gy) without hormone therapy. Outcomes were measured from the conclusion of radiotherapy. Biochemical failure was defined as PSA nadir + 2.0 ng/dL. Toxicities were assessed using the NCI-CTCAE-version 3.0. Median follow-up was 58 months. Results Biochemical failure occurred in 13.6% of patients. Actuarial 5-year biochemical control rates were 91.7%, 82.5% and 85.9% for low-, intermediate-, and high-risk patients, respectively. Stage T2 patients presented a risk of biochemical failure almost three times higher than stage T1 (RR = 2.91; 95% CI: 1.04; 8.17). Distant metastases occurred in 3 (2%) patients. Five-year metastasis-free and overall survivals were 96% and 97.5%, respectively. Late grade 3 genitourinary and gastrointestinal toxicity rates were, respectively, 1.6% and 3%. Conclusion High-dose IMRT alone with 1 cm posterior PTV margin was effective and safe for patients with localized prostate cancer.

Intensity-modulated radiation therapy (IMRT) provides the possibility of dose-escalation with better normal tissue sparing. This study was performed to assess whether IMRT can improve clinical outcomes when compared with two-dimensional (2D-RT) or three-dimensional conformal radiation therapy (3D-CRT) in patients with head and neck cancer.Only prospective phase III randomized trials comparing IMRT with 2D-RT or 3D-CRT were eligible. Combined surgery and/or chemotherapy were allowed. Two authors independently selected and assessed the studies regarding eligibility criteria and risk of bias.Five studies were selected. A total of 871 patients were randomly assigned for 2D-RT or 3D-CRT (437), versus IMRT (434). Most patients presented with nasopharyngeal cancers (82%), and stages III/IV (62.1%). Three studies were classified as having unclear risk and two as high risk of bias. A significant overall benefit in favor of IMRT was found (hazard ratio - HR=0.76; 95% CI: 0.66, 0.87; p0.0001) regarding xerostomia scores grade 2-4, with similar loco-regional control and overall survival.IMRT reduces the incidence of grade 2-4 xerostomia in patients with head and neck cancers without compromising loco-regional control and overall survival.

1059Background: Several phase III trials of breast IORT have recently been published with findings that have generated significant controversy and discussion. As different techniques were used in these trials in a broad range of patients, it is unclear if the results obtained were due to differences in technique, type of radiation or patient selection. The goal of the current study was to review findings from studies using only electron IORT in appropriately selected patients considered suitable for APBI. Methods: We performed a literature search addressing the use of electron IORT as the sole radiation treatment for early stage breast cancer. Publications that delivered IORT prior to tumor excision, and those that did not deliver the prescription dose as deeply as the chest wall, were excluded. The ASTRO and ESTRO Consensus guidelines were used to select patients from these studies based upon society derived criteria for the application of APBI. ESTRO Good category differs from ASTRO Suitable in that it ...

Brachytherapy is an adequate option as monotherapy for localised prostate cancer. The objective of this study was to evaluate and compare biochemical failure free survival (BFFS) after low-dose-rate brachytherapy (LDRB) alone for patients with prostate cancer using ASTRO and Phoenix criteria, and detect prognostic factors.Data on 220 patients treated between 1998 and 2002 with LDRB were retrospectively analysed. Neoadjuvant hormone therapy was used in 74 (33.6%) patients.Median follow-up was 53.5 months (24-116). Five year BFFS was 83.0% and 83.7% using, respectively, the ASTRO and Phoenix criteria. Low -and intermediate- risk patients presented, respectively, 86.7% and 77.8% 5-year BFFS using the ASTRO definition (p=0.069), and 88.5% and 78.6% considering the Phoenix criteria (p=0.016). Bounce was observed in 66 (30%) patients. Multivariate analysis detected PSA at diagnosis10 ng/ml and less than 50% positive biopsy fragments as favourable prognostic factors, regarding BF using both criteria. For the Phoenix criteria, also Gleason score7 and low-risk group were identified as independent favourable prognostic factors.LDRB alone should be considered mostly for low-risk patients. PSA level was a strong independent prognostic factor. We support the use of the Phoenix criteria for detection of BF in patients submitted to LDRB alone.

Background: Mycosis fungoides (T-cell non-Hodgkin’s lymphoma) is a quite rare neoplasia, which follows an indolent course, characterized by presenting epidermotropism in spite that there is a possibility of compromise of structures like lymph nodes and visceral organs. Its incidence increases starting from the fourth decade of life with posterior drop after more or less the age of 80, having preference for men. Objective: To analyze the role of radiotherapy in the therapeutic approach of patients with diagnosis of mycosis fungoides. Conclusions: Radiotherapy is indicated for patients suffering from mycosis fungoides in all stages especially when the disease has affected more than 50% of the body surface. Starting from stage IB, total skin irradiation is employed with a dose of 30 to 36 Gy with boost at medical criterion.

Background This study aimed to compare the clinical target volumes (CTV) delineated by computed tomography (CT) and positron emission tomography (PET)/CT using fluoro-deoxy-glucose to assess the impact of using PET information for radiotherapy (RT) planning. Methods We retrospectively reviewed data on patients with tumors from different sites who had indications for RT and had undergone RT treatment planning with PET/CT at our institution between July 2003 and July 2009. Statistical analysis included the comparison of CTV planned for treatment only by CT (CTV(CT)) with that by PET/CT (CTV(PET)) using the Wilcoxon test for paired samples. Results Of 105 patients eligible for analysis, 56.2% were men. The most common diagnoses were head and neck cancer (28.6%), lung cancer (21.9%), lymphoma (11.4%), upper gastrointestinal (10.5%), and others (14.3%). Comparison of CTV(CT) and CTV(PET) revealed that RT planning has changed in 77% of cases because of PET/CT additional information, with impact on treatment volume varying according to diagnosis. Despite the absolute difference observed between median CTVs, there was no significant difference between CTV(CT) and CTV(PET) (114 vs. 90.4 ml, respectively; P=0.1266), considering all patients. Nonetheless, a significant difference between CTVs delineated by CT and PET/CT was found when only head and neck, lung and lymphoma cases--representing more than 60% of the sample--were examined (112.5 and 80.7 ml, respectively; P=0.0053). Conclusion We have shown that PET/CT use promotes significant changes in the CTV delineated for treatment of different tumors, modifying RT planning. Our data suggest that PET/CT has a good potential for optimizing RT treatment planning, especially in head and neck, lung, and lymphoma tumors.

Considering the psychosocial beneits obtained with immediate breast reconstruction (IBR), this procedure has been increasingly applied in Brazil, mainly in the immediate surgical context. he two main modalities of IBR used are the ones that employ autogenous tissue or artiicial breast implants or expanders. here is no consensus regarding the ideal time to carry out the IBR within the multimodal context of oncological treatment, especially when there is indication of radiotherapy (RT) ater the mastectomy – which depends on the surgical specimen – and also considering the lack of randomized studies comparing RT preand post-plasty. here is a rationale followed by many large American centers, to choose RT before IBR for two main reasons: Ater the procedure, tissue that does not belong to the breast bed (muscle laps, skin and prosthesis) would be irradiated without need. he IBR carried out before the RT can lead to inadequate planning, either with excessive irradiation of adjacent organs, or insuicient irradiation of the surgical bed and/or lymph node draining. Other obstacles to be faced are related to the size of breast reconstruction that is carried out, which very oten modiies the patient’s anatomy due to the large-volume plasty and the use of expanders with metallic components within the irradiation ield, which can result in regions of under and overdose, clinically translating as a higher chance of developing complications ater the RT. Moreover, breast medialization, symmastia and lat chest naturally impair radiotherapy planning. On the other hand, in addition to the aforementioned psychological gain with the immediate breast reconstruction, another justiication by those supporting this technique is that RT can compromise the skin and subjacent tissue quality, thus impairing the plasty, consequently afecting the cosmetic results. In this context, complications can arise ater IBR folGUSTAVO NADER MARTA, SAMIR ABDALLAH HANNA, EDUARDO MARTELLA, JOAO LUIS FERNANDES DA SILVA

Mycosis fungoides is a rare type of non-Hodgkin's lymphoma of T cells that primarily affects the skin. It is characterized by the presence of erythematous plaques that evolve into ulcerated lesions, tumors throughout the skin or even bone marrow infiltration in advanced stages. Chemotherapy and topical steroids, phototherapy and radiotherapy are treatment options for early cases. This study reports the case of patient with multiple tumor lesions in the skin already biopsied with diagnosis of mycosis fungoides. The patient was refractory to both treatments with topical chemotherapy and phototherapy. It was then indicated total skin irradiation with electrons.

Purpose: To present and evaluate the results of the use of Image Guided Radiotherapy(IGRT) using Megavoltage Cone Beam CT (MVCBCT) in prostate patients with fiducial markers. Method and Materials: 14 patients with 3 gold seed markers each were treated. The treatment unit was a Siemens Primus. The MVCBCT images were acquired using 3 MU, after skin mark alignment, prior to the treatment and registered manually with the planning CT using the seeds as surrogates. The resulting table coordinates shift in each direction (Lateral, Longitudinal and Vertical) to align the prostate in respect to the isocenter was stored. Different action levels (AL) were simulated and population margins (2.5∑+0.7σ) calculated for each scenario considering a residual error of 2 mm for intra‐fraction and observer errors; as well as the fraction of the days that would need table corrections. Results: 335 MVCBCT images were generated. The average prostate localization errors detected prior to the treatment were: 2±2 mm (Lateral), 3±2 mm (Longitudinal), 3±3 mm (Vertical). The population margins calculation for a non‐AL and for ALs from 8 to 2 mm, indicates that the margins for the non‐AL scenario of 5, 7 and 6 mm, in the Lateral, Longitudinal and Vertical directions respectively, can be reduced to 3 mm in all directions, applying IGRT daily with an AL of 3 mm, and thus acting in 84% of the days. Conclusion: The technique enables a fast and precise prostate localization with low dose. The AL is an important choice and will have a direct impact in the CTV to PTV margin that can be used for the procedure. The simulations indicate that with a 3 mm action level, a 3 mm margin could be used and thus reducing toxicity without compromising the local control.

e11560 Background: To report single-institution series of breast intra-operative radiotherapy (IORT) using nondedicated linear accelerator. Methods: Prospective phaseII trial opened in May 2004. El...