High Brachial Artery Bifurcation is Associated with Failure of Brachio-Cephalic Autologous Arteriovenous Fistulae

Objective Although European Best Practice Guidelines on vascular access recommend universal pre-operative duplex scan in patients receiving brachio-cephalic (BC) arteriovenous fistulae (AVF), this is not widespread practice. Furthermore, cadaveric and angiographic studies suggest that variation in upper limb arterial anatomy is common. Our aim was to investigate the prevalence of high brachial artery bifurcation (HB) and its impact on BC AVF patency. Methods A retrospective analysis of consecutive autologous BC AVF created over an 18-month period (January 2008 to June 2009). Patients with high bifurcations identified at duplex scan were compared with a control group who had normal bifurcations. All patients were followed up at 1, 6 and 12 weeks post-operatively. The study endpoint was AVF patency. Results One hundred and five autologous BC AVF procedures were performed in our institution, of which 29 (27.6%) were identified as having a high brachial bifurcation on pre-operative duplex scan. The bifurcation was axillary in six patients and located at the proximal, middle and distal third of the humerus in nine, seven and seven patients, respectively. The actuarial functional patency rate was 53.2% (standard error = 9.6%) in the HB group and 76.2% (standard error = 4.9%) in the control group (log-rank test, p=0.027). Conclusions These data show that aberrant brachial artery anatomy is both common (12%) and a predictor of autologous BC AVF failure. These data support the universal use of pre-AVF duplex scanning.

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Randomized trial of hyperthermic intraperitoneal chemotherapy (HIPEC) in women with primary advanced peritoneal, ovarian, and tubal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.5520 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 5520-5520 ◽

Cited By ~ 32

Author(s):

Myong Cheol Lim ◽

Suk-Joon Chang ◽

Heong Jong Yoo ◽

Byung-Ho Nam ◽

Robert Bristow ◽

...

Keyword(s):

Ovarian Cancer ◽

Cytoreductive Surgery ◽

Residual Tumor ◽

Study Endpoint ◽

Rank Test ◽

Control Group ◽

Term Survival ◽

Log Rank Test ◽

And Control ◽

The Impact

5520 Background: Cytoreductive surgery followed by taxane and platinum-based chemotherapy is standard treatment for advanced ovarian cancer. We compared results of randomly allocated HIPEC in primary advanced epithelial ovarian cancer who have optimal cytoreductive surgery in this prospective randomized multicenter trial. The study endpoint is to evaluate progression free survival (PFS) and overall survival (OS). Methods: 184 patients staged III and IV were randomly allocated to trial arm (HIPEC, cisplatin 75 mg/m2, 90 min) or control arm (no HIPEC), intraoperatively based on residual tumor (size <1cm) from July 2010 to January 2016. The groups were well balanced according to the age, body mass index, performance status, stage, histology, serum CA125 level, and use of neoadjuvant chemotherapy (NAC) at study entry. Results: 184 pts (HIPEC, 92; control, 92) were included in this preplanned analysis. No mortality after surgery ± HIPEC was identified in both groups. Postoperative outcomes including extent of surgery, estimated blood loss, residual tumor, and hospitalization day were not different between both group, except operation time (487 vs. 404 min, p<0.001) due to HIPEC procedure. The most common adverse event was anemia: 67.4% in HIPEC and 50% in control group (p=0.025). The other toxicity common in HIPEC group is the elevation of creatinine (15.2% vs. 4.3%, p=0.026). There were no differences between both groups for transfusion (35.9 vs. 29.3, p=0.432), neutropenia (19.6 vs. 10.9%, p=0.151), and thrombocytopenia (9.8 vs. 3.3%, p=0.136). Two-year PFS was 43.2% and 43.5% and 5-year PFS was 20.9% and 16.0% in HIPEC and control group, respectively (p=0.569). Five-year OS was 51.0% and 49.4% in HIPEC and control group, respectively (p=0.574). In women who received NAC, the median PFS for HIPEC and control group were 20 and 19 months, respectively (log-rank test, p = 0.137) and the median OS for HIPEC and control group were 54 and 51 months, respectively (log-rank test, p = 0.407). In the subgroup with NAC, 2-year PFS was 37.2% in HIPEC group and 29.5% in control group and 5-year OS was 47.9% in HIPEC group and 27.7% in control group. After 20 months in PFS and 30 months in OS, two survival curves in women who received NAC showed the trend of gradual distinction, favoring HIPEC group. Conclusions: No mortality was identified and postoperative morbidities were not statistically different between two groups except anemia and creatinine elevation in HIPEC group. The survival analysis did not show the statistical superiority of the HIPEC arm. More follow-up is required to confirm the impact of HIPEC on long-term survival outcome in ovarian cancer, especially in NAC group. Clinical trial information: NCT01091636.

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Palliative medicine consultation impacts DNR designation and length of stay for terminal medical MICU patients

Palliative & Supportive Care ◽

10.1017/s1478951511000423 ◽

2011 ◽

Vol 9 (4) ◽

pp. 401-406 ◽

Cited By ~ 20

Author(s):

Dana Lustbader ◽

Renee Pekmezaris ◽

Michael Frankenthaler ◽

Rajni Walia ◽

Frederick Smith ◽

...

Keyword(s):

Length Of Stay ◽

Palliative Medicine ◽

Intervention Group ◽

Hospital Length Of Stay ◽

Rank Test ◽

Control Group ◽

Do Not Resuscitate ◽

Log Rank Test ◽

The Impact ◽

Reduced Time

AbstractObjective:The purpose of this study was to assess the impact of a palliative medicine consultation on medical intensive care unit (MICU) and hospital length of stay, Do Not Resuscitate (DNR) designation, and location of death for MICU patients who died during hospitalization.Method:A comparison of two retrospective cohorts in a 17-bed MICU in a tertiary care university-affiliated hospital was conducted. Patients admitted to the MICU between January 1, 2003 and June 30, 2004 (N = 515) were compared to MICU patients who had had a palliative medicine consultation between January 1, 2005 and June 1, 2009 (N = 693). To control for disease severity, only patients in both cohorts who died during their hospitalization were considered for this study.Results:Palliative medicine consultation reduced time until death during the entire hospitalization (log-rank test,p < 0.01). Time from MICU admission until death was also reduced (log-rank test,p < 0.01), further demonstrating the impact of the palliative care consultation on the duration of dying for hospitalized patients. The intervention group contained a significantly higher percentage of patients with a DNR designation at death than did the control group (86% vs. 68%, χ2test,p < 0.0001).Significance of results:Palliative medicine consultation is associated with an increased rate of DNR designation and reduced time until death. Patients in the intervention group were also more likely to die outside the MICU as compared to controls in the usual care group.

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Vitreous levels of interleukin-35 as a prognostic factor in B-cell vitreoretinal lymphoma

Scientific Reports ◽

10.1038/s41598-020-72962-z ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Atsunobu Takeda ◽

Eiichi Hasegawa ◽

Shintaro Nakao ◽

Keijiro Ishikawa ◽

Yusuke Murakami ◽

...

Keyword(s):

B Cell ◽

Poor Prognosis ◽

Tumor Development ◽

Rank Test ◽

Control Group ◽

Log Rank Test ◽

Vitreoretinal Lymphoma ◽

Infectious Uveitis ◽

Cancer Types ◽

Promote Tumor Development

Abstract Vitreoretinal lymphoma (VRL) is a rare disease of B-cell origin with poor prognosis. Regulatory cytokines promote tumor development by suppressing antitumor immunity in several cancer types, including B-cell malignancies. To identify the regulatory cytokines associated with poor prognosis in patients with B-cell VRL, we determined the regulatory cytokines profiles in the vitreous humor of patients with VRL. This retrospective study included 22 patients with VRL, 24 with non-infectious uveitis (NIU), and 20 with idiopathic epiretinal membrane (control). Vitreous concentrations of regulatory cytokines were assessed using a cytometric beads assay and association with clinical data was examined. IL-35 and soluble IL-2 receptor α levels were significantly higher in patients with VRL and NIU than those in the control group. The 5-year overall survival (OS) rates for the group with high intravitreal IL-35 was significantly poorer than those for the group with low intravitreal IL-35, who were diagnosed with VRL at the onset (P = 0.024, log-rank test). The 5-year OS rates with intravitreal IL-35 levels above and below the median were 40.0% and 83.3%, respectively. Our results suggest that high intravitreal IL-35 levels indicate poor prognosis for patients diagnosed with B-cell VRL at the onset.

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Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly with Imatinib Mesylate (STI571) and Chemotherapy. an Interim Analysis of the GRAALL AFR09 Trial.

Blood ◽

10.1182/blood.v104.11.2742.2742 ◽

2004 ◽

Vol 104 (11) ◽

pp. 2742-2742 ◽

Cited By ~ 1

Author(s):

Andre Delannoy ◽

Véronique Lhéritier ◽

Xavier Thomas ◽

Sylvie Castaigne ◽

Hassan Farhat ◽

...

Keyword(s):

Elderly Patients ◽

Induction Chemotherapy ◽

Interim Analysis ◽

Complete Response ◽

Rank Test ◽

Induction Treatment ◽

Control Group ◽

Free Survival ◽

Log Rank Test ◽

One Year

Abstract Ph+ ALL accounts for approximately one third of ALL cases in patients aged 55 years or older. The median survival of older Ph+ ALL patients is one year, with practically no long-term survivor (Blood, 98, Supp1 p319a, 2001). Imatinib has demonstrated remarkable, although transient, activity in relapsed and refractory Ph+ ALL, which prompted the GRAALL to implement a treatment protocol associating imatinib and chemotherapy in previously untreated elderly patients: ALL patients aged 55 years or older are treated with steroids during one week and Ph+ve cases are then offered a specific therapy including an induction treatment with steroids, cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during 2 months. Patients in complete response are then given 10 blocks of alternating chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment duration of 2 years. Therapy of occult central nervous system leukemia includes 5 intrathecal injections of methotrexate and cranial irradiation. The study is intended to include 30 patients and its main objective is to improve overall one-year survival to 70%. Results are compared with those obtained in 21 Ph+ ALL elderly patients treated according to our previous protocol. Since January 2003, 21 patients aged 58 to 78 years (median: 64.7 years) were included in the AFR09 protocol. Their median follow-up is 3 months. 15/19 patients are in complete response after induction chemotherapy vs 6/21 in the historical controls given similar induction regimen but with no steroids before chemotherapy (p=0.002). The projected overall survival is 95% at 9 months vs 62% in the control group (p=0.08, log-rank test). The 9-month projected event-free survival is 83% vs 10% (p<0.0001) and the projected 6-month relapse-free survival is 79% vs 22% (p=0.006, log-rank test). In conclusion, although preliminary, this interim analysis suggests that the use of imatinib in elderly patients with Ph+-ALL is very likely to dramatically improve prognosis. Of note, an unexpected high proportion of patients accrued in this study achieved a CR after induction chemotherapy possibly denoting a beneficial impact of steroids given before starting chemotherapy.

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Evaluation of the antitumour activity of local intraperitoneal hyperthermia in a model of advanced high-grade ovarian carcinoma in rats

Siberian Journal of Oncology ◽

10.21294/1814-4861-2021-20-6-78-87 ◽

2022 ◽

Vol 20 (6) ◽

pp. 78-87

Author(s):

Ya. G. Murazov ◽

A. L. Semenov ◽

K. Yu. Senchik ◽

A. O. Nyuganen ◽

A. S. Artemyeva ◽

...

Keyword(s):

Sodium Chloride ◽

Ovarian Carcinoma ◽

Chloride Solution ◽

Room Temperature ◽

Sodium Chloride Solution ◽

Peritoneal Cancer Index ◽

Rank Test ◽

Control Group ◽

Cytostatic Drug ◽

Log Rank Test

In our study we carried out an exploratory assessment of the antitumor activity of hyperthermic intraperitoneal perfusion (Hipep) with 0.9 % sodium chloride solution and compared it with the effect of a single normothermic intraperitoneal (i.p.) Administration of cisplatin in the maximum tolerated dose (mtd). Thirty-six mature female Wistar rats with transplanted i.p. Syngeneic ovarian carcinoma were randomized into three groups: control group (2 ml of 0.9 % sodium chloride i.p. At room temperature, n=12); cisplatin group (cisplatin 4 mg/kg i.p. At room temperature, n=12); Hipep group (open i.p. Perfusion with 0.9 % sodium chloride solution at a temperature of 40,5–41,5 °c for 45 minutes, n=12). The primary endpoint was the overall survival (os) of the animals in each of the three groups. The total peritoneal cancer index (pci), weight and degree of ascites haemorrhagia were assessed at autopsy. The median os in the control group, Hipep, and cisplatin was 19, 39, and 40 days, respectively (log-rank test р<0.0001). In comparison to the control group, the differences were statistically significant for both cisplatin (HR=0.22; 95 % ci: 0.08–0.62; log-rank test р<0.0001) and Hipep (HR=0.32; 95 % ci 0.13–0.82; log-rank test р=0.0013). There were no differences in os between the cisplatin and Hipep groups (log-rank test р=0.4853). The Hipep procedure was associated with a significant decrease in total pci, a tendency towards a decrease in the ascites weight and a higher severity of haemorrhagia. In terms of os, local hyperthermia, provided by Hipep without a cytostatic drug, was comparable with single normothermic i.p. Administration of cisplatin in mtd and exceeded the effects of the latter in relation to the development of peritoneal carcinomatosis.

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Wenxin Keli versus Sotalol for Paroxysmal Atrial Fibrillation Caused by Hyperthyroidism: A Prospective, Open Label, and Randomized Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/101904 ◽

2015 ◽

Vol 2015 ◽

pp. 1-9 ◽

Cited By ~ 7

Author(s):

Zhaowei Meng ◽

Jian Tan ◽

Qing He ◽

Mei Zhu ◽

Xue Li ◽

...

Keyword(s):

Atrial Fibrillation ◽

Paroxysmal Atrial Fibrillation ◽

Randomized Study ◽

Rank Test ◽

Antithyroid Drugs ◽

Control Group ◽

Open Label ◽

Log Rank Test ◽

And Control

We aimed to compare effectiveness of Wenxin Keli (WK) and sotalol in assisting sinus rhythm (SR) restoration from paroxysmal atrial fibrillation (PAF) caused by hyperthyroidism, as well as in maintaining SR. We randomly prescribed WK (18 g tid) or sotalol (80 mg bid) to 91 or 89 patients. Since it was not ethical not to give patients antiarrhythmia drugs, no control group was set. Antithyroid drugs were given to 90 patients (45 in WK group, 45 in sotalol group);131I was given to 90 patients (46 in WK group, 44 in sotalol group). Three months later, SR was obtained in 83/91 or 80/89 cases from WK or sotalol groups(P=0.762). By another analysis, SR was obtained in 86/90 or 77/90 cases from131I or ATD groups(P=0.022). Then, we randomly assigned the successfully SR-reverted patients into three groups: WK, sotalol, and control (no antiarrhythmia drug was given) groups. After twelve-month follow-up, PAF recurrence happened in 1/54, 2/54, and 9/55 cases, respectively. Log-Rank test showed significant higher PAF recurrent rate in control patients than either treatment(P=0.06). We demonstrated the same efficacies of WK and sotalol to assist SR reversion from hyperthyroidism-caused PAF. We also showed that either drug could maintain SR in such patients.

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A modified weighted log-rank test for confirmatory trials with a high proportion of treatment switching

PLoS ONE ◽

10.1371/journal.pone.0259178 ◽

2021 ◽

Vol 16 (11) ◽

pp. e0259178

Author(s):

José L. Jiménez ◽

Julia Niewczas ◽

Alexander Bore ◽

Carl-Fredrik Burman

Keyword(s):

Statistical Power ◽

Experimental Treatment ◽

Hazard Ratio ◽

Rank Test ◽

Control Group ◽

Potential Hazard ◽

Intention To Treat ◽

Treatment Switching ◽

Log Rank Test ◽

The Impact

In confirmatory cancer clinical trials, overall survival (OS) is normally a primary endpoint in the intention-to-treat (ITT) analysis under regulatory standards. After the tumor progresses, it is common that patients allocated to the control group switch to the experimental treatment, or another drug in the same class. Such treatment switching may dilute the relative efficacy of the new drug compared to the control group, leading to lower statistical power. It would be possible to decrease the estimation bias by shortening the follow-up period but this may lead to a loss of information and power. Instead we propose a modified weighted log-rank test (mWLR) that aims at balancing these factors by down-weighting events occurring when many patients have switched treatment. As the weighting should be pre-specified and the impact of treatment switching is unknown, we predict the hazard ratio function and use it to compute the weights of the mWLR. The method may incorporate information from previous trials regarding the potential hazard ratio function over time. We are motivated by the RECORD-1 trial of everolimus against placebo in patients with metastatic renal-cell carcinoma where almost 80% of the patients in the placebo group received everolimus after disease progression. Extensive simulations show that the new test gives considerably higher efficiency than the standard log-rank test in realistic scenarios.

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Diabetes and female gender are found to increase the hazard of deterioration? Results from the MEETinCY trial

European Heart Journal ◽

10.1093/ehjci/ehaa946.3409 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

E Lambrinou ◽

A Protopapas ◽

N Christoforou ◽

N Vouri ◽

A Malaktou ◽

...

Keyword(s):

Clinical Characteristics ◽

Cox Regression ◽

Hospital Readmissions ◽

The Other ◽

Rank Test ◽

Control Group ◽

Funding Source ◽

Log Rank Test ◽

Significant Difference

Abstract Background Despite advances in the treatment of heart failure (HF), HF deteriorations are characterized by high hospital readmissions and linked with increased morbidity and mortality. Aim The aim of this study was to determine the effectiveness of a nurse-led management program on the reduction of the number of visits to ER, unplanned readmissions and mortality of patients with HF due to acute events of decompensation at 12 and 24-weeks post discharge. Secondary aim was to identify possible association between demographic or clinical characteristics and the hazard for acute events. Methods This study was designed as a multicenter single-blinded randomized clinical trial (RCT), The MEETinCY, with three different intervention groups (IGs) and one control group (CG) that received the usual care which did not include a structured educational programme. The first IG received only education (EE) before discharge, the second IG received only telephone follow-up (TT) for three months after discharge, the third IG included combination of education before discharge and telephone follow-up (ET) for three months after discharge. The efficacy of interventions on mortality and rehospitalization rates were estimated using a Kaplan Meier analysis and were compared with log rank test. The association of demographic and clinical characteristics to the hazard for acute events was explored using a multivariate Cox regression. Results Two hundred and forty-two (242) patients completed the study [CG n=68, EE n=57, ET n=59, TT n=58]. During the 90 and 180 days study periods, the intervention groups, although appearing to have a “better survival experience” than the CG, no statistically significant difference was found for the periods 90 (log-rank test, x2 = 3.7 p=0.28) and 180 (log rang x2=2.87, p=0.41) days. Regarding the incidence risk of acute events (Readmission, ER visit, HF death) at 3 months seems to be higher in the CG (N=28–41.2%) than the other groups [EE n:16 28.1%, ET n:20 33.9%, TT n:16 27.6%], but not statistically significant (p=0.32). Results at 6 months showed the frequency of acute events in the CG (N=34, 50%), to be lower compared to the other groups [EE N:23 40.4%, ET n:24 39%, TT n:25, 43.1%], but not statistically significant (p=0.59). The hazard of deterioration was found to be significantly higher in patients with diabetes and in females, where the acute event hazard increased by 72% [HR: 1.72 (95% CI: 1.047–2.844), p=0.033)], and 88% [HR: 1.88 (95% CI: 1.172–3.013), p=0.009)] respectively. In addition, NYHA status was found to be associated with increased hazard of acute events; NYHA IV patients had 2.6 times higher risk [HR: 2,637, (95% CI: 1,007 - 6,902)] than NYHA I patients. Conclusions This highlights the need for further investigation of educational and supportive programs to reduce the risk of incidence of acute events in HF. It is also important to identify possible associated factors that may be reversible or preventable. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Cyprus University of Technology State Funding

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Type I error inflation of log-rank test with small sample size : A permutation approach and simulation studies

10.47302/jsr.2019530201 ◽

2020 ◽

Vol 53 (2) ◽

pp. 93-109

Author(s):

ZHENG WANG ◽

ALICIA ZHANG ◽

YUQI CHEN ◽

QUI TRAN ◽

CHRIS HOLLAND

Keyword(s):

Sample Size ◽

Type I Error ◽

Influential Factors ◽

Small Sample ◽

Standard Normal Distribution ◽

Rank Test ◽

Control Group ◽

Type I ◽

Sequential Designs ◽

Log Rank Test

The log-rank test is a well-accepted non parametric test in comparing the survival time be- tween experimental and control group in regulatory settings. However, we have observed type I error inﬂation as high as 28% using the test in the simulation settings we have with even moderate sample sizes. In this paper, we explore several factors that potentially con- tribute to the inﬂation by simulation. Sample size, randomization ratio and signiﬁcance levels are found to be inﬂuential factors. We propose an alternative log-rank test using an approximate permutation distribution instead of the standard normal distribution. It is shown that type I error is controlled when applying the approximate permutation test to both simple clinical trial designs and complicated group sequential designs.

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Neoadjuvant chemotherapy followed by interval debulking surgery for unresectable stage IVB Serous endometrial cancer

Tumori Journal ◽

10.1177/0300891618784785 ◽

2018 ◽

Vol 105 (1) ◽

pp. 92-97 ◽

Cited By ~ 4

Author(s):

Giorgio Bogani ◽

Antonino Ditto ◽

Umberto Leone Roberti Maggiore ◽

Cono Scaffa ◽

Lavinia Mosca ◽

...

Keyword(s):

Endometrial Cancer ◽

Neoadjuvant Chemotherapy ◽

Rank Test ◽

Control Group ◽

Transfusion Rate ◽

Debulking Surgery ◽

Log Rank Test ◽

Unresectable Stage ◽

Interval Debulking Surgery ◽

Stage Ivb

Objective: To test the safety and effectiveness of neoadjuvant chemotherapy followed by interval debulking surgery in unresectable stage IVB serous endometrial cancer. Methods: Data of consecutive stage IVB serous endometrial cancer are reviewed. Patients undergoing neoadjuvant chemotherapy plus interval debulking surgery were propensity matched with patients undergoing primary surgery followed by adjuvant treatment. Results: Thirty-four patients were diagnosed with a stage IVB endometrial cancer. Fifteen (44.1%) patients had neoadjuvant chemotherapy followed by interval debulking surgery; while 19 (55.8%) patients had primary cytoreduction. Among this latter group, 15 (78.9%) patients were selected, using a propensity-matched algorithm. Results of propensity-matching baseline characteristics of patients included were similar between groups. Patients having neoadjuvant chemotherapy plus interval debulking surgery had shorter length of hospital stay (4 [1.40] vs 6 [2.5] days; p=0.011) compared with patients in the control group. Moreover, patients in the neoadjuvant chemotherapy group experienced a trend toward shorter operative time (127 [62] vs 177.6 [84.5] minutes; p=0.072) and lower transfusion rate than patients in the control group (6.6% vs 33.3%; p=0.067). Cytoreduction rate was similar between groups (p=0.962). No difference in postoperative morbidity was recorded. Median disease-free survival was 12.0 vs 15.3 months in the experimental vs control group (p=0.663; log-rank test). Median overall survival was 16.7 vs 18.0 months in the experimental vs control group (p=0.349; log-rank test). Conclusions: Neoadjuvant chemotherapy might be a valuable treatment modality for patients with unresectable stage IVB serous endometrial cancer. Innovative treatments are warranted in this cluster of patients.

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