P506Brugada Syndrome: is the addition of the electrocardiographic risk markers the clue?

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
A Tronconi ◽  
G Carnero ◽  
M Mysuta ◽  
A Bozza ◽  
M Peltzer ◽  
...  

Abstract Background Risk stratification in Brugada Syndrome (BS) remains a clinical challenge. Several electrocardiografic (ECG) risk markers had been described, as a spontaneous type 1 Brugada pattern (ST1B), maximal time interval between the peak and the end of the t wave in precordial leads (Tpe Max), the presence of an S Wave on DI, a PR interval (PRi) ≥ 200ms and fragmented QRS (f-QRS). Purpose Evaluate the association of ECG risk markers with sudden cardiac death (SCD) or appropriate shocks (A-Sh) by implantable cardioverter defibrillator (ICD) in patients (p) with BS. Methods From a registry of 97 p with BS with a median follow up of 2.3 years (Q1 0.7-Q3 7.8), 12 lead ECG were recorded in every p. QT peak interval (QTp) was measured between the QRS onset and the peak of the T wave. Tpe was calculated between the difference of QT and QTp in precordial leads (V1 to V6). TpeMax was defined as the most prolonged Tpe. If an S-DI was present, duration and amplitude was measured. PRi was measured on DII. Baseline characteristics: Age 44 ± 13 years, male 74 (76%), secondary prevention 2 (3%), malignant syncope 10 (10%), inducible electrophysiology study 22/43 (51%), SCD on first grade family < 35 years 12 (12%) and ICD 34 (35%). A-Sh and SCD were compared among p with ST1B vs no ST1B, TpeMax≥100 vs <100ms, S-DI ≥0.4 vs <0.4ms, S-D ≥0.1 vs <0.1mV, PRi≥200 vs <200ms and presence of f-QRS ≥ 2 spike ≥ 2 leads. Variables that were associated with A-Sh or SCD were combined. For variables with significant difference sensibility (Sen) and specificity (Spe) was calculated. Results During follow up 6 p presented A-Sh and no p SCD. Results are described in the Table. Conclusion In our study population, there was a significant higher incidence of A-Sh in p with ST1B, Tpe Max ≥ 100ms and S-DI ≥ 0.1mV. We found that the presence of one ECG risk marker had a high sensibility to predict A-Sh. The presence of the 3 ECG risk markers highly increased specificity to predict A-Sh. Further trials should be carried out to asses if ECG risk markers would allow us to differentiate which asymptomatic patients could benefit from electrophysiological study for risk stratification (high sensibility - One ECG Risk marker) or would benefit from ICD implantation (high specificity - 3 ECG Risk markers). Abstract Figure.

2003 ◽  
Vol 131 (5-6) ◽  
pp. 226-231
Author(s):  
Ivana Golubicic ◽  
Jelena Bokun ◽  
Marina Nikitovic ◽  
Jasmina Mladenovic ◽  
Milan Saric ◽  
...  

PURPOSE The aim of this study was: 1. to evaluate treatment results of combined therapy (surgery, postoperative craniospinal radiotherapy with or without chemotherapy) and 2. to assess factors affecting prognosis (extend of tumor removal, involvement of the brain stem, extent of disease postoperative meningitis, shunt placement, age, sex and time interval from surgery to start of postoperative radiotherapy). PATIENTS AND METHODS During the period 1986-1996, 78 patients with medulloblastoma, aged 1-22 years (median 8.6 years), were treated with combined modality therapy and 72 of them were evaluable for the study end-points. Entry criteria were histologically proven diagnosis, age under 22 years, and no history of previous malignant disease. The main characteristics of the group are shown in Table 1. Twenty-nine patients (37.2%) have total, 8 (10.3%) near total and 41 (52.5%) partial removal. Seventy-two of 78 patients were treated with curative intent and received postoperative craniospinal irradiation. Radiotherapy started 13-285 days after surgery (median 36 days). Only 13 patients started radiotherapy after 60 days following surgery. Adjuvant chemotherapy was applied in 63 (80.7%) patients. The majority of them (46 73%) received chemotherapy with CCNU and Vincristine. The survival rates were calculated with the Kaplan-Meier method and the differences in survival were analyzed using the Wilcoxon test and log-rank test. RESULTS The follow-up period ranged from 1-12 years (median 3 years). Five-year overall survival (OS) was 51% and disease-free survival (DFS) 47% (Graph 1). During follow-up 32 relapses occurred. Patients having no brain stem infiltration had significantly better survival (p=0.0023) (Graph 2). Patients with positive myelographic findings had significantly poorer survival compared to dose with negative myelographic findings (p=0.0116). Significantly poorer survival was found in patients with meningitis developing in the postoperative period, with no patient living longer than two years (p=0.0134) (Graph 3). By analysis of OS and DFS in relation to presence of the malignant cells in liquor, statistically significant difference, i. e. positive CSF cytology was not obtained, which was of statistical importance for survival (p=0.8207). Neither shunt placement nor shunt type showed any impact on survival (p=0.5307 and 0.7119, respectively). Children younger than three years had significantly poorer survival compared to those older than 16 years (p=0.0473). Although there was a better survival rate in females than in males this was not statistically significant (p=0.2386).The analysis results of treatment showed that significantly better survival occurred in patients in whom total or subtotal tumor removal was possible (p=0.0022) (Graph 4). Patients who started radiotherapy within two months after surgery have better survival, but again this was not statistically significant, probably due to the small number of patients receiving delayed radiotherapy (p=0.2231)(Graph5). CONCLUSION Based on this factors standard and high risk group could be defined. Combined chemotherapy should to be investigated particularly for high risk subgroup. Future research should be done to define new therapeutic modalities (gene therapy, compounds active in tumor antiangiogenesis etc).


2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Claudio Licciardello ◽  
Jacopo Marazzato ◽  
Michele Golino ◽  
Francesca Seganfreddo ◽  
Federica Matteo ◽  
...  

Abstract Aims According to European guidelines, aborted sudden cardiac death (SCD) in Brugada syndrome (BrS) is regarded as a I class recommendation for secondary prevention implantable cardioverter defibrillator (ICD). However, the risk stratification of BrS patients for primary prevention ICD still represents a clinical conundrum. Although intracardiac electrophysiology (EP) study proved useful for the selection of high-risk patients in this setting. Therefore, aim of this study was to assess all clinical and EP variables associated with the induction of VA at EP study and the rate of appropriate/inappropriate ICD interventions and/or clinical SCD events in these patients occurring at follow-up. Methods and results From 2001 to 2021, all EP studies performed in symptomatic/asymptomatic patients (46 ± 14 years, M 88%) with/without family history of SCD spontaneous/drug-induced type I pattern (TIP) on ECG and no spontaneous ventricular arrhythmias were retrospectively considered at our study centre. Clinical variables, BrS pattern, EP study data (including right ventricular site and type of stimulation protocol), and ICD interventions (DC-shocks or Anti-Tachycardia Pacing events, ATP) and/or SCD events occurring at follow-up were all evaluated. EP study was deemed positive for any polymorphic VA induced during programmed ventricular stimulation; non-sustained episodes included. ICD was routinely implanted in all patients with a positive EP study. Follow-up data were detected by the collection of medical and home-monitoring recordings at study-site level. Follow-up data were available in 50 patients (9 ± 6 years on average). Patients were generally young with few cardiovascular comorbidities. SCD history was known in 21 (42%) with a significant number of asymptomatic patients (48%). Br patterns were equally distributed in the investigated population (spontaneous and drug-induced TIP in 52% and 48%, respectively) and AF history was fairly common (16%). In the study population, EP study tested positive in 30 patients (60%): spontaneous TIP (P = 0.0518), few extrastimuli during programmed ventricular stimulation (P = 0.0015), and right ventricular stimulation at the apical site (P ≤ 0.0001) were the only variables to be clearly associated with a positive EP study in the appraised patients. At follow-up, appropriate ICD shocks were documented in 4 out of 30 implanted patients (13%) at generally 5 ± 7 years from EP study evaluation. Although three ICD interventions (75%) occurred in patients with spontaneous TIP, one patient with drug-induced TIP pattern and positive EP study referred to Emergency Department for unrelenting VT storm after roughly 13 years from ICD implantation. Inappropriate ICD interventions for fast rate AF were detected in 10% of cases. Finally, no SCD events were documented at follow up in patients with a negative EP study. Conclusions In a retrospective analysis, EP study proved useful in the risk stratification of SCD in BrS patients. A few ventricular extrastimuli delivered at the right ventricular apex seem sufficient to prompt the induction of life-threatening VA in high-risk BrS patients during EP study. Moreover, in this setting, a negative EP study seems protective against the development of VA/SCD events at follow-up. However, not only is spontaneous TIP associated with an increased risk of arrhythmic death, but a drug-induced TIP, generally regarded as a low-risk condition, might also be associated with a long-term hazard of SCD in these patients.


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Masahiko Takagi ◽  
Yasuhiro Yokoyama ◽  
Kazutaka Aonuma ◽  
Naohiko Aihara ◽  
Masayasu Hiraoka

Background Neither the clinical characteristics nor risk stratification of symptomatic and asymptomatic patients with Brugada syndrome have been clearly determined. We compared clinical and ECG characteristics of symptomatic and asymptomatic patients with Brugada syndrome to identify new markers for distinguishing high- from low-risk patients. Methods A total of 216 consecutive individuals with Brugada syndrome (mean age 52±14 years, 197 males) were enrolled in the Japan Idiopathic Ventricular Fibrillation Study (J-IVFS). Clinical and ECG characteristics were compared among 3 groups of patients: VF group; patients with aborted sudden death and documented VF (N=34), Syncope (Sy) group; patients with syncope without documented VF (N=70), and Asymptomatic (As) group; subjects without symptoms (N=112). Comparisons were made among the 3 groups as well as between the symptomatic (VF/Sy) and asymptomatic (As) groups. Short-term prognosis was also compared among the 3 groups, and between the VF/Sy and As groups. Results 1) Clinical characteristics: incidence of past history of AF was significantly higher in the VF and Sy groups than in the AS group (26, 26, and 12 %, respectively; [p=0.04]), though no other clinical parameters differed among the groups. 2) On resting 12-lead ECG, r-J interval (interval from QRS onset to J point) in lead V2 and QRS duration in lead V6 were highest in the VF group (104, 98, and 92 msec in V2 [p<0.001]; 106, 103, and 94 msec in V6 [p<0.0001], respectively, VF vs. Sy vs. As). 3) Positive late potential and inducibility of VF by EPS did not differ in incidence among the 3 groups. 4) Clinical follow-up: during a mean follow-up of 36±16 months, incidence of cardiac events (sudden death and/or VF) was higher in the VF/Sy groups than in the As group (29, 8, and 0 %, respectively [p<0.001]). Multivariate analysis showed that the frequencies of r-J interval ≥ 90 msec in lead V2 and QRS duration ≥ 90 msec in lead V6 were significantly higher in patients with cardiac events (p=0.02, 0.02, respectively). Conclusions In symptomatic patients, prolonged ventricular depolarization in precordial leads of the ECG was prominent in the VF group, and this sign can be used to distinguish high- from low-risk patients with Brugada syndrome.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5340-5340
Author(s):  
Alaa A Muslimani ◽  
Fadi Bailony ◽  
Madappa Kundranda ◽  
Timothy Spiro ◽  
Asif Chaudhry ◽  
...  

Abstract Introduction: MGUS is considered to be a pre-malignant condition, and previous studies have reported VTE as a marker for a subsequent malignancy. We conducted a retrospective study to evaluate the incidence of VTE among MGUS patients (pts) and to correlate this incidence with different risk groups for developing malignancy in MGUS pts. Methods: The complete medical records of all MGUS pts at Cleveland Clinic Cancer Center at Fairview hospital from Jun/2005–Jun/2008 were retrospectively reviewed. Of 237 pts diagnosed with MGUS, 112 pts (65 males, 47 females) were eligible for our study. These pts were divided into 2 risk groups: low risk (LR)/low-intermediate risk (LIR) group (78 pts.) and high intermediate risk (HIR)/high risk (HR) group (34 pts) based on the Risk Stratification Model using three adverse risk factors; serum M-protein level ≥ 3 gm/dL, non-IgG MGUS, and an abnormal kappa/lambda free light chain ratio. Only pts with ≥ 12 months follow up were included. Exclusion criteria included a personal history of inherited thrombophilia, previous episode of VTE or anticoagulant treatment, thrombocytosis, malignancy, and renal impairment. Risk factors (RF) for VTE were identified in each pt and categorized into four groups: no RF, 0; one RF, 1; two RF, 2; and &gt; 2 RF, &gt;2. RF included &gt; 48 hours of immobilization, surgery in the past 3 months, current hospitalization at the time of VTE occurrence, oral contraceptive use, and congestive heart failure. Objectives: To compare the proportion of pts with MGUS who developed VTE to the proportion of pts in the general population who developed VTE. To compare VTE incidence between the two risk groups. Results: During the study period, 9 pts with MGUS experienced VTE. In the general population, the incidence of VTE is 117/100,000 persons/year (from literature). Therefore, the proportion of pts in the general population over 3 years was 117/100000 × 3 =0.0035. The proportion of VTE in MGUS pts, adjusted for 3 years, of 0.080 is significantly higher than that for the general population (p&lt;0.001). Comparison of VTE incidence between the two risk groups, while adjusting for the number of risk factors, showed no difference (Cox Proportional Model, p=0.38). There is no significant difference in the risk of VTE among different levels of risk factors (p=0.96). The Kaplan-Meier estimates of the proportions of pts free of VTE at 24 months are 0.96 and 0.93 for the LR/LIR and HIR/HR groups, respectively. Conclusions: MGUS is associated with a significantly higher rate of VTE compared to the general population. Despite many studies indicating VTE as a marker for subsequent malignancy, we did not find a difference in the incidence of VTE among the various risk factor groups. Any suggestive signs of VTE in pts with MGUS should be promptly evaluated and treatment initiated as soon as possible. Since the number of pts is small and the period of follow-up relatively short, a prospective cohort study is needed to verify our results. Table?: Comparison of event rate: VTE Po p-value Total number of pts Risk stratification model (pts) Groups (pts) VTE Proportion Note: Po is the VTE proportion for the general population over a 3-year time period. 112 LR (38) LR/LIR (78) (5) LIR (40) 0.080 0.0035 &lt;0.001 HIR (26) HIR/HR (34) (4) HR (8)


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Pak ◽  
A Kobori ◽  
S Shizuta ◽  
Y Sasaki ◽  
T Toyota ◽  
...  

Abstract Background Catheter ablation (CA) of atrial fibrillation (AF) for symptomatic patients improves the quality of life and prognosis of patients with heart failure. However, the impact of CA for asymptomatic patients is still controversial. Purpose We aimed to investigate the clinical outcomes of CA of AF for asymptomatic patients compared to those for symptomatic patients. Methods A total of 5,013 patients from the Kansai Plus Atrial Fibrillation (KPAF) Registry who underwent CA were screened. The patients were divided into three groups by type of AF; paroxysmal (PAF), persistent (PEAF) and long standing (LSAF) and the patients in each type of AF were divided into two groups: asymptomatic and symptomatic. The primary endpoint was recurrent supraventricular tachyarrhythmias lasting for more than 30 seconds during follow-up 4 years after CA. The secondary endpoint was a composite of cardiovascular, cerebral, and gastrointestinal events during follow-up 4 years after CA. The incidence of complications related to CA between asymptomatic and symptomatic patients was also evaluated. Kaplan–Meier analysis was employed to estimate the primary and secondary endpoints. The statistical differences in primary and secondary endpoints between asymptomatic and symptomatic patients were evaluated using a log–rank test. The impact of symptom due to AF on the primary and secondary endpoint was evaluated using a Cox hazard analysis. The difference in incidence of complications between asymptomatic and symptomatic patients was evaluated using a chi–square test. Results In this study population, PAF was the most frequent at 64.4%, followed by PEAF (22.7%) and LSAF (13.0%). There were some significant differences in the baseline characteristics between asymptomatic and symptomatic patients in each type of AF. The proportion of male was significantly higher in asymptomatic patients than symptomatic patients in PAF (81.2% versus 67.2%, p&lt;0.001) and PEAF (86.4% versus 74.3%, p&lt;0.001). Left atrial diameter was larger in asymptomatic patients than symptomatic patients only in PAF (40±6mm versus 38±6mm, p&lt;0.001). In all types of AF, there was no significant difference in primary endpoint between asymptomatic and symptomatic patients as follows: 37.5% versus 40.6% (p=0.6) in PAF, 45.2% versus 55.1% (p=0.09) in PEAF and 59.3% versus 63.6% (p=1.0) in LSAF. There was also no significant difference in secondary endpoint between asymptomatic and symptomatic patients: 7.1% versus 6.8% (p=0.7) in PAF, 5.4% versus 8.7% (p=0.3) in PEAF and 4.4% versus 5.1% (p=0.5) in LSAF. In a Cox hazard analysis, the symptom did not affect both of the primary and secondary endpoints in each type of AF. In regard to the incidence of complications related to CA, there was no significant difference between asymptomatic and symptomatic patients in each type of AF. Conclusion CA of AF for asymptomatic patients can be safe and can lead to equivalent outcomes as well as symptomatic patients. Funding Acknowledgement Type of funding source: None


2011 ◽  
Vol 21 (6) ◽  
pp. 766-770 ◽  
Author(s):  
Maria Muzyka-Woźniak

Purpose. To evaluate visual results of phacoemulsification in eyes with neovascular age-related macular degeneration (AMD) treated with anti–vascular endothelial growth factor (VEGF) intravitreal injections. Methods. This retrospective noncomparative interventional case-series study assessed best-corrected visual acuity (BCVA) at 4 timepoints: 1) baseline, immediately before first anti-VEGF injection; 2) preoperative, immediately before phacoemulsification; 3) postoperative, 1 month after phacoemulsification; 4) endpoint, at the last visit. Anti-VEGF retreatment regimen was based only on optical coherence tomography. The median time between anti-VEGF injections was evaluated for the time period before and after phacoemulsification. Results. Sixteen eyes of 16 patients were included. The median (range) baseline, preoperative, post-operative, and endpoint BCVA was 0.7 (0.3–1.3), 0.72 (0.4–1.3), 0.5 (0.05–1.0), and 0.36 (0.0–1.0) logMAR, respectively. Best-corrected visual acuity significantly improved after phacoemulsification (mean 3 logMAR lines) and remained stable during follow-up (median 14 months, range 7–28). There was no statistically significant difference in the median time interval between injections before phacoemulsification and after phacoemulsification. Conclusions. Phacoemulsification significantly improved BCVA in patients with choroidal neovascular AMD. This effect persisted during follow-up with no increased need for anti-VEGF injections to keep macula dry.


Author(s):  
Francesca Cattoni ◽  
Luca Chirico ◽  
Alberto Merlone ◽  
Michele Manacorda ◽  
Raffaele Vinci ◽  
...  

The aim of the present study was to evaluate and compare the traditional “All on Four” technique with digital smile designed computer-aided “All on Four” rehabilitation; with a 4-years follow-up. The protocol was applied to a total of 50 patients randomly recruited and divided in two groups. Digital protocol allows for a completely virtual planning of the exact position of the fixtures, which allows one to perform a flapless surgery procedure with great accuracy (mini-invasive surgery) and also it is possible to use virtually planned prostheses realized with Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) (methods for an immediate loading of the implants. After 4 years from the treatments 98% of success were obtained for the group of patients treated with the traditional protocol and 100% for the digital protocol. At each time interval a significant difference in peri-implant crestal bone loss between the two groups was detected; with an average Marginal Bone Loss (MBL) at 4 years of 1.12 ± 0.26 mm in the traditional group and 0.83 ± 0.11 mm in the digital group. Patients belonging to the digital group have judged the immediate loading (92%), digital smile preview (93%), the mock-up test (98%) and guided surgery (94%) as very effective. All patients treated with a digital method reported lower values of during-surgery and post-surgery pain compared to patients rehabilitated using traditional treatment. In conclusion, the totally digital protocol described in the present study represents a valid therapeutic alternative to the traditional “All on Four” protocol for implant-supported rehabilitations of edentulous dental arches.


2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Faried M. Wagdy ◽  
Hassan G. Farahat ◽  
Amin F. Ellakwa ◽  
Sameh S. Mandour

Objectives. To evaluate the safety and efficacy of augmenting conjunctival autografting with intraoperative mitomycin C (MMC) application versus Ologen implantation in the management of recurrent pterygium. Materials and Methods. This prospective randomised study included 63 eyes of 63 patients, with recurrent nasal pterygium, who presented to the outpatient clinic of Menoufia University Hospital in Shebin El Kom and Manshiet Soltan from January 2016 to December 2019. Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with the topical application of MMC (0.2 mg/mL), and group B included 31 eyes of 31 patients who underwent conjunctival autografting augmented with Ologen implantation. All the patients underwent follow-up examinations for a period of 24 months. During each visit, a complete ophthalmic examination was performed. Pterygium regrowth of 1 mm or more, over the cornea, was considered a recurrence. Results. In the MMC group, no recurrence was reported during the 24-month follow-up period. In the Ologen implantation group, recurrence was reported in 2 (8%) eyes. The time interval from surgery to recurrence was 5 months in one case and 8 months in the other. No other serious postoperative complications were reported, and there was no statistically significant difference between the groups in this regard. Conclusion. Ologen implantation with conjunctival autografting shows promising results in the surgical management of recurrent pterygium with mild non-vision-threatening postoperative complications comparable to that of MMC application with conjunctival autografting. Registration number: ClinicalTrials.govNCT04419038.


Author(s):  
Renjun Huang ◽  
Jingfen Zhu ◽  
Jianguo Zhou ◽  
Yalei Shang ◽  
Xiaoming Lin ◽  
...  

Background: An outbreak of coronavirus disease 2019 (COVID-19) has occurred worldwide. However, the small-airway disease in patients with COVID-19 has not been explored. Aim: This study aimed to explore the small-airway disease in patients with COVID-19 using inspiratory and expiratory chest high-resolution computed tomography (CT). Methods: This multicenter study included 108 patients with COVID-19. The patients were classified into five stages (0–IV) based on the CT images. The clinical and imaging data were compared among CT images in different stages. Patients were divided into three groups according to the time interval from the initial CT scan, and the clinical and air trapping data were compared among these groups. The correlation between clinical parameters and CT scores was evaluated. Results: The clinical data, including age, frequency of breath shortness and dyspnea, neutrophil percentage, lymphocyte count, PaO2, PaCO2, SaO2, and time interval between the onset of illness and initial CT, showed significant differences among CT images in different stages. A significant difference in the CT score of air trapping was observed between stage I and stage III. A low negative correlation was found between the CT score of air trapping and time interval between the onset of symptoms and initial CT. No significant difference was noted in the frequency and CT score of air trapping among different groups. Conclusions: Some patients with COVID-19 developed small-airway disease. Air trapping was more distinguished in the early stage of the disease and persisted during the 2-month follow-up. Longer-term follow-up studies are needed to confirm the findings.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15583-e15583
Author(s):  
L. Dahan ◽  
N. Methy ◽  
J. Seitz ◽  
E. Mitry ◽  
M. Ychou ◽  
...  

e15583 Background: The FFCD phase III trial in pts with MPA comparing LV5FU2-P followed by gemcitabine (arm A) versus the opposite sequence (arm B) had failed to demonstrate a significant difference in median OS and PFS. The aim of this ancillary study was to investigate definitions of 1st and 2nd line PFS and their impacts on results. Methods: From 08/2003 to 05/2006, 202 pts with measurable MPA, PS 0–2, non prior CT were included in 33 centers, 102 in arm A and 100 in arm B. PFS1 in 1st line was defined as time interval between randomization and progression (P) or death (D) during the 1st line. Alive patients without P have been censored at the beginning of 2nd line or at the last FU. PFS2 in 2nd line was defined as time interval between randomization and P or D during the 2nd line. Alive patients without P during 2nd line have been censored at the last FU. For patients receiving only one line, PFS2 was defined as time interval between randomization and first P or D. Survival curves has been estimated using Kaplan Meier and compared using log-rank Tests. Strict ITT and modified ITT (ie pts receiving 2 lines) analyses were performed Results: Amongst the 202 pts after a median follow-up of 44 months, 69 pts (45 pts due to P) in Arm A and 55 pts (48 pts due to P) in Arm B have received a 2nd line. Median PFS was respectively equal to 3.4 months in Arm A and 3.5 months in Arm B (Stratified Log-Rank p = 0.78). For PFS1 we observed 77 and 93 events respectively in Arm A and B. Median PFS1 was equal to 4.0 months in Arm A and 3.5 months in Arm B (Stratified Log-Rank p = 0.57). For PFS2 we observed 99 and 100 events respectively in Arm A and B. Median PFS2 was equal to 5.0 months in Arm A and 5.8 months in Arm B (Stratified Log-Rank p = 0.68). Restraining PFS2 amongst patients receiving 2 lines (N = 124 pts), we observed 67 and 55 events respectively in Arm A and B, median PFS2 was equal to 6.3 months in Arm A and 8.8 months in Arm B (Stratified Log-Rank p = 0.03) Conclusions: Our results suggest that PFS2 for patients receiving 2 lines was longer when pts received Gemcitabine in 1st line. To be clinically meaningful definition of PFS1 and PFS2 should be optimized regarding censoring rules. New definitions should be proposed and assessed. No significant financial relationships to disclose.


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