Multiple Myeloma Treatment in Real-world Clinical Practice : Results of a Prospective, Multinational, Noninterventional Study

Funding Information: The authors would like to thank all patients and their families and all the EMMOS investigators for their valuable contributions to the study. The authors would like to acknowledge Robert Olie for his significant contribution to the EMMOS study. Writing support during the development of our report was provided by Laura Mulcahy and Catherine Crookes of FireKite, an Ashfield company, a part of UDG Healthcare plc, which was funded by Millennium Pharmaceuticals, Inc, and Janssen Global Services, LLC. The EMMOS study was supported by research funding from Janssen Pharmaceutical NV and Millennium Pharmaceuticals, Inc. Funding Information: The authors would like to thank all patients and their families and all the EMMOS investigators for their valuable contributions to the study. The authors would like to acknowledge Robert Olie for his significant contribution to the EMMOS study. Writing support during the development of our report was provided by Laura Mulcahy and Catherine Crookes of FireKite, an Ashfield company, a part of UDG Healthcare plc, which was funded by Millennium Pharmaceuticals, Inc, and Janssen Global Services, LLC. The EMMOS study was supported by research funding from Janssen Pharmaceutical NV and Millennium Pharmaceuticals, Inc. Funding Information: M.M. has received personal fees from Janssen, Celgene, Amgen, Bristol-Myers Squibb, Sanofi, Novartis, and Takeda and grants from Janssen and Sanofi during the conduct of the study. E.T. has received grants from Janssen and personal fees from Janssen and Takeda during the conduct of the study, and grants from Amgen, Celgene/Genesis, personal fees from Amgen, Celgene/Genesis, Bristol-Myers Squibb, Novartis, and Glaxo-Smith Kline outside the submitted work. M.V.M. has received personal fees from Janssen, Celgene, Amgen, and Takeda outside the submitted work. M.C. reports honoraria from Janssen, outside the submitted work. M. B. reports grants from Janssen Cilag during the conduct of the study. M.D. has received honoraria for participation on advisory boards for Janssen, Celgene, Takeda, Amgen, and Novartis. H.S. has received honoraria from Janssen-Cilag, Celgene, Amgen, Bristol-Myers Squibb, Novartis, and Takeda outside the submitted work. V.P. reports personal fees from Janssen during the conduct of the study and grants, personal fees, and nonfinancial support from Amgen, grants and personal fees from Sanofi, and personal fees from Takeda outside the submitted work. W.W. has received personal fees and grants from Amgen, Celgene, Novartis, Roche, Takeda, Gilead, and Janssen and nonfinancial support from Roche outside the submitted work. J.S. reports grants and nonfinancial support from Janssen Pharmaceutical during the conduct of the study. V.L. reports funding from Janssen Global Services LLC during the conduct of the study and study support from Janssen-Cilag and Pharmion outside the submitted work. A.P. reports employment and shareholding of Janssen (Johnson & Johnson) during the conduct of the study. C.C. reports employment at Janssen-Cilag during the conduct of the study. C.F. reports employment at Janssen Research and Development during the conduct of the study. F.T.B. reports employment at Janssen-Cilag during the conduct of the study. The remaining authors have stated that they have no conflicts of interest. Publisher Copyright: © 2018 The AuthorsMultiple myeloma (MM) remains an incurable disease, with little information available on its management in real-world clinical practice. The results of the present prospective, noninterventional observational study revealed great diversity in the treatment regimens used to treat MM. Our results also provide data to inform health economic, pharmacoepidemiologic, and outcomes research, providing a framework for the design of protocols to improve the outcomes of patients with MM. Background: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. Patients and Methods: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months. Results: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and 2%, and 27% and 27%, 27% and 23%, and 6% and 4%, respectively. In the SCT and non-SCT patients, the overall response rate was 86% to 97% and 64% to 85% in line 1, 74% to 78% and 59% to 68% in line 2, 55% to 83% and 48% to 60% in line 3, and 49% to 65% and 36% and 45% in line 4, respectively, for regimens that included bortezomib and/or thalidomide/lenalidomide. Conclusion: The results of our prospective study have revealed great diversity in the treatment regimens used to manage MM in real-life practice. This diversity was linked to factors such as novel agent accessibility and evolving treatment recommendations. Our results provide insight into associated clinical benefits.publishersversionPeer reviewe

Prevalence of HPV high and low risk types in cervical samples from the Italian general population: a population based study

<p>Abstract</p> <p>Background</p> <p>This multicenter study describes the type-specific prevalence of HPV infection in the general population from central and southern Italy, comparing the data with previously published Italian studies.</p> <p>Methods</p> <p>Women aged from 25 to 65 who attended cervical cancer screening in five different Italian regions were tested for HPV infection with Hybrid Capture II (HCII) low and high risk probes. Women repeating Pap-test upon unsatisfactory or positive results, or as a post-treatment and post-colposcopy follow-up analysis, were excluded from our study. High risk (HR) HPV positive samples were typed using GP5+/GP6+ primed PCR, followed by Reverse Line Blot for 18 high/intermediate risk HPV types, while low risk (LR) HPV positive samples were tested with type specific primers for HPV6 and HPV11.</p> <p>Results</p> <p>3817 women had a valid HCII test: 350 of them (9.2%) were positive for HR probes, 160 (4.2%) for LR probes, while 57 women were positive for both. Multiple infections were detected in 97 HR HPV positive women. The most common types were HPV 16 (3%), 31 (1.2%), 51 (1%). HPV6 ranked fifth (0.6%), HPV18 ranked tenth (0.5%) and HPV11 sixteenth (0.3%).</p> <p>In Sardinia the prevalence of high-risk infection was 13%, significantly higher than the mean value (p < 0.00005).</p> <p>The distribution of the most frequent types did not significantly differ by centre (p = 0.187) and age (p = 0.085).</p> <p>Conclusions</p> <p>Because cervical cancer incidence and Pap test coverage is lower in southern than in northern Italy, a lower prevalence of high-risk infections in the general population was expected in the south. However, prevalence detected in this study for the south of the country is slightly but significantly higher than the rest of Italy. The consequence may be an epidemic of cervical cancer in the next decades if adequate screening programs are not implemented there.</p

Conocimiento y practicas sobre estimulación temprana en madres de niños menores de 1 año, Hospital Barranca Cajatambo 2016

TesisSe planteó el problema ¿Cuál es el conocimiento en las prácticas de estimulación temprana en madres de niños menores de 1 año, del Hospital Barranca – Cajatambo 2016? Se tuvo como objetivo general: Determinar el conocimiento y las prácticas sobre estimulación temprana en madres de niños menores de un año, atendidos en el hospital Barranca Cajatambo-2016. Hipótesis: El conocimiento sobre estimulación temprana es significativamente adecuada con las prácticas que tienen las madres de niños menores de 1 año.Tipo y diseño de investigación de enfoque cuantitativo, descriptivo, correlacional, prospectivo, no experimental y transversal. Poblacion: La población estuvo conformada por las madres de niños menores de un año atendidos en el Hospital Barranca Cajatambo.Muestra: Estuvo conformada por 59 madres de niños menores de 1 año registrados en el programa de CRED del hospital Barranca Cajatambo. Técnica e instrumento de recolección de datos: Se utilizó como técnica la encuesta, se utilizó como instrumento el cuestionario, las prácticas se evaluaron con la escala de Likert.Resultados. El 74,59% de las madres conocen sobre la estimulación temprana, y el 25,41% no conocen sobre la estimulación temprana. En cuanto a la práctica, el 59,32% de las madres tienen prácticas adecuadas sobre la estimulación temprana y el 40,68% de las madres tienen prácticas inadecuadas sobre la estimulación temprana.Se concluyó que: El nivel de conocimiento influye significativamente en las prácticas sobre estimulación temprana en madres de niños menores de 1 año (p=0,03

Bay of Bengal intraseasonal oscillations and the 2018 monsoon onset

Author Posting. © American Meteorological Society, 2021. This article is posted here by permission of American Meteorological Society for personal use, not for redistribution. The definitive version was published in Bulletin of the American Meteorological Society 102(10), (2021): E1936–E1951, https://doi.org/10.1175/BAMS-D-20-0113.1.In the Bay of Bengal, the warm, dry boreal spring concludes with the onset of the summer monsoon and accompanying southwesterly winds, heavy rains, and variable air–sea fluxes. Here, we summarize the 2018 monsoon onset using observations collected through the multinational Monsoon Intraseasonal Oscillations in the Bay of Bengal (MISO-BoB) program between the United States, India, and Sri Lanka. MISO-BoB aims to improve understanding of monsoon intraseasonal variability, and the 2018 field effort captured the coupled air–sea response during a transition from active-to-break conditions in the central BoB. The active phase of the ∼20-day research cruise was characterized by warm sea surface temperature (SST > 30°C), cold atmospheric outflows with intermittent heavy rainfall, and increasing winds (from 2 to 15 m s−1). Accumulated rainfall exceeded 200 mm with 90% of precipitation occurring during the first week. The following break period was both dry and clear, with persistent 10–12 m s−1 wind and evaporation of 0.2 mm h−1. The evolving environmental state included a deepening ocean mixed layer (from ∼20 to 50 m), cooling SST (by ∼1°C), and warming/drying of the lower to midtroposphere. Local atmospheric development was consistent with phasing of the large-scale intraseasonal oscillation. The upper ocean stores significant heat in the BoB, enough to maintain SST above 29°C despite cooling by surface fluxes and ocean mixing. Comparison with reanalysis indicates biases in air–sea fluxes, which may be related to overly cool prescribed SST. Resolution of such biases offers a path toward improved forecasting of transition periods in the monsoon.This work was supported through the U.S. Office of Naval Research’s Departmental Research Initiative: Monsoon Intraseasonal Oscillations in the Bay of Bengal, the Indian Ministry of Earth Science’s Ocean Mixing and Monsoons Program, and the Sri Lankan National Aquatic Resources Research and Development Agency. We thank the Captain and crew of the R/V Thompson for their help in data collection. Surface atmospheric fields included fluxes were quality controlled and processed by the Boundary Layer Observations and Processes Team within the NOAA Physical Sciences Laboratory. Forecast analysis was completed by India Meteorological Department. Drone image was taken by Shreyas Kamat with annotations by Gualtiero Spiro Jaeger. We also recognize the numerous researchers who supported cruise- and land-based measurements. This work represents Lamont-Doherty Earth Observatory contribution number 8503, and PMEL contribution number 5193.2022-04-0

Incidence, Risk Factors and Outcome of Pre-engraftment Gram-Negative Bacteremia after Allogeneic and Autologous Hematopoietic Stem Cell Transplantation: An Italian Prospective Multicenter Survey

Abstract BACKGROUND: Gram-negative bacteremia (GNB) is a major cause of illness and death after hematopoietic stem cell transplantation (HSCT), and updated epidemiological investigation is advisable. METHODS: We prospectively evaluated the epidemiology of pre-engraftment GNB in 1118 allogeneic HSCTs (allo-HSCTs) and 1625 autologous HSCTs (auto-HSCTs) among 54 transplant centers during 2014 (SIGNB-GITMO-AMCLI study). Using logistic regression methods. we identified risk factors for GNB and evaluated the impact of GNB on the 4-month overall-survival after transplant. RESULTS: The cumulative incidence of pre-engraftment GNB was 17.3% in allo-HSCT and 9% in auto-HSCT. Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa were the most common isolates. By multivariate analysis, variables associated with GNB were a diagnosis of acute leukemia, a transplant from a HLA-mismatched donor and from cord blood, older age, and duration of severe neutropenia in allo-HSCT, and a diagnosis of lymphoma, older age, and no antibacterial prophylaxis in auto-HSCT. A pretransplant infection by a resistant pathogen was significantly associated with an increased risk of posttransplant infection by the same microorganism in allo-HSCT. Colonization by resistant gram-negative bacteria was significantly associated with an increased rate of infection by the same pathogen in both transplant procedures. GNB was independently associated with increased mortality at 4 months both in allo-HSCT (hazard ratio, 2.13; 95% confidence interval, 1.45-3.13; P <.001) and auto-HSCT (2.43; 1.22-4.84; P = .01). CONCLUSIONS: Pre-engraftment GNB is an independent factor associated with increased mortality rate at 4 months after auto-HSCT and allo-HSCT. Previous infectious history and colonization monitoring represent major indicators of GNB. CLINICAL TRIALS REGISTRATION: NCT02088840