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Background Cutaneous allodynia is a common clinical feature of migraine that has been associated with reduced efficacy of acute migraine treatments and an increased risk of disease progression. Objective Identify factors associated with allodynia in a sample of adults with migraine. Methods An online survey panel was used to identify adults with migraine who averaged at least 1 monthly headache day over the previous 3 months. Data on sociodemographics, headache frequency, headache pain intensity, migraine symptom severity, medication use, depression and anxiety, and cutaneous allodynia (via the Allodynia Symptom Checklist) were obtained. Binary logistic modeling predicted the presence of allodynia. Odds ratios and 95% confidence intervals (CI) were calculated. Results In total, 15,133 individuals with migraine met the eligibility criteria. Mean age was 43.1 years, 73.0% were female, and 81.0% were Caucasian. Allodynia was present in 39.9%. The fully adjusted model, controlling for sociodemographics and headache features, demonstrated that allodynia was significantly associated with a higher migraine symptom severity score (odds ratio 1.17, confidence interval 1.15, 1.19) and more severe pain intensity (odds ratio 1.11, confidence interval 1.08, 1.14); probable depression and/or anxiety (odds ratio 1.83, confidence interval 1.67, 2.00); and overuse of acute medication (odds ratio 1.23, confidence interval 1.09, 1.38). A higher number of monthly headache days increased the likelihood of allodynia, but the effect was attenuated in the fully adjusted model. Conclusion In a representative sample of US adults with migraine, there were significant associations between allodynia and headache frequency and intensity, anxiety and/or depression, symptom severity, and acute medication overuse.

ABSTRACT Vertebral augmentation is among the current standards of care to reduce pain in patients with vertebral fractures (VF), yet a lack of consensus regarding efficacy and safety of percutaneous vertebroplasty and kyphoplasty raises questions on what basis clinicians should choose one therapy over another. Given the lack of consensus in the field, the American Society for Bone and Mineral Research (ASBMR) leadership charged this Task Force to address key questions on the efficacy and safety of vertebral augmentation and other nonpharmacological approaches for the treatment of pain after VF. This report details the findings and recommendations of this Task Force. For patients with acutely painful VF, percutaneous vertebroplasty provides no demonstrable clinically significant benefit over placebo. Results did not differ according to duration of pain. There is also insufficient evidence to support kyphoplasty over nonsurgical management, percutaneous vertebroplasty, vertebral body stenting, or KIVA®. There is limited evidence to determine the risk of incident VF or serious adverse effects (AE) related to either percutaneous vertebroplasty or kyphoplasty. No recommendation can be made about harms, but they cannot be excluded. For patients with painful VF, it is unclear whether spinal bracing improves physical function, disability, or quality of life. Exercise may improve mobility and may reduce pain and fear of falling but does not reduce falls or fractures in individuals with VF. General and intervention-specific research recommendations stress the need to reduce study bias and address methodological flaws in study design and data collection. This includes the need for larger sample sizes, inclusion of a placebo control, more data on serious AE, and more research on nonpharmacologic interventions. Routine use of vertebral augmentation is not supported by current evidence. When it is offered, patients should be fully informed about the evidence. Anti-osteoporotic medications reduce the risk of subsequent vertebral fractures by 40–70%. © 2018 American Society for Bone and Mineral Research.

Abstract Retrospective studies have suggested that older adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) have better survival rates when treated using a pediatric ALL regimen administered by pediatric treatment teams. To address the feasibility and efficacy of using a pediatric treatment regimen for AYA patients with newly diagnosed ALL administered by adult treatment teams, we performed a prospective study, CALGB 10403, with doses and schedule identical to those in the Children's Oncology Group study AALL0232. From 2007 to 2012, 318 patients were enrolled; 295 were eligible and evaluable for response. Median age was 24 years (range, 17-39 years). Use of the pediatric regimen was safe; overall treatment-related mortality was 3%, and there were only 2 postremission deaths. Median event-free survival (EFS) was 78.1 months (95% confidence interval [CI], 41.8 to not reached), more than double the historical control of 30 months (95% CI, 22-38 months); 3-year EFS was 59% (95% CI, 54%-65%). Median overall survival (OS) was not reached. Estimated 3-year OS was 73% (95% CI, 68%-78%). Pretreatment risk factors associated with worse treatment outcomes included obesity and presence of the Philadelphia-like gene expression signature. Use of a pediatric regimen for AYAs with ALL up to age 40 years was feasible and effective, resulting in improved survival rates compared with historical controls. CALGB 10403 can be considered a new treatment standard upon which to build for improving survival for AYAs with ALL. This trial was registered at www.clinicaltrials.gov as #NCT00558519.

Abstract Novel treatment strategies are needed for older patients with acute myeloid leukemia (AML). This randomized phase 2 trial compared the efficacy and safety of 20 mg/m2 of IV decitabine on days 1 to 10 alone (arm A) with those of 1.3 mg/m2 of subcutaneous bortezomib (arm B) on days 1, 4, 8, and 11 for up to 4 10-day cycles followed by monthly 5-day cycles. Previously untreated AML patients age ≥60 years (excluding those with FLT3 mutations and favorable-risk cytogenetics) without restrictions in performance status (PS) or organ function were eligible. Median age was 72.4 years (range, 60.5-92.3 years); 31 patients (19%) had baseline PS ≥2, 35 (22%) had an antecedent hematological disorder, 58 had (39%) adverse cytogenetics, and 7 (5%) and 23 (14%) had abnormal cardiac or renal function. There were no statistically significant differences in overall survival (OS) or responses between the 2 treatment arms. The overall response rate (complete remission + complete remission with incomplete blood count recovery) was 39% (n = 64), with median OS of 9.3 months. Nineteen responders (31%) underwent allogeneic stem cell transplantation. The most common adverse event was febrile neutropenia, and there were no unexpected toxicities. Adding bortezomib to decitabine did not improve outcomes, but responses were better than those in previous trials using 5-day decitabine cycles. This trial was registered at www.clinicaltrials.gov as #NCT01420926.

AbstractBackgroundAcute promyelocytic leukemia (APL) is a unique leukemia subtype requiring specialized treatment including all‐trans retinoic acid (ATRA). A prior report demonstrated worse outcome among young children <5 years old compared with older children.MethodsWe evaluated outcomes for pediatric patients (<18 years old; N = 83) with APL treated on North American intergroup study CALGB 9710 at Children's Oncology Group sites. Induction and consolidation included ATRA, cytarabine, and anthracyclines. Patients ≥15 years old were randomized to addition of arsenic trioxide (ATO) consolidation. All patients were randomized to ATRA maintenance with versus without oral chemotherapy.ResultsThe estimated 5‐year overall survival (OS) rate was 82%, and the event‐free survival (EFS) rate was 54%. Seven patients (8.4%) died during induction due to coagulopathy. Maintenance randomization demonstrated that addition of oral chemotherapy to ATRA significantly reduced relapse rate, but difference in EFS did not reach statistical significance (P = 0.12; 5‐year rates [95% CI]: 41% [17%–64%] ATRA only vs 72% [56%–88%] ATRA plus chemotherapy). There was no difference (P = 0.93) in EFS for age <5 years versus 5–12.99 years versus 13–17.99 years (5‐year rates: 56%, 47%, and 45%, respectively). Among adolescents 15–17.99 years old in the ATO randomization, there was a significantly lower relapse risk at 5 years for those receiving ATO (0% ATO vs 44% no ATO; P = 0.02).ConclusionOur data demonstrate that intensified ATRA, cytarabine, and anthracycline chemotherapy is effective for pediatric APL including very young patients, but early deaths and relapses remain barriers to cure. Further improvements are likely with incorporation of ATO into pediatric APL regimens.

Abstract Objectives To summarize the baseline methods for the Migraine in America Symptoms and Treatment (MAST) Study and evaluate gender differences in sociodemographics and headache features; consultation and diagnosis patterns; and patterns of acute and preventive treatment use for migraine among study participants. Background The MAST Study is a longitudinal, internet‐based panel study of symptoms, approaches to management, and unmet treatment needs among US adults with migraine. This analysis focuses on the initial cross‐sectional survey, conducted beginning in 2016, and is intended to update results from earlier national epidemiologic surveys of people with migraine in the United States. Methods Respondents to the MAST Study were recruited from a US nationwide online research panel. Stratified random sampling identified a representative cohort of adults (aged ≥18 years). We administered a validated diagnostic screener based on modified ICHD‐3 beta criteria to identify individuals with migraine averaging at least 1 monthly headache day (MHD) over the previous 3 months. A baseline assessment evaluated sociodemographic and headache features, patterns of consultation and diagnosis, and use of acute and preventive medications for migraine. Frequency data and chi‐square contrasts ( P < .05) were used to compare respondents based on gender. Results Baseline survey data (N = 95,821) identified 18,353 respondents who met criteria for migraine, including 15,133 (women n = 11,049, men n = 4084) reporting at least 1 MHD for the preceding 3 months. The mean age of the sample was 43.1 (13.6) years; 73.0% of respondents were women, and 81.0% were Caucasian. Compared with men, women were younger (46.1 vs 42.0 years; P < .001); had more MHDs (5.6 vs 5.3; P < .001); and were more likely to report moderate or severe headache‐related disability (45.9% vs 35.8%; P < .001) and cutaneous allodynia (43.7% vs 29.5%; P < .001). The lifetime rate of medical consultation for headache was 79.8% overall and slightly higher in women than in men. Women were more likely than men to have been diagnosed with migraine (48.3% vs 38.8%, P < .001). While 95.1% of people with migraine currently used acute treatment, the majority (58.9%) used over‐the‐counter (OTC) drugs to the exclusion of prescription drugs, while 11.3% used exclusively prescription drugs, and 20.5% used both. Among acute prescription medication users, women were more likely than men to take triptans (17.7% vs 14.3%, P < .001), while men were more likely than women to take opioids (14.5% vs 9.2%, P < .001). Oral formulations were used predominately (92.7% of the medication users), but men were more likely to use nasal sprays (13.6% vs 9.4%, P < .001) and injectables (7.9% vs 3.4%, P < .001). Men (14.5%) were also significantly more likely than women (10.4%) to be taking daily oral preventive medication ( P < .001). Conclusions The MAST Study identified a large sample of women and men with migraine from a sampling frame that broadly resembles the US population. Low participation rate increases the risk of response bias, however, comparisons with Census data and prior population studies for the demographic and headache characteristics of the current sample suggest that findings are generalizable to the population of people with migraine. Women had more MHDs than men, and they were more likely to report migraine‐related disability and cutaneous allodynia. The lifetime consultation rate for headache was relatively high, but many with migraine symptoms reported never having received a diagnosis of migraine from a healthcare professional. Acute prescription and preventive migraine treatments are underused. Migraine persists as an underdiagnosed and undertreated public health problem in 2018, and there are many opportunities to improve the diagnosis and treatment of people with this painful, disabling condition.

Abstract BACKGROUND More than a million Americans harbor a cerebral cavernous angioma (CA), and those who suffer a prior symptomatic hemorrhage have an exceptionally high rebleeding risk. Preclinical studies show that atorvastatin blunts CA lesion development and hemorrhage through inhibiting RhoA kinase (ROCK), suggesting it may confer a therapeutic benefit. OBJECTIVE To evaluate whether atorvastatin produces a difference compared to placebo in lesional iron deposition as assessed by quantitative susceptibility mapping (QSM) on magnetic resonance imaging in CAs that have demonstrated a symptomatic hemorrhage in the prior year. Secondary aims shall assess effects on vascular permeability, ROCK activity in peripheral leukocytes, signal effects on clinical outcomes, adverse events, and prespecified subgroups. METHODS The phase I/IIa placebo-controlled, double-blinded, single-site clinical trial aims to enroll 80 subjects randomized 1-1 to atorvastatin (starting dose 80 mg PO daily) or placebo. Dosing shall continue for 24-mo or until reaching a safety endpoint. EXPECTED OUTCOMES The trial is powered to detect an absolute difference of 20% in the mean percent change in lesional QSM per year (2-tailed, power 0.9, alpha 0.05). A decrease in QSM change would be a signal of potential benefit, and an increase would signal a safety concern with the drug. DISCUSSION With firm mechanistic rationale, rigorous preclinical discoveries, and biomarker validations, the trial shall explore a proof of concept effect of a widely used repurposed drug in stabilizing CAs after a symptomatic hemorrhage. This will be the first clinical trial of a drug aimed at altering rebleeding in CA.

e21605 Background: Several studies have demonstrated patients have a poor understanding of prognosis, survival and effectiveness of chemotherapy, particularly in the setting of advanced cancer. This study examines oncology patients’ understanding of their illness based on accurate reporting of stage at diagnosis as well as knowledge of remission status. Methods: 208 cancer patients previously treated at our large community based cancer institute participated in The Consumer-Based Cancer Care Value Index (CCCVI) Field Survey. Electronic medical record (EMR) documentation of stage at diagnosis and remission status were compared to patients’ self-reported responses. Concordance of responses and variables influencing discordance were evaluated. Results: 51.0% of patients’ self-reported cancer stage matched the abstracted stage with the highest concordance in the advanced cancer patients (72%) versus stage I-III patients (36.4%-61.5%). Unexpectedly, discordance was lower among advanced cancer patients as compared to stage I-III patients (p = 0.0528) Those who were concordant for cancer stage at diagnosis were significantly more likely to be female (p = 0.001), under the age of 65 (p = 0.01), have an income greater than $60,000 (p = 0.03), and have more education (p = 0.02). 64.4% of patients’ self-reported remission status matched the abstracted status. Nearly 30% of patients were not sure about their status even when they were in remission. Conclusions: Our findings confirm that more than one quarter of patients with advanced cancer have poor illness understanding, as well as highlights that an even greater number of patients with early stage I-III cancers have poor illness understanding. These observations highlight the need to improve illness understanding for patients across the entire cancer continuum.