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Gregory S.A.,Rush University | Schwartzberg L.S.,The West Clinic | Mo M.,Amgen Inc. | Sierra J.,Hospital Of La Santa Creu I Sant Pau | Vogel C.,Boca Research
Community Oncology | Year: 2010

Bone pain associated with pegfilgrastim has been perceived to occur at higher frequency and with greater severity than bone pain associated with filgrastim. This retrospective study analyzed patient-level data from randomized controlled trials (RCTs) conducted by Amgen to compare bone pain incidence in patients receiving: (1) once-per-chemotherapy-cycle pegfilgrastim (100 μg/kg or 6-mg fixed dose) versus daily filgrastim (5 μg/kg) in seven studies, and (2) once-per-chemotherapy- cycle pegfilgrastim (100 μg/kg or 6 mg) versus no granulocyte colony-stimulating factor (G-CSF) in five studies. An exploratory analysis that included patients who received once-per-chemotherapy-cycle pegfilgrastim (100 μg/kg or 6 mg) in 23 RCTs, non-RCTs, or single-arm interventional trials was also performed. In RCTs that compared pegfilgrastim versus filgrastim, the incidence (95% CI) of any grade and grade 3/4 bone pain was similar in the pegfilgrastim and filgrastim groups for the first four chemotherapy cycles: any grade, 62% (57%, 67%) and 66% (61%, 71%); grade 3/4, 7% (4%, 10%) and 8% (5%, 11%), respectively. In RCTs that compared pegfilgrastim versus no G-CSF, patients receiving pegfilgrastim appeared to have experienced more bone pain of any grade in the first chemotherapy cycle than patients not receiving G-CSF: 33% (30%, 36%) versus 23% (21%, 26%). Grade 3/4 bone pain was infrequently reported in the first cycle for both treatment arms: 3% (2%, 5%) versus 2% (1%, 3%). Results from subgroup analyses suggest that bone pain may be associated with age, tumor type, and chemotherapy regimen. In this retrospective analysis, bone pain associated with pegfilgrastim did not occur at higher frequency or with greater severity than bone pain associated with filgrastim. © 2010 Elsevier Inc.

PubMed | University of Houston, University of Colorado at Denver, Instituto Nacional Of Cancerologia Mexico, Clinical and Translational Oncology Group and 8 more.
Type: | Journal: Clinical lung cancer | Year: 2016

Lung cancer, the deadliest cancer worldwide, is of particular concern in Latin America. The rising incidence poses a myriad of challenges for the region, which struggles with limited resources to meet the health care needs of its low- and middle-income populations. In this environment, we are concerned that governments are relatively unaware of the pressing need to implement effective strategies for screening, diagnosis, and treatment of lung cancer. The region has also been slow in adopting molecularly-based therapies in the treatment of advanced disease: testing for epidermal growth factor receptor mutations and anaplastic lymphoma kinase rearrangements are not routine, and access to targeted agents such as monoclonal antibodies and tyrosine kinase inhibitors is problematic. In this paper, we review the current situation in the management of lung cancer in Latin America, hoping that this initiative will help physicians, patient associations, industry, governments, and other stakeholders better face this epidemic in the near future.

PubMed | Complutense University of Madrid, CIBER ISCIII, University of Missouri-St. Louis, Spanish National Center for Cardiovascular Research and 3 more.
Type: Journal Article | Journal: PloS one | Year: 2015

Glycated hemoglobin (HbA1c) is currently used to diagnose diabetes mellitus, while insulin has been relegated to research. Both, however, may help understanding the metabolic syndrome and profiling patients. We examined the association of HbA1c and fasting insulin with clustering of metabolic syndrome criteria and insulin resistance as two essential characteristics of the metabolic syndrome.We used baseline data from 3200 non-diabetic male participants in the Aragon Workers Health Study. We conducted analysis to estimate age-adjusted odds ratios (ORs) across tertiles of HbA1c and insulin. Fasting glucose and Homeostatic model assessment - Insulin Resistance were used as reference. Here we report the uppermost-to-lowest tertile ORs (95%CI).Mean age (SD) was 48.5 (8.8) years and 23% of participants had metabolic syndrome. The ORs for metabolic syndrome criteria tended to be higher across HbA1c than across glucose, except for high blood pressure. Insulin was associated with the criteria more strongly than HbA1c and similarly to Homeostatic model assessment - Insulin Resistance (HOMA-IR). For metabolic syndrome, the OR of HbA1c was 2.68, of insulin, 11.36, of glucose, 7.03, and of HOMA-IR, 14.40. For the clustering of 2 or more non-glycemic criteria, the OR of HbA1c was 2.10, of insulin, 8.94, of glucose, 1.73, and of HOMA-IR, 7.83. All ORs were statistically significant. The areas under the receiver operating characteristics curves for metabolic syndrome were 0.670 (across HbA1c values) and 0.770 (across insulin values), and, for insulin resistance, 0.647 (HbA1c) and 0.995 (insulin). Among non-metabolic syndrome patients, a small insulin elevation identified risk factor clustering.HbA1c and specially insulin levels were associated with metabolic syndrome criteria, their clustering, and insulin resistance. Insulin could provide early information in subjects prone to develop metabolic syndrome.

Weinreb N.J.,Boca Research | Finegold D.N.,Childrens Hospital of Pittsburgh | Feingold E.,University of Pittsburgh | Zeng Z.,University of Pittsburgh | And 3 more authors.
Orphanet Journal of Rare Diseases | Year: 2015

Background: GD1-DS3 is an integrated assessment of type 1 Gaucher disease (GD1) burden based on bone, hematologic and visceral domains. We investigated this disease severity scoring system (DS3) methodology for initial assessment, long-term follow-up and evaluation of treatment responses. Methods: We enrolled 133 treated adult GD1 patients. Baseline DS3 scores were calculated near the initial treatment date and patients stratified by severity as marked (DS3 6.00-19.00), moderate (DS3 3.00-5.99), mild (DS3 < 3.00). Follow-up scores were calculated annually. Minimal clinically important improvement (MCII), is defined as ΔDS3 of -3.1. Results: Patient characteristics: N370S was the most common allele (118 patients had at least one), 52 were N370S/N370S (48/52 were Ashkenazi Jews), N370S/L444P was the most common genotype among non-Jews. Median age of treatment: 45 years; median follow-up: 14 years. Baseline DS3 scores: Patients with marked disease (N = 58; median 7.84) were least likely to be N370S homozygous (19 %) and most likely to have had splenectomy (53 %), early age at diagnosis (median 18 years) and major pre-treatment bone pathology (76 %). Among patients with moderate disease (N = 53; median 4.33), 49 % were N370S/N370S, 15.1 % had splenectomy and 17 % had major bone disease. Median age at diagnosis: 32 years. No patient with mild disease (N = 22; median 2.4) had splenectomy or major skeletal disease. Median age at diagnosis: 40 years. 68 % were N370S homozygous. Response to treatment: Health-state transitions occurred primarily during the early treatment years. At Year 5, among 48 evaluable patients with marked baseline disease, eight were unchanged in severity status whereas 40 had MCII of varying degrees with 11 scored as mild. Among 42 evaluable moderate patients, none worsened, 16 remained moderate and 26 improved to mild. Among 16 evaluable mild patients, 14 remained so and 2 had DS3 scores in the low moderate range. Conclusions: DS3 is effective for assessing disease burden in GD1 and for monitoring response. ERT was associated with MCII in DS3 scores in patients with high severity. Nevertheless, despite better DS3 scores with treatment, GD1 patients especially those with splenectomy and pre-treatment bone pathology, continued to have bone complications. © 2015 Weinreb et al.

PubMed | Northwestern University, Cincinnati Childrens Hospital Medical Center, Yale University, Children's Hospital of Philadelphia and 5 more.
Type: Journal Article | Journal: Molecular genetics and metabolism | Year: 2016

In Gaucher disease, deficient activity of acid -glucosidase results in accumulation of its substrates, glucosylceramide and glucosylsphingosine, within the lysosomes of cells primarily in the spleen, liver, bone marrow, and occasionally the lung. The multisystem disease is predominantly characterized by hepatosplenomegaly, anemia, thrombocytopenia, and skeletal disease. Enzyme replacement therapy with recombinant human acid -glucosidase has been the first-line therapy for Gaucher disease type 1 for more than two decades. Eliglustat, a novel oral substrate reduction therapy, was recently approved in the United States and the European Union as a first-line treatment for adults with Gaucher disease type 1. Eliglustat inhibits glucosylceramide synthase, thereby decreasing production of the substrate glucosylceramide and reducing its accumulation. Although existing recommendations for the care of patients with Gaucher disease remain in effect, unique characteristics of eliglustat require additional investigation and monitoring. A panel of physicians with expertise in Gaucher disease and experience with eliglustat in the clinical trials provide guidance regarding the use of eliglustat, including considerations before starting therapy and monitoring of patients on eliglustat therapy.

Weinreb N.J.,Boca Research | Weinreb N.J.,University of Miami | Lee R.E.,University of Pittsburgh
Critical Reviews in Oncogenesis | Year: 2013

Patients with type 1 Gaucher disease (GD1) have increased risk of developing myeloma, other hematological cancers, hepatocellular carcinoma, and other solid tumors. Patient awareness of the GD1-cancer association causes anxiety and fear. Little is known about cancer as a cause of death in GD1, especially in patients never treated with GD1-specific therapies. Consequently, the effect of treatment on cancer mortality in GD1 patients is difficult to evaluate. In this review, starting with a population of 184 GD1 cases never treated, we annotate and analyze the causes of death of 57 GD1 patients who died of cancer. The proportional mortality ratio (PMR) for all malignancies in patients with GD1 is 1.57 (p=0.0002), but it is much higher for myeloma (PMR = 9.66) and other hematological cancers, hepatocellular carcinoma, and kidney cancer (PMR = ~4). However, deaths from colorectal and pancreatic cancers were not more frequent than expected, and deaths from lung, breast, gynecological, and prostate cancer occurred less than anticipated. Herein, we discuss whether GD1 is truly a hereditary cancer syndrome and the problem of comorbidities and cancer risk assessment, and we speculate as to whether the variability in death by cancer type might be attributable to biochemical sequelae of tumor cell and macrophage/stromal cell GBA1 mutation affecting signals for metastasis, the process most closely associated with cancer mortality. © 2013 by Begell House, Inc.

Rendon M.I.,Boca Research | Rendon M.I.,University of Miami | Cardona L.M.,Boca Research | Pinzon-Plazas M.,Boca Research
Journal of Cosmetic and Laser Therapy | Year: 2010

We report the use of injectable poly-l-lactic acid (PLLA) for volume restoration in a 45-year-old white female who was concerned about the appearance of her hands. The patient expressed a desire for long-term restoration, and selected injectable PLLA because of its known 2-year duration of effect, although she was informed that injectable PLLA is not FDA-approved for use in the hands. After reconstitution with 8 ml of diluent plus lidocaine, 0.10.2-ml aliquots of injectable PLLA were injected into selected sites, up to 5 ml per hand. The patient underwent three identical treatments, followed by postinjection use of moisturizing cream and massage; improvement in appearance was noted by the patient between the second and third treatments. Correction was maintained for at least 18 months, with no adverse events. We have also briefly reviewed the literature on the use of injectable PLLA for volume restoration in the hand. © 2010 Informa UK, Ltd.

Rendon M.I.,Boca Research | Rendon M.I.,University of Miami
Journal of Cosmetic Dermatology | Year: 2012

Background Facial rejuvenation techniques have evolved in recent decades driven by a paradigm shift to restoration of lost volume, and an increase in the number of available products. As clinical experience has increased, practitioners have further refined the use of these products. Objectives To share observations and practical recommendations based on clinical experience with the aesthetic use of injectable poly-l-lactic acid (PLLA) in patients followed for up to 5years. Methods Literature review and retrospective case history review of the first 100 patients treated with injectable PLLA, many of whom have been followed for over 5years. Results Use of injectable PLLA, alone or in combination with other products, has provided excellent and long-lasting (up to 5years) aesthetic results for most of the reviewed patients. Typically, patients have received one or two touch-up sessions between years 2 and 4 after initial full correction. There were minimal adverse events of papule formation; these eventually resolved. Conclusions Injectable PLLA is a safe and effective option for achieving long-term patient satisfaction with soft-tissue augmentation. © 2012 Wiley Periodicals, Inc.

Dakic I.,Florida Atlantic University | Stevanovic J.,Boca Research | Stevanovic A.,Florida Atlantic University
IEEE Conference on Intelligent Transportation Systems, Proceedings, ITSC | Year: 2015

Traffic signal control is one of the most common means of traffic management in urban areas. To create an efficient urban transportation network, the optimization of signal control strategy is required. Various methods and tools can be used for that purpose. This study proposes two signal control algorithms that are based on backpressure model, which is originally developed to maximize the throughput in communication networks. Thus, one of the goals was to determine if such control strategies can lead to maximum throughput through an urban traffic network. In addition, the evaluation of the two algorithms included comparison of their performances with the performances of the conventional signal control strategies in microsimulation software. Evaluation results, in terms of various performance measures, demonstrate that backpressure control models are outperformed by conventional (fixed and actuated) signal timings optimized by a genetic algorithm. © 2015 IEEE.

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