Mindful, mindless, or misunderstood? A critical perspective of the mindfulness concept.

Mindfulness is everywhere, but the term is often used mindlessly. This article discusses the growth of mindfulness-based interventions in many countries over the past fifty years and, more recently, the emergence of the idea of 'McMindfulness', with particular emphasis on the concept of 'spiritual bypassing'. Critical discourse is a valuable resource in any discipline. Proportionate, mindful incorporation of reasoned critiques strengthens mindfulness, rather than undermining it. Misunderstandings and misinterpretations of mindfulness highlight a need to counter the notions that mindfulness involves avoiding difficult issues in our lives or simply accepting social problems that need to be addressed. The opposite is true: mindfulness of reality inevitably generates insights about change. Before we change the world, we need to see it. Mindfulness practice is opting in, not opting out.

Mindfulness "Here and Now": Strategies for Helping Adolescents With Autism.

Mindfulness-based interventions (MBIs) are increasingly popular and have a growing empirical basis of support for improving physical and mental health, general functioning, and quality of life. MBIs are an especially attractive approach to improve emotion regulation (ER) in adolescents who have autism spectrum disorder (ASD), as they are thought to directly target ER and can be tailored to individual needs, symptoms, and cognitive capacity. Despite growing interest in MBIs for adolescents with ASD, there are few clinical delivery resources to support clinicians untrained in the use of mindfulness within therapy. This article uses an ASD-specific MBI as an exemplar to outline common challenges and solutions for clinicians using MBIs with adolescents with ER impairment. Mindfulness teaching practices described in this article have been trialed and refined over several years with >40 participants, across three different sites, and with 16 clinicians from four clinical professional backgrounds-most of whom had no prior experience with MBIs-in the Emotion Awareness and Skills Enhancement (EASE) program trials with adolescents with ASD. Although we describe the use of an MBI program with adolescents with ASD, the suggestions offered herein are relevant to use of MBIs with other clinical populations and include basic strategies for mental health professionals untrained in MBIs to enhance delivery to patients with ER impairment.

Uncaria tomentosa improves cognition, memory and learning in middle-aged rats.

Aging accelerates neurodegeneration, while natural and safe neuroprotective agents, such as Uncaria tomentosa, may help to overcome this problem. This study assessed the effects of U. tomentosa extract treatment on the aging process in the brain of Wistar rats. The spatial memory and learning, acetylcholinesterase (AChE) activity, and DNA damage were assessed. Animals of 14 months were tested with different doses of U. tomentosa (5 mg/kg, 15 mg/kg, and 30 mg/kg) and with different durations of treatment (one month and one year). In the Morris Water Maze (MWM), the escape latency was significantly (p < 0.0001) shorter in rats that received 5 mg/kg, 15 mg/kg, and 30 mg/kg of U. tomentosa for both one month and one year of treatment. There was a significant difference in time spent at the platform zone (p < 0.05) of the middle-aged rats treated with U. tomentosa extract for one year when compared to the control rats. The cortex and hippocampus of rats treated with U. tomentosa for one year showed significant (p > 0.05) reduction in AChE activity. DNA damage index on cortex was significantly lower (p < 0.05) in animals treated with 30 mg/kg of U. tomentosa for one month while all the tested doses demonstrated significant (p < 0.001) reductions in DNA damage index in animals treated for one year. In conclusion, U. tomentosa may represent a source of phytochemicals that could enhance memory activity, repair DNA damage, and alter AChE activity, thereby providing neuroprotection during the aging process.

Antibiotic Susceptibility and Therapy in Central Line Infections in Pediatric Home Parenteral Nutrition Patients.

BACKGROUND: Patients receiving home parenteral nutrition (HPN) are at high-risk for central line-associated bloodstream infections (CLABSI). There are no published management guidelines, however, for the antibiotic treatment of suspected CLABSI in this population. Historical microbiology data may help inform empiric antimicrobial regimens in this population. OBJECTIVE: The aim of the study was to describe antimicrobial resistance patterns and determine the most appropriate empiric antibiotic therapy in HPN-dependent children experiencing a community-acquired CLABSI. METHODS: Single-center retrospective cohort study evaluating potential coverage of empiric antibiotic regimens in children on HPN who developed a community-acquired CLABSI. RESULTS: From October 1, 2011 to September 30, 2017, there were 309 CLABSI episodes among 90 HPN-dependent children with median age 3.8 years old.Fifty-nine percent of patients carried the diagnosis of surgical short bowel syndrome. Organisms isolated during these infections included 60% Gram-positive bacteria, 34% Gram-negative bacteria, and 6% fungi. Among all staphylococcal isolates, 51% were methicillin sensitive. Among enteric Gram-negative organisms, sensitivities were piperacillin-tazobactam 71%, cefepime 97%, and meropenem 99%. Organisms were sensitive to current institutional standard therapy with vancomycin and piperacillin-tazobactam in 69% of cases compared with vancomycin and cefepime or vancomycin an meropenem in 85% and 96% of cases (both P < 0.01). CONCLUSIONS: Empiric antimicrobial therapy for suspected CLABSI in HPN-dependent children should include therapy for methicillin-resistant staphylococci as well as enteric Gram-negative organisms. Future studies are needed to evaluate clinical outcomes based upon evidence-based antimicrobial regimens.

3D printing with peptide-polymer conjugates for single-step fabrication of spatially functionalized scaffolds.

Biodegradable polymer-based scaffolds are widely used to provide support during early stages of regeneration and can be functionalized with various chemical groups or bioactive cues to promote desired cellular behavior. However, these scaffolds are often modified post-fabrication, which can lead to undesired changes and homogeneously distributed chemistries that fail to mimic the spatial biochemical organization found in native tissues. To address these challenges, surface functionalization can be achieved by 3D printing with pre-functionalized biodegradable polymers, such as peptide-modified polymer conjugates, to control the deposition of preferred chemistries. Peptide-PCL conjugates were synthesized with the canonical cell adhesion peptide motif RGDS or its negative control RGES and 3D printed into scaffolds displaying one or both peptides. The peptides were also modified with bioorthogonal groups, biotin and azide, to visualize peptide concentration and location by labeling with complementary fluorophores. Peptide concentration on the scaffold surface increased with increasing peptide-PCL conjugate concentration added to the ink prior to 3D printing, and scaffolds printed with the highest RGDS(biotin)-PCL concentrations showed a significant increase in NIH3T3 fibroblast adhesion. To demonstrate spatial control of peptide functionalization, multiple printer heads were used to print both peptide-PCL conjugates into the same construct in alternating patterns. Cells preferentially attached and spread on RGDS(biotin)-PCL fibers compared to RGES(azide)-PCL fibers, illustrating how spatial functionalization can be used to influence local cell behavior within a single biomaterial. This presents a versatile platform to generate multifunctional biomaterials that can mimic the biochemical organization found in native tissues to support functional regeneration.

A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting.

INTRODUCTION: Chronic and distressing genito-pelvic pain associated with vaginal penetration is most frequently due to provoked vestibulodynia (PVD). Cognitive behavioral therapy (CBT) significantly reduces genital pain intensity and improves psychological and sexual well-being. In general chronic pain populations, mindfulness-based approaches may be as effective for improving pain intensity as CBT. AIM: To compare mindfulness-based cognitive therapy (MBCT) with CBT in the treatment of PVD. METHODS: To ensure power of 0.95 to find medium effect size or larger in this longitudinal design, we enrolled 130 participants. Of these, 63 were assigned to CBT (mean age 31.2 years), and 67 to MBCT (mean age 33.7 years). Data from all participants who completed baseline measures were analyzed, with intent-to-treat analyses controlling for years since diagnosis. MAIN OUTCOME MEASURES: Our primary outcome was self-reported pain during vaginal penetration at immediate post-treatment and at 6 months' follow-up. Secondary endpoints included pain ratings with a vulvalgesiometer, pain catastrophizing, pain hypervigilance, pain acceptance, sexual function, and sexual distress. RESULTS: There was a significant interaction between group and time for self-reported pain, such that improvements with MBCT were greater than those with CBT. For all other endpoints, both groups led to similar significant improvements, and benefits were maintained at 6 months. CLINICAL IMPLICATIONS: Mindfulness is a promising approach to improving self-reported pain from vaginal penetration and is as effective as CBT for several psychological endpoints. STRENGTH & LIMITATIONS: A strength of the present study was the robust sample size (n = 130 women) who had received confirmed clinical diagnoses of PVD. CONCLUSION: The present study showed mindfulness to be as effective for most pain- and sexuality-related endpoints in the treatment of PVD. Brotto LA, Bergeron S, Zdaniuk B, et al. A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting. J Sex Med 2019;16:909-923.

Improving emotion regulation ability in autism: The Emotional Awareness and Skills Enhancement (EASE) program.

Emotion regulation impairments are common among individuals with autism spectrum disorder and are believed to often underlie commonly seen problems with aggression, depression, and anxiety. The Emotional Awareness and Skills Enhancement program was developed to reduce emotion regulation impairment and thereby improve behavioral disturbance, via mindfulness. Emotional Awareness and Skills Enhancement consists of a 16-week individual therapy treatment targeting emotion regulation impairments among individuals with autism spectrum disorder. We describe the conceptual framework and development of the program and present data on feasibility and preliminary efficacy from a pilot trial. The Emotional Awareness and Skills Enhancement manual was developed using a participatory action framework, based on emotion regulation research specific to autism spectrum disorder and input from individuals with autism spectrum disorder, therapists, and parents of children with autism spectrum disorder. Emotional Awareness and Skills Enhancement was piloted in a two-site open trial with 20 participants with autism spectrum disorder (12-17 years old, confirmed autism spectrum disorder diagnosis, IQ > 80).Outcome data support program feasibility and acceptability to participants, as well as significant improvement in emotion regulation impairments and related concerns.Findings offer preliminary support for both the feasibility and clinical effectiveness of the Emotional Awareness and Skills Enhancement program.

Female genital mutilation in the UK- where are we, where do we go next? Involving communities in setting the research agenda.

BACKGROUND: Female Genital Mutilation (FGM) is all practices involving cutting, alteration or injury to the female genitalia for non-medical reasons. It is a form of violence against women and children, with no benefits and many harms. In 2014, the UK Government committed to working to eliminate FGM. Steps taken towards this aim included creation of educational and safeguarding resources for professionals, and legislative changes including a mandatory reporting duty for professionals in England and Wales (where if a girl under 18 discloses or is found on examination to have FGM then the professional is mandated to report this to the police), and an FGM Enhanced Dataset applicable to NHS organisations in England requiring the submission of personal data about women and girls who have had FGM to NHS Digital. To date, compliance with dataset returns from primary care services have been low. This report describes using patient and public involvement (PPI) to identify research and service priorities to support communities affected by FGM. METHODS: We held a series of PPI events (4 focus groups, and a multi-agency seminar) in 2015-2016, following the introduction of these legislative changes, speaking to community members, and professionals involved in their care. We asked participants to consider what they identified as research, knowledge and service priorities to support communities affected by FGM. RESULTS: The impact of these legislative and reporting requirements on the trust needed for community members to seek to consult health services was identified as important for further research. Priorities for service development were holistic services, that met a woman's needs throughout her lifecourse. Participants emphasised the importance of understanding how to listen, involve and utilise community voices in developing education for professionals, designing services, and developing policy. CONCLUSIONS: There was a desire for change to develop from within affected communities; any learning and resources need to be co-created and constructed in such a way that they can be effectively shared between women, communities, and professionals. Questions remain about how to define community consultation, how to recognise when it was adequate, and how to hear beyond community activists to hear a wider range of voices.

Psychosocial Treatments Targeting Anxiety and Depression in Adolescents and Adults on the Autism Spectrum: Review of the Latest Research and Recommended Future Directions.

PURPOSE OF REVIEW: This synthesis of treatment research related to anxiety and depression in adolescents and adults with autism spectrum disorder (ASD) focuses on the scientific support for various forms of psychosocial interventions, useful adaptations to standard interventions, and engagement of candidate therapeutic mechanisms. RECENT FINDINGS: There is considerable evidence for the efficacy of cognitive-behavioral therapy (CBT) to treat co-occurring problems with anxiety, but there has been relatively little research on treatment of co-occurring depression. Multiple mechanisms of treatment effect have been proposed, but there has been little demonstration of target engagement via experimental therapeutics. Comorbidity between ASD and anxiety and/or mood problems is common. Although there is evidence for the use of CBT for anxiety, little work has addressed how to effectively treat depression. There is emerging support for alternative treatment approaches, such as mindfulness-based interventions. We encourage rigorous, collaborative approaches to identify and manipulate putative mechanisms of change.

Systematic Review of Treatment Outcome Measures for Vulvodynia.

OBJECTIVES OF THE STUDY: To systematically evaluate the literature regarding vulvodynia treatment outcome measures. METHODS: A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition. RESULTS: Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies-9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by "cotton swab" test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT. CONCLUSIONS: Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.

Forgiveness, spirituality and love: thematic analysis of last statements from Death Row, Texas (2002-17).

BACKGROUND: Psychological features associated with execution are not fully understood. AIMS: To analyse demographics of individuals executed in Texas and investigate whether there has been any change in common themes and psychological factors evident in last statements before execution between 2002 and 2017. DESIGN: Analysis of last statements from Death Row, Texas. METHODS: We (a) studied themes and psychological factors in last statements in Texas between August 2011 and May 2017; and (b) combined our 2011-17 data with our previous data (2002-06 and 2006-11) to present an overall analysis of last statements from 2002 to 2017. RESULTS: Between April 2002 and May 2017 (279 executions; 240 last statements), the execution rate in Texas fell from 25 per year to 12; median time on death row increased from 108.5 months to 149.5; median age at execution increased from 38 years to 40.5; and the proportion of offences involving multiple victims rose from 28.4% to 47.1%. The most common themes in last statements were love (78%), spirituality (58%), regret (35%) and apology (35%). The most common psychological factors were identification-egression (51%), unbearable psychological pain (47%) and rejection-aggression (40%). Two themes (forgiveness, use of poetry/literature) and three psychological factors (inability to adjust, interpersonal relations, identification-egression) became less common. CONCLUSIONS: Between 2002 and 2017, executed prisoners in Texas became fewer and older, spent longer on death row and had committed more serious offences. Themes of love and spirituality were constants, but requests for forgiveness declined.

Analysis of last statements prior to execution: methods, themes and future directions.

Worldwide, over 1000 people were executed in 2016 and over 3000 sentenced to death. Death row prisoners have high rates of mental illness, often combined with neurological impairment. Prolonged confinement has further negative effects on psychological function. There is a growing literature examining key themes and psychological constructs in death row prisoners immediately prior to execution. To date, this literature centres largely but not exclusively on last statements from death row in Texas, owing to ease of availability. The most common themes in last statements are love, spirituality and apology or regret. The most common psychological constructs are 'identification-egression' (e.g. attachment to a lost person or ideal, such as freedom), unbearable psychological pain and rejection-aggression. This is still a relatively new area of research and new techniques, such as computerised quantitative text analysis, are likely to complement rather than replace more traditional forms of thematic and textual analysis. For the future, it is essential that studies in this field continue to specify precisely, which last statements they use, so that overlap can be identified, and that more countries are studied (if possible). It would also be useful to expand the research frame to relate the content of last statements to additional variables relating to prisoners' offences, physical health, mental health, family structure and broader circumstances. Finally, ethical issues require continued consideration in this complex, fascinating, growing field.

How to assess gay, bisexual and other men who have sex with men for chemsex.

OBJECTIVES: Sexualised substance use, 'chemsex', is being increasingly reported by gay, bisexual and other men who have sex with men (GBMSM) in sexual health clinics. We aim to describe the evidence base and practical ways in which clinicians can assess and advise patients disclosing chemsex. METHODS: We review published literature on chemsex, discuss vulnerability to substance use, highlight the importance of clinical communication and discuss a management approach. RESULTS: GBMSM are vulnerable to substance use problems, which interplay with mental, physical and sexual health. Knowledge on sexualised drug use and related communication skills are essential to facilitating disclosure. Identifying sexual health and other consequences of harmful drug use may motivate patients to seek change. CONCLUSIONS: Sexual health clinicians are well placed to make more holistic assessments of GBMSM accessing their services to promote broader sexual health and well-being beyond the management of HIV and sexually transmitted infections (STIs) alone.

Early-onset copper deficiency following Roux-en-Y gastric bypass.

Weight loss surgery can provide many health benefits to those suffering from morbid obesity. The surgery, however, is not without potential complications. This clinical observation describes a patient who experienced gait disturbances, lower extremity weakness, and neuropathy which led to a diagnosis of copper deficiency less than 2 years following a Roux-en-Y gastric bypass. Neurological symptoms were improved within 2 months of copper supplementation. The need to monitor patients for less common micronutrient deficiencies such as copper following Roux-en-Y gastric bypass is reinforced by this case.

The Effect of Omega-3 Fatty Acid Supplementation on the Inflammatory Response to eccentric strength exercise.

Omega-3 fatty acids (omega-3) have anti-inflammatory properties. However, it is not known if omega-3 supplementation attenuates exercise-induced inflammation. We tested the hypothesis that omega-3 supplementation reduces inflammation that is induced by eccentric arm curl exercise. Healthy adult men and women (n=11; 35 ± 10 y) performed eccentric biceps curls on two occasions, once after 14d of dietary omega-3 restriction (control trial) and again after 7d of 3,000 mg/d omega-3 supplementation (omega-3 trial). Before and 48 h after eccentric exercise, signs of inflammation was assessed by measuring soreness ratings, swelling (arm circumference and arm volume), and temperature (infrared skin sensor). Arm soreness increased (p < 0.0001) in response to eccentric exercise; the magnitude of increase in soreness was 15% less in the omega-3 trial (p = 0.004). Arm circumference increased after eccentric exercise in the control trial (p = 0.01) but not in the omega-3 trial (p = 0.15). However, there was no difference between trials (p = 0.45). Arm volume and skin temperature did not change in response to eccentric exercise in either trial. These findings suggest that omega-3 supplementation decreases soreness, as a marker of inflammation, after eccentric exercise. Based on these findings, omega-3 supplementation could provide benefits by minimizing post-exercise soreness and thereby facilitate exercise training in individuals ranging from athletes undergoing heavy conditioning to sedentary subjects or patients who are starting exercise programs or medical treatments such as physical therapy or cardiac rehabilitation. Key pointsDietary supplementation with omega-3 fatty acids has been shown to reduce inflammation in numerous inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease, and Chrohn's disease.Although strenuous exercise is known to cause acute increases in inflammation, it is not clear if omega-3 fatty acid supplementation attenuates this adverse response to exercise.Our research demonstrates that 3000 mg·d-1 omega-3 fatty acid supplementation minimizes the severe, delayed-onset muscle soreness that results from strenuous eccentric strength exercise.This information, along with a plethora of information showing that omega-3 fatty acid supplementation has other health benefits, demonstrates that a readily available over the counter nutritional supplement (i.e. omega-3 fatty acids) reduces delayed-onset soreness caused by strenuous strength exercise.This information has obvious relevance to athletic populations but also to other groups such as physical therapy patients and newly admitted cardiac rehabilitation patients, as muscle soreness, if left unchecked, can slow the progress in adapting to a new exercise program.Furthermore, as inflammation is known to be involved in the pathogenesis if numerous diseases, including heart disease, cancer, and diabetes, it is likely prudent for individuals to use inflammation-attenuating interventions, such as omega-3 supplementation, to keep inflammatory responses to physical activity at a minimum.

An evidence-based review of yoga as a complementary intervention for patients with cancer.

OBJECTIVE: To conduct an evidence-based review of yoga as an intervention for patients with cancer. Specifically, this paper reviewed the impact of yoga on psychological adjustment among cancer patients. METHODS: A systematic literature search was conducted between May 2007 and April 2008. Data from each identified study were extracted by two independent raters; studies were included if they assessed psychological functioning and focused on yoga as a main intervention. Using a quality rating scale (range = 9-45), the raters assessed the methodological quality of the studies, and CONSORT guidelines were used to assess randomized controlled trials (RCTs). Effect sizes were calculated when possible. In addition, each study was narratively reviewed with attention to outcome variables, the type of yoga intervention employed, and methodological strengths and limitations. RESULTS: Ten studies were included, including six RCTs. Across studies, the majority of participants were women, and breast cancer was the most common diagnosis. Methodological quality ranged greatly across studies (range = 15.5-42), with the average rating (M = 33.55) indicating adequate quality. Studies also varied in terms of cancer populations and yoga interventions sampled. CONCLUSIONS: This study provided a systematic evaluation of the yoga and cancer literature. Although some positive results were noted, variability across studies and methodological drawbacks limit the extent to which yoga can be deemed effective for managing cancer-related symptoms. However, further research in this area is certainly warranted. Future research should examine what components of yoga are most beneficial, and what types of patients receive the greatest benefit from yoga interventions.

Anatomic relationship of the optic radiations to the atrium of the lateral ventricle: description of a novel entry point to the trigone.

OBJECTIVE: The aim of this study was to delineate the anatomic relationship of the optic radiations to the atrium of the lateral ventricle using the Klingler method of white matter fiber dissection. These findings were applied to define a surgical approach to the trigone that avoids injury to the optic radiations. METHODS: Sixteen cadaveric hemispheres were prepared by several cycles of freezing and thawing. With the use of wooden spatulas, the specimens were dissected in a stepwise fashion. Each hemisphere was dissected first from a lateromedial direction and then from a mediolateral approach, and careful attention was given to the course and direction of the optic radiation fibers at all points from Meyer's loop to their termination at the cuneus and the lingual gyrus. RESULTS: In all 16 dissected hemispheres, the following observations were made: 1) the entire lateral wall of the lateral ventricle-from the temporal horn to the trigone to the occipital horn-is covered by the optic radiations; and 2) the medial wall of the lateral ventricle in the area of the trigone is entirely free of the optic radiations. CONCLUSION: The results of this study confirm that the medial parieto-occipital interhemispheric approach to the ventricular trigone will avoid injury to the optic radiations and the calcarine cortex. The authors describe the most direct trajectory to the ventricular trigone using this approach and propose a point of entry that transects the cingulate gyrus at a point 5 mm superior and 5 mm posterior to the falcotentorial junction.

Phase III, double-blind, controlled trial of atamestane plus toremifene compared with letrozole in postmenopausal women with advanced receptor-positive breast cancer.

PURPOSE: To compare time to progression (TTP) with a steroidal aromatase inhibitor (AI) atamestane (ATA) combined with toremifene (TOR; complete estrogen blockade) versus letrozole (LET) in receptor-positive advanced breast cancer (ABC). PATIENTS AND METHODS: Eligibility included postmenopausal receptor-positive ABC and adjuvant hormonal therapy completed more than 12 months prior to study entry. Participants received daily ATA 500 mg with TOR 60 mg (ATA + TOR), or letrozole 2.5 mg (LET). The primary end point was TTP, whereas secondary objectives included objective response (OR), overall survival (OS), and time to treatment failure (TTF). The study had 80% power to detect a 25% increase in TTP assuming a TTP of 9.4 months in the LET population. RESULTS: A total of 865 patients were randomly assigned (434 to ATA + TOR and 431 to LET) in 60 centers in the United States, Canada, Russia, and Ukraine. Baseline characteristics were balanced. Median TTP was identical in the two arms at 11.2 months (P < .92). Median TTF was similar at 9.24 months (ATA + TOR) versus 10.44 months (LET). The hazard ratios (LET/ATA + TOR) were 1.00 (95% CI, 0.92 to 1.08) for TTP, 0.99 (95% CI, 0.92 to 1.06) for TTF, and 0.98 (95% CI, 0.87 to 1.11) for OS. OR occurred in 30% of patients receiving ATA + TOR and in 36% of patients receiving LET (P < .1). Adverse events (AEs) were similar for patients receiving ATA + TOR versus LET, and serious AEs were 10% v 11%, respectively. CONCLUSION: TTP for patients receiving ATA + TOR was identical to that for patients receiving LET, representing the first endocrine therapy comparable to LET in ABC. Unlike in the Anastrozole, Tamoxifen, and Combined trial, addition of an antiestrogen did not decrease efficacy of the AI. Future studies of AIs in combination with more effective selective estrogen receptor modulators or selective receptor downregulators is warranted.