Abstract T P96: Short-term and Mid-term Results of Carotid Artery Revascularization as Carotid Artery Stenting for First-line Treatment: Single Center Experience in Japan

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Haruka Miyata ◽  
Ichiro Nakahara ◽  
Shoji Matsumoto ◽  
Tsuyoshi Ohta ◽  
Yutaka Fukushima ◽  
...  

Objective: Penetration ratio of carotid artery stenting (CAS) in carotid revascularization caught up that of carotid endarterectomy (CEA) in 2005, exceeding more than 60% in recent years after CREST in Japan. We choose CAS for first-line treatment, while CEA is applied to CAS high-risk patients dependent on factors including accessibility, plaque diagnosis, and symptom. The aim of this study is to evaluate short-term and mid-term results of single center experience of 266 consecutive cases with CAS / CEA. Materials / Methods: This is a retrospective analysis of 227 CAS and 39 CEA during January 2009 to March 2013. The primary outcome measures (short-term results) were any periprocedural (within 30 days after procedure) death, stroke, and acute coronary syndrome, and the rate of postoperative positive lesion in diffusion weighted imaging (DWI) on MRI. The mid-term results include death, stroke, and restenosis requiring retreatment during the follow-up periods. Results: There were no significant differences in age, underlying disease, and the severity of stenosis in both CEA and CAS group. However, the percentage of symptomatic lesion and the MRI T1WI plaque-sternocleidomastoid muscle ratio (index of the vulnerability of plaque) were higher in CEA than CAS group (69% vs. 48%, p=0.015; 1.79±0.46 vs. 1.31±0.37, p<0.0001). Short-term results revealed no mortality in both groups, any stroke 2.6% CEA vs. 4.9% CAS (p=1); major stroke 2.6% CEA vs. 0.9% CAS (p=0.38); acute coronary syndrome 0% CEA vs. 0.9% CAS (p=1); the rate of DWI-positive 24% vs. 39% (p=0.10). Mid-term results during the follow-up periods (CEA 18.3±13.5 month, CAS 20.3±14.1 month): death 5.1% CEA vs. 5.7% CAS (p=1), stroke 7.7% CEA vs. 11.0% CAS (p=0.78), restenosis requiring retreatment 0% vs. 6.6% (p=0.14). Conclusion: The short-term and the mid-term results were excellent and equivalent in CAS and CEA although we apply CEA to high-risk lesions such as fragile plaque or symptomatic lesion. Our protocol, in which most patients undergo less invasive CAS as the first-line while CEA is selected for CAS high-risk patients, enables to provide high quality treatment for carotid artery revascularization.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1784-1784 ◽  
Author(s):  
Sabina Chiaretti ◽  
Marilisa Marinelli ◽  
Ilaria Del Giudice ◽  
Silvia Bonina ◽  
Sara Gabrielli ◽  
...  

Abstract Abstract 1784 Introduction: The introduction of whole exome sequencing has allowed to unravel novel molecular lesions in CLL. NOTCH1, SF3B1 and BIRC3 mutations are detected, according to the phases of disease, in 4–12%, 5–17% and 4–24% of patients, respectively. In retrospective studies, their presence has been shown to correlate with overall survival (OS) and treatment-free interval shortening. Aims: To define the incidence, correlation with known prognostic factors and clinical impact of NOTCH1, SF3B1 and BIRC3 mutations in CLL patients undergoing first-line treatment. Methods: We evaluated 162 CLL patients enrolled in the GIMEMA LLC0405 protocol (n=80) for patients aged <60 yrs and in the ML21445 protocol (n=82) for elderly patients (aged >65 yrs or 60–65 if not eligible for fludarabine-based programs). In the GIMEMA LLC0405 protocol, patients were stratified into low and high-risk: patients with del17p or with del11q plus an unmutated IGHV status and/or CD38 positivity and/or ZAP70 positivity were considered as high-risk (HR) and underwent Fludarabine plus Campath, followed by stem cell transplantation procedures, whereas low-risk patients received Fludarabine and Cyclophosphamide. The MLL21445 protocol consisted of 8 cycles of Chlorambucil and 6 of Rituximab induction treatment. NOTCH1 (exon 34), SF3B1 (exons 14 and 15) and BIRC3 (exons 2–9, including splicing sites) were screened by Sanger sequencing on either genomic DNA (gDNA) or whole genome amplified DNA (WGA) collected at the time of treatment. These studies were not part of the clinical protocols. Results: NOTCH1 mutations were detected at the time of treatment in 18 cases (22%) enrolled in the LLC0405 study. There was a significant association with high-risk stratification (p=0.036), namely with an IGHV unmutated status (p=0.0035), CD38 (p=0.03), +12 (p=0.034) and, partly, ZAP-70 expression (p=0.059). While the overall response rate (ORR) did not differ between NOTCH1 mutated vs wild-type (WT) cases (82% vs 77%, respectively), the complete response (CR) rate was significantly lower in NOTCH1 mutated patients (43% for WT vs 17% for NOTCH1 mutated cases; p=0.05). So far, no significant difference between mutated and WT patients has emerged in terms of OS and progression-free survival (PFS); this may be contributed by the fact that most NOTCH1 mutated cases were HR and were therefore treated more aggressively. SF3B1 mutations were recorded in 9 cases (11%); no significant associations were found with known biological parameters and, so far, with the ORR and CR rate. A single case harbored a BIRC3 mutation; this patient had an IGHV unmutated status, no FISH abnormalities and a concomitant SF3B1 mutation. In the ML21445 cohort, NOTCH1 mutations were found in 12 cases (15%), were associated with an unmutated IGHV status (p=0.047) and ZAP-70 expression (p=0.007), and did not impact on the ORR and CR rate. SF3B1 mutations were found in 11 cases (13%); no significant associations were found with known biological parameters and the ORR rate. Of interest, only 1/11 SF3B1 mutated patients achieved a CR. BIRC3 mutations were recorded in 3 patients (3.6%); of these, 2 were IGHV mutated, 1 had no cytogenetic abnormalities and 1 carried a del11q, while the third patient was IGHV unmutated status and had no cytogenetic abnormalities. No NOTCH1 and/or SF3B1 mutations were detected. Overall, NOTCH1, SF3B1 and BIRC3 mutations were largely mutually exclusive among each other and with TP53 lesions in the whole cohort. Conclusions: This study confirms the association of NOTCH1 mutations with unfavorable biologic markers and +12, while the presence of SF3B1 mutations was not coupled to poor prognostic markers in CLL patients requiring first-line treatment. Furthermore, it suggests that NOTCH1 mutations impact on the CR rate of young patients receiving Fluda-based regimens, while SF3B1 appears to impact on the CR rate of elderly patients treated with Chlorambucil and Rituximab. Given the small numbers of patients harboring BIRC3, it is at present difficult to draw any conclusion on the clinical impact of this mutation in the cohort of patients hereby analyzed. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1081-1081
Author(s):  
Dana Diaz-Canales ◽  
Maria Rosario Prieto-Bonilla ◽  
Maria Eva Mingot-Castellano ◽  
Ana Isabel Heiniger Mazo

Abstract Introduction Primary immune thrombocytopenia (ITP) is an acquired autoimmune disorder with a very variable outcome. Bleeding manifestations and platelets count are considered the main criteria to start treatment in these patients. The initial recommended therapy are corticosteroids and intravenous immunoglobulin (IgsIV). The aim of our study is the description of efficacy and safety of high-dose dexamethasone (Dx) used as frontline therapy in newly diagnosed ITP patients. Methods A series of patients diagnosed in our centre from March 2009 to August 2012 has been studied. They have received first-line treatment with Dx (40 mg/d four consecutive days every 2 or 4 weeks) for 1 to 6 courses. Sex, age, cardiovascular risk factors, reasons to treat, response, courses of treatment, complications and relapse rate were recorded and analyzed. Results Our series of twenty-nine patients, 18 women (62%) and 11 men (38%), had a median age of 54 years (range 16-92 years). Twenty-five patients (86%) were treated after low platelet counts (30x 10e9 / L) with or without clinical bleeding, whereas the other four patients were treated as a surgery preparation. One patient received a reduced dose of Dx (20 mg/d x 4 days) because of comorbidities and high risk of infection. In thirteen patients, IgsIV were added to Dx in the first course (1g/kg/d x 2 days), because of high bleeding risk or more severe bleeding at diagnosis. Platelets count at baseline was 15x109/ L (range 1-29 x109/ L). Ninety-three percent of patients responded after the first course of Dx (69% complete response CR, 24% partial response PR), and 45% of the patients did not require additional Dx treatment. The median time to reach a response was 5 days since the first day of treatment (range 2-60). The sixteen patients who need more than one course received a median of 4 (range 2-10), all of them without IgsIV. After a median follow-up of 14 months (range 2-45), 69% of these patients maintained the response without further treatment. Therefore, the overall response of the series reaches 83%. After 6 courses of treatment, 5 subjects did not achieved response and were classify as corticosteroid dependent. Of these, one patient was splenectomized and at present he remains at CR after 30 months of follow up. Another patient is waiting for splenectomy, and other three received thrombopoietin analogs, remaining all them in CR under treatment. Thirteen patients received a combination of Igs and Dx in the first course due to high risk of bleeding (platelets less than 20 x 10e9/L and hemorrhagic manifestations). Eleven of them (81%) achieved response (4 PR, 7CR) at a median time of 4 days (range 2–60). After the first course of treatment, 61% (8 of 13) of patients receiving both IgsIV and Dx responded, vs 35% (5 of 16) of those treated only with Dx. This difference was not statistically significant, probably because of the small number of patients in our series. All patients treated with IgsIV and Dx in the first course got the best response after 4 cycles of dexamethasone, compared to 75% of subjects treated with Dx for 4 to 6 courses. Dx was usually well tolerated, since only 13% of the patients experienced side effects: one case of hypertension, another patient developed hyperglycemia associated to corticosteroids and other two presented mild transient steroid psychosis episodes. Infectious events were not observed. Conclusions Treatment with high-dose dexamethasone as first-line treatment for ITP is a good alternative to prednisone because it shows a high efficacy and a good safety profile. In our experience, the association of IgsIV and Dx in the first course may improve the response rate and decrease the total dose of steroids needed to achieve a similar response. Disclosures: No relevant conflicts of interest to declare.


2013 ◽  
Vol 68 ◽  
pp. S16
Author(s):  
Philip Borg ◽  
John M. Trotter ◽  
Heather Harris ◽  
Nick Everett ◽  
Krish Ravi ◽  
...  

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4425-4425 ◽  
Author(s):  
Marek Trneny ◽  
Pavel Klener ◽  
David Belada ◽  
Heidi Mocikova ◽  
Vit Prochazka ◽  
...  

Abstract Background: MCL is a distinct lymphoma entity with improved outcome achieved by the introduction of rituximab, high dose Ara-C and autologous stem cell transplantation (ASCT) into the first line therapy. The outcome of the relapsed patients (pts) remain however poor and there is little data on the outcome after subsequent relapses and there is no information on secondary MIPI prognostic value. Aim: To analyze the outcome of the MCL patients after first line treatment failure and to evaluate the prognostic role of the sec MIPI which is MIPI calculated at the time of relapse/progression. Methods: This analysis is a part of the Lymphoma project in which consecutive lymphoma patients are registered since the year 1999. Altogether 519 newly diagnosed MCL patients were registered in 5 university centers and 9 regional departments between 1999 and 2011. Patients who were treated with rituximab as part of the first line treatment (n=388) were included into the analysis. The diagnoses were confirmed according to WHO classification in the reference pathology centers. The median follow up is 4.5 years. Results: The whole cohort consists of 261 males and 127 females (2.1:1) with median age 65 y (28-87), the majority of pts had advanced disease (CS IV in 81.6% pts), PS ECOG ≥ 2 in 23.6% pts, elevated LDH in 52.5% of pts. The MIPI risk profile was as follows: low risk 21.7%, intermediate risk 27.2% and high risk in 51.1%. All pts received rituximab as part of the induction, 48.7% pts received CHOP, 5.7% alternation of CHOP and HD Ara-C, 26.2% intensive induction with HD Ara-C, 10.3% CVP, 6.4% FC. High dose therapy with ASCT was performed in 23.9% of pts. The ORR was 89.0% with 63.8 CR/CRu, 6.3% had stable disease and 4.9% were primary progressive. The PFS and OS were 2.9 y and 5.5 y with significant impact of MIPI risk (p<0.0001) for both PFS and OS. There were observed 179 relapses/progressions (R/P) and 70 deaths not related to subsequent progression. The cohort of patients with 1st R/P consisted out of 125 males and 54 females (2.3:1) with median age 68 years (38-89). The sed MIPI at the time of 1st R/P was low in 12.7% pts, intermediate in 32.1% and high 59.8% pts. Rituximab was used in 69.5% of patients, DHAP or ESHAP was used in 25.1% cases, FC in 22.8% of cases, CHOP like regimen in 9.4%, HD Ara-C in 11.8%, only 4.7% were treated with targeted therapy temsirolimus or lenalidomide. Altogether 77.2% pts were treated with the polychemotherapy and 22.8 with monotherapy. ASCT and AlloSCT were performed in 5.5% and 8.7% pts resp. During follow up there were observed 74 deaths not related to subsequent progression and 53 2nd R/Ps. The median of 2nd PFS and 2nd OS from the date of 1st R/P was 1.0 and 1.3 years resp. The sec MIPI low vs. intermediate vs. high risk had significant prognostic impact on 2nd PFS: 5.8 vs 1.7 vs 0.9 years (p<0.0001) (fig 1) as well as on OS : 5.8 vs 3.4 vs 1.1 years (p<0.0001) (fig 2). The cohort of 53 pts with 2nd R/P had median age 68 (38-85) yers, male/female ratio was 1.4. Rituximab was used in 45.9% of treated patients and 48.3% of pts were treated with single drug. During follow up 11 pts developed 3rd R/P and other 30 pts died due to current progression, toxicity or in remission. The median of 3rd PFS from the time of 2nd R/P was 6.8 m and OS 7.4 months. Pts who were treated for 3rd R/P recieved rituximab in 50% of cases and the majority (81.2%) were treated with other single drug. The median of 4th PFS from 3rdR/P was 4.9 m and OS 5.5 months . Conclusions: Our analysis of relapsed MCL patients shows that 1: Median PFS from the Dg was 2.9 y but each subsequent relapse resulted in significantly shorter PFS median 12.1, 6.8 and 4.9 months resp. 2: The median OS from Dg was 5.5y but after each relapse it became shorter - 15.7 m, 7.4 m and 5.5 months resp. 3: The sec MIPI at the time of relapse discriminates the groups with significantly different prognosis. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 30-30
Author(s):  
Chieh-Lin Jerry Teng ◽  
Tran-Der Tan ◽  
Yu-Wen Lin ◽  
Pei-Wen Lien ◽  
Hsin-Chun Chou ◽  
...  

Background Hodgkin lymphoma (HL) is a highly curable hematological neoplasm, even in an advanced stage. However, despite improvements in treatment, patients with primary refractory and/or relapsed HL (RRHL) still have a poor prognosis. Because of relatively low incidence, studies focusing on the clinical characteristics or outcomes for patients with advanced-stage HL and RRHL in Asia are few. The present study aimed to describe the clinical features and survival of these patients in Taiwan using a nationwide database. Methods This retrospective descriptive study was conducted by using the Taiwan Cancer Registry and the National Health Insurance Research Database. All newly diagnosed HL patients who started frontline treatment with an intent to cure were enrolled from 2009 to 2016. Patients who had an advanced-stage disease (i.e., stage III/IV) at diagnosis were identified. All chemotherapy agents prescribed during the 60-day period after the date of first treatment were considered as the same line regimen. Patients with RRHL were identified as those receiving a new chemotherapy for HL (across stages) other than the first-line regimen or undergoing an autologous stem cell transplantation (ASCT) at any time. We described the first-line regimens for newly diagnosed advanced-stage HL and salvage therapy for RRHL. Characteristics and survival outcomes, including overall survival (OS) and time to next treatment (TTNT, as a surrogate for progression-free survival, PFS), were further analyzed for patients who received ABVD or ABVD-like (BVD and AVD) regimen as the first-line treatment, specifically in those with advanced stage at diagnosis and RRHL patients who received ASCT. Results Between 2009 and 2016, 1,156 newly diagnosed HL patients with an intent-to-cure treatment were enrolled; of whom 490 were advanced stage at diagnosis. A bimodal age distribution with peaks around 20-44 and after 65 years was observed. Among the patients with an advanced stage disease, ABVD was the dominant frontline regimen, accounting for 79% of treated HL cases, followed by ABVD-like regimens (15%), and BEACOPP (3%). The median age of patients receiving ABVD/ABVD-like regimen was 34 years, and 62% were male. Over half of the patients were stage IV (57%), having extra-nodal disease (58%), and/or B-symptoms (54%). Only 19% of them received radiotherapy along with chemotherapy. With a median follow-up of 4.7 years, the OS and PFS rates were 76% and 52%, respectively. Among 321 RRHL patients, 288 had received ABVD/ABVD-like regimens as frontline therapy. In this 288-patient cohort, 135 (47%) proceeded to ASCT. Among these 135 patients, ESHAP was the commonest salvage therapy (62%), followed by ICE (15%), and others (7%). After a 3.9-year median follow-up, the OS and PFS rates were 76% and 47%, respectively. Discussion The current study describes the clinical characteristics and treatment outcomes of patients with advanced-stage HL and RRHL in Taiwan. Prior studies describing clinical features and outcomes of HL patients in Taiwan are limited to a single medical center experience. Our study provides nationwide data and suggests the clinical features of advanced-stage HL patients are not much different from those in Western countries. Though the OS of advanced-stage HL remained high, half of the patients who received standard treatment developed relapsed/refractory disease, suggesting a strong unmet need for better novel therapies. Among the RRHL patients receiving ASCT, about half of them experienced further disease progression, and a quarter died afterwards. This observation highlights the importance of identifying high-risk patients for progression. Moreover, regimens that include novel agents may improve the outcomes of early high-risk patients. Further studies are needed to determine the real-world treatment outcomes and cost-effectiveness of these novel agents. Conclusion The characteristics of advanced-stage HL in Taiwan were comparable to those in Western countries. Considering the poor prognosis of RRHL, it is crucial to identify patients with a high risk of progression in the first line so that we can optimize their treatment outcomes. Disclosures Lien: Takeda Pharmaceuticals Taiwan: Ended employment in the past 24 months. Chou:Takeda Pharmaceuticals Taiwan: Current Employment. Lin:Takeda Pharmaceuticals Taiwan: Research Funding.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3559-3559
Author(s):  
Huayuan Zhu ◽  
Yeqin Sha ◽  
Wei Wu ◽  
Jingyan Qiu ◽  
Yilian Yang ◽  
...  

Abstract Introduction To evaluate the safety and efficacy of zanubrutinib, lenalidomide plus R-CHOP (ZR 2-CHOP) as the first-line treatment for DLBCL patients, we conducted this single-arm retrospective observational study. Methods Treatment-naïve patients with DLBCL(including but not limited to double-hit, double expression) aged 18 to 75 years were enrolled.ZR 2-CHOP was given as follows, Oral zanubrutinib was given continuously (160 mg twice daily) from Day 0, lenalidomide 25 mg daily Day 1-7. Patients were administered intravenously rituximab (375 mg/m 2 Day 0), cyclophosphamide (750 mg/m 2 Day 1), doxorubicin (50 mg/m 2 Day 1), vincristine (1.4 mg/m 2 Day 1), and oral prednisone (100 mg Day 1-5). All patients were recommended to receive 6 cycles of ZR 2-CHOP (R-CHOP or R 2-CHOP were allowed in cycle 1-2 due to poor physical condition at treatment) and patients older than 70 years old were administered ZR 2-miniCHOP (Figure 1). CT or PET-CT scans were applied to mid-term efficacy and PET-CT scan was conducted after 6 cycles. ctDNA was dynamically detected before treatment, after 3 and 6 cycles to evaluate tumor mutational burden. The primary endpoint was complete response ratio (CRR) at mid-term and after 6 cycles. The secondary endpoint was overall response rate (ORR), ctDNA dynamics and adverse events (AE). AEs were graded based on CTCAE (version 5.0). Results 12 treatment-naïve DLBCL patients diagnosed in Pukou CLL Center were enrolled in this cohort between July 2020 and June 2021. The median age was 56 years old and all patients had ECOG-PS ≤2. 1 patient (1/12) was diagnosed as double-hit DLBCL and 9 patients (9/12) as double-expression. 10 patients were non-GCB and 2 were GCB. 7 patients were classified as high-intermediate and high-risk group according to NCCN-IPI (Table 1). At data cutoff (1st July, 2021), the median follow-up was 8 months (3-12 months) with all patients have completed at least 3 cycles and mid-term assessment has been conducted. The ORR was 100.0%, with 10 patients achieved CR and 2 patients achieved PR (both two patients received R-CHOP regimen in cycle 1/cycle 1-2 due to poor physical condition at initial treatment, Figure 1). 10 patients have received 6 cycles, all of them achieved CR (Figure 2). ctDNA was dynamically detected in six patients. The median number of detectable ctDNA mutation among six patients was 8 (0-12) with two patients classified as MCD subtype and one patients as EZB subtype. All six patients showed undetectable ctDNA after 3 cycles. During end of treatment follow-up, one patient (triple-hit, EZB) who scheduled to receive auto-SCT underwent disease progression 4 months later and reemergence of ctDNA showed previous homologous clones. The most common hematological toxicity events were lymphocytes count decreased, neutrophil count decreased, thrombocytopenia and anemia, with 3-4 level occurrence rate was 66.7%, 25.0%, 25.0% and 16.7%. The most common non-hematological toxicity events were nausea, fatigue and anorexia. One patients discontinued oral zanubrutinib and lenalidomide in last two cycles due to drug rash. Conclusion ZR 2-CHOP could attain high CR rate and ctDNA clearance in TN DLBCL, including patients with DEL and/or high-risk. The overall tolerability was manageable. ZR 2-CHOP could be one of the promising choice for TN DLBCL. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: Zanubrutinib was used in the initial treatment of high-risk DLBCL.


Author(s):  
Samaneh Yousefi ◽  
Ehsan Bahramali ◽  
Safoora Kokabi ◽  
Seyed Taghi Heydari ◽  
Abdolhamid Shariat ◽  
...  

Background: Carotid angioplasty and stenting (CAS) is an accepted treatment to prevent stroke in patients with carotid artery stenosis. The purpose of this study is to identify risk factors for major complications after carotid angioplasty and stenting.Methods and Material: This is a prospective study conducted at Shiraz University of Medical Sciences in southern Iran from March 2011 to June 2014. Consecutive patients undergoing carotid angioplasty and stenting were enrolled. Both standard risk and high risk patients for endarterectomy were enrolled. Demographic data, atherosclerotic risk factors, site of stenosis, degree of stenosis, and data regarding technical factors were recorded. 30-day stroke, myocardial infarction, and/or death were considered as the composite primary outcome of the study.Results:  two hundred and fifty one patients were recruited (mean age: 71.1+ 9.6 years, male: 65.3%).  One hundred and seventy eight (70.9%) patients were symptomatic; 73 (29.1%), 129 (51.4%), 165 (65.7%) and 62 (24.7%) patients were diabetic, hyperlipidemic, hypertensive and smoker respectively. CAS performed for left ICA in 113 (45.4%) patients. 14 (5.6%) patients had Sequential bilateral stenting. Mean stenosis of operated ICA was 80.2 +13.8 %. Embolic protection device was used in 203 (96.2%) patients. Predilation and post-dilation were performed in 39 (18.5%) and 182 (86.3%) patients respectively. Composite outcome was observed in 3.6% (3.2% stroke, 0% myocardial infarction and 1.2% death). Left sided lesions and presence of DM was significantly associated with poor short term outcome. (P value: 0.025 and 0.020, respectively)Conclusion: There was a higher risk of short term major complications in diabetic patients and left carotid artery intervention. 


Sign in / Sign up

Export Citation Format

Share Document