Association of risk of febrile neutropenia (FN) with docetaxel in prostate cancer (PC) patients: A meta-analysis of published phase II-III trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21683-e21683
Author(s):  
Blazquez Arroyo Maria ◽  
Antonio Merida Garcia ◽  
David Lora ◽  
Brandon David Bernard ◽  
Lorente David ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Relative Risk ◽  
Phase Ii ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Bone Marrow Involvement ◽  
Risk Groups ◽  
Castration Resistant Prostate Cancer ◽  
Fixed Effects Model

e21683 Background: Reported rates of FN with docetaxel (DTX) in PC patients are variable. This creates uncertainty regard the use of granulocyte colony-stimulating factor primary prophylaxis (G-CSF) in this setting. We conducted a meta-analysis of randomized clinical trials to determine the relative risk (RR) of FN in patients receiving DTX. Methods: To perform this analysis we systematically searched in PUBMED and MEDLINE database the following terms: “DTX”, “randomized clinical trial” and “prostate cancer” only for articles published between January 1996 and August 2016. Phase II-III clinical studies comparing DTX to non-DTX control arms (best supportive care [BSC] including non-cytotoxic therapy or mitoxantrone) for PC were included. The meta-analyses were performed by computing RRs with 95% confidence intervals (CI) using fixed-effects model with the Mantel-Haenszel method. Results: Seven studies (N = 5088 patients) were included. The global incidence of FN in patients treated with DTX was 10.7%. The RR of FN was higher in patients receiving DTX compared to patients did not receive DTX (RR 16.8 [95% CI 10.7; 26.4] p < 0.0001). 6.6% of patients with metastatic castration resistant prostate cancer (CRPC) treated with DTX developed FN, the RR of FN with DTX compared to mitoxantrone was 28.6 (95% CI 5.6; 145.1). 12.4% of patients with hormone-sensitive prostate cancer (HSPC) treated with DTX developed FN, the RR of FN was 15.3 (95% CI 9.6; 24.6) compared to BSC. There was no statistically significant differences in the rate of FN according to the hormone sensitivity (HSPC vs CRPC) (p = 0.7). In most studies the use of G-CSF was at the discretion of the investigator. Conclusions: This meta-analysis shows that DTX is associated with a significant increase in the relative risk of FN in patients with PC. The effectiveness of primary prophylactic G-CSF in this setting has not been fully established. The incidence reported here does not meet the threshold recommended by ESMO and ASCO guidelines for the use of prophylactic G-CSF. Special attention should be given to high risk groups for FN, including elderly patients and those with bone marrow involvement or previous radiotherapy/chemotherapy.

A Systematic Review and Meta-Analysis about the Effect of Bisphosphonates on the Risk of Skeletal-Related Event in Men with Prostate Cancer

2020 ◽  
Vol 20 (13) ◽  
pp. 1604-1612
Author(s):  
Congcong Wu ◽  
Hua Jiang ◽  
Jianghua Chen
Keyword(s):  
Prostate Cancer ◽  
Fixed Effects ◽  
Data Extraction ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Control Group ◽  
Fixed Effects Model ◽  
Related Event ◽  
Mineral Density ◽  
Skeletal Related Event

Background: Although the adjuvant therapy of bisphosphonates in prostate cancer is effective in improving bone mineral density, it is still uncertain whether bisphosphonates could decrease the risk of Skeletal- Related Event (SRE) in patients with prostate cancer. We reviewed and analyzed the effect of different types of bisphosphonates on the risk of SRE, defined as pathological fracture, spinal cord compression, radiation therapy to the bone, surgery to bone, hypercalcemia, bone pain, or death as a result of prostate cancer. Methods: A systemic literature search was conducted on PubMed and related bibliographies. The emphasis during data extraction was laid on the Hazard Ratio (HR) and the corresponding 95% Confidence Interval (CI) from every eligible Randomized Controlled Trial (RCT). HR was pooled with the fixed effects model, and preplanned subgroup analyses were performed. Results: 5 RCTs (n = 4651) were included and analyzed finally after screening 51 articles. The meta-analysis of all participants showed no significant decrease in the risk of SRE when adding bisphosphonates to control group (HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536) with low heterogeneity (I2 = 0.0% (d.f. = 4) p = 0.679). There was no significant improvement on SRE neither in the subgroups with Metastases (M1) or Castration-Sensitive Prostate Cancer (CSPC) (respectively HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536, I2 = 0.0% (d.f. = 4) p = 0.679; HR = 0.954, 95% CI = 0.837 - 1.088, p = 0.484, I2 = 0.0% (d.f. = 3) p = 0.534). Conclusion: Our study demonstrated that bisphosphonates could not statistically significantly reduce the risk of SRE in patients with prostate cancer, neither in the subgroups with M1 or CSPC.

Use of Statins and Breast Cancer: A Meta-Analysis of Seven Randomized Clinical Trials and Nine Observational Studies

2005 ◽  
Vol 23 (34) ◽  
pp. 8606-8612 ◽  
Author(s):  
Stefanos Bonovas ◽  
Kalitsa Filioussi ◽  
Nikolaos Tsavaris ◽  
Nikolaos M. Sitaras
Keyword(s):  
Breast Cancer ◽  
Breast Cancer Risk ◽  
Cancer Risk ◽  
Publication Bias ◽  
Observational Studies ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Sensitivity Analyses ◽  
Fixed Effects Model

Purpose A growing body of evidence suggests that statins may have chemopreventive potential against breast cancer. Laboratory studies demonstrate that statins induce apoptosis and reduce cell invasiveness in various cell lines, including breast carcinoma cells. However, the clinical relevance of these data remains unclear. The nonconclusive nature of the epidemiologic data prompted us to conduct a detailed meta-analysis of the studies published on the subject in peer-reviewed literature. Patients and Methods A comprehensive search for articles published up until 2005 was performed; reviews of each study were conducted; and data were abstracted. Before meta-analysis, the studies were evaluated for publication bias and heterogeneity. Pooled relative risk (RR) estimates and 95% CIs were calculated using the random and the fixed-effects models. Subgroup and sensitivity analyses were also performed. Results Seven large randomized trials and nine observational studies (five case-control and four cohort studies) contributed to the analysis. We found no evidence of publication bias or heterogeneity among the studies. Statin use did not significantly affect breast cancer risk (fixed effects model: RR = 1.03; 95% CI, 0.93 to 1.14; random effects model: RR = 1.02; 95% CI, 0.89 to 1.18). When the analyses were stratified into subgroups, there was no evidence that study design substantially influenced the estimate of effects. Furthermore, the sensitivity analysis confirmed the stability of our results. Conclusion Our meta-analysis findings do not support a protective effect of statins against breast cancer. However, this conclusion is limited by the relatively short follow-up times of the studies analyzed. Further studies are required to investigate the potential decrease in breast cancer risk among long-term statin users.

Risk of mineralocorticoid excess syndrome with CYP17 inhibitor abiraterone in prostate cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15140-e15140
Author(s):  
Sandy Ann Itwaru ◽  
Arun Gopal ◽  
Omer Bashir ◽  
Joomee Shim ◽  
Xiaolei Zhu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Side Effects ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Abiraterone Acetate ◽  
Fixed Effects Model ◽  
Starting Dose ◽  
Grade 3 ◽  
American Society

e15140 Background: CYP17 inhibitor abiraterone acetate has been used for the treatment of patients with metastatic castration-refractory prostate cancer (CRPC). Hypertension, hypokalemia and edema are the major side effects associated with its use, and may be secondary to the excess of mineralocorticoids due to CYP17 inhibition. We performed a systematic review and meta-analysis of published clinical trials to determine the effect of abiraterone on the development of these side effects. Methods: Databases including Pubmed (July, 1966 to July, 2011), Web of Science, and abstracts presented at the American Society of Clinical Oncology meetings from 2008 to 2011 were searched to identify relevant studies. Eligible studies were prospective clinical trials of patients with prostate cancer receiving abiraterone acetate at the starting dose of 1,000 mg daily with available data on hypertension, hypokalemia and edema. Incidence and relative risk (RR) were calculated using a random-effects or fixed-effects model. Results: A total of seven studies including 1,387 patients with CRPC were selected for analysis. The incidences of all-grade hypertension, hypokalemia, and edema were 13.3% (95% CI: 8.3 to 20.5%), 31.4 % (95% CI: 12.5-59.5%), and 23.4 % (95% CI: 15.6-33.5%) respectively. The incidences of high-grade (grade 3 and above) toxicity were low, with a rate of 3.6% (95% CI: 2.6-5.1%), 2.8 % (95% CI: 0.9 to 8.2%), and 2.1% (95%CI: 1.3-3.2%) for hypertension, hypokalemia, and edema respectively. The risk of hypertension and edema did not change with and without the addition of prednisone (p=0.48 and p=0.40, respectively); however, the risk of hypokalemia was significantly reduced with the addition of prednisone (p = 0.003). In comparison with prednisone alone, the addition of abiraterone did not increase the risk of hypertension (RR 1.22, 95% CI: 0.82 – 1.83, p=0.31), but significantly increased the risk of edema (RR 1.36, 95% CI: 1.10-1.69, p=0.004) and hypokalemia (RR 2.04, 95% CI: 1.42–2.92, p<0.001). Conclusions: There were differential effects of abiraterone on the development of hypertension, hypokalemia, and edema in patients with advanced prostate cancer. Further studies are recommended for optimal treatment.

Relative risk of HTN and major cardiovascular events associated with use of androgen receptor antagonists for nonmetastatic, castration-resistant prostate cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17605-e17605
Author(s):  
Nusrat Jahan ◽  
Francis Mogollon-Duffo ◽  
Shabnam Rehman ◽  
Sakshi Singal ◽  
Fred L. Hardwicke
Keyword(s):  
Prostate Cancer ◽  
Androgen Receptor ◽  
Relative Risk ◽  
Meta Analysis ◽  
Castration Resistant Prostate Cancer ◽  
Phase 3 ◽  
Castration Resistant ◽  
Increased Risk ◽  
Myocardial Infraction ◽  
Grade 3

e17605 Background: Metastatic, castration-resistant prostate cancer (mCRPC) is a lethal disease, often preceded by nonmetastatic, castration-resistant phase. Recently, three androgen receptor (AR) antagonists — apalutamide, enzalutamide, and darolutamide — have been approved for nonmetastatic, castration-resistant prostate cancer (nmCRPC). AR-antagonists have been associated with increased risk of hypertension (HTN) and major cardiovascular (CV) events. We conducted a systematic review and meta-analysis of the published phase 3 randomized controlled trials (RCTs) to determine the relative risk of HTN and major CV events associated with use of AR-antagonists for nmCRPC. Methods: We conducted a systematic search at PUBMED, MEDLINE, EMBASE, and meeting abstracts from inception until November 2019. Published phase 3 RCTs using AR-antagonists in the study arm for nmCRPC and reporting the number of events of HTN and major CV events were included in the analyses. We used Mantel-Haenszel (MH) method and random effects model to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Heterogeneity was tested with I2 value and Cochran’s Q-test. Results: Three phase 3 RCTs (ARAMIS, PROSPER, and SPARTAN) randomizing 2687 patients in the AR-antagonist arms and 1417 patients in the control arms were included in the final analysis for HTN. SPARTAN did not include data for major CV events; hence, other two studies comprising 2903 patients were analyzed for major CV events. Major CV events included myocardial infraction/coronary artery disease, ischemic/hemorrhagic cerebrovascular events, and heart failure. AR-antagonists used in the study arms were — ARAMIS: darolutamide, PROSPER: enzalutamide, and SPARTAN: apalutamide. Placebo was used in the control arms. All patients continued androgen deprivation therapy. Randomization was 2:1 in all studies. The pooled RR of any-grade HTN is 1.5 (95% CI: 1.03 – 2.18, p = 0.03, I2 = 70%); and, the pooled RR of grade ≥3 HTN is 1.39 (95% CI: 1.03 – 1.88, p = 0.03, I2 = 13%). The pooled RR of any-grade major CV events is 1.49 (95% CI: 1.05 – 2.13, p = 0.03, I2 = 0%); and, the pooled RR of grade ≥3 major CV events is 1.80 (95% CI: 1.11 – 2.92, p = 0.02, I2 = 0%). Conclusions: Our meta-analysis demonstrated use of AR-antagonists for nmCRPC is associated with increased risk of HTN and major CV events. A careful selection of patients and aggressive management of the CV risk factors are crucial to enhance safety and proper utilization of these promising drugs.

Changing the Physical Activity Behavior of Adults With Fitness Trackers: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 34 (4) ◽  
pp. 418-430 ◽  
Author(s):  
Chris Lynch ◽  
Stephen Bird ◽  
Noel Lythgo ◽  
Isaac Selva-Raj
Keyword(s):  
Physical Activity ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Physical Activity Behavior ◽  
Step Count ◽  
Fixed Effects Model ◽  
Alternative Intervention ◽  
Positive Effect

Objective: To examine whether a fitness tracker (FT) intervention changes physical activity (PA) behavior compared to a control condition or compared to an alternative intervention. Data Source: Searches between January 01, 2010, and January 01, 2019, were conducted in PubMed, CINAHL, Cochrane CENTRAL, EMBASE, and PsycINFO. Inclusion/Exclusion Criteria: Randomized clinical trials of adults using an FT to change PA behavior were included. Nonclinical trials, studies that included the delivery of structured exercise, and/or studies that only used the FT to assess PA were excluded. Data Extraction: Extracted features included characteristics of the study population, intervention components, PA outcomes, and results. Data Synthesis: Papers were pooled in a statistical meta-analysis using a fixed effects model. Where statistical pooling was not possible, standardized mean difference (SMD) and 95% confidence intervals (CI) were calculated. Findings were presented in a narrative form and tables. Results: Of 2076 articles found, 21 were included in the review. A small yet significant positive effect (SMD = 0.25, 95% CI = 0.17-0.32; P < .01; I2 = 56.9%; P = .03) was found in step count for interventions compared to control. A small yet significant negative effect (SMD = −0.11, 95% CI = −0.20 to −0.02; P = .02; I2 = 58.2%; P = 0.03) was found in moderate-to-vigorous PA for interventions compared to an alternative intervention. Conclusion: Trackers may enhance PA interventions, as a general positive effect is found in step count compared to a control. However, there is no evidence of a positive effect when interventions are compared to an alternative intervention. It is unknown whether results are due to other intervention components and/or clinical heterogeneity.

scholarly journals Can Statin Treatment Reduce the Risk of Hepatocellular Carcinoma? A Systematic Review and Meta-Analysis

2020 ◽  
Vol 19 ◽  
pp. 153303382093488
Author(s):  
Yue Chang ◽  
Qinyu Liu ◽  
Zidong Zhou ◽  
Yuping Ding ◽  
Mei Yang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Relative Risk ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Statin Treatment ◽  
Fixed Effects Model ◽  
The Relationship ◽  
Dose Dependent ◽  
Reduced Risk ◽  
Statin Use

Background: Whether statins can reduce the incidence of cancers has been an interesting topic in recent years. This meta-analysis aimed to determine the relationship between statin treatment with the risk of hepatocellular carcinoma. Methods: Studies published up to July 2019 were screened from databases. The data from approved studies were pooled. Random-effects or fixed-effects model was used to calculate the relative risk with 95% CIs in the overall group and subgroups. Sensitivity and meta-regression analyses were performed, and publication bias was evaluated. Results: A total of 18 studies involving 1 611 596 patients were included in this meta-analysis. The overall result showed a significantly reduced risk of hepatocellular carcinoma (relative risk = 0.54, 95% CI: 0.42-0.66) in statin users. In comparison to the risk in nonstatin users, the risk of hepatocellular carcinoma was reduced in all subgroups. The dose of statins and their pharmacokinetics can partly explain the heterogeneity in the overall meta-analysis ( I 2 = 94.6%, P = .000). A dose-dependent effect of statin use for the reduced risk of hepatocellular carcinoma was found. Conclusions: Findings from this meta-analysis support that statin use can significantly reduce the incidence of hepatocellular carcinoma.

scholarly journals Association between renal urolithiasis after extracorporeal shock wave lithotripsy therapy and new-onset hypertension: an updated meta-analysis

2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110020
Author(s):  
Qiao Wu ◽  
Rui Liang ◽  
Yi Huang ◽  
Chunlin Tan ◽  
Guangqiang Zhu ◽  
...  
Keyword(s):  
Shock Wave ◽  
Relative Risk ◽  
Extracorporeal Shock Wave Lithotripsy ◽  
Fixed Effects ◽  
Shock Wave Lithotripsy ◽  
Meta Analysis ◽  
Fixed Effects Model ◽  
Extracorporeal Shock Wave ◽  
Long Term Effect ◽  
New Onset

Objective The long-term effect of extracorporeal shock wave lithotripsy (SWL) is still controversial. A previous meta-analysis showed no association between new-onset hypertension and entire upper urinary urolithiasis after SWL. Recently, there have been some reports on this topic. Therefore, we aimed to examine the association between new-onset hypertension and nephrolithiasis after SWL therapy. Methods Embase, the Cochrane Central Search Library, and PubMed were used to search for reports on new-onset hypertension and patients with nephrolithiasis after SWL. A meta-analysis of the association between new-onset hypertension and nephrolithiasis after SWL was carried out. The data of relevant research were synthesized and the relative risk was computed. Results Seven eligible studies were included in our meta-analysis. There was a significant association between nephrolithiasis after SWL and new-onset hypertension. The overall relative risk with a 95% confidence interval was 1.21 (1.11–1.31) in a fixed-effects model. Conclusion Our meta-analysis suggests an association between new-onset hypertension and patients with nephrolithiasis after SWL, which is in contrast with the finding of a previous meta-analysis.

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