Rates Of Acute Adverse Events Research Articles

Stereotactic Radiosurgery for Intracranial Breast Metastases: A Systematic Review and Meta-Analysis

Background/Objectives: To determine the impact of stereotactic radiosurgery on outcomes of metastatic breast cancer with intracranial metastases. Methods: We systematically searched the PubMed and EMBASE databases for studies published between 1 January 1990 and 1 August 2024. Primary research articles evaluating the outcomes of stereotactic radiosurgery on intracranial metastases from breast cancer were included. Adverse events were defined as leptomeningeal disease, radiation necrosis, seizure, and headache. The pooled estimate was calculated using the DerSimonian and Laird approach. Results: Sixteen studies encompassing 1228 patients met the inclusion criteria. Our analysis revealed a median survival duration of 13.1 ± 3.8 months and a pooled 1-year overall survival rate of 53.1% after SRS treatment. There was a 29% local recurrence rate at 1 year and a 35% overall distant recurrence rate. In addition, our analysis found a relatively low rate of acute adverse events at 15.5%. Conclusions: SRS demonstrates promising efficacy and safety in managing intracranial metastases from breast cancer, with a favorable toxicity profile.

Is Ultrahypofractionated Whole Pelvis Radiation Therapy (WPRT) as Well Tolerated as Conventionally Fractionated WPRT in Patients With Prostate Cancer? Early Results From the HOPE Trial

ObjectiveTo evaluate acute toxicity and quality of life (QOL) impact of ultra-hypofractionated whole pelvis radiotherapy (WPRT) compared to conventional WPRT fractionation post high-dose rate (HDR) prostate brachytherapy (BT). MethodsBLINDED FOR REVIEW is a phase 2, multi-institutional randomized controlled trial involving men with prostate-confined disease and NCCN unfavorable intermediate, high, or very-high-risk prostate cancer. Patients were randomly assigned to receive conventionally fractionated WPRT (standard arm) or ultra-hypofractionated WPRT (experimental arm) in a 1:1 ratio. All patients underwent radiotherapy with 15 Gy HDR-BT boost in a single fraction followed by WPRT delivered with conventional fractionation (45 Gy in 25 daily fractions or 46 Gy in 23 fractions) or ultra-hypofractionation (25 Gy in 5 fractions delivered on alternate days). Acute toxicities, measured during radiotherapy and at 6 weeks post-treatment, were assessed using the clinician-reported Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, and QOL was measured using the Expanded Prostate Cancer Index Composite (EPIC-50) and International Prostate Symptom Score (IPSS). ResultsA total of 80 patients were enrolled and treated across three Canadian institutions. A total of 39 and 41 patients received external radiotherapy with conventionally fractionated and ultra-hypofractionated WPRT, respectively. All patients received androgen deprivation therapy, except for 2 patients treated in the ultra-hypofractionated arm. Baseline clinical characteristics were similar between the two arms, with 51 (63.8%) patients having high or very high-risk prostate cancer disease. Treatment was well tolerated with no significant differences in the rate of acute adverse events between arms. No grade 4 adverse events or treatment-related deaths were reported. Ultra-hypofractionated WPRT had a less detrimental impact in the EPIC-50 bowel total, function and bother domain scores when compared to conventional WPRT in the acute setting. On the contrary, more patients treated with ultra-hypofractionated WPRT reached the minimum clinical important difference on EPIC-50 urinary domains. No significant QOL differences between arms were noted in the sexual and hormonal domains. ConclusionUltra-hypofractionated WPRT following HDR-BT is a well-tolerated treatment strategy in the acute setting and leads to less detrimental impact on bowel QOL domains when compared to conventional WPRT.

Risk of complications in patients undergoing pulmonary vein antrum isolation: a single centre experience

Abstract Background Pulmonary vein antrum isolation (PVAI) is the gold standard approach to treat symptomatic atrial fibrillation (AF) refractory to medical therapy. While PVAI may result in a number of potential complications, there is a growing body of literature supporting safety of same day discharge post-PVAI. Purpose To retrospectively evaluate the incidence of post-procedure acute adverse events (AE), and elucidate factors associated with increased risk of such complications in patients undergoing PVAI. Methods Patients underwent PVAI between 2004-2021 at a tertiary care centre, and were followed-up at 3, 6 and 12 months post-PVAI. All procedures were performed utilizing intra-cardiac echocardiography. Baseline characteristics of patients who experienced acute AE were compared with those in patients who did not. Univariate and multivariate logistic regression models adjusted for age, sex, type of AF, left atrial size, and comorbidities were employed to evaluate risk factors for acute AE. Results 2829 patients (mean age: 61.5±10.4 years, 33.7% female, 64.1% paroxysmal AF) were included in this study. Overall incidence of acute AE was 92 (3.3%), which included: 60 (2.1%) patients with access site hematoma, 20 (0.7%) patients with hematoma requiring treatment, and 12 (0.4%) patients with cardiac tamponade. Other complications included: 5 (0.18%) strokes or transient ischemic attacks (TIA), 3 (0.10%) esophageal fistulas, and 1 (0.03%) phrenic nerve injury. Females (4.2% vs 2%, P=0.001), patients older than 75 years (3.3% vs 2.7%, P=0.8), non-paroxysmal AF (3.4% vs 2.4%, P=0.1), body mass index ≥ 35 kg/m2 (3.6% vs 2.7%, p=0.04), those with an implanted device (6.7% vs 2.3%, p=0.004), and sinus node dysfunction (SND) (6.6% vs 2.5%, p=0.001) had a greater rate of acute AEs. Patients with comorbidities, including hypertension (3.4% vs 2%, P=0.04), Type 2 diabetes ( 3.2% vs 2.7%, p=0.7), congestive heart failure (5.6% vs 2.5%, P=0.008), and coronary artery disease (3.9% vs 2.6%, p=0.1) also manifested higher rate of acute AE. In the multivariate logistic regression model, female sex (OR= 2.5 [1.4, 4.4]), CHF (OR= 2.6 [1.3, 4.9]) and SND (OR=2.6 [1.1, 5.5] were associated with increased AE risk when adjusted for age, AF type, and other comorbidities. Conclusion In the multivariate model, female sex, a history of congestive heart failure, and SND were independently associated with a greater risk of AE following PVAI.

Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma

Patients with locally advanced non-human papillomavirus (HPV) head and neck cancer (HNC) carry an unfavorable prognosis. Chemoradiotherapy (CRT) with cisplatin or anti-epidermal growth factor receptor (EGFR) antibody improves overall survival (OS) of patients with stage III to IV HNC, and preclinical data suggest that a small-molecule tyrosine kinase inhibitor dual EGFR and ERBB2 (formerly HER2 or HER2/neu) inhibitor may be more effective than anti-EGFR antibody therapy in HNC. To examine whether adding lapatinib, a dual EGFR and HER2 inhibitor, to radiation plus cisplatin for frontline therapy of stage III to IV non-HPV HNC improves progression-free survival (PFS). This multicenter, phase 2, double-blind, placebo-controlled randomized clinical trial enrolled 142 patients with stage III to IV carcinoma of the oropharynx (p16 negative), larynx, and hypopharynx with a Zubrod performance status of 0 to 1 who met predefined blood chemistry criteria from October 18, 2012, to April 18, 2017 (median follow-up, 4.1 years). Data analysis was performed from December 1, 2020, to December 4, 2020. Patients were randomized (1:1) to 70 Gy (6 weeks) plus 2 cycles of cisplatin (every 3 weeks) plus either 1500 mg per day of lapatinib (CRT plus lapatinib) or placebo (CRT plus placebo). The primary end point was PFS, with 69 events required. Progression-free survival rates between arms for all randomized patients were compared by 1-sided log-rank test. Secondary end points included OS. Of the 142 patients enrolled, 127 (median [IQR] age, 58 [53-63] years; 98 [77.2%] male) were randomized; 63 to CRT plus lapatinib and 64 to CRT plus placebo. Final analysis did not suggest improvement in PFS (hazard ratio, 0.91; 95% CI, 0.56-1.46; P = .34) or OS (hazard ratio, 1.06; 95% CI, 0.61-1.86; P = .58) with the addition of lapatinib. There were no significant differences in grade 3 to 4 acute adverse event rates (83.3% [95% CI, 73.9%-92.8%] with CRT plus lapatinib vs 79.7% [95% CI, 69.4%-89.9%] with CRT plus placebo; P = .64) or late adverse event rates (44.4% [95% CI, 30.2%-57.8%] with CRT plus lapatinib vs 40.8% [95% CI, 27.1%-54.6%] with CRT plus placebo; P = .84). In this randomized clinical trial, dual EGFR-ERBB2 inhibition with lapatinib did not appear to enhance the benefit of CRT. Although the results of this trial indicate that accrual to a non-HPV HNC-specific trial is feasible, new strategies must be investigated to improve the outcome for this population with a poor prognosis. ClinicalTrials.gov Identifier: NCT01711658.

Ultrarapid Iron Polymaltose Infusions Are Safe for Management of Iron Deficiency

Introduction: Iron deficiency is a common condition, especially among patients with kidney and heart failure and inflammatory bowel disease. Intravenous iron is the preferred method of treatment in these patients, but it usually requires prolonged iron polymaltose infusions or multiple administrations of alternative preparations. The aim of the study was to confirm the safety and patient acceptance of ultrarapid iron polymaltose infusions as an alternative to slower treatments and ferric carboxymaltose. Method: An open-label, phase 4 safety study was conducted at a tertiary hospital, with consenting participants diagnosed with iron deficiency and requiring iron polymaltose up to 1,500 mg receiving the infusion over 15 min. The acute adverse event (AE) rates and their severities were compared to historical controls of 1- and 4-h iron polymaltose infusions from a retrospective study of 648 patients from the same study site. Delayed AEs as well as participant infusion acceptability were also studied. Results: Three hundred participants over a 2-year period received ultrarapid infusions of iron polymaltose with an acute AE rate of 18.7% and severe AE rate of 1.0%. The total and mild infusion AE rates were higher compared to those of slower infusions (p < 0.001), but comparable for moderate and severe AEs. Delayed reactions occurred in 12.5% of participants, with over 95% of them preferring repeat ultrarapid infusions if required again. Conclusion: Iron polymaltose can be safely infused at ultrarapid rates when compared to slower infusions, with similar safety to ferric carboxymaltose, offering greater convenience for patients and reduced healthcare costs.

Comparison of Severe Toxicities Following High Dose Methotrexate Administration By Demographics and over Time in Pediatric Patients with Acute Lymphoblastic Leukemia

Background: Methotrexate (MTX) is a cornerstone of therapy for pediatric patients with acute lymphoblastic leukemia (ALL). Administration of high dose (HD) MTX requires hospitalization and concurrent intravenous fluids and leucovorin while awaiting drug excretion. HDMTX has been associated with acute adverse events (AEs), such as mucositis, neurotoxicity, and myelosuppression, that can impact quality of life and ability to administer subsequent chemotherapy. There are limited data evaluating differences in AEs after HDMTX among demographic groups.Objective: The objective of this study was to describe AEs for patients receiving HDMTX (defined as >500 mg/m2 to account for dose reductions from protocol dosing) and to compare rates by age, race, ethnicity and dose number using a multicenter cohort.Methods: A multi-center retrospective study collected data on pediatric ALL patients ages 0-21 years at diagnosis who received at least one dose of HDMTX at Children's Healthcare of Atlanta or Cincinnati Children's Hospital Medical Center from January 2010 through December 2020. Demographic (age, sex, race, ethnicity) and clinical (vital status, Down Syndrome, HDMTX doses) variables were manually abstracted from the electronic medical record. Algorithms were developed a priori based on Common Terminology Criteria for Adverse Events v5 to identify the presence and grade of targeted AEs after HDMTX administration. The following AEs were abstracted for the time period from each HDMTX dose until the next HDMTX or other chemotherapy administration: mucositis, neurotoxicity, neutropenia, and thrombocytopenia. Only grade 4 neutropenia and grades 3-4 thrombocytopenia were collected. Institutional review board approval was obtained at each site. Descriptive and inferential statistics, including chi-square, Fisher's exact test, and generalized estimating equations (GEE) as appropriate, were calculated to evaluate differences in AEs by dichotomized age (<10, 10+), race, ethnicity, and HDMTX administration number. All analyses were performed using SAS Enterprise Guide v7.1.Results: Across sites, 543 patients with ALL patients received HDMTX (2064 administrations). The median age at first HDMTX was 8.0 years (0.1-21.0); 230 (42.4%) were female, 381 (70.2%) were White, and 441 (81.2%) were Non-Hispanic or Latino (Table 1). The median number of HDMTX administrations was 4.0 (Range 1-10). In total, 469 (86.4%) patients had at least one AE. Mucositis occurred in 386 (71.1%) patients, grade 4 neutropenia occurred in 243 (50.1%) and grade 3-4 thrombocytopenia occurred in 156 (32.2%, Table 2). Mucositis, neurotoxicity, and thrombocytopenia were significantly more likely in patients 10+ years (p=0.02, p<0.01, p<0.01, respectively, Table 2). There were no significant differences in AE rates by race or ethnicity. Table 3 describes percentages of administrations with each AE grade. Half of HDMTX administrations had at least one AE. AE rates decreased significantly from first to fourth administration (67.5% of first and 33.0% of fourth administrations with at least one AE, p<0.01). Rates of mucositis and neurotoxicity individually decreased over administrations (p<0.01, Table 3).Conclusion: AEs after administration of HDMTX are common, with 86% of patients experiencing at least one AE after receipt of HDMTX and half of administrations leading to at least one AE. Greater than half of patients experienced mucositis and neutropenia. Older patients experienced significantly more mucositis, neurotoxicity, and thrombocytopenia. Unsurprisingly, we found that overall the rate of AEs was highest after the first HDMTX administration and decreased significantly across doses, which is likely due to dose reductions in HDMTX or concurrent antimetabolite therapy and to increased supportive care (hydration and leucovorin) after experience of an AE. Chart abstraction is ongoing at a third hospital that will increase the sample size of patients, particularly those of Hispanic/Latino ethnicity, to delineate potential differences by race and ethnicity. In addition, current analyses are evaluating the impact of supportive care and dosing changes between administrations on the burden of HDMTX-related AEs and differences by age. The results of this study will provide valuable data regarding who is at highest risk for AEs and can be used to tailor supportive care during this potentially toxic chemotherapy. [Display omitted] DisclosuresBernhardt: Bristol Myers Squibb: Research Funding; BTG International: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; Jazz Pharmaceuticals: Consultancy; Mesoblast: Membership on an entity's Board of Directors or advisory committees; Servier: Membership on an entity's Board of Directors or advisory committees. O'Brien: Jazz: Honoraria; Pfizer: Honoraria, Research Funding. Ramsey: BTG Specialty Pharmaceuticals: Honoraria, Research Funding.

Long-term effectiveness and adverse effects of ketogenic diet therapy in infants with drug-resistant epilepsy treated at a single center in Argentina

IntroductionKetogenic diet therapy (KDT) is a metabolic treatment with proven effectiveness for the treatment of drug-resistant epilepsy in children. Although previously not used in infants under 2 years of age, recent studies have shown KDT to be highly effective and well tolerated in infants with epilepsy, especially those with epileptic encephalopathies. Here, we describe the effectiveness and tolerability of the diet in infants up to 2 years of age. Material and methodsA prospective study was conducted in a cohort of infants younger than 2 years of age with drug-resistant epilepsy who received the classic ketogenic diet using a specific protocol at a single center in Argentina. Results56 infants with treatment-refractory epilepsy were evaluated. The etiology was genetic in 21.4%, structural in 28.6%, unknown in 44.7%, and metabolic in 5.4%. At 3 months, a > 50% decrease in seizure frequency was observed in 35 patients (62.4%), of whom 11 (19.6%) became seizure free. At 6 months, 34 patients (60.7%) had a decrease in seizure frequency of > 50%, of whom 10 (17.8%) were seizure free. At the one-year follow-up, 27 patients (48.2%) had a > 50% decrease in seizure frequency, of whom six (10.7%) were seizure free. At two years, 14 patients (25%) had a > 50% seizure control, of whom four (7.1%) were seizure free. The most common early adverse effects were hypoglycemia and vomiting, while after 1 month and beyond metabolic acidosis, vomiting, and constipation more commonly found. A trend towards a higher rate of acute adverse events in infants younger than 1 year was observed. ConclusionsCKD showed to be a useful option in infants with treatment-resistant epilepsy. Adverse effects were common, but not a reason to discontinue the diet. Further studies are necessary to evaluate in which epilepsy syndromes and etiologies KDT is most effective.

Real-world comparison of different periprocedural antithrombotic strategies for atrial fibrillation catheter ablation

Abstract Introduction Atrial Fibrillation (AF) catheter ablation carries high bleeding and thromboembolic risks, requiring a detailed assessment of overall risk-benefit profile regarding antithrombotic strategy. Vitamin K Anticoagulant (VKA) and Non-Vitamin K Antagonist Oral Anticoagulant (NOAC) have been used in the latest years in this setting, and with different interruption protocols periprocedural. Our goal was to evaluate the rate of acute adverse events (AAE) and compare them according to antithrombotic strategy used periprocedural, in a real-world basis. Methods A single-center retrospective study, including adult patients admitted to first AF catheter ablation, from 2004 to 2020. Different antithrombotic strategies (anticoagulation with VKA uninterrupted, anticoagulation with NOAC uninterrupted, no therapy or antiaggregation/interrupted ACO) were compared concerning the rate of any clinically relevant AAE; the composite of major AAE (hemopericardium and stroke/transient ischemic attack [TIA]) and minor AAE associated with vascular access. Descriptive statistics and logistic regression were used to compare groups according to the antithrombotic strategy with an alpha level of 0.05. Results Among the 868 patients included (mean age 59±12 yo, 67,5% [n=586] men), pulmonary vein isolation was performed under uninterrupted anticoagulation in 640 (73,7%), of which 595 patients with NOAC (68,5%) and 45 with VKA (5,2%). AF was paroxysmal, persistent and long-standing persistent in 63,4% (n=550), 21,4% (n=185) and 15,4% (n=133) patients, respectively. Mean CHADS-VASc score was 1,86±1,48. Over time there was a shift in the distribution of the type of antithrombotic therapy used, consistent with changes in recommendations (Graph 1). The composite outcome occurred in 6,8% (n=62), including hemopericardium in 1,8% (n=16), stroke/TIA in 0,7% (n=6) and events related to vascular access in 1,4% (n=13) [Table 1]. No anticoagulation therapy or antiaggregation/interrupted ACO was more associated to the outcome, driven by major AAE, although the difference did not meet statistical significance (p=0,06) [Table 1]. No difference was found between VKA and NOAC group. Additionally, there was no diference in the incidence of hemorrhagic AAE since the implementation of an uninterrupted anticoagulation strategy periprocedural. Conclusion In our population of patients submitted to AF catheter ablation, an uninterrupted anticoagulation strategy is associated with lower rate of AAE, either with VKA or NOAC. Our real-world results are reassuring of the benefit of an uninterrupted strategy, and consistent with recent controlled trials. Funding Acknowledgement Type of funding sources: None. Antithrombotic therapies over timeClinically relevant acute adverse events

Postoperative Single-Fraction Partial-Breast Irradiation for Stage 0 and I Breast Carcinoma: Results of a Prospective Single Institution Phase I/II Clinical Trial

To assess tolerability, efficacy, quality of life and cosmetic outcomes of a prospective phase I/II trial of single fraction high gradient partial breast irradiation (SFHGPBI) given postoperatively after partial mastectomy in select patients with stage 0/I breast cancers. Postmenopausal women aged ≥50 years with hormone receptor positive, HER2/neu nonamplified pathologic T1N0 or Tis (=< 2cm) N0 breast cancer treated with partial mastectomy with negative histologic margins by at least 2 mm were treated with postoperative SFHGPBI, 20 Gy to the cavity surface while simultaneously prescribing 7 Gy to a planning target volume (PTV) defined as the surgical bed plus 1 cm of surrounding breast tissue. Co-primary endpoints were grade 3+ toxicity per CTCAE v4.0 and ipsilateral breast tumor recurrence (IBTR). Between 2014 and 2018, 50 patients were enrolled and received SFHGPBI. Patients had either stage I (n=40) or stage 0 (n=10) breast carcinomas. Mean heart dose was 0.43 Gy (range, 0.07 – 1.52 Gy), and maximum skin rind dose was 17.87 Gy (range, 8.43 – 28.53 Gy).With a median follow-up of 21 months, one patient developed a non-invasive IBTR in a separate untreated quadrant 18 months after HGPBI. One other patient developed an ipsilateral axillary recurrence 30 months after HGPBI. There have been no recurrences in the treated quadrant or distantly, with no intercurrent deaths observed. No grade 3-5 toxicities have been observed. All but 3 toxicities have been grade 1, with 17 patients (34%) having small areas of hyperpigmentation in the treatment region, 9 patients having grade 1 fibrosis, and 9 patients having transient breast pain. Grade 2 fibrosis and grade 2 chest wall pain was observed in 2 and 1 patients, respectively. Patient-reported quality of life (QOL) data per EORTC QLQ-30 and QLQ-BR23 collected at baseline and at each follow-up revealed that SFHGPBI had no detrimental effect on overall QOL as well as each of the sub-domains evaluated. Quantitative cosmetic evaluation using the percentage of breast retraction assessment (pBRA) revealed that there was a trend toward improvement in pBRA at 8 weeks (mean, 7.25%) and 12 months (6.97%) post-RT, compared to pretreatment pBRA (8.26%). The rates of good-to-excellent cosmesis reported by patients and the treating physician were 98% and 100% pretreatment, 98% and 100% at 8 weeks, and 100% and 100% at 1 year, respectively. SFHGPBI is a feasible, convenient, and well-tolerated method for delivering adjuvant radiation in patients with low-risk stage 0 and I breast cancers. No grade 3+ toxicity was observed, with low rates of acute adverse events. SFHGPBI had no detrimental effect on patient-reported quality of life, and both patient and physician-reported qualitative and quantitative cosmesis was preserved. Initial local, regional, and distant control rates were excellent.

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients

ObjectivesTo assess the incidence of acute adverse events (AAEs) in gadolinium-enhanced cardiac magnetic resonance (CMR) imaging.MethodsGadolinium-based contrast agent (GBCA)–enhanced CMR data from the multinational, multicenter European Society of Cardiovascular Radiology MRCT Registry was included. AAE severity was classified according to the American College of Radiology Manual on Contrast Media (mild, moderate, severe). Multivariable generalized linear mixed effect models were used to assess the likelihood of AAEs in various GBCA, adjusting for pharmacological stressor, main indications (i.e., suspected or known coronary artery disease or myocarditis), age, sex, and submitting center as a random effect.ResultsIn the study population of 72,839 GBCA-enhanced CMRs, a total of 260 AAEs were reported (0.36%), with a minority of severe AAEs (n = 24, 0.033%). Allergic-like AAEs were less likely than physiologic AAEs (29% versus 71%). Patients without pharmacological stress imaging had a lower AAE rate (0.22%) compared to stress imaging (0.75%), with the highest AAE rates for regadenoson (2.95%). AAE rates also varied by GBCA subtype (overall p < 0.001). There was significant interaction between GBCA and pharmacological stressor (interaction p = 0.025), with AAE rates ranging between 0 and 10% for certain GBCA/stressor combinations. There was further marginal evidence that higher GBCA volume was associated with higher AAE incidence (OR = 1.02, p = 0.05).ConclusionGBCA-enhanced CMR imaging demonstrates low AAE rates comparable to those of other body regions. AAE likelihood correlates with GBCA subtype, pharmacological stressor, and imaging indication. Intravenous fluid administration in patients with cardiac impairment might contribute to these findings.Key Points• Acute adverse event rates in cardiac magnetic resonance (CMR) imaging with gadolinium-based contrast agents (GBCAs) are low (0.36%), especially for severe adverse events (0.033%).• Mild and moderate adverse events are more frequent during stress CMR imaging.• Physiologic AAEs are more common than allergic AAEs in CMR imaging.

Breast size impact on adjuvant radiotherapy adverse effects and dose parameters in treatment planning.

BackgroundBreast radiotherapy is an established adjuvant treatment after breast conserving surgery. One of the important individual factors affecting the final cosmetic outcome after radiation is breast size. The purpose of this review is to summarise the clinical toxicity profile of adjuvant radiotherapy in women with breasts of various sizes, and to evaluate the treatment planning studies comparing target coverage and dose to thoracic organs at risk in relation to breast size.ConclusionsInhomogeneity and excessive radiation dose (hot spots) in the planning of target volume as well as large volume of the breast per se, all contribute to a higher rate of acute adverse events and suboptimal final cosmetic outcome in adjuvant breast cancer radiotherapy, regardless of the fractionation schedule. Improved homogeneity leads to a lower rate of ≥ grade 2 toxicity and can be achieved with three-dimensional conformal or modulated radiotherapy techniques. There may be an association between body habitus (higher body mass index, bigger breast size, pendulous breast, and large chest wall separation) and a higher mean dose to the ipsilateral lung and whole heart. A combination of the technical innovations (i.e. the breath-hold technique, prone position with or without holding breath, lateral decubitus position, and thermoplastic bra), dose prescription (i.e. moderate hypofractionation), and irradiated volume (i.e. partial breast irradiation) should be tailored to every single patient in clinical practice to mitigate the risk of radiation adverse effects.

Iodinated contrast agents in patients with myasthenia gravis: a retrospective cohort study

Currently, it has not been satisfactorily established, whether modern low-osmolality iodinated contrast agents (ICAs) used in computed tomography (CT) studies are a risk factor for exacerbation of myasthenic symptoms. The rate of acute adverse events as well as delayed clinical worsening up to 30 days were analyzed in 73 patients with confirmed myasthenia gravis (MG) who underwent contrast-enhanced CT studies and compared to 52 patients who underwent unenhanced CT studies. One acute adverse event was documented. 12.3% of MG patients experienced a delayed exacerbation of symptoms after ICA administration. The rate of delayed severe exacerbation was higher in the contrast-enhanced group. Alternative causes for the exacerbation of MG-related symptoms were more likely than ICA administration in all cases. ICA administration for CT studies in MG patients should not be withheld if indicated, but patients particularly those with concomitant acute diseases should be carefully monitored for exacerbation of symptoms.

The comparison of outcomes between hypofractionated and conventional 3D-CRT regimens used in combination with TACE as first-line treatment of advanced hepatocellular carcinoma.

Treatment of primary hepatocellular carcinoma (HCC) with transcatheter hepatic arterial chemoembolization (TACE) and three-dimensional conformal radiotherapy (3D-CRT) achieves good short-term but poor long-term survival. We retrospectively assessed whether outcomes differ between hypofractionated and conventional 3D-CRT regimens. Patients were treated in our institution between June 2005 and October 2009. All patients received two cycles of TACE followed by either hypofractionated 3D-CRT (6-8 Gy fractions for 3-4 weeks to 48-64 Gy) or conventional 3D-CRT (2 Gy fractions for 6-7 weeks to 60-70 Gy) 4 weeks later. We assessed data from 110 patients (55 in each 3D-CRT group). Overall response rates were similar in the two groups. Acute adverse event rates were not significantly higher in the hypofractionated 3D-CRT group than in the conventional 3D-CRT group; two patients and one patient, respectively, died of late radiation-induced liver failure. Overall survival at 1 year was 83.6 % in the hypofractionated 3D-CRT group versus 68.8 % in the conventional 3D-CRT group (P = 0.019), and at 3 years, it was 31.7 versus 13.9 % (P = 0.004). Median survival was 27.97 versus 16.13 months (P = 0.002). Hypofractionated 3D-CRT seemed to provide better overall survival than conventional 3D-CRT regimens combined with TACE as a first-line treatment for advanced HCC.

Management of acute atrial fibrillation in the emergency department

The aim of the study was to provide an overview on the current evidence on the method of cardioversion in patients presenting with recent-onset atrial fibrillation at the emergency department. ISI Web of Science and MEDLINE were explored for articles published between January 2000 and December 2011 in English or Spanish for the keywords 'acute', 'recent-onset' or 'paroxysmal' AND 'atrial fibrillation' AND 'treatment' AND 'emergency'. Original published articles were included if they enrolled patients with atrial fibrillation episodes of short duration (<48 h) and if they specifically addressed time to conversion, length of stay in the emergency department, safety, and/or relapses. Data extracted included the number of patients included, agent(s) studied, type and level of evidence of the article, rate of sinus rhythm conversion, time to conversion, discharge rate, length of stay, adverse events, embolic complications, and relapses. Fourteen papers were included in the review, eight of them prospective and randomized. Cardioversion in the emergency department had an overall high rate of conversion and few side-effects and/or embolic complications. Direct current cardioversion was the most effective therapeutic strategy in terms of sinus rhythm restoration, rate of discharge, length of stay, and safety. Class I drugs were also effective in a selected population. Amiodarone had a longer conversion time, with a similar rate of acute adverse events. Cardioversion in the emergency department is feasible and safe. Direct current cardioversion is the most effective therapeutic strategy.

Abstract 111: Comparison of Long-term Outcomes Associated with Endovascular Treatment Versus Surgical Treatment Among Medicare Beneficiaries with Unruptured Intracranial Aneurysms

Objective: To determine the 5 year risk of new intracranial hemorrhage, second procedure, and all-cause mortality in elderly patients with unruptured intracranial aneurysms who underwent either surgical or endovascular treatment. Methods: The study included a representative sample of fee-for-service Medicare beneficiaries aged 65 years or older who underwent endovascular or surgical treatment for unruptured intracranial aneurysms between 1999 through 2010. The Medicare Provider Analysis and Review files were linked to the Center for Medicaid and Medicare Services denominator files for 2000-2010 to ascertain any new admission or mortality. Cox proportional hazards and Kaplan Meir survival analyses were used to assess the relative risk of all-cause mortality, new intracranial hemorrhage, or second procedure for patients treated with endovascular treatment compared with those treated with surgical treatment after adjusting for potential confounders. Results: A total of 1005 patients with unruptured intracranial aneurysms were treated with either endovascular (n=569) or surgical treatment (n=436) with post-procedure follow-up available for 4.64 (±2.98) years. The rate of immediate post-procedural neurological complications (8.7% vs. 3.2%, p&lt;0.0001) and requirement for intraventricular catheter (2.8% vs. 0.7%, p=0.019) was higher among patients treated with surgery compared with those treated with endovascular treatment. The estimated 5 year survival was 93.6% and 95.8% in patients treated with surgical and endovascular treatments, respectively. After adjusting for age, gender, and race/ethnicity, relative risks of all-cause mortality (RR 0.5, 95% CI 0.3-0.9) and new intracranial hemorrhage (RR 0.4, 95% CI 0.2-0.8) were significantly lower with endovascular treatment. Conclusions: In elderly patients with unruptured intracranial aneurysms, endovascular treatment was associated with lower rates of acute adverse events, long-term all-cause mortality and new intracranial hemorrhages.

Rate of acute adverse events for narrow-band UVB and Psoralen-UVA phototherapy

Rate of acute adverse events for narrow-band UVB and Psoralen-UVA phototherapy

Rate of acute adverse events for narrow‐band UVB and Psoralen‐UVA phototherapy

Ultraviolet (UV) radiation therapies are commonly used to treat a wide range of dermatological conditions. However, no published data exist regarding the rate of acute adverse events occurring within the different UV therapy modalities. The aim of this study was to determine the rate of acute adverse events experienced by patients receiving narrow-band UVB or photochemotherapy in 3 neighboring dermatology units. Standardized adverse event forms from all 3 units were retrospectively analysed over a 12-month period between October 2003 and September 2004. The treatments included were narrow-band UVB and systemic, bath and hand/foot PUVA. A total of 8784 treatments were given over the study period. The total number of acute adverse events recorded for all phototherapy treatments was 70 (0.8%). The rates of acute adverse events for each treatment modality were 0.6% for narrow-band UVB, 1.3% for systemic PUVA, 1.3% for bath PUVA and 0.8% for hand/foot PUVA. Adverse events were due to patient non-compliance with standard operating procedures in 15 cases (21%) and operator error in 2 (3%). Only 4 of the acute adverse events were considered to be severe, accounting for 0.05% of all treatments. The rates of acute adverse events with phototherapy in this analysis were low, in particular the rate of severe adverse events. The highest rate was seen with both systemic and bath PUVA. The number of adverse events resulting from operator error was low. These published rates for adverse events associated with narrow-band UVB and PUVA may help other units when analyzing their own rate of adverse events.