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

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5520-5520 ◽  
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.

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

2011 ◽  
Vol 9 (4) ◽  
pp. 401-406 ◽  
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.

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

2010 ◽  
Vol 11 (2) ◽  
pp. 132-137 ◽  
Author(s):  
Christos Lioupis ◽  
Hiren Mistry ◽  
Cornelia Junghans ◽  
Niamh Haughey ◽  
Ben Freedman ◽  
...  
Keyword(s):  
Brachial Artery ◽  
Standard Error ◽  
Best Practice ◽  
Study Endpoint ◽  
Rank Test ◽  
Control Group ◽  
Duplex Scan ◽  
Arteriovenous Fistulae ◽  
Best Practice Guidelines ◽  
Log Rank Test

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.

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

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
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.

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

PLoS ONE ◽  
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.

scholarly journals Developing a Prognostic Gene Panel of Epithelial Ovarian Cancer Patients by a Machine Learning Model

Cancers ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. 270 ◽  
Author(s):  
Tzu-Pin Lu ◽  
Kuan-Ting Kuo ◽  
Ching-Hsuan Chen ◽  
Ming-Cheng Chang ◽  
Hsiu-Ping Lin ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Predictive Model ◽  
Cancer Patients ◽  
Tumor Size ◽  
Residual Tumor ◽  
Rank Test ◽  
Log Rank Test ◽  
Response Group ◽  
Significant Factors

Epithelial ovarian cancer patients usually relapse after primary management. We utilized the support vector machine algorithm to develop a model for the chemo-response using the Cancer Cell Line Encyclopedia (CCLE) and validated the model in The Cancer Genome Atlas (TCGA) and the GSE9891 dataset. Finally, we evaluated the feasibility of the model using ovarian cancer patients from our institute. The 10-gene predictive model demonstrated that the high response group had a longer recurrence-free survival (RFS) (log-rank test, p = 0.015 for TCGA, p = 0.013 for GSE9891 and p = 0.039 for NTUH) and overall survival (OS) (log-rank test, p = 0.002 for TCGA and p = 0.016 for NTUH). In a multivariate Cox hazard regression model, the predictive model (HR: 0.644, 95% CI: 0.436–0.952, p = 0.027) and residual tumor size < 1 cm (HR: 0.312, 95% CI: 0.170–0.573, p < 0.001) were significant factors for recurrence. The predictive model (HR: 0.511, 95% CI: 0.334–0.783, p = 0.002) and residual tumor size < 1 cm (HR: 0.252, 95% CI: 0.128–0.496, p < 0.001) were still significant factors for death. In conclusion, the patients of high response group stratified by the model had good response and favourable prognosis, whereas for the patients of medium to low response groups, introduction of other drugs or clinical trials might be beneficial.

Impact of intensified therapy on clinical outcome in infants and children with neuroblastoma: the St Jude Children's Research Hospital experience, 1962 to 1988.

1991 ◽  
Vol 9 (9) ◽  
pp. 1599-1608 ◽  
Author(s):  
L C Bowman ◽  
M L Hancock ◽  
V M Santana ◽  
F A Hayes ◽  
L Kun ◽  
...  
Keyword(s):  
Metastatic Disease ◽  
Disease Stage ◽  
Rank Test ◽  
Antineoplastic Drugs ◽  
Limited Disease ◽  
Term Survival ◽  
The Past ◽  
Log Rank Test ◽  
The Impact

To gauge the impact of intensified therapy on the survival of infants (younger than 1 year, n = 129) and children (greater than or equal to 1 year of age, n = 275) with neuroblastoma, we analyzed the results of eight successive clinical trials comparing various combinations of antineoplastic drugs, surgery, and radiotherapy. Changes in treatment did not affect the survival of children with involved noncontiguous lymph nodes or distant metastatic disease until the combination of cisplatin and teniposide (CDDP/VM26) was added to a basic regimen of cyclophosphamide and doxorubicin (CTX/DOX). The resulting 4-year survival was 28% +/- 5% (SE) compared with 7% +/- 2% for previous treatments (P less than .001 by the log-rank test). The 4-year survival of infants with metastatic disease was improved by administering CTX/DOX to all patients, reserving CDDP/VM26 for those whose disease was resistant to the former combination: 82% +/- 6% versus 45% +/- 8% in earlier studies; P less than .001. In the subset of infants whose tumors had disseminated to bone or bone marrow at diagnosis, this therapeutic approach increased the probability of long-term survival from 48% +/- 10% to 85% +/- 9% (P = .01). The small group of children over 1 year of age with localized unresectable tumors also fared significantly better with the switch to CTX/DOX chemotherapy (4-year survival, 93% +/- 7% v 42% +/- 13%; P = .02). Multivariate analysis indicated that young age, limited-disease stage, nonadrenal primary site, and intensified treatment were independent predictors of a more favorable outcome. We conclude that substantial advances in the treatment of neuroblastoma have occurred over the past 25 years at this institution. The current overall 4-year survival probability of 57% +/- 4% compares favorably with estimates for most other common solid tumors of childhood.

scholarly journals Selective approach in thromboprophilaxis in patients with pancrearic cancer on chemotherapy

2017 ◽  
Author(s):  
S. V. Zemskov
Keyword(s):  
Massive Bleeding ◽  
Main Group ◽  
Rank Test ◽  
Control Group ◽  
Free Survival ◽  
Log Rank Test ◽  
Selective Approach ◽  
The Difference ◽  
And Control

Pancreatic cancer (PC) is associated with high risk of thromboembolism (TE). However, the question of out-patient thromboprophylaxis and its feasibility in patients with PC is still disputable. The purpose of the study was to evaluate the efficacy of enoxaparin application as as thromboprophylaxis based on Khorana index in patients with unresectable PC on chemotherapy. Out-patients with PC on chemotherapy were retrospectively consecutively included in the study. Main and control group included 43 patients each. Patients of the main group were treated with 40mg of enoxaparin daily if Khorana index was >3 for at least 7 days or until Khorana index went <3. No thromboprophylaxis was applied in control group. Follow up time was 24 weeks and coincided with chemotherapy period. The rate TE in control group was 37.2 % (16 of 43) and 14 % (6 of 43) in the main group. The difference in event-free survival when calculated by log-rank test was statistically considerable (p=0.02). No massive bleeding was detected in the main group. Thromboprophylaxis with enoxaparin based on Khorana index in PC patients on chemotherapy may decrease the rate of TE.

scholarly journals The Impact of Islamic Counseling Intervention towards Students’ Mindfulness and Anxiety during the COVID-19 Pandemic

2021 ◽  
Vol 4 (1) ◽  
pp. 55-66
Author(s):  
Asroful Kadafi ◽  
Alfaiz Alfaiz ◽  
M. Ramli ◽  
Dahlia Novarianing Asri ◽  
Juwita Finayanti
Keyword(s):  
Psychological Intervention ◽  
Virus Disease ◽  
Self Report ◽  
Rank Test ◽  
Control Group ◽  
Control Group Design ◽  
Counseling Intervention ◽  
Quasi Experimental ◽  
And Control ◽  
The Impact

The pandemic caused by the Corona Virus Disease (COVID-19) has had psychological and health impacts on people's lives around the world.  On a psychological aspect, this pandemic has caused anxiety due to low mindfulness.  To increase the potential of mindfulness, one of the ways taken is by counselor psychological intervention.  The authors used an Islamic counseling approach to reduce anxiety and increase mindfulness. Therefore, the research was conducted using a quasi-experimental design with non-equivalent control group design.  Participants in this study were 14 students consisting of 7 students for each experimental and control group. Participants were invited after filling self-report the anxiety scale facing COVID-19 and indicated that they were in the high category. The data analyzed with the Wilcoxon sign rank test to determine the impact of before and after the intervention was given, then used the Mann Whitney to find out the mean differences between the experimental and control group, and the Rank Spearman to determine the correlation between mindfulness and anxiety.  The results showed that Islamic counseling intervention is effective to increase mindfulness which impacted on reducing anxiety in facing the COVID-19 pandemic. Besides, the results of correlation analysis using the Rank Spearman show that there is a correlation between mindfulness and anxiety.

scholarly journals The Anti-PD-1/PD-L1 Immunotherapy for Gastric Esophageal Cancer: A Systematic Review and Meta-Analysis and Literature Review

2021 ◽  
Vol 28 ◽  
pp. 107327482199743
Author(s):  
Ke Chen ◽  
Xiao Wang ◽  
Liu Yang ◽  
Zheling Chen
Keyword(s):  
Overall Survival ◽  
Esophageal Cancer ◽  
Survival Rate ◽  
Meta Analysis ◽  
Response Rates ◽  
Control Group ◽  
Term Survival ◽  
Long Term Survival ◽  
And Control

Background: Treatment options for advanced gastric esophageal cancer are quite limited. Chemotherapy is unavoidable at certain stages, and research on targeted therapies has mostly failed. The advent of immunotherapy has brought hope for the treatment of advanced gastric esophageal cancer. The aim of the study was to analyze the safety of anti-PD-1/PD-L1 immunotherapy and the long-term survival of patients who were diagnosed as gastric esophageal cancer and received anti-PD-1/PD-L1 immunotherapy. Method: Studies on anti-PD-1/PD-L1 immunotherapy of advanced gastric esophageal cancer published before February 1, 2020 were searched online. The survival (e.g. 6-month overall survival, 12-month overall survival (OS), progression-free survival (PFS), objective response rates (ORR)) and adverse effects of immunotherapy were compared to that of control therapy (physician’s choice of therapy). Results: After screening 185 studies, 4 comparative cohort studies which reported the long-term survival of patients receiving immunotherapy were included. Compared to control group, the 12-month survival (OR = 1.67, 95% CI: 1.31 to 2.12, P < 0.0001) and 18-month survival (OR = 1.98, 95% CI: 1.39 to 2.81, P = 0.0001) were significantly longer in immunotherapy group. The 3-month survival rate (OR = 1.05, 95% CI: 0.36 to 3.06, P = 0.92) and 18-month survival rate (OR = 1.44, 95% CI: 0.98 to 2.12, P = 0.07) were not significantly different between immunotherapy group and control group. The ORR were not significantly different between immunotherapy group and control group (OR = 1.54, 95% CI: 0.65 to 3.66, P = 0.01). Meta-analysis pointed out that in the PD-L1 CPS ≥10 sub group population, the immunotherapy could obviously benefit the patients in tumor response rates (OR = 3.80, 95% CI: 1.89 to 7.61, P = 0.0002). Conclusion: For the treatment of advanced gastric esophageal cancer, the therapeutic efficacy of anti-PD-1/PD-L1 immunotherapy was superior to that of chemotherapy or palliative care.

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