Vascular Access Type Was Not Associated with Mortality and the Predictors for Cardiovascular Death in Elderly Chinese Patients on Hemodialysis

2019 ◽  
Vol 49 (1-2) ◽  
pp. 63-70
Author(s):  
Yang Yu ◽  
Yuqin Xiong ◽  
Chunle Zhang ◽  
Martina Fu ◽  
Yi Li ◽  
...  
Keyword(s):  
Vascular Access ◽  
Venous Catheter ◽  
Multivariate Regression Analysis ◽  
Cardiovascular Death ◽  
Chinese Patients ◽  
West China Hospital ◽  
Kaplan Meier ◽  
Elderly Chinese ◽  
The Impact

Objectives: Current studies suggest arteriovenous fistula (AVF) and arteriovenous graft as superior vascular access (VA) types for elderly hemodialysis (HD) patients due to better outcomes. This study aimed to examine the impact of VA type on cardiovascular and all-cause mortality as well as the predictors for outcome in elderly Chinese patients. Methods: Patients who initiated HD aged ≥70 years and received a primary VA creation at the West China Hospital were enrolled in this retrospective study. Clinical characteristics, maturation, utilization, conversion of VA, and outcomes were collected. The observational period for each patient was from the point of the first permanent VA creation to the last time of follow-up. Kaplan-Meier and multivariate regression analysis were employed. Results:A total of 358 elderly Chinese HD patients with a median age of 74 (72–78) years were analyzed. During the study period of 25.8 (12–43) months, 54 (15.1%) and 113 patients (15.1%) died of cardiovascular events and all-cause, respectively. With regard to VA type, the modality of AVF, tunneled cuffed central venous catheter (tcCVC), or AVF and tcCVC was not associated with mortality. Furthermore, diastolic blood pressure (DBP) and congestive heart failure (CHF) were the independent predictors for cardiovascular mortality. Conclusions: The modality of VA types showed an insignificant effect on mortality in elderly Chinese population, while preoperative DBP and the presence of CHF might be used for the risk assessment of cardiovascular death. Disparities among nations in the areas of VA and HD necessitate additional studies.

Impacts of age, diabetes, gender, and access type on costs associated with vascular access among Chinese patients on hemodialysis

2020 ◽  
pp. 039139882096211
Author(s):  
Yuqin Xiong ◽  
Yang Yu ◽  
Yuan Yang ◽  
Liya Wang ◽  
Ping Shi ◽  
...  
Keyword(s):  
Vascular Access ◽  
Venous Catheter ◽  
Cost Effective ◽  
Chinese Patients ◽  
Chi Square ◽  
West China Hospital ◽  
Tertiary Hospitals ◽  
Materials Used ◽  
Gender Groups

Objectives: Examine the impacts of age, diabetes, gender, and access type on vascular access (VA) associated costs among Chinese hemodialysis (HD) patients. Methods: We retrospectively included patients whose first permanent VA was created at the West China Hospital. Clinical characteristics, maturation, intervention, utilization, and exchange of every VA, as well as VA-related infection were collected. The study period for each patient was from HD initiation to the last follow-up. VA-related costs, including those for placement and intervention procedures, were calculated according to the standards set in 2019 for Chinese tertiary hospitals. Mann-Whitney U and Chi-square tests were conducted for comparisons between groups. Results: A total of 358 Chinese HD patients experienced functionally 143 arteriovenous fistula (AVF), 22 arteriovenous graft (AVG), and 439 tunneled cuffed central venous catheter (tcCVC) during a median study period of 26 (IQR 13–44) months, of which 42.5% used more than one permanent VA. The median annual VA-related cost in the groups of age >75 years and ⩽75 years, diabetes and non-diabetes, male and female, was $525 and $397 ( p = 0.016), $459 and $462 ( p = 0.64), $476 and $445 ( p = 0.94), respectively. The median monthly costs for AVF ($18), AVG ($289), and tcCVC ($37) were significantly different. Conclusion: HD patients aged >75 years had significantly higher annual VA-related costs. However, the annual VA-related costs did not differ across the diabetes groups or the gender groups. AVF was the most cost-effective permanent VA type in China, partly due to the inexpensive materials used compared to AVG or tcCVC.

The Efficacy of Etoposide-Based Therapy in Adult Secondary Hemophagocytic Lymphohistiocytosis

2021 ◽  
pp. 1-9
Author(s):  
Leonard Naymagon ◽  
Douglas Tremblay ◽  
John Mascarenhas
Keyword(s):  
Hemophagocytic Lymphohistiocytosis ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Rank Test ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Significant Difference ◽  
The Impact

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank <i>p</i> = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, <i>p</i> = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.

The impact of multimodality therapies in marginally inoperable soft tissue sarcomas (STS): The Toronto Sarcoma Program (TSP) experience.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11548-11548
Author(s):  
Olga Vornicova ◽  
Jay Wunder ◽  
Peter W. M. Chung ◽  
Abha A. Gupta ◽  
Rebecca Anne Gladdy ◽  
...  
Keyword(s):  
Cox Regression ◽  
Soft Tissue Sarcomas ◽  
Tumor Board ◽  
Disease Characteristics ◽  
Kaplan Meier ◽  
Progression Of Disease ◽  
Modality Approach ◽  
Poor Outcomes ◽  
The Impact

11548 Background: The mainstay therapy of operable STS remains surgery, which may include (neo)adjuvant therapies. Within the TSP, marginally inoperable STS are often treated with sequential chemo (CTX) and radiation (RT) therapy, followed by surgery (SX). Herein we present our experience of multi-modality therapies for marginally inoperable STS patients (pts). Methods: This was a dual-center, single program, retrospective review. Pts were included if deemed to have marginally inoperable primary or recurrent STS, as determined at the TSP tumor board. Pts included must have had CTX with the intent of having RT and SX after. Pts demographics, treatment details and clinical outcomes data were collected. Relapse free survival (RFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Multivariate analysis of the influence of disease characteristics and treatment on outcomes was assessed using Cox regression. Results: From June 2005 to May 2019, 75 pts were identified. Median age was 52 years (range 16-72). Pts were predominantly male (55%). Histological subtypes included dedifferentiated liposarcoma (29%), leiomyosarcoma (27%), synovial sarcoma (19%) and others (25%). Primary tumor was located in the retroperitoneum (48%), extremity (23%), pelvis (12%), thorax (9%), and other sites (8%). All pts had doxorubicin and ifosfamide CTX (median 4 cycles; range 1-6), while RT dose delivered was 50.4Gy/28 fractions in 58 (77%) of cases. Twenty three pts (31%) achieved partial response, 40 pts (53%) had stable disease and 12 pts (16%) had progression of disease (PD) on CTX, of which half (8%) did not undergo further treatment. Nine pts (12%) underwent CTX followed by SX due to significant response, 9 pts (12%) underwent CTX and RT without SX due to persistent tumor unresectability or PD. The final 50 pts (67%) completed multi-modality treatment (CTX, RT & SX). Overall, 59 pts (79%) had SX; negative margins were achieved in 53 (71%). 19 pts (25%) had postoperative complications, causing death in 2 pts (2.7%). With a median follow-up of 72 months, median RFS and OS were 26.9 months (95% CI: 0-86.0), and 65 months (95% CI: 13.5-116.4). Extremity location was associated with superior RFS (median not reached [NR], HR 0.28 95% CI 0.09-0.83, p = 0.022), and OS (median NR, HR 0.29 95% CI 0.09-0.90, p = 0.032). Receipt of RT was associated with superior RFS (median NR, HR 0.23 95% CI 0.10-0.52, p < 0.001); and OS (median NR, HR 0.21 95% CI 0.09-0.50, p < 0.001). Pts who had PD after CTX were associated with poor outcomes - RFS (median 4.7 months, HR 2.03 95% CI 0.61-6.76, p = 0.24); and OS (median 21.9 months, HR 2.48 95% CI 0.73-8.47, P = 0.144). Conclusions: Multi-modality approach resulted in successful resection for most pts with marginally inoperable STS. Extremity location and RT administration were associated with better RFS and OS, while progression on CTX confers worse survival outcomes.

scholarly journals Impact of Moderate to Severe Renal Impairment on Mortality and Appropriate Shocks in Patients with Implantable Cardioverter Defibrillators

2010 ◽  
Vol 2010 ◽  
pp. 1-6 ◽  
Author(s):  
Venkata M. Alla ◽  
Kishlay Anand ◽  
Mandeep Hundal ◽  
Aimin Chen ◽  
Showri Karnam ◽  
...  
Keyword(s):  
Linear Models ◽  
Severe Renal Impairment ◽  
Medical Center ◽  
Implantable Cardioverter Defibrillators ◽  
Free Survival ◽  
Kaplan Meier ◽  
Appropriate Shocks ◽  
The Impact ◽  
Cardioverter Defibrillators

Background. Due to underrepresentation of patients with chronic kidney disease (CKD) in large Implantable-Cardioverter Defibrillator (ICD) clinical trials, the impact of ICD remains uncertain in this population.Methods. Consecutive patients who received ICD at Creighton university medical center between years 2000–2004 were included in a retrospective cohort after excluding those on maintenance dialysis. Based on baseline Glomerular filtration rate (GFR), patients were classified as severe CKD: GFR < 30 mL/min; moderate CKD: GFR: 30–59 mL/min; and mild or no CKD: GFR ≥ 60 mL/min. The impact of GFR on appropriate shocks and survival was assessed using Kaplan-Meier method and Generalized Linear Models (GLM) with log-link function.Results. There were 509 patients with a mean follow-up of 3.0 + 1.3 years. Mortality risk was inversely proportional to the estimated GFR: 2 fold higher risk with GFR between 30–59 mL/min and 5 fold higher risk with GFR < 30 mL/min. One hundred and seventy-seven patients received appropriate shock(s); appropriate shock-free survival was lower in patients with severe CKD (GFR < 30) compared to mild or no CKD group (2.8 versus 4.2 yrs).Conclusion. Even moderate renal dysfunction increases all cause mortality in CKD patients with ICD. Severe but not moderate CKD is an independent predictor for time to first appropriate shock.

scholarly journals Evaluation of Lumbar Stiffness after Long-Level Fusion  for Degenerative Lumbar Scoliosis in Chinese population

2020 ◽  
Author(s):  
Xinling Zhang ◽  
Lei Yuan ◽  
Yan Zeng ◽  
Zhongqiang Chen ◽  
Weishi Li ◽  
...  
Keyword(s):  
Internal Consistency ◽  
Chinese Population ◽  
Chinese Patients ◽  
Personal Hygiene ◽  
Degenerative Lumbar Scoliosis ◽  
Lumbar Scoliosis ◽  
Patient Reported ◽  
Elderly Chinese ◽  
The Impact ◽  
Level Fusion

Abstract Study Design: a retrospective study.Summary of Background Data: Long-level spinal instrumented fusion for DLS by intention eliminated spinal motion in an attempt to alleviate pain, improve deformity, and reduce disability. However, this surgery considerably impaired performance of activities of daily living (ADL) due to the resulting stiffness. The lumbar stiffness disability index (LSDI) was a validated measure of the effect of lumbar stiffness on functional activity, however, which might not be fully applicable to elderly Chinese population because of their several special lifestyles.Objective: To evaluate the lumbar stiffness in patients with degenerative lumbar scoliosis (DLS) after long-level fusion by Chinese-LSDI (C-LSDI).Methods: 129 DLS patients underwent long-level (≧4 levels) fusion surgery with at least one-year follow-up were included. The C-LSDI was designed by modifying LSDI and Korean-LSDI (K-LSDI) considering elderly Chinese lifestyles, and the patient-reported outcome questionnaire measuring the impact of lumbar stiffness on functional abilities in elderly Chinese with DLS was assessed for internal consistency and retest repeatability.Results: All patients showed increased lumbar stiffness with significantly improvement in pain and deformity postoperatively, and for items of performing personal hygiene after toileting and getting out of a car, people performed more inconvenient with increasing fixed levels. Compared with LSDI and K-LSDI, the C-LSDI demonstrated high internal consistency (Cronbach’s alpha=0.902) and retest reliability (ICC=0.904) in the elderly Chinese population. Conclusion: This study demonstrated that the C-LSDI questionnaire was a reliable and valid instrument for assessing functional limitations due to lumbar stiffness among elderly Chinese patients with DLS after long-level fusion. Although the effects of stiffness did trend toward greater impacts among patients underwent longer fusions, most patients were satisfied with trade-offs of function and pain relief in exchange for perceived increases in lumbar stiffness.

P5431The relationship between pulse rate and the risk of cardiac events in patients with atrial fibrillation: the Fushimi AF registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Iguchi ◽  
N Masunaga ◽  
M Ishii ◽  
Y An ◽  
M Esato ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
Confidence Intervals ◽  
Pulse Rate ◽  
Cardiovascular Death ◽  
Left Ventricular ◽  
Hazard Ratio ◽  
Cardiac Events ◽  
The Impact

Abstract Background Relationship between pulse rate (PR) and cardiac events in patients with sustained (persistent and permanent) atrial fibrillation (AF) in routine clinical practice remains unclear. Methods The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto. Follow-up data were available for 4,454 patients, and we obtained PR at baseline in 2,209 patients of 2,248 sustained AF patients. We divided these patients into four groups based on their PR; G1 (PR≥100 bpm, n=249), G2 (80 bpm≤PR<100 bpm, n=821), G3 (60 bpm≤PR<80 bpm, n=986), and G4 (PR<60 bpm, n=153), and examined the relationship between PR and cardiac events (composite of cardiovascular death and hospitalization for heart failure (HF)). Results Proportion of female and symptomatic AF were more in G1 group, and diastolic blood pressure was higher in G1 group, despite that systolic blood pressure was similar between the four groups. Prevalence of anemia was higher in G1 group, and that of chronic kidney disease was higher in G4 group. Prevalence of HF and left ventricular dysfunction tended to be higher in G1 group but not statistically significant. Beta-blockers and non-dihydropyridine calcium blockers were more often prescribed in G1 group. During the median follow-up of 1,449 days, cardiac events occurred in 399 patients (358 hospitalization for HF and 41 cardiovascular death). In Kaplan-Meier analysis, the incidence of cardiac events were comparable between the four groups (p=0.3). The incidence of all cause death (p=0.06) and stroke or systemic embolism (p=0.4) was also similar between the four groups. The incidence of cardiac events did not differ between the four groups when we divided the patients based on the presence of HF at baseline, and the incidence of cardiac events was also comparable between the four groups after adjusting potential confounders. However, when we examined the impact of PR according to 10 bpm increment, patients with very low PR (<50 bpm) (hazard ratio [95% confidence intervals], 2.22 [1.04–4.15]) and very high PR (≥110 bpm) (hazard ratio [95% confidence intervals], 1.67 [1.00–2.64]) had higher incidence of cardiac events than patients with PR of 70–79 bpm (Figure). Furthermore, we acquired the annual follow-up data of PR. Mean PR during the follow-up periods was not different between patients with cardiac events and those without (with vs without, 79.5±15.3 bpm vs 79.7±12.7 bpm; p=0.8), whereas maximum PR was less in patients with cardiac events (85.2±17.5 bpm vs 89.3±16.2 bpm; p<0.0001). Patients with maximum PR<60 bpm showed higher incidence of cardiac events, and the incidence of cardiac events was the lowest in patients with maximum PR of 80 to 99 bpm (maximum PR<60 bpm: 31.3%, 60–79 bpm: 24.5%, 80–99 bpm: 14.5%, 100 bpm: 16.1%; P<ehz746.03881). Conclusion PR did not appear to have strong impact on cardiac events in patients with sustained AF. However, low PR might be a risk for developing cardiac events. Acknowledgement/Funding Japan Agency for Medical Research and Development, AMED (15656344, 16768811), Boehringer Ingelheim, Bayer Healthcare, Pfizer, Bristol-Myers Squibb

ASXL1 Mutations in AML: Molecular Biomarker for Secondary AML?

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2343-2343
Author(s):  
Jingmei Hsu ◽  
Anita J. Kumar ◽  
Martin P. Carroll ◽  
Noelle V. Frey ◽  
Nirav N. Shah ◽  
...  
Keyword(s):  
Overall Survival ◽  
De Novo ◽  
Conflicts Of Interest ◽  
Prognostic Significance ◽  
Myeloproliferative Neoplasm ◽  
Molecular Characteristics ◽  
Intermediate Risk ◽  
Kaplan Meier ◽  
The Impact

Abstract Background: Additional sex combs like transcription factor 1 (ASXL1) is a member of the polycomb group protein. ASXL1 mutation has been implicated in myeloid malignancy transformation. It is hypothesized that mutated ASXL1 leads to the loss of polycomb repressive complex 2 (PRC2) mediated gene repression and subsequent transforming events. Recent studies identify ASXL1 mutation as a poor prognostic marker in patients (pts) with de novo acute myeloid leukemia (AML) who present with intermediate–risk cytogenetic lesions (Patel, NEJM 2012; Schnittger, Leukemia2013). To study the impact of ASXL1 mutations in an unselected AML population, we analyzed clinical and molecular characteristics of patients with untreated AML who express ASXL1 mutation at presentation. Methods: Using next generation sequencing, 254 adult patients with AML seen at the Hospital of the University of Pennsylvania were analyzed for mutations, including ASXL1, using a 33-gene hematologic malignancy panel. Clinical characteristics were obtained from retrospective chart review. Kaplan-Meier estimates were used to calculate overall survival (OS) from time of diagnosis. Living patients were censored at date last seen. Results: ASXL1 mutations were detected in 36/254 (14%) AML pts. There were 29 known pathologic mutations, 1 benign, 1 probable pathologic, and 9 variants of unknown clinical significance (VUS). In 6/36 (16.7%) pts, ASXL1 was the sole mutation identified. Of the 30 pts with additional mutations (Figure 1), 6/30 (20%) pts harbored 2 independent ASXL1 mutations. When the 27 patients with pathologic ASCL mutations were analyzed for co-mutations, TET2 (13/27, 48%) was the most frequent ASXL1 co-mutation. FLT3 (0/27, 0%) and NPM1 (1/27, 3.7%) were notable for their absence. Median age of pts at diagnosis was 69 years (range 23-80). Prior myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) was noted in 9/36 (25%) and 11/36 (30.6%) pts, respectively. Four pts (11.1%) had received chemotherapy and/or radiation therapy for a prior non-myeloid neoplasm. Karyotype was normal in 18/36 (50%) pts, and 7 additional pts had intermediate cytogenetic lesions. There were 7 pts (19.4%) with unfavorable cytogenetics (complex karyotype (3 pts), 7q- (3 pts), and 5q- (1 pt)). Four pts (11.1%) had a favorable karyotype, with t(8;21) in 3 pts and t(15;17) in 1 pt. At presentation, median white blood cell count (WBC) was 6.4x103/uL (1.0 x -103). In pts whose AML transformed from prior MPN, median WBC was 50 X103/uL (3.3-140). Standard induction chemotherapy with an anthracycline and cytarabine was given to 17/36 (47%) pts. An additional 3/36 (8.3%) pts underwent induction therapy with clofarabine. Complete remission (CR) was documented in 14/20 (70%) evaluable pts. Of the remaining pts, 11 received a hypomethylating agent, and 5 received other therapies. Thirty-day treatment mortality for all 36 pts and for 27 pts with known ASXL1 pathologic mutation was 13.4% and 18.5% respectively. Kaplan-Meier estimate showed a median overall survival of 349 days (median follow up of 107 days (range 15-1570)). For the 27 pts with a pathologic ASXL1 mutation, the OS was 276 days (Figure 2, median follow up of 145 days (range 18-1570)). Conclusion: ASXL1 mutations in de novo AML with intermediate-risk cytogenetics is associated with poor clinical outcome in cooperative group trials. Strikingly we demonstrate in a single institution, retrospective analysis that 66.7% of pts who present with ASXL1 mutations in the setting of previously untreated AML had documented MDS, MPN and/or prior chemotherapy/radiation. Further studies are necessary to evaluate if ASXL1 mutation has independent prognostic significance in AML or if it is primarily a marker for secondary leukemia. Figure 1: ASXL1 and co-mutations Figure 1:. ASXL1 and co-mutations Figure 2: Overall survival for AML patients with ASXL1 pathologic mutation Figure 2:. Overall survival for AML patients with ASXL1 pathologic mutation Disclosures No relevant conflicts of interest to declare.

Incidence and characterization of venous thromboembolic events (VTE) in patients with pancreatic cancer: Effect of timing of VTE on survival.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4037-4037
Author(s):  
Maithili A Shethia ◽  
Aparna Hegde ◽  
Xiao Zhou ◽  
Michael J. Overman ◽  
Saroj Vadhan-Raj
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Survival Analysis ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
One Year ◽  
The Impact

4037 Background: Patients (pts) with pancreatic cancer are at high risk for VTE, and the occurrence of VTE can affect pts’ prognosis. The purpose of this study was to evaluate the incidence of VTE and the impact of timing of VTE (early vs. late) on survival. Methods: Medical record of 260 pts with pancreatic cancer, newly referred to UT MDACC during one year period from 1/1/2006 to 12/31/2006, were reviewed for the incidence of VTE during a 2-year follow-up period from the date of diagnosis. All VTE episodes were confirmed by radiologic studies. Survival analysis was conducted using Kaplan-Meier analysis and Cox proportional hazard models. Results: Of the 260 pts, 47 pts (18%) had 51 episodes of VTE during the 2-year follow-up. The median age of the pts with VTE was 61 years (range: 28-86) and 53% were males. Of the 47 pts with VTE, 27 (57%) had PE, 19 (40%) had DVT and 1 had concurrent PE/DVT. Three pts had recurrent VTE during the study period. Median follow-up time for OS was 192 days (range: 1-1652 days). Kaplan-Meier Survival analysis showed that those who developed VTE earlier (within 30 or 90 days) had shorter median overall survival (OS) compared with those who had VTE beyond these time points. The hazard ratios, 95% CI, and median OS at 1 year are summarized in the table below. Conclusions: The incidence of VTE is high in pts with pancreatic cancer. The timing of VTE had a significant impact on OS; pts who had an early development of VTE had a shorter overall survival. [Table: see text]

Comparative study of six cycles versus twelve cycles of adjuvant temozolomide post concurrent chemoradiation in newly diagnosed glioblastoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e13034-e13034
Author(s):  
Menal Bhandari ◽  
Ajeet K Gandhi ◽  
Pramod Kumar Julka ◽  
Chitra Sarkar ◽  
Dayanand Sharma ◽  
...  
Keyword(s):  
Univariate Analysis ◽  
Progression Free Survival ◽  
Extent Of Resection ◽  
Rank Test ◽  
Karnofsky Performance Score ◽  
Free Survival ◽  
Kaplan Meier ◽  
The Impact ◽  
Mib 1

e13034 Background: This study assesses the impact of 6 cycles of adjuvant TMZ (conventional arm) versus 12 cycles (Extended arm) on Progression free survival (PFS), evaluate the toxicity and correlate the outcome with EGFR, P53 and MIB I labelling Index. Methods: Between December 2010 to October 2012, 36 post operative patients of Glioblastoma between age 18-65 years and Karnofsky Performance Score (KPS) ≥ 70 were included. Patients were randomized to receive Radiation with a dose of 60 Gray in 30 fractions over 6 weeks at 2 gray/fraction with concomitant TMZ (75 mg/m2/day) and Adjuvant therapy with either 6 or 12 cycles of TMZ(150 mg/m2 for 5 days, 28 days cycle). Patients were then assessed monthly clinically and imaged with MRI/CT every 3 monthly or when symptomatic. Toxicity was assessed using CTCAE version 3.0. Statistical Analysis was done using SPSS version 17.0.Kaplan Meier method was used for analysis of survival and log rank test was used for assessing the impact of variables on survival. Results: Of 36 patients, 18 patients were treated in each arm. Median age and KPS in both the arms was 47 years and 80 respectively. 44 % patients in the conventional arm and 50% patients in the Extended arm underwent complete surgical resection. 22% patients in the conventional arm and 28% in the extended arm did not complete their intended treatment. Grade ¾ Thrombocytopenia was seen in 16% in the extended arm and 0% in the conventional arm.EGFR, P 53 and MIB 1 >20% was seen in 26%, 45% and 20% patients respectively, overall. Median follow up was 18 months for both the arms (Range 10-23 months).At last follow up,8 patients in each arm had progression. Median PFS was 10 months vs.18.4 months (p 0.47) in conventional and extended arm respectively. On Univariate analysis, patients with KPS ≤ 80 had poorer survival than those >80 (Median PFS 9.5 Months vs. 16.9 Months; p 0.02).Age, extent of resection, EGFR, P53, MIB 1 did not significantly alter survival in the two treatment groups. Conclusions: Our study showed that schedule of extended Temozolomide is well tolerated by patients and tend to have better progression free survival. Further prospective randomized studies are needed to validate the findings of our study.

Sorafenib in hepatocellular carcinoma (HCC): Is there a role for starting patients on a total daily dose of 400mg daily?

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 364-364
Author(s):  
Olugbenga Olanrele Olowokure ◽  
Brian Singeltary ◽  
Abhimanyu Ghose, ◽  
Michelle Lynn Mierzwa ◽  
Tahir Latif ◽  
...  
Keyword(s):  
Asia Pacific ◽  
Locoregional Therapy ◽  
Total Daily Dose ◽  
Rank Test ◽  
Loss To Follow Up ◽  
Kaplan Meier ◽  
Daily Dose ◽  
Ecog Ps ◽  
The Impact

364 Background: S at a starting daily dose of 400mg twice daily (800mg) is considered the standard systemic therapy for HCC, in pts with well preserved liver function and advanced stage HCC, based largely on data reported by the SHARP and Asia-pacific trials. Due to complaints regarding SE and reluctance to start at full dose, we decide to retrospectively look at our HCC data base. This single institution retrospective review, evaluated the impact of starting S at a 400mg daily (200mg twice daily). Methods: From 06/01/09-09/01/13, using ICD code 155, newly registered advanced HCC pts, ECOG PS 2, Childs Pugh (CP) class A or B who were started on S 400mg daily were identified : CT scans and AFP levels were followed. PFS was estimated from the date of commencing therapy to date of progression or death if this occurred first and OS was estimated from date of commencing therapy until date of death or loss to follow up. Kaplan Meier survival estimates were obtained with 95% (CI). Log rank test was used to compare the PFS according to CP class. Results: 33 pts (M:F, 21:12), mean age of 59.8y (SD: 12.40) met inclusion criteria, the median duration (MD) of follow up was 8.7 m ( 1.07-27.43). 23(69.7%) pts were CP-A. 70% had abnormal AFP and this decreased > 50% from baseline in 8 (35%). 96% of the pts received prior locoregional therapy in CP-A and 50% in CP-B. Initial dose tolerance was observed in 23 (69.7%) pts. 16 pts (48.5%) needed dose reduction (CP-A: 56.5%, CP-B: 30%) while 19 (57.6%) pts were able to escalate their dose at some point (CP-A: 60.9%, CP-B: 50%). MD of (400mg/d) was 3m prior to any adjustment (CP-A: 3, CP-B: 2). Mean duration of S use was 8.88m (A-10.04, B-6.2). During follow up, 26 pts had POD and 24 pts died. There was no difference in PFS between CP-A and B and following POD 10/19 evaluable pts continued S. OS was 79 % (95%CI: 61-89%) at 3m, 67% (95%CI: 48-80%) at 6m, 50% (95%CI: 32-66%) at 9m, and 40% (95%CI: 23-57%) at 12m. The most common reported toxicities were fatigue 87.5%, diarrhea 53.1% and HFS/rash 43.8% Conclusions: In this cohort of pts S started at 400mg/d did not seem to result in worse outcomes compared to historic controls possibly due to the ability to tolerate therapy for a longer period of time.

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