P518Inappropriate shocks in atrial fibrillation patients: are they really deleterious?

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
R Marinheiro ◽  
L Parreira ◽  
P Amador ◽  
D Mesquita ◽  
J Farinha ◽  
...  

Abstract Introduction Data suggest inappropriate defibrillator shocks are associated with a higher risk of all-cause mortality, particularly those delivered for atrial fibrillation (AF). However, the impact of inappropriate shocks has not been studied specifically in a population with AF. Aims to determine if AF-triggered inappropriate shocks are associated with long- term mortality in patients with AF and defibrillators implanted for primary prevention. Methods Retrospective single-center study. We analyzed all patients with defibrillators implanted for primary prevention in whom AF was diagnosed until the end of 2017. The cause of inappropriate shocks was evaluated by analysis of the stored intracardiac electrogram. Basal characteristics, cardiovascular risk factors, left ventricle ejection fraction, heart failure etiology (ischemic and non-ischemic), kidney function (creatinine) and medication were evaluated. Death was assessed during the follow-up. Results We studied 177 patients [median age 66 years (IQR 59-71); 82% male], with defibrillators and AF. AF was diagnosed before defibrillator implantation in 131 patients (74%) and after the implantation in the remaining 46 (26%). Inappropriate shocks occurred in 31 patients and 24 (14%) were caused by AF with rapid ventricular response: 13 patients with previously diagnosed AF and 11 with new-onset AF. During a median follow-up of 65 (IQR: 36-104) months, 74 patients died. Multivariate Cox-regression analysis demonstrated inappropriate shocks caused by AF were not independently related with death (adjusted HR 0.53; CI 0.23-1.23, p = 0.14). Kaplan-Meier survival curve demonstrated patients with AF-triggered inappropriate shocks had a better survival comparing to those with AF but without inappropriate shocks (logrank, p = 0.03) (figure). Conclusions In this group of AF patients, inappropriate shocks caused by AF did not increase the risk of death. Instead, these patients had a better survival comparing to those with AF but no shocks, probably due to a re-evaluation of the patient´s status and subsequent closer medical monitoring, strictly control of symptoms and optimization of drug treatment. These results demonstrate that inappropriate shocks are probably not deleterious per si through a direct mechanism. Abstract Figure. Kaplan-Meier survival curve

2018 ◽  
Vol 47 (1-3) ◽  
pp. 101-108 ◽  
Author(s):  
Renhua Lu ◽  
Chenqi Xu ◽  
Yan Li ◽  
Ling Yu ◽  
Xinghua Shao ◽  
...  

Objective: To investigate the incidence and the prognosis of cognitive impairment (CI) and to find out the risk factors associated with the outcome in maintenance haemodialysis (MHD) patients. Methods: Enrolled the patients who met the criteria as below: MHD (≥3 months) patients before July 2014, ≥18 years old and could carry on the cognitive function test (Montreal Cognitive Assessment [MoCA]). All enrolled patients were divided into 2 groups: CI group (MoCA < 26) and non-CI group (MoCA ≥26). All patients were followed up for 36 months. The incidence, demography data, medical history, haemodialysis data, laboratory examination and prognosis of CI in haemodialysis patients were prospectively compared and analyzed. Multivariate logistic regression analysis was used to investigate the risk factors of CI. Kaplan-Meier survival curve was used for survival analysis. Results: In the present study, 219 patients were enrolled. The ratio of male to female was 1.46: 1. Age was 60.07 ± 12.44 and dialysis vintage was 100.79 ± 70.23 months. One hundred thirteen patients’ MoCA scores were lower than 26 were divided into CI group. Education status (OR 3.428), post-dialysis diastolic pressure (OR 2.234) and spKt/V (OR 1.982) were independent risk factors for CI in MHD patients. During the follow-up period, 15 patients died (13.2%) in the CI group and 5 died (4.72%) in the non-CI group (p < 0.05). The Kaplan-Meier survival curve analysis showed that the survival rate of patients with CI was lower than that of non-CI group in MHD patients during 3 years follow-up (p = 0.046). Conclusion: CI is one of the most common complications in MHD patients. The mortality is high in patients who had CI. Education status, post-dialysis diastolic pressure and spKt/V are independent risk factors for CI in MHD patients.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 682-682
Author(s):  
Brian Cox ◽  
Nicholas Manguso ◽  
Humair Quadri ◽  
Jessica Crystal ◽  
Katelyn Mae Atkins ◽  
...  

682 Background: Lymph node (LN) metastases affect overall survival (OS) in pancreatic cancer (PC). However, a LN sampling threshold does not exist. We examined the impact of nodal sampling on overall survival (OS). Methods: Patients with Stage I-III PC ≥55 years old who underwent curative resection from 2004-2016 were identified from the National Cancer Database (NCDB). After adjusting for age, gender, grade, stage, and Charlson-Deyo score, multiple binomial logistic regression analyses assessed the impact of the LN ratio (LNR) on OS. LNR was defined as the number of positive LN over the number of LN examined. Regression analyses, a Cox-Regression, and a Kaplan-Meier survival curve assessed how many LN should be sampled. Results: A total of 13,673 patients, median age 69 years (55-90), were included. Most were Caucasian (86.6%) males with Charlson-Deyo scores ≤ 1 (90.3%) and moderately to poorly differentiated PC (90.1%). Median number of LN examined was 15 (1-75) with a median of 1 positive LN (0-35). As expected, increased number of positive LNs was associated with reduced OS, p < 0.001. After data normalization, an increasing LNR was associated with a 12-fold likelihood of death [OR: 11.9, p < 0.001 (CI 6.0, 23.7)]. Subsequent regression models established evaluation of ≥ 16 LNs as the greatest predictor of OS. A regression model evaluating < or ≥ 16 lymph nodes was performed to ascertain the effects of age, gender, ethnicity, grade, stage, and LN examined on OS. The logistic regression model correctly classified 74.5% of cases with a specificity of 99.6% (p < 0.001). Examination of < 16 LN, Caucasian race, grade, stage, and higher Charlson-Deyo scores were significantly associated with decreased OS. If ≥ 16 LNs were examined, patients had a 1.5-fold likelihood of better OS, p < 0.001 (CI 1.4, 1.6). An adjusted Cox Regression showed increased HR of 1.2, p < 0.001 (CI 1.1, 1.2) and an unadjusted Kaplan Meier survival curve predicted ≥ 16 LN examined are associated with an increase in OS of 2.8 months [log-rank: 32.0, p < 0.001]. Conclusions: Patients undergoing curative intent resection for PC should have adequate nodal sampling. Stratification of patients by LNR may provide useful information of OS. Examination of ≥ 16 LNs impacts OS in patients with Stage I-III PC.


2013 ◽  
Vol 2 (3) ◽  
pp. 151
Author(s):  
Oktahermoniza Oktahermoniza ◽  
Wirsma Arif Harahap ◽  
Tofriza Tofriza ◽  
Rosfita Rasyid

AbstrakKanker tiroid merupakan kanker yang jarang terjadi, namun kanker tersering pada organ endokrin. Tujuan penelitian ini untuk mengetahui ketahanan hidup lima tahun kanker tiroid yang di tatalaksana di RS Dr. M. Djamil Padang dari Januari 2007 sampai dengan Desember 2011. Metode: Subjek penelitian adalah 117 penderita kanker tiroid yang ditatalaksana di RS Dr. M. Djamil Padang dari Januari 2007 sampai dengan Desember 2011. Data dianalisis dengan pendekatan survival time menggunakan Kaplan-Meier survival curve dan Log rank test. Hasil: Median umur 39 tahun (range, 11 sampai 77 tahun), median waktu follow up 32 bulan (range, 1 sampai 70 bulan), median ukuran tumor 6 cm (range, 1 sampai 16 cm). Didapatkan 100 (85,5%) %) penderita sehat bebas tumor, 7 (6%) penderita kambuh lokal, 1 (0,9%) metastasis jauh serta 9 (7,7%) penderita meninggal. Overall five survival rate pada penelitian ini 92,3%. Faktor umur, ukuran tumor, dan jenis histopatologi berhubungan secara bermakna dengan survival (p 0,000), (p= 0,046) dan (p= 0,000). Sedangkan faktor-faktor jenis kelamin, jenis operasi, dan terapi adjuvan tidak mempunyai hubungan bermakna dengan survival. Pembahasan: Umur, ukuran tumor, dan jenis histopatologi memiliki hubungan bermakna dengan survival. Jenis kelamin, jenis operasi, dan terapi adjuvan tidak tidak berhubungan bermakna dengan survival.Kata kunci: Umur, Ukuran Tumor, Jenis Histopatologi, Survival, Kanker TiroidAbstractThyroid cancer is a rare cancer, but most common in endocrine organ. The purpose of this research is to determine about at five year survival of thyroid cancer which recorded at RS M. Djamil Padang Hospital from January 2007 until December 2011. Methods: Subjects were 117 patients with thyroid cancer be recorded in hospital Dr. M. Djamil Padang from January 2007 to December 2011. Data were analyzed with the survival time using Kaplan-Meier survival curve and log rank test. Result: Median age 39 years (range, 11 to 77 years), median follow-up time of 32 months (range, 1 to 70 months), median tumor size was 6 cm (range, 1 to 16 cm). Obtained 100 (85.5%)%) patients with tumor-free healthy, 7 (6%) patients with local recurrence, 1 (0.9%) distant metastases, and 9 (7.7%) patients died. Five overall survival rate in this study was 92.3%. Factors of age, tumor size and histopathological type was significantly associated with survival (p 0.000), (p = 0.046) and (p = 0.000). While the factors gender, type of surgery, and adjuvant therapy had no significant association with survival. Discussion: Discussion: Age, tumor size and histopathological type has a significant relationship with survival. Gender, type of surgery, and adjuvant therapy did not significantly associated with survival.Keywords: Age, Tumor Size, Type of Histopathology, Survival, Thyroid Cancer


2020 ◽  
Author(s):  
Wang Xiaofei ◽  
Wang Wenli ◽  
Zou Cao

Abstract Background Left atrial diameter (LAD) has been confirmed to predict recurrence of atrial fibrillation (AF) after catheter ablation (CA). The influence of right atrium (RA) size on the prognosis after CA was relatively unclear and lack of research. The objective of the present study was to investigate the relationship between right atrial diameter (RAD) and the mid-term outcome of AF after CA. Methods This study retrospectively examined 121 patients who underwent initial CA for symptomatic AF. Cox regression model was used to find risk factors of recurrence. Receiver operating characteristic (ROC) curve was used to evaluate predictive power and determine clinic cutoff value. Kaplan-Meier survival curve and log-rank test were used to analyze success rate. Results There were 94 (77.7%) patients of freedom from AF after 24.2 ± 4.5 months’ follow-up. Multivariate Cox regression analysis showed both hypertension and RAD were independent risk factors of arrhythmia recurrence after ablation regardless of AF type (HR: 4.915; 95% CI: 1.370-17.635; P = 0.015 and HR: 1.059; 95% CI: 1.001–1.120; P = 0.045, respectively). However, in patients with paroxysmal AF (par-AF), Multivariate analysis showed RAD become the only independent risk factor (HR: 1.031; 95% CI: 1.016–1.340; P = 0.029). ROC curve demonstrated the cutoff value of RAD was 35.5 mm with an area under the curve (AUC) of 0.715 (95% CI: 0.586–0.843, P = 0.009), sensitivity of 81.3% and specificity of 54.2%. Kaplan-Meier survival curve showed significant difference of freedom from par-AF (67.5 vs. 91.4%, log-rank, P = 0.015) between patients with RAD ≥ 35.5 mm and < 35.5 mm in this subgroup. Nevertheless, in patients with persistent AF (per-AF), no risk factor of arrhythmia recurrence was found. In addition, Kaplan-Meier survival curve showed no significant difference of freedom from per-AF (69.7 vs. 87.5%, log-rank, P = 0.31) between patients with RAD ≥ 35.5 mm and < 35.5 mm. Conclusions RAD was the independent risk factor predicting recurrence of AF after CA only in patients with par-AF. In patients with RAD < 35.5 mm, there was a significantly higher freedom from par-AF recurrence compared with RAD ≥ 35.5 mm after a mid-term follow-up.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 650.1-650
Author(s):  
A. Hočevar ◽  
A. Viršček ◽  
R. Jese ◽  
M. Tomsic ◽  
Z. Rotar

Background:Recent meta-analysis reported no difference in the long-term mortality of GCA patients at a population level, but an increased mortality in hospital-based cohorts1.Objectives:The aim of our study was to evaluate for the first time the survival of GCA patients in Slovenia.Methods:We included patients with clinical diagnosis of GCA supported by histology or imaging diagnosed between September 2011 and December 2019 and prospectively followed at our secondary/tertiary rheumatology center. To evaluate mortality the censor date of 24. June 2020 was used. Kaplan–Meier analysis was used to analyze mortality. Standardized mortality ratio (SMR) was calculated using data of age matched Slovenian population as the reference.Results:Between September 2011 and December 2019 we identified 309 new GCA patients (203 (65.7%) females, median (IQR) age 74.9 (67.7–80.1.7), range 53.7 to 97.5 years). Patients were followed (until death or censor date) of a median (IQR) 33.3 (17.5-60.8) months. Until the censor date 51 (16.5%) GCA patients died (24 females, 27 males). We found no significant sex related differences in the net survival estimates during the first five years of follow up (p=0.68). Figure 1 shows the survival curve of GCA patients and general population as a comparator according to Kaplan–Meier analysis. In the first year following GCA diagnosis the mortality rate was 1.9 times higher compared to general Slovenian population (95% CI 1.19 - 2.88, p=0.03). For patients who survived the first year after diagnosis the mortality was comparable to the general population (Table 1).Figure 1.Survival curve according to Kaplan–Meier analysis in GCATable 1.Standardized mortality ratios of patients who survived the first year after diagnosing GCA (ie. were followed at least one year) compared to the general populationYearsof FUObserved deathsExpected deathsSMR (95%CI)P-value2119.71.14 (0.57-2.03)0.75331416.50.85 (0.46-1.43)0.62642121.60.97 (0.60-1.49)0.98752525.01.00 (0.65-1.48)0.92162627.60.94 (0.61-1.38)0.831Legend: FU follow up; SMR Standardized mortality ratios; CI confidence intervalConclusion:GCA patients had an increased risk of death in the first year from the GCA diagnosis.References:[1]Hill CL, et al. Semin Arthritis Rheum. 2017;46(4):513-9.Disclosure of Interests:None declared


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Vitolo ◽  
M Proietti ◽  
S Harrison ◽  
Z Kalarus ◽  
L Tavazzi ◽  
...  

Abstract Background Physical activity (PA) may have a beneficial contribution for outcomes in patients with atrial fibrillation (AF). Purpose We aimed to evaluate the impact of self-reported PA in a large contemporary cohort of European AF patients on the risk of all-cause mortality. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. Self-reported PA was categorized, on the basis of reported time spent exercising, as follows: i) No PA; ii) Occasional PA; iii) Regular PA; iv) Intense PA. The primary outcome was all-cause death. Results Over 11096, a total of 8699 (78.4%) patients (mean age (SD) 69.1 (11.5); 40.7% female) had available data about PA and follow-up observation and were included in the analysis. Of these, 3703 (42.6%) reported no PA, 2829 (32.5%) occasional PA, 1824 (21.0%) regular PA, with only 343 (3.9%) reporting intense PA. With the 4 increasing PA categories, mean age, proportion of female patients, CHA2DS2-VASc and HAS-BLED scores were progressively lower (all p&lt;0.001). Use of vitamin K antagonist (VKA) declined across the classes of PA (53.1% vs. 52.2% vs. 44.5% vs. 33.9%, p&lt;0.001), while use of non-VKA OACs (NOACs) conversely increased. During a mean (SD) 680.6 (171.5) days of follow-up, there were a total of 848 (9.7%) all-cause death events. Based on Kaplan-Meier analysis, there was a progressively lower cumulative risk for all-cause death according to PA categories [Figure]. A multivariable Cox regression analysis, adjusting for CHA2DS2-VASc score, use of OAC at baseline and type of AF, found a lower risk of all-cause death associated with increasing levels of PA (Hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.59–0.81 for occasional PA, HR: 0.45, 95% CI: 0.35–0.58 for regular PA, HR: 0.41, 95% CI: 0.23–0.76 for intense PA, when compared to no PA). In a sensitivity analysis, a regular-intense PA was inversely associated with occurrence of cardiovascular (CV) death, after multivariable adjustments for comorbidities (HR: 0.54, 95% CI: 0.37–0.77). Conclusions In a large contemporary cohort of European AF patients, self-reported PA was found to be inversely associated with all-cause death and CV death. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP, several companies have supported the programme with unrestricted grants


Author(s):  
Yuseon Cheong ◽  
Sangho Lee ◽  
Do-Kyeong Lee ◽  
Kyoung-Sun Kim ◽  
Bo-Hyun Sang ◽  
...  

Background: Generally, lactate levels > 2 mmol/L represent hyperlactatemia, whereas lactic acidosis is often defined as lactate > 4 mmol/L. Although hyperlactatemia is common finding in liver transplant (LT) candidates, association between lactate and organ failures with Acute-on-chronic Liver Failure (ACLF) is poorly studied. We searched the important variables for pre-LT hyperlactatemia and examined the impact of preoperative hyperlactatemia on early mortality after LT. Methods: A total of 2,002 patients from LT registry between January 2008 and February 2019 were analyzed. Six organ failures (liver, kidney, brain, coagulation, circulation, and lung) were defined by criteria of EASL-CLIF ACLF Consortium. Variable importance of preoperative hyperlactatemia was examined by machine learning using random survival forest (RSF). Kaplan-Meier Survival curve analysis was performed to assess 90-day mortality.Results: Median lactate level was 1.9 mmol/L (interquartile range: 1.4, 2.4 mmol/L) and 107 (5.3%) patients showed > 4.0 mmol/L. RSF analysis revealed that the four most important variables for hyperlactatemia were MELD score, circulatory failure, hemoglobin, and respiratory failure. The 30-day and 90-day mortality rates were 2.7% and 5.1%, whereas patients with lactate > 4.0 mmol/L showed increased rate of 15.0% and 19.6%, respectively. Conclusion: About 50% and 5% of LT candidates showed pre-LT hyperlactatemia of > 2.0 mmol/L and > 4.0 mmol/L, respectively. Pre-LT lactate > 4.0 mmol/L was associated with increased early post-LT mortality. Our results suggest that future study of correcting modifiable risk factors may play a role in preventing hyperlactatemia and lowering early mortality after LT.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Yoshizawa ◽  
H Shiomi ◽  
M Tanaka ◽  
T Aizawa ◽  
S Yamagami ◽  
...  

Abstract Background Catheter ablation has been rapidly spread as a first line therapy for atrial fibrillation (AF). A recent randomized trial have shown that AF ablation reduces the risk of death or hospitalization for heart failure (HF). However, the impact of maintained sinus rhythm (SR) on long-term risk of death or HF hospitalization has not been adequately evaluated. Purpose To investigate the impact of maintaining SR by AF ablation on long-term risk of all-cause death or HF hospitalization. Methods The long-term clinical outcomes were compared between patients with maintained SR and those with recurrent AF using a landmark analysis in which the landmark point was set at 1.5-year after the 1st ablation. Results Among consecutive 1467 patients who underwent AF ablation in our institution between February 2004 and December 2017, the study population consisted of 1311 patients after excluding 150 patients because of death or lost to follow-up. Mean age was 67.9±0.3 and paroxysmal AF was 67%. Among 460 patients who had AF recurrence within 1.5 years after the 1st ablation, 328 underwent 2nd ablation. Therefore, at 1.5-year after the 1st AF ablation, 1145 patients had maintained SR rhythm (SR-group), and 166 patients had recurrent AF episodes (AF-group). During 4.7±2.4 years of follow-up, the cumulative 5-year incidence of death or HF beyond 1.5 years after the 1st ablation was 5.1% in SR-group and 15.6% in AF-group (log rank P<0.001). After adjusting for baseline confounders, the lower risk of SR-group relative to AF-group for death or HF was still statistically significant (HR: 2.05, 95% CI: 1.11–3.58, P=0.02). Risks for a Composite of Death or HF Hazard Ratio (95% CI) Crude HR P value Adjusted HR P value AF recurrence 2.59 (1.43–4.43) 0.002 2.05 (1.11–3.58) 0.02 Age>75 years old 2.55 (1.56–4.10) <0.001 2.32 (1.39–3.81) 0.002 Female 0.85 (0.49–1.43) 0.56 0.73 (0.40–1.25) 0.26 PeAF 1.25 (0.68–2.16) 0.45 0.98 (0.52–1.75) 0.94 LSAF 1.10 (0.46–2.23) 0.82 0.70 (0.28–1.53) 0.39 LVEF>50% 0.27 (0.16–0.48) <0.001 0.57 (0.31–1.09) 0.09 Past history of HF 7.06 (4.18–11.6) <0.001 4.67 (2.51–8.41) <0.001 CKD 4.74 (2.08–9.39) <0.001 2.23 (0.94–4.69) 0.07 AF, Atrial fibrillation; PeAF, Persistent AF; LSAF; Long standing AF; HF, Heart failure; CKD, Chronic kidney disease. Figure 1 Conclusions Successfully maintained SR was associated with reduced long-term risk for death or HF hospitalization in real world patients undergoing AF ablation.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4259-4259
Author(s):  
Velu Nair ◽  
Ajay Sharma ◽  
M Bhikshapathy ◽  
Deepak Mishra ◽  
Satyaranjan Das ◽  
...  

Abstract Background: Chronic myeloid leukemia (CML) is a hematopoietic stem cell disorder characterized by reciprocal t(9;22) translocation, which creates a juxtaposition of the BCR and ABL genes to form the p230-, p190- or p210- constitutively active tyrosine kinases. Imatinib mesylate (Gleevec) is a novel molecule, which inhibits the protein product of this fusion gene and hence has been used as a targeted therapy in CML. It is remarkably effective as a single agent therapy of newly diagnosed CML in chronic phase (CP). We report here an independent validation of therapeutic efficacy in CML-CP using an Indian generic of imatinib. Methods: At our institution from October, 2006 and March, 2008; 100 consecutive newly diagnosed CML-CP patients were started on imatinib mesylate (Indian generic molecules from Ms NATCO, Ranbaxy, CIPLA) 400mg PO within 6 months from diagnosis. The median age was 40.1years (age range: 9–80 years). The median follow-up was 12 months (range: 6–18 months). Monitoring of response was carried out by BCR-ABL dual colour dual fusion FISH and RT-PCR at diagnosis and thereafter by quantitative BCR-ABL FISH and RQ-PCR at 3 monthly intervals. All patients were treated with intention to treat and accordingly analysed. Non detectable BCR-ABL: ABL ratio was taken as complete molecular response and ratio &lt; 0.1 % is considered as major molecular response. Of the 100 patients with CML-CP, 85 patients could be followed up for 12 months and remaining 15 were lost to follow-up. All 100 patients (100%) achieved complete hematological response (CHR) at 9 months (92% at 3 months and 94% at 6 months). Seven percent patients achieved complete molecular response and 8% major molecular response at 6 months. Of the 85 patients evaluable at 12 months, 22 (28 %) achieved complete molecular response (CMolR) and 15(18%) achieved major molecular response (MMolR) and 35(41%) patients showed a BCR-ABL:ABL of &gt; 0.1% – 20%. The median BCR-ABL: ABL by Wilcoxon signed rank test was 12% at 6 months and 1% at 12 months (P = 0.003); whereas median BCR-ABL FISH was 65.75% at baseline and 14% at 6 months (P = 0.0006). The molecular response pattern conforms to all the published literature on the subject. Two patients showed molecular relapse followed by hematological relapse at 18 months. Kaplan- Meier Survival curve for CML Patients on imatinib projected a mean survival of 58.12 months (95% CI 54.17 – 62.10). Hypo-pigmentation (40%), wt gain(15%), leucopenia (11%), muscle cramps (10%), facial puffiness(10%), skin rashes (9%), fullness of stomach (6%), anemia (5%), raised trans-aminases (5%), pedal edema (3%), mucosal bleeding (2%), raised uric acid levels (2%) and decreased libido (1%) were toxicities encountered during our study. The drug was well tolerated and the adverse effects noted were manageable with supportive care. The results were comparable with trials from the West where Gleevec (Novartis) was used with comparable molecular responses and side effect profile. The cost of Indian generic molecule of imatinib is less than INR 10,000 (250 USD) while the cost of imatinib (Gleevec) is approx INR 1, 00,000 (2500 USD) per month. We conclude that the Indian generic of imatinib mesylate is effective and safe first line therapy for CML-CP. Kaplan- Meier Survival curve: CML Patients on Imatinib Mean Surv – 58.12 months (95% CI 54.17 – 62.10) Comparative Kaplan- Meier Survival curves:&#x2028; Based on Molecular Remission Status Mean Surv – 58.12 months (95% CI 54.17 – 62.10) Comparative Kaplan- Meier Survival curves:&#x2028; Based on Molecular Remission Status 1 − CMR + MMR, 2 − MI + NR Log Rank Chi Sq = 4.19, P=0.041 1 − CMR + MMR, 2 − MI + NR Log Rank Chi Sq = 4.19, P=0.041


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8023-8023 ◽  
Author(s):  
Cristina Gasparetto ◽  
Rafat Abonour ◽  
Sundar Jagannath ◽  
Brian G. Durie ◽  
Jatin J. Shah ◽  
...  

8023 Background: t(11;14) is a common cytogenetic abnormality historically associated with standard-risk and generally favorable MM outcomes, but has shown poor prognosis in some retrospective analyses. Connect MM is a prospective, US, observational, multicenter registry that collects data on management and natural history of NDMM pts in clinical practice. The impact of t(11;14) on survival outcomes was assessed in AA and NAA pts. Methods: Adult NDMM pts who completed induction and were tested for t(11;14) by FISH/cytogenetics were grouped by race (AA vs NAA). Endpoints were PFS and OS. Kaplan-Meier analyses were adjusted for differences in cohort, age, ISS stage, transplant intent, t(4;14), hemoglobin, platelets, calcium, creatinine, and diabetes history. Data cutoff was Jul 7, 2016. Results: 3011 pts were enrolled in 2 cohorts (Cohort 1: n = 1493, Sep 2009–Dec 2011, median follow-up = 39.3 mos; Cohort 2: n = 1518, Dec 2012–Apr 2016, median follow-up = 16.4 mos). Of 1539 (52%) pts tested for t(11;14), 363 (24%) were t(11;14)-positive, including 53 (26%) of 205 AA and 310 (23%) of 1334 NAA pts. First-line bortezomib exposure was similar across groups. A trend of shorter PFS was observed in AA pts with t(11;14) vs AA without t(11;14) (Table). AA pts with t(11;14) had significantly higher risk of death compared to those without t(11;14) and higher rate of early mortality than NAA pts. No differences in PFS or OS were noted in NAA pts with or without t(11;14). For OS, the interaction between race and t(11;14) status was statistically significant ( P= 0.004). Conclusions: In Connect MM, the effect of t(11;14) on OS was significantly different between AA and NAA pts. t(11;14) was associated with poorer survival outcomes in AA pts, and thus, may be a risk factor for poor prognosis. Additional analyses will be conducted to elucidate the role of induction treatment, transplant and maintenance in AA and non-AA pts with t(11;14). Clinical trial information: NCT01081028. [Table: see text]


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