Axitinib, an antiangiogenic multikinase inhibitor (MKI), was evaluated in the compassionate use programme (CUP) in Spain (October 2012-November 2014).
47 patients with advanced radioactive iodine ...(RAI)-refractory differentiated thyroid cancer (DTC,
= 34) or medullary thyroid cancer (MTC,
= 13) with documented disease progression were treated with axitinib 5 mg b.i.d. The primary efficacy endpoint was objective response rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Progression-free survival (PFS) and adverse events (AEs) were secondary objectives. Regulatory authorities validated the CUP, and all patients signed informed consent form.
Axitinib was administered as first-line therapy in 17 patients (36.2%), as second-line in 18 patients (38.3%) and as third/fourth-line in 12 patients (25.5%). With a median follow-up of 11.5 months (0-24.3), ORR was 27.7% (DTC: 29.4% and MTC: 23.1%) and median PFS was 8.1 months (95% CI: 4.1-12.2) (DTC: 7.4 months (95% CI: 3.1-11.8) and MTC: 9.4 months (95% CI: 4.8-13.9)). Better outcomes were reported with first-line axitinib, with an ORR of 53% and a median PFS of 13.6 months compared with 16.7% and 10.6 months as second-line treatment. Twelve (25.5%) patients required dose reduction to 3 mg b.i.d. All-grade AEs included asthenia (53.2%), diarrhoea (36.2%), hypertension (31.9%) and mucositis (29.8%); grade 3/4 AEs included anorexia (6.4%), diarrhoea (4.3%) and cardiac toxicity (4.3%).
Axitinib had a tolerable safety profile and clinically meaningful activity in refractory and progressive thyroid cancer regardless of histology as first-line therapy. To our knowledge, this is the first time that cross-resistance between MKIs is suggested in thyroid cancer, highlighting the importance of prospective sequential clinical studies.
FPGA embedded multichannel analyzer Garcia-Duran, Angel; Hernandez-Davila, Victor Martin; Vega-Carrillo, Hector Rene ...
Applied radiation and isotopes,
November 2018, 2018-Nov, 2018-11-00, 20181101, Letnik:
141
Journal Article
Recenzirano
An multichannel analyzer has been designed, and its performance has been evaluated. The multichannel analyzer is embedded into a Field programmable gate array. The design incudes the virtual ...instrument in order to hand and to visualize the pulse height spectrum. Two commercially available multichannel analyzers using a NaI(Tl) and HPGe detectors were used to obtain the pulse height spectra of 137Cs, 60Co and 152Eu sources and were compared with the pulse height spectra obtained with the embedded multichannel analyzer, being alike the spectra obtained with the commercial multichannel analyzer. Our design is smaller, low cost and it has options to add other features.
•An MCA embedded into a FPGA was designed, built and evaluated.•To hand and visualize the spectra a VI was designed.•The obtained pulse height spectra are alike to spectra measured with commercial MCA.
Introduction:Renal impairment (RI) is a common complication in multiple myeloma (MM) with an incidence of 20-40%, due to the older age of the affected patients (pts) and the nature of the disease. ...Prognosis of pts with RI has improved in recent years (yrs), but remains closely associated with the recovery of renal function. There is little information on the renal response of relapsed refractory MM (RRMM) to new antimyeloma drugs within clinical practice, using standardized criteria such as glomerular filtration rate (GFR) estimated by the Cockroft-Gault (CG) and the Modification of Diet in Renal Disease (MDRD) formulas.The primary objective of the study is to describe the renal response in RRMM pts with moderate (CrCl 30–50 mL/min) or severe renal impairment (RI) (CrCl < 30 mL/min) after initiating treatment (Tx). Secondary objectives include response rate, overall survival (OS), safety, and health resource utilization. We present results from a pre-planned, interim analysis with a data cut-off of June 15, 2014.
Methods:This is a large ongoing observational, prospective, multicenter study in RRMM pts with moderate or severe RI (based on the CG formula) receiving antimyeloma Tx. The overall planned sample size is 300 pts to be followed for up to 36 months (mos) after the end of Tx. Renal and MM responses are evaluated according to the International Myeloma Working Group criteria. Renal complete response (renalCR) is defined as a sustained (for at least 2 mos) increase of baseline estimated glomerular filtration rate (eGFR) to ≥ 60 mL/min; a partial renal response (renalPR) is defined as an increase from < 15 to 30–59 mL/min, and a minor renal response (renalMR) from < 15 to 15–29 mL/min or, from 15–29 to 30–59 mL/min.
Results:A total of 150 pts were included in the interim analysis, mean ± SD age was 74 ± 9 yrs, 53% were male, and 53% had moderate and 47% had severe RI. At baseline, 57% of pts were in first relapse. At diagnosis, 45% of pts had ISS stage III, 29% had ISS stage II, 9% had ISS stage I, and 17% had no ISS stage available. Main antimyeloma therapies were: lenalidomide (LEN)-based (37%), bortezomib (BORT)-based (30%), BORT + LEN based (5%), chemotherapy-based (25%) and, thalidomide-based (3%). The median follow-up was 4 mos. To date 38% of pts have discontinued Tx, 13% due to adverse events (AEs), and 29% have died. The main causes of death were: disease progression (8.7%), infection (6.7%), respiratory failure (3.3%), kidney insufficiency (2%), fractures (2%). The mean baseline CG/MDRD was 39.7/42.2 (± 6.3/10.2) mL/min in the moderate RI subgroup and 20.2/19.8 (± 7.6/9.8) mL/min in pts with severe RI (correlation coefficient CG vs. MDRD: 0.93). Overall, 15.3% (n = 23; 95% confidence interval CI 9.5–21.1,) had a renal response according to the CG formula, i.e. renal function iimproved by at least 1 KDIGO stage; 4.7% had renalCR, 0.7% renalPR and 10% renalMR. According to the MDRD formula, the renal response was 21.3% (8.6% renalCR, 12.7% renalMR). Median time to best renal response was 1.5 (range 0.6–4.6) mos. The renal response based on CG/MDRD according to antimyeloma therapies was 10.9%/20% for LEN-based, 26.7%/31.1% for BORT-based, 0%/12.5%, for LEN + BORT-based, and 10.2%/15.4%, for chemotherapy-based therapies. 24 hour (hr) proteinuria measurement was available at baseline in 70 pts (median of 1.3 g/24 hr), 77.1% of whom had > 0.3g/24 hr. Of these, 4 (7.4%) achieved complete proteinuria response (< 0.3g/24 hr) and 4 (7.4%) achieved partial response (< 1g/24 hr) by the 4th follow-up visit. The overall myeloma response (≥ partial response) was 38.0% achieved after a median of 2.9 (1.3–5.2) mos. LEN-based myeloma response was 45.5%, BORT-based 48.9% and LEN + BORT-based 50.0%. These responses seemed to be higher than those obtained with chemotherapy-based therapies (17.6%). The median time to progression (TTP) was 4.5 mos (95% CI 4.2–7.3). TTP was 16.2 mos with LEN-based, 11.8 mos with BORT-based, not reached with LEN + BORT-based, and 8.3 mos with chemotherapy-based therapies. Overall, 52% of pts had an AE and 12% a serious related AE.
Conclusions: The most commonly used Tx in clinical practice in RRMM pts with RI are LEN or BORT-based. The results of this interim analysis suggest that these Tx can improve RI in approximately 15% of cases, and are associated with a higher antimyeloma response than chemotherapy-based Tx.
Morales:Celgene: Consultancy. Ruiz Boza:Celgene : Employment, Other. Garcia:Celgene: Honoraria.
This report presents the findings of the 2018 Spanish Catheter Ablation Registry.
Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers.
...Data sent by 100 centers were analyzed, with a total number of 16566 ablation procedures performed (the highest historically reported in this registry) for a mean of 165.5±127.9 and a median of 119 procedures per center. The ablation targets most frequently treated were atrial fibrillation (n=4234; 25.6%), atrioventricular nodal re-entrant tachycardia (n=3525; 21.3%) and cavotricuspid isthmus (n=3425; 20.7%). A new peak was observed in the ablation of atrial fibrillation, increasing the distance from the other substrates. The overall success rate was 91%. The rate of major complications was 2.2%, and the mortality rate was 0.04%. A total of 2.1% of the ablations were performed in pediatric patients.
The Spanish Catheter Ablation Registry enrolls systematically and continuously enrolls the ablation procedures performed in Spain, showing a progressive increasing in the number of ablations over the years, with a high success rate and low percentage of complications.
Se describen los resultados del Registro Nacional de Ablación con Catéter correspondientes al año 2018.
La recogida de datos se ha realizado de manera retrospectiva con la cumplimentación de un formulario de recogida de datos por cada uno de los centros participantes.
Se han analizado los datos enviados por 100 centros, con un número total de procedimientos de ablación de 16.566, el más alto comunicado históricamente en este registro (con una media de 165,5±127,9 y una mediana de 119 procedimientos por centro). Se consolida la ablación de fibrilación auricular como el sustrato abordado con más frecuencia (n=4.234; 25,6%), seguida de la taquicardia por reentrada nodular (n=3.525; 21,3%) y el istmo cavotricuspídeo (n=3.425; 20,7%). Se observa un nuevo pico en el número de procedimientos de ablación de fibrilación auricular y aumenta la distancia respecto a los demás sustratos. La tasa total de éxito fue del 91%; la de complicaciones mayores, del 2,2% y la mortalidad, del 0,04%. El 2,1% de las ablaciones se realizaron en pacientes pediátricos.
El Registro Nacional de Ablación con Catéter con Catéter recoge sistemática e ininterrumpidamente los procedimientos de ablación realizados en España, lo que permite observar a lo largo de los años un aumento progresivo del número de ablaciones manteniendo una tasa de éxito elevada y unos porcentajes de complicaciones bajos.
Several risk scores have been used to predict risk after an acute coronary syndrome (ACS), but none of these risk scores include functional class. The aim was to assess the predictive value of risk ...stratification (RS), including functional class, and how cardiac rehabilitation (CR) changed RS. Two hundred and thirty-eight patients with ACS from an ambispective observational registry were stratified as low (L) and no-low (NL) risk and classified according to exercise compliance; low risk and exercise (L-E), low risk and control (no exercise) (L-C), no-low risk and exercise (NL-E), and no-low risk and control (NL-C). The primary endpoint was cardiac rehospitalization. Multivariable analysis was performed to identify variables independently associated with the primary endpoint. The L group included 56.7% of patients. The primary endpoint was higher in the NL group (18.4% vs. 4.4%, p < 0.001). After adjustment for age, sex, diabetes, and exercise in multivariable analysis, HR (95% CI) was 3.83 (1.51−9.68) for cardiac rehospitalization. For RS and exercise, the prognosis varied: the L-E group had a cardiac rehospitalization rate of 2.5% compared to 26.1% in the NL-C group (p < 0.001). Completing exercise training was associated with reclassification to low-risk, associated with a better outcome. This easy-to-calculate risk score offers robust prognostic information. No-exercise groups were independently associated with the worst outcomes. Exercise-based CR program changed RS, improving classification and prognosis.
The number of indications for total hip replacement (THR) and total knee replacement (TKR) surgery is increasing. Enhanced recovery after surgery (ERAS) represents the next step in the evolution of ...standardised care. The primary aim of this study is to measure the in-hospital 30-day medical and surgical postoperative complications rate. The study's secondary aims are to determine the length of stay, 30-day mortality rate, 30-day reoperation and readmission rates, the ERAS overall compliance and predefined ERAS individual items compliance.
This multicentre, prospective, observational study will include adult patients (aged >18 years) undergoing elective THR and TKR surgery. Consecutive patients undergoing surgery within the 2-month data collection period will be included. Centres that offer the THR and/or TKR surgery will be eligible to participate. The data collection will be done through an online data collection form via a secure, password-protected platform at each centre with predefined data fields.
Ethical approval for this study has been obtained from the Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón (C.P.-C.I. PI18/135; on 23 May 2018). It was prospectively registered on 27 June 2018, at www.clinicaltrials.gov with identification no. NCT03570944.
The study will be disseminated through the SPARN-RedGERM, SEDAR, GERM and through social media. Peer-reviewed publications will be published under corporate authorship, including POWER.2 Study Group and SPARN-RedGERM.
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