scholarly journals P–097 The impact of SARS-CoV–2 on male gonadal function. A longitudinal study

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
M P Lauritsen ◽  
T D Leineweber ◽  
C B Hansen ◽  
U V Schneider ◽  
H Westh ◽  
...  
Keyword(s):  
Cohort Study ◽  
Semen Quality ◽  
Endocrine Function ◽  
Semen Parameters ◽  
Reproductive Hormone ◽  
Rt Pcr ◽  
Hormone Profile ◽  
Oropharyngeal Swab ◽  
The Impact

Abstract Study question Can severe acute respiratory syndrome coronavirus 2 (SARS-CoV–2) be detected in the semen of SARS-CoV–2 positive men, and does SARS-CoV–2 infection affect male reproductive function? Summary answer No SARS-CoV–2 RNA was detected in semen. An impact of SARS-CoV–2 infection on semen quality and reproductive hormone profile awaits evaluation at 3 + 6 months follow-up. What is known already SARS-CoV–2 may use angiotensin-converting enzyme (ACE)2 as an entry point into the cell. As ACE2 is expressed in testicular tissue, it has been speculated that SARS-CoV–2 may affect the male reproductive system. A cohort study including 38 male COVID–19 patients showed that SARS-CoV–2 was present in the semen of six patients (15.8%) [Li et al., 2020]. Later studies including a total of 223 patients have not provided evidence of transmission of SARS-CoV–2 via semen. There are to date no available longitudinal studies on semen quality following SARS-CoV–2 infection. Study design, size, duration Longitudinal cohort study including 50 non-hospitalized men from the general population in the Capital Region of Denmark. All participants had a confirmed SARS-CoV–2 infection by reverse-transcription polymerase chain reaction (RT-PCR) on oropharyngeal swab material within the last week. The presence of SARS-CoV–2 in semen samples by RT-PCR, semen parameters and reproductive hormone profile were assessed at inclusion and at 3 + 6 months follow-up. SARS-CoV–2 antibody levels were assessed 3–5 weeks after inclusion. Participants/materials, setting, methods SARS-CoV–2-positive males (age 18–60 years) were included. Oropharyngeal and semen samples were tested by RT-PCR applying the E-Sarbeco primers and probe published by Corman et al. 2020 and adapted to TaqMan Fast Virus 1-step master mix and LightCycler 480 as previously reported by Jørgensen et al. 2020. SARS-CoV–2 antibodies were detected using the serological immunoassay from Shenzhen YHLO Biotech on the iFlash 1800. Semen quality parameters were analysed according to World Health Organisation (WHO) standards. Main results and the role of chance To date, 25 men with a mean age of 35 years have been included in the study. SARS-CoV–2 RNA could not be detected in the semen samples of any of the 25 men at the time of inclusion. Twenty-one of the 25 men (84,0%) had a same day RT-PCR-confirmed SARS-CoV–2 infection in an oropharyngeal swab. RT-PCR cycle threshold (ct) values were distributed as follows: four (19,0%) were strongly positive (ct < 25), 16 (76,2%) intermediately positive (ct 25–35) and one (4,8%) weakly positive (ct 35–45). The four men without PCR-confirmed SARS-CoV–2 infection all had a positive IgG response to SARS-CoV–2 at the time of inclusion. Longitudinal semen and reproductive hormone profiles analyses will be performed. Further studies are needed to prove whether SARS-CoV–2 can be transmitted to the male reproductive tract and whether SARS-CoV–2 infection may cause alterations of spermatogenesis and endocrine function. Limitations, reasons for caution Strengths of this study are the unselected population of men examined within a week after confirmed SARS-CoV–2 infection and the follow-up of semen parameters and endocrine profile. Limitations are the limited sample size and the fact that semen quality was not known before the participants were diagnosed with COVID–19. Wider implications of the findings: Knowledge of viral detection and semen persistence of SARS-CoV–2 is essential for clinical practice and public health. There is a need for evidence-based counselling on the impact of SARS-CoV–2 infection for patients undergoing assisted reproduction technology and patients who have a need for semen cryopreservation. Trial registration number H–20027362

scholarly journals P–070 Evaluation of SARS-CoV–2 in human semen and effect on total sperm number: A prospective observational study

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
J Best ◽  
M Kuchakulla ◽  
K Khodamoradi ◽  
T Lima ◽  
F Frech ◽  
...  
Keyword(s):  
Semen Analysis ◽  
Epidemiological Data ◽  
Semen Parameters ◽  
Human Semen ◽  
Sperm Number ◽  
Rt Pcr ◽  
Sperm Analysis ◽  
Reproductive Techniques ◽  
The Impact

Abstract Study question Is the SARS-CoV–2 virus present in human semen and what is the impact on semen parameters following an infection? Summary answer SARS-CoV–2 infection, though not detected in semen of recovered men, can affect TSN in ejaculate in the acute setting. What is known already Early epidemiological data has suggested that the primary mode of transmission is through respiratory droplets, but the presence of SARS-CoV–2 has been identified in other bodily fluids such as feces, urine, and semen. Study design, size, duration We prospectively recruited thirty men diagnosed with acute SARS-CoV–2 infection using real-time reverse transcriptase-polymerase chain reaction (RT-PCR) of pharyngeal swab specimens. Thirty semen samples from recovered men were obtained 11–64 days after testing positive for SAR-CoV–2 infection. The median duration between positive SAR-CoV–2 test and semen collection was 37 days (IQR=23). Participants/materials, setting, methods Semen samples were collected from each individual using mailed kits. Follow-up semen samples were done with mailed kits or in-person in office setting. Semen analysis and PCR was performed after samples were received. Main results and the role of chance The median total sperm number (TSN) in ejaculate was 12.5 million (IQR=53.1). When compared with age-matched SARS-CoV–2(-) men, TSN was lower among SARS-CoV–2(+) men (p = 0.0024). Five men completed a follow-up sperm analysis (median 3 months) and had a median TSN of 18 million (IQR=21.6). No RNA was detected by means of RT-PCR in the semen in 16 samples tested. Limitations, reasons for caution First, most of the semen samples came from non-severe men of whom were in the recovery stage and lacked symptoms. Additionally, our sample size was relatively small and overnight mail-in semen analysis kits were used during the acute phase of infection to minimize contact with positive subjects. Wider implications of the findings: Our findings suggest extremely low risk of viral transmission during sexual contact and assisted reproductive techniques, although further data need to be obtained. The impact on TSC in recovered men from SARS-CoV–2 infection is concerning, nevertheless long-term follow-up of these men is critical to determine the nadir of TSC. Trial registration number 20200401

Cognitive Impairment and Physical Activity in Old Age: The Impact on All-Cause Mortality in a 15-Year Follow-Up of the Bambuí Cohort Study of Aging

2020 ◽  
Author(s):  
Erico Castro-Costa ◽  
Jerson Laks ◽  
Cecilia Godoi Campos ◽  
Josélia OA Firmo ◽  
Maria Fernanda Lima-Costa ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cohort Study ◽  
Cognitive Impairment ◽  
Old Age ◽  
All Cause Mortality ◽  
The Impact

scholarly journals Cohort study of ageing from Bagé (SIGa-Bagé), Brazil: profile and methodology

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elaine Thumé ◽  
Marciane Kessler ◽  
Karla P. Machado ◽  
Bruno P. Nunes ◽  
Pamela M. Volz ◽  
...  
Keyword(s):  
Older Adults ◽  
Health Care ◽  
Cohort Study ◽  
Primary Health Care ◽  
Rio Grande ◽  
Cognitive Testing ◽  
Rio Grande Do Sul ◽  
Primary Health ◽  
The Impact

Abstract Background The Bagé Cohort Study of Ageing is a population-based cohort study that has recently completed the first follow-up of a representative sample of older adults from Bagé, a city with more than 100,000 inhabitants located in the state of Rio Grande do Sul, Brazil. This is one of the first longitudinal studies to assess the impact of primary health care coverage on health conditions and inequalities. Our aim is to investigate the prevalence, incidence and trends of risk factors, health behaviours, social relationships, non-communicable diseases, geriatric diseases and disorders, hospitalisation, self-perceived health, and all-cause and specific-cause mortality. In addition, we aim to evaluate socioeconomic and health inequalities and the impact of primary health care on the outcomes under study. Methods/design The study covers participants aged 60 or over, selected by probabilistic (representative) sampling of the urban area of the city of Bagé, which is covered by Primary Health Care Services. The baseline examination included 1593 older adults and was conducted from July 2008 to November 2008. After eight to nine years (2016/2017), the first follow-up was conducted from September 2016 to August 2017. All participants underwent an extensive core assessment programme including structured interviews, questionnaires, cognitive testing (baseline and follow-up), physical examinations and anthropometric measurements (follow-up). Results Of the original participants, 1395 (87.6%) were located for follow-up: 757 elderly individuals (47.5%) were re-interviewed, but losses in data transfer occurred for 22. The remaining 638 (40.1%) had died. In addition, we had 81 (5.1%) refusals and 117 (7.3%) losses. Among the 1373 older adults who were followed down, there was a higher proportion of female interviewees (p=0.042) and a higher proportion of male deaths (p=0.001) in 2016/2017. There were no differences in losses and refusals according to gender (p=0.102). There was a difference in average age between the interviewees (68.8 years; SD ±6.5) and non-interviewees (73.2 years; SD ±9.0) (p<0.001). Data are available at the Department of Social Medicine in Federal University of Pelotas, Rio Grande do Sul, Brazil, for any collaboration.

scholarly journals Survival analysis of time to SARS-CoV-2 PCR negativisation to optimise PCR prescription in health workers: the Henares COVID-19 healthcare workers cohort study

2021 ◽  
pp. oemed-2020-106903
Author(s):  
Julio González Martin-Moro ◽  
Marta Chamorro Gómez ◽  
Galicia Dávila Fernández ◽  
Ana Elices Apellaniz ◽  
Ana Fernández Hortelano ◽  
...  
Keyword(s):  
Cohort Study ◽  
Healthcare Workers ◽  
Cox Regression ◽  
Health Workers ◽  
Upper Respiratory Tract ◽  
Rt Pcr ◽  
Kaplan Meier ◽  
Confounding Variables ◽  
The Impact ◽  
Associated Variables

ObjectivesReverse transcriptase PCR (RT-PCR) is considered the gold standard in diagnosing COVID-19. Infected healthcare workers do not go back to work until RT-PCR has demonstrated that the virus is no longer present in the upper respiratory tract. The aim of this study is to determine the most efficient time to perform RT-PCR prior to healthcare workers’ reincorporation.Materials and methodsThis is a cohort study of healthcare workers with RT-PCR-confirmed COVID-19. Data were collected using the medical charts of healthcare workers and completed with a telephone interview. Kaplan-Meier curves were used to determine the influence of several variables on the time to RT-PCR negativisation. The impact of the variables on survival was assessed using the Breslow test. A Cox regression model was developed including the associated variables.Results159 subjects with a positive RT-PCR out of 374 workers with suspected COVID-19 were included. The median time to negativisation was 25 days from symptom onset (IQR 20–35 days). Presence of IgG, dyspnoea, cough and throat pain were associated with significant longer time to negativisation. Cox logistic regression was used to adjust for confounding variables. Only dyspnoea and cough remained in the model as significant determinants of prolonged negativisation time. Adjusted HRs were 0.68 (0.48–096) for dyspnoea and 0.61 (0.42–0.88) for dry cough.ConclusionsRT-PCR during the first 3 weeks leads to a high percentage of positive results. In the presence of respiratory symptoms, negativisation took nearly 1 week more. Those who developed antibodies needed longer time to negativisate.

scholarly journals The U-Shaped Association between Bilirubin and Diabetic Retinopathy Risk: A Five-Year Cohort Based on 5323 Male Diabetic Patients

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Miao Liu ◽  
Jianhua Wang ◽  
Yao He
Keyword(s):  
Diabetic Retinopathy ◽  
Cohort Study ◽  
Risk Model ◽  
Continuous Variable ◽  
Hazard Ratio ◽  
Diabetic Patients ◽  
Lower Baseline ◽  
The Impact ◽  
Chinese Male

Aims. This study aimed at assessing the impact of baseline bilirubin (TBiL) on the incidence of diabetic retinopathy (DR) based on a five-year cohort study which consisted of 5323 Chinese male diabetic patients.Methods. A cohort study based on 5323 male diabetic patients was conducted in Beijing, from 2009 to 2013. Both baseline TBiL and follow-up changes were measured. Cox proportional risk model was used to calculate the hazard ratio (HR) of TBiL for DR risk.Results. During the follow-up period, there were 269 new DR cases. The incidence of five-year follow-up was 5.1% (95% CI: 4.5%~5.6%). The TBiL level of those who had diabetic retinopathy was lower than that of those without (12.51+ 1.20 mol/L and 13.11+ 1.32μmol/L,P=0.033). And more interestingly, along with the quintiles of baseline TBiL, there showed a U-shaped curve with DR incidence. And the RRs were 0.928 (95% CI: 0.646–1.331), 0.544 (95% CI: 0.365–0.811), 0.913 (95% CI: 0.629–1.324), and 1.035 (95% CI: 0.725–1.479) for the second, third, fourth, and fifth quintiles of baseline TBiL levels, respectively, compared with the first quintile. For follow-up TBiL changes, after being adjusted for related covariables and baseline TBiL levels (as continuous variable) in the model, the RRs for DR were 1.411 (95% CI: 1.081–1.842) for those who had decreased TBiL level and 0.858 (95% CI: 0.770–0.947) for those who had increased TBiL level during follow-up. And this association was more prominent among those with lower baseline TBiL level.Conclusions. Serum TBiL had a U-shaped relationship with DR incidence, which was independent of control status of diabetes and other related covariates.

scholarly journals What Is the Impact of Excessive Iodine and Semen Quality in Fertile Men of China: An Association Study 

2021 ◽  
Author(s):  
Ning Wang ◽  
Fang Lv ◽  
Ge Yu ◽  
Cuige Shi ◽  
Shangming Wang ◽  
...  
Keyword(s):  
Semen Quality ◽  
Sperm Count ◽  
Sperm Concentration ◽  
Urinary Iodine ◽  
Iodine Concentration ◽  
Male Reproduction ◽  
Semen Parameters ◽  
Human Thyroid ◽  
Urinary Iodine Concentration ◽  
The Impact

Abstract Background: Iodine is an essential element for hormones synthesized by the human thyroid gland. Thyroid hormone deficiency affects all body tissues, including multiple endocrine changes that alter growth hormones, corticotrophin, glucocorticoids, and gonadal function. In many countries, subfertility is an important problem affecting about 10–15% of all couples trying to conceive. Male subfertile factors have accounted for 25–30% of all cases in their studies. The aim of this study was to study the correlation between urinary iodine concentration (UIC) and semen quality of fertile male in China.Methods: semen and urine samples were collected from males who attended a survey for the reproductive physiological constants of male and female in China. All participants were fertile and they should be free from diseases of male reproductive system and thyroid related diseases. We studied the correlation between UIC and semen quality parameters in fertile males and the effect of iodine concentration on male reproduction. Participants were divided into six groups based on UIC. We measured semen parameters and UIC. Semen parameters or time-to-pregnancy (TTP) were analyzed by Spearman correlation, linear regression and multivariable logistic regression. Results: 1089 men were recruited in the study. The mean and median age of participants were 27.46±0.12 and 27±3.88 years, respectively. UIC of 274 (25.16%) men was lower than the UIC of WHO recommended. UIC of 405 men located in the region of WHO recommended. 62.35% of them were not located in the optimal region. Semen concentration and total sperm count were found to decrease when UIC increases when the UIC≥100 ug/L. Conclusions: A male with deficient UIC or excessive UIC has more risk of lower semen quality such as sperm concentration and total sperm count. In addition, if a male with deficient UIC or excessive UIC, his wife has longer TTP than the males who had normal UIC. Deficient UIC associated with lower semen quality and TTP than excessive UIC.

scholarly journals Evaluating bull fertility based on non-return method

2012 ◽  
Vol 66 (1-2) ◽  
pp. 27-40
Author(s):  
Igor Prka ◽  
Dragan Vukovic ◽  
Stevan Perkovic
Keyword(s):  
Semen Quality ◽  
Sperm Quality ◽  
Quality Parameters ◽  
Semen Parameters ◽  
Service Period ◽  
Microscopic Evaluation ◽  
Live Sperm ◽  
Return Method ◽  
The Impact ◽  
First Time

In order to evaluate the results of reproductive cows and heifers, different parameters of fertility are used, such as the service period, insemination index, intercalving time and others, and of the breeding bulls the values obtained through non-return. An ejaculate is taken up for further processing by veterinary centres only provided it meets the prescribed quality parameters. Rating semen parameters includes a macroscopic (volume, colour, consistency, smell and pH) and a microscopic evaluation (mobility, density, percentage of live sperm and abnormal and damaged sperm). In addition to sperm quality and the fertility of the female animal, the results of the non-return method are also influenced by a number of exogenous causes (season, age, race, insemination techniques) that have no small impact on the end result of insemination - pregnancy. In order to obtain more objective results of the fertility of bulls the following tasks were undertaken, namely: 1. to calculate with the non-return method the fertility of bulls in over 10,000 cows inseminated for the first time during a period of 6 years; and 2. to analyze the impact of semen quality, season, age of cow and bull, and the bull breed on the results of fertility.

scholarly journals The impact of the Safer Anaesthesia from Education (SAFE) Obstetric Anaesthesia training course in Ethiopia: A mixed methods longitudinal cohort study

2020 ◽  
Vol 48 (4) ◽  
pp. 297-305
Author(s):  
Jolene N Moore ◽  
Wayne W Morriss ◽  
Gebrehiwot Asfaw ◽  
Gosa Tesfaye ◽  
Aaliya R Ahmed ◽  
...  
Keyword(s):  
Cohort Study ◽  
Mixed Methods ◽  
Maternal Mortality ◽  
Longitudinal Cohort Study ◽  
Structured Interviews ◽  
Middle Income ◽  
Longitudinal Cohort ◽  
Obstetric Anaesthesia ◽  
The Impact

Summary Reducing maternal mortality remains a global priority, particularly in low- and middle-income countries (LMICs). The Safer Anaesthesia from Education (SAFE) Obstetric Anaesthesia (OB) course is a three-day refresher course for trained anaesthesia providers addressing common causes of maternal mortality in LMICs. This aim of this study was to investigate the impact of SAFE training for a cohort of anaesthesia providers in Ethiopia. We conducted a mixed methods longitudinal cohort study incorporating a behavioural questionnaire, multiple-choice questionnaires (MCQs), structured observational skills tests and structured interviews for anaesthesia providers who attended one of four SAFE-OB courses conducted in two regions of Ethiopia from October 2017 to May 2018. Some 149 participants from 60 facilities attended training. Behavioural questionnaires were completed at baseline ( n = 101, 69% response rate). Pre- and post-course MCQs ( n = 121, n = 123 respectively) and pre- and post-course skills tests ( n = 123, n = 105 respectively) were completed, with repeat MCQ and skills tests, and semi-structured interviews completed at follow-up ( n = 88, n = 76, n = 49 respectively). The mean MCQ scores for all participants improved from 80.3% prior to training to 85.4% following training ( P < 0.0001) and skills test scores improved from 56.5% to 83.2% ( P < 0.0001). Improvements in MCQs and skills were maintained at follow-up 3–11 months post-training compared to baseline ( P = 0.0006, < 0.0001 respectively). Participants reported improved confidence, teamwork and communication at follow-up. This study suggests that the SAFE-OB course can have a sustained impact on knowledge and skills and can improve the confidence of anaesthesia providers and communication within surgical teams.

Cohort study evaluating the impact of a discharge letter (DL) compared with usual care on adherence to surveillance following treatment for stage II/III colorectal cancer (CRC).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 620-620 ◽  
Author(s):  
Janine Marie Davies ◽  
Eugene Batuyong ◽  
Sasha M. Lupichuk ◽  
Robert Hilsden ◽  
Misha Eliasziw ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adjuvant Therapy ◽  
Clinical Laboratory ◽  
Ct Imaging ◽  
Care Physician ◽  
Stage Ii ◽  
Disease Stage ◽  
Cancer Centre ◽  
The Impact

620 Background: The 2005 ASCO guidelines recommend surveillance testing and frequencies following surgical +/− adjuvant therapy for stage II/III CRC. In Canada, many patients are discharged from their oncologist to their primary care physician (PCP) for ongoing surveillance. However, adherence to surveillance recommendations is low. This cohort study evaluated adherence to surveillance 1 year after treatment of stage II/III CRC prior to and following implementation of a DL. Methods: Cohort 1 (C1) patients were retrospectively identified from the Alberta Cancer Registry following adjuvant therapy (as applicable) at a tertiary cancer centre (07/2006 - 09/2007). Cohort 2 (C2) patients were prospectively identified from the Registry and clinic records following adjuvant therapy (as applicable), as those discharged from the centre (10/2007 - 4/2009); DL was sent to the patient and PCP recommending surveillance tests and dates. Clinical, laboratory, diagnostic imaging, and endoscopy data was collated. Adherence at 1 year follow-up was compared between cohorts using Kaplan-Meier time-to-event analyses. Results: C1 (n=218) was larger than C2 (n=114) despite the longer accrual time for C2. There were no differences between cohorts by age, sex, primary site of disease, stage, or adjuvant oxaliplatin use. During year 1 of follow-up, 11.8% and 11.4% recurred (local or metastatic) and 6.5% and 2.7% died (p=0.1) in C1 and C2 respectively. Comparing C1 with C2, 14.8% vs. 23.0% of patients had one CEA test within 3 months, 45.2% vs. 72.2% within 6 months, and 71.7% vs. 85.1% within 1 year (p<0.001). Only 44.0% (C1) and 68.6% (C2) had 2 CEA tests within 1 year. Only 3.9% (C1) vs. 6.6% (C2) of patients had 4 CEA tests within the year following treatment as recommended. The rate of CT imaging was 32.3% (C1) and 56.1% (C2); endoscopy was 36.7% (C1) and 42.1% (C2). Conclusions: Implementation of a DL improved compliance with surveillance at 1 year of follow-up following discharge from a tertiary cancer centre, although optimal adherence remains low. However, adherence to CT imaging nearly doubled. Evaluation of compliance at 3 years of follow-up is ongoing.

scholarly journals Imatinib Suspension and Validation (ISAV) Study: Final Results at 79 Months

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 461-461 ◽  
Author(s):  
Silvia Mori ◽  
Philipp le Coutre ◽  
Elisabetta Abruzzese ◽  
Bruno Martino ◽  
Ester Pungolino ◽  
...  
Keyword(s):  
Relapse Rate ◽  
Median Duration ◽  
Research Funding ◽  
Well Being ◽  
Imatinib Treatment ◽  
Rt Pcr ◽  
Molecular Remission ◽  
The Impact ◽  
Risk Of Relapse

Abstract Introduction. It is known that imatinib can be safely discontinued in patients (pts) with Chronic Myeloid Leukemia (CML) with minimal residual disease. Here we report an update of the Imatinib Suspension And Validation (ISAV) study at 79 months (mts) from study initiation to provide long term follow up data. Aims. The ISAV study aims to validate the capability of digital PCR (dPCR) to predict relapses after imatinib discontinuation in CML pts with negative Q-RT-PCR and to evaluate relapse rate, time to recurrence, survival and the impact of imatinib treatment on Quality of Life (QoL). Methods. This study involves 15 sites, 10 in Italy and 1 in each of the following countries: Germany, Spain, The Netherlands, Canada and Israel. CML pts (chronic or accelerated phase) treated with imatinib for more than 2 years and in complete molecular remission (CMR) were eligible. Patients had to be in CMR for at least 18 mts, with a minimum of 3 Q-RT-PCR performed at their own sites. After discontinuation of imatinib therapy, Q-RT-PCR was performed monthly (mts 1-6), bimonthly for 36 mts and then every 6 mts for additional 2 years, to assess the maintenance of the molecular remission. The loss of molecular remission was defined as two consecutive positive Q-RT-PCR tests with at least one BCR-ABL/ABL value above 0.1%. Patients losing molecular remission resumed imatinib treatment at the same dosage used before interruption. dPCR was performed at screening and at 36 mts for those pts who were still in remission. Patients' QoL during imatinib discontinuation/resumption was evaluated through the EORTC QLQ-C30 questionnaire. Results. The ISAV study enrolled 112 pts with a median follow-up time of 60.0 mts [95% CI: 59.6-60.6] for pts who do not relapsed; 66.1% of them completed the study as per protocol. The 58.9% of pts were male and 37.4% were aged 65 or older; median duration of imatinib treatment was 103.2 mts with median duration of CMR of 25.6 mts before imatinib discontinuation. At 79 mts from imatinib discontinuation, 56 pts of the 107 eligible ones relapsed and resumed imatinib with a relapse rate of 52.3% [95%CI: 20.4-32.6]; 69.6% of them relapsed in the first 9 mts. Of the 52 not-relapsed pts, 40 (76.9%) regained Q-RT-PCR positivity without losing MMR. In this latter group 2 pts experienced late relapses, at 30.6 and 45.5 mts respectively. A loss of CCyR occurred in 13 pts (23.6%): 10/13 CCyR losses were recovered, the remaining 3 were not assessed for response. No case of CML progression or resistance to imatinib was observed. After the resumption of imatinib the median time to MMR/CMR was 1.8 [95% CI: 1.0-2.0] mts. No significant correlation between relapse and previous duration of imatinib treatment, use of interferon, time to CCyR, Sokal score or duration of CMR was identified, while an inverse relationship between pts age and risk of relapse was evident. dPCR results before imatinib discontinuation showed that 23.4% of pts were positive and 76.6% negative at the time of discontinuation, with a Negative Predictive Value ratio (dPCR/Q-RT-PCR) of 1.1 [95%CI: 0.99-1.22]. At 36 mts from imatinib discontinuation 80.4% [95%CI: 30.6-50.4] of the pts tested were positive in dPCR. Moreover, the results of dPCR performed at imatinib discontinuation and age together can predict the risk of relapse: pts with less than 45 years and with a positive dPCR had the highest risk of relapse (100%) as opposed to pts ≥45 years and with negative dPCR (36.1%). The analysis of QoL evidenced a statistically significant improvement in the general well-being and symptoms scales at 1 month after imatinib discontinuation, particularly with regard to nausea, diarrhea, fatigue and insomnia (p<0.05). An inverse and transient trend toward increased pain emerged at mts 1 and 3. Conclusions. At 79 mts from the beginning of the study, 52.3% of pts relapsed, with 24% loosing CCyR. The majority of relapses occurred in the first 9 mts after discontinuation however late relapses were also observed, up to the 4th year. Therefore, pts who discontinue imatinib should be monitored for a long period of time, especially if they show positive PCR values after discontinuation. All relapsed pts including those who lost CCyR regained their original response after restarting TKI. Age <45 years and dPCR positivity are significantly associated with relapses. QoL analysis showed a significant decrease in symptoms after imatinib discontinuation. Funded by Regione Lombardia. Disclosures le Coutre: Pfizer: Honoraria; Incyte: Honoraria; BMS: Honoraria; Novartis: Honoraria. Abruzzese:BMS: Consultancy; Novartis: Consultancy; Pfizer: Consultancy; Ariad: Consultancy. Assouline:Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Honoraria, Research Funding, Speakers Bureau; Pfizer: Honoraria, Research Funding, Speakers Bureau; BMS: Honoraria, Research Funding, Speakers Bureau; Novartis: Research Funding. Kim:Pfizer: Research Funding; BMS: Research Funding; Ilyang: Research Funding; Novartis: Research Funding. Gambacorti-Passerini:Pfizer: Consultancy, Honoraria, Research Funding; BMS: Consultancy.

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