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Nevin Manimala Statistics

Effects of alirocumab on cardiovascular events and all-cause mortality: a systematic review and meta-analysis

Rev Cardiovasc Med. 2021 Sep 24;22(3):873-881. doi: 10.31083/j.rcm2203093.

ABSTRACT

Evaluation of the effects of alirocumab on cardiovascular (CV) events, CV mortality and all-cause mortality. Data search was carried out using the Cochrane Library, PubMed, Web of Science and Embase. The search time is up to November 18, 2020. All randomized clinical trials (AEs) comparing alirocumab with placebo were searched. Meta-analysis was performed by Review Manager version 5.3 (The Cochrane Collaboration, Copenhagen, Denmark), and the heterogeneity between studies was tested by Cochrane’s Q test and measured with I2 statistics. A total of 13 randomized controlled trials with 24,815 participants were included. Alirocumab usage can considerably lower the incidence of CV events when compared to the control group (risk ratio(RR) 0.89, 95% confidence interval(CI) 0.83-0.95). No significant difference in CV mortality between the two groups was observed (RR 0.87, 95% CI 0.74-1.04). Treatment with alirocumab has been associated with a major decrease in all-cause mortality compared to placebo (RR 0.80, 95% CI 0.66-0.96). The incidence of serious adverse events (AEs) was similar in the two groups (RR 0.94, 95% CI 0.90-0.99). Alirocumab can reduce CV events and all-cause mortality. The AEs were mild and tolerable.

PMID:34565085 | DOI:10.31083/j.rcm2203093

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Nevin Manimala Statistics

Pancreatic cancer patients who cannot undergo curative surgery live as much as patients over 70 years old

J BUON. 2021 Jul-Aug;26(4):1607-1611.

ABSTRACT

PURPOSE: Patients over the age of 65 constitute approximately 54% of newly diagnosed cancers and approximately 70% of cancer-related deaths. These patients aged ≥65 years, who form the majority of clinical practice, are represented less in clinical studies than in real life. We designed this retrospective study to examine the treatment and response of patients to pancreatic cancer in patients over 70 years of age.

METHODS: Our study is a retrospective study that included patients from 5 centers in Turkey. Inclusion criteria were being over the age of 18 years, diagnosed with pancreatic cancer, and with ECOG performance score between 0-2. These patients were divided into two groups according to their age. The classification was made as patients over 70 years of age in the first group (geriatric group) and patients under 70 years of age (<70 age group) in the second group.

RESULTS: Overall survival of the <70 age group was statistically significantly longer (median 10 months vs 9.1 months p=0.027). When the patients who underwent only curative surgery were examined, the survival was statistically significant in favor of the <70 age group (median 20.96 months vs 14.5 months p=0.011). No statistically significant difference was found between the two groups in terms of the overall survival of patients with metastatic diagnosis (median 8.1 months vs 8.4 months p=0.182).

CONCLUSION: The survival of patients with pancreatic cancer aged 70 and over was shorter than other age groups. While this difference was significant in patients who could undergo surgery at an early stage, it was not found in the metastatic patient group. Prospective larger-scale studies are needed to evaluate the treatment of geriatric patients better.

PMID:34565025

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Real-life data on first-line Sunitinib and Pazopanib therapy in metastatic renal cell carcinoma patients: a single center experience

J BUON. 2021 Jul-Aug;26(4):1628-1634.

ABSTRACT

PURPOSE: In this study, we aimed to compare the data of sunitinib and pazopanib used in the first-line treatment of metastatic renal cell carcinoma (RCC) cases and to evaluate the effective factors in terms of survival.

METHODS: The records of 125 patients with metastatic RCC admitted between January 2005 and February 2018 were retrospectively analyzed and 63 patients who received pazopanib or sunitinib were included in the study while 62 patients were excluded due to insufficient data. Clinical and histological characteristics, treatment responses, progression-free survival (PFS), and overall survival (OS) of the patients were compared.

RESULTS: Patients with metastatic RCC who received pazopanib or sunitinib as tyrosine kinase inhibitors (TKI) in first-line treatment were analyzed; 45 (71.4%) were male while 18 (28.6%) were female, and the median age was 60. 43 (68.3%) patients were treated with sunitinib and 20 (31.7%) with pazopanib. PFS ​​of pazopanib and sunitinib were 10.6 and 7.2 months, respectively. Median OS was 14.5 months in patients receiving pazopanib and 13.6 months in those receiving sunitinib. There was no statistical difference in PFS and OS between both treatments. The median OS of clear-cell RCC was 15.2 months, while of non-clear-cell RCC was 7.7months.

CONCLUSIONS: High ECOG score, non-clear-cell histology, presence of liver metastasis in metastatic RCC patients were found to be associated with shorter OS and PFS. Sunitinib and pazopanib produced similar OS and PFS rates in first-line treatment of metastatic RCC.

PMID:34565028

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Chemoradiotherapy followed by surgery versus observation in esophageal squamous cell carcinoma

J BUON. 2021 Jul-Aug;26(4):1509-1516.

ABSTRACT

PURPOSE: We aimed to examine the effect of esophagectomy after chemoradiotherapy (CRT) or non-surgical follow-up after CRT in patients with locally advanced esophageal squamous cell carcinoma (ESCC).

METHODS: A total of 653 patients under follow-up for locally advanced ESCC between 2010-2019 were reviewed for enrollment. Patients with no distant metastasis at the time of diagnosis who underwent esophagectomy or were taken under observation following CRT were included in the study. Overall, 127 eligible patients were included, 55 of whom were male (43.3%) and 72 female (56.7%).

RESULTS: After CRT, 59 patients (53.5%) had undergone surgery and 68 (46.5%) were taken under observation. Median disease-free survival (mDFS) was not reached in the group that underwent surgery and was 13 months in the observation group (p<0.001). Median overall survival (mOS) was significantly longer in the operated group (p=0.006). There was no statistically significant difference in DFS and OS between patients who underwent surgery and those included in the observation group after achieving clinical and pathological complete response following CRT (p=0.119, p=0.699, respectively). The multivariate analysis identified surgery and increased CRT response as the factors that affect DFS (p=0.042, p<0.001, respectively).

CONCLUSION: In this study, surgery provided no additional benefit on survival in locally advanced ESCC patients with complete response while prolonged survival was observed in those without complete response. Key words: esophageal cancer, chemoradiotherapy, squamous cell carcinoma, observation .

PMID:34565012

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Results of upfront surgery in a mixed stage population of patients with esophageal carcinoma: early outcome and long term survival

J BUON. 2021 Jul-Aug;26(4):1523-1530.

ABSTRACT

PURPOSE: To evaluate early outcome and long term survival in a mixed stage population of patients undergoing upfront esophagectomy for esophageal cancer.

METHODS: Retrospective analysis of the data of 92 patients who underwent esophagectomy (thoracoabdominal: 76, Ivor-lewis: 16) between 1998 and 2017. Tumors were located in gastro-esophageal junction (52), lower third (31) and middle third (9) of the esophagus. Histology was: 73 adenocarcinomas and 19 squamous cell carcinomas. The stomach was used for reconstruction in 90 patients. A neck anastomosis was performed in 7 patients. End points of the study included: mortality, morbidity and long term survival. Kaplan-Meier and Cox regression analyses were used to identify prognostic factors for survival.

RESULTS: The mortality was 10.9% and 29 patients presented 49 complications. Anastomotic dehiscence occurred in 17.4% of the patients and represented the most common cause of death with mortality of 37.5%. Reoperation was necessary in 14 patients. Median survival reached 25 months with 3 and 5 year survival of 30.5% and 21% respectively. Early stage tumors, absence of nodal disease, well differentiated carcinomas and lymph node ratio ≤ 0.2 were associated with 5 year survival of 82.6%, 81.6%, 83.3% and 40.4% respectively. In multivariate analysis early stage disease (OR: 15.746, 95%CI: 4.332-58.579, p < 0.001) and lymph node ratio (OR: 1.700 95%CI: 1.051-2.752, p = 0.031) were statistically associated with long term survival.

CONCLUSIONS: Our results support the role of upfront surgery as the treatment of choice in early stage esophageal carcinomas without or with low nodal involvement.

PMID:34565014

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Effects of MSCT enhanced scan image diagnosis on clinical outcome of patients after radical gastrectomy and its influence on misdiagnosis rate

J BUON. 2021 Jul-Aug;26(4):1479-1484.

ABSTRACT

PURPOSE: To explore the effect of multi-slice spiral computed tomography (MSCT) enhanced scan image diagnosis on clinical outcome of patients after radical gastrectomy and its influence on misdiagnosis rate.

METHODS: A total of 62 patients diagnosed with gastric cancer and undergoing radical gastrectomy were selected. All patients were reexamined 2-6 months after operation. Conventional CT and MSCT enhanced scan were performed for image diagnosis, and the results were compared with those of gastroscopic biopsy. Finally, the misdiagnosis rate, negative predictive value, positive predictive value, sensitivity and specificity of conventional CT and MSCT enhanced scan for postoperative recurrence were analyzed.

RESULTS: According to the results of gastroscopic biopsy, there were 35 cases suspected of recurrence, and 27 cases without postoperative recurrence. The specificity and sensitivity of conventional CT and MSCT enhanced scan were 85.19% vs. 92.59%, and 65.71% vs. 92.16%, respectively. Both specificity and sensitivity of MSCT enhanced scan were higher than those of conventional CT, with statistically significant differences (p<0.05). MSCT enhanced scan had a lower misdiagnosis rate for postoperative recurrence than conventional CT (5.71% vs. 22.86%) (p<0.05). Moreover, the negative predictive value and positive predictive value of conventional CT and MSCT enhanced scan were 65.71% vs. 86.21%, and 85.19% vs. 93.94%, respectively. The results showed that MSCT enhanced scan had higher negative predictive value and positive predictive value for postoperative recurrence than conventional CT, with statistically significant differences (p<0.05).

CONCLUSION: MSCT enhanced scan image diagnosis is of great significance for assessing the condition of disease, determining the recurrent foci after radical gastrectomy, and developing the subsequent therapeutic regimen.

PMID:34565007

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Clinical and pathological significance of proliferation index and p53 expression in gastric adenocarcinoma

J BUON. 2021 Jul-Aug;26(4):1466-1478.

ABSTRACT

PURPOSE: The purpose of our work was to investigate the association between proliferative index [proIDX] and expression index p53 (p53IDX) with the clinical and pathological characteristics of gastric adenocarcinoma.

METHODS: The biopsy material of 90 patients operated on for gastric cancer was routinely processed in paraffin and archived. After the histopathological report was made, two study groups were formed, the first group (n=45) comprised biopsies with intestinal carcinoma and the second (n=45) biopsies of diffuse gastric cancer. In both cases, the control group consisted of biopsies of surrounding non-tumor tissue The routine Hematoxylin-Eosin and immunohistochemical ABC method with anti-Ki67 and anti-p53 antibodies was applied at sections 3-5 μm thick. The expression of Ki67 and p53 was quantified stereometrically. For statistical analysis SPSS (19.0) was used.

RESULTS: Significantly higher Ki67 expression was found in both types of adenocarcinoma compared to the control group, as well as significant association of proIDX with most of testing parameters. Expression of p53 was significantly higher in the intestinal type compared to the diffuse type and the control group and was significantly associated with age and histological grade. Diffuse type particulary showed, significant association of p53IDX with most of the histological parameters tested.

CONCLUSION: Our results point a highly significant correlation of the Ki67 and p53 expression with indicators of gastric adenocarcinoma progression, which may help to identify patients with an aggressive gastric adenocarcinoma phenotype.

PMID:34565006

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Analysis of risk factors related to breast cancer metastasis: a retrospective nested case-control study

J BUON. 2021 Jul-Aug;26(4):1415-1421.

ABSTRACT

PURPOSE: To explore the laboratory indexes related to breast cancer metastasis, so as to provide scientific basis for the control of breast metastasis.

METHODS: A retrospective cohort-based nested case-control study was used to screen 732 breast cancer patients recorded in the First and the Third Hospitals of Jilin University’s electronic medical record system between January 2008 through December 2015 without metastasis at admission. Those with subsequent metastasis were classified as the metastasis group and those without metastasis as the control group. The suspected confounders were matched by propensity score matching, then univariate analysis was conducted, and the variables with statistical significance were included in multivariate conditional logistic regression analysis.

RESULTS: A total of 86 patients were matched in the transfer group and 315 in the control group, with a total sample size of 401.In univariate analysis, fasting plasma glucose (FPG), gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and direct bilirubin (DBIL) in two groups were statistically different (p<0.05), multiple conditional logistic regression showed that FPG (OR=1.335) and ALP (OR=1.016) were factors related to breast cancer metastasis.

CONCLUSIONS: For breast cancer patients, the higher FPG and ALP levels may be associated with metastasis. Therefore, daily monitoring and control of these indicators may be helpful for the control of cancer metastasis.

PMID:34564999

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Short- and medium-term outcomes after uniportal and multiportal video-assisted thoracic surgery lobectomy in elderly patients with non-small cell lung cancer

J BUON. 2021 Jul-Aug;26(4):1453-1459.

ABSTRACT

PURPOSE: To investigate the short- and medium-term outcomes following treatment with uniportal video-assisted thoracic surgery lobectomy (uniportal VATS) in elderly patients with non-small cell lung cancer (NSCLC).

METHODS: We conducted a retrospective analysis on the clinical and follow-up data of 74 elderly patients with NSCLC who underwent uniportal VATS between January 2015 and January 2020. One-to-one propensity score matching (PSM) was employed to select 71 elderly patients with NSCLC who underwent multiportal video-assisted thoracoscopic lobectomy (multiportal VATS) during the same period.

RESULTS: The baseline characteristics of the two patient groups were comparable, with no statistically significant differences in postoperative complications, operation time, conversion to thoracotomy, or lymph node dissection. The amount of intraoperative blood loss and postoperative pain were lower in the uniportal VATS group than in the multiportal VATS group. The 3-year overall survival and disease-free survival of the two groups were similar.

CONCLUSIONS: Uniportal VATS achieved similar short- and medium-term outcomes as Multiportal VATS in elderly patients with NSCLC.

PMID:34565004

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Evaluation of factors predicting pathologic complete response in locally advanced HER2 positive breast cancer treated with neoadjuvant pertuzumab, trastuzumab and chemotherapy; Real life data

J BUON. 2021 Jul-Aug;26(4):1398-1404.

ABSTRACT

PURPOSE: Recently, neoadjuvant treatment approach has gained importance in locally advanced HER-2 positive breast cancer. Adding pertuzumab increases pathological complete response (pCR). In this study, we aimed to examine the clinicopathologic features that predict the pCR in patients receiving neoadjuvant pertuzumab, trastuzumab, and chemotherapy in locally advanced HER2 positive breast cancer.

METHODS: Locally advanced HER2 positive breast cancer patients who were followed up in 4 different oncology centers and received 4 cycles of pertuzumab, trastuzumab and taxane were retrospectively evaluated. A total of 58 (92%) patients received anthracycline chemotherapy before combination of dual her-2 blockade and taxanes. Fisher’s and chi-square tests were used for nominal variables and numeric data analyses.

RESULTS: A total of 63 female patients were included in the study. Their median age was 46 years (21-75) and 40 (63.5%) patients were premenopausal. Median tumor size was 25 mm (2-70) and there were 22 (34.9%) patients with Stage 3a. pCR was 66% and 75% in the whole group and in the hormone negative group, respectively. Statistically significant increase was found in pCR in patients with grade 3 tumors and cerbB2 with 3+ immunohistochemical staining. No relationship was found between pCR and age at diagnosis, menopausal status, tumor infiltrating lymphocyte, dose-dense anthracycline, Ki67≥40, body mass index (BMI) ≥ 30 kg/m2 and accompanying DCIS.

CONCLUSION: Four cycles of pertuzumab, trastuzumab and taxane after neoadjuvant anthracycline for locally advanced HER2 breast cancer are associated with increased pCR in patients with grade 3 tumors and high cerbB2 expression.

PMID:34564997