scholarly journals Twist and Shout: One Decade of Meta-Analyses of Erythropoiesis-Stimulating Agents in Cancer Patients

2011 ◽  
Vol 125 (1-2) ◽  
pp. 55-67 ◽  
Author(s):  
Julia Bohlius ◽  
Thomy Tonia ◽  
Guido Schwarzer
Lung Cancer ◽  
2012 ◽  
Vol 76 (3) ◽  
pp. 478-485 ◽  
Author(s):  
Johan Vansteenkiste ◽  
John Glaspy ◽  
David Henry ◽  
Heinz Ludwig ◽  
Robert Pirker ◽  
...  

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4675-4675 ◽  
Author(s):  
Julia Bohlius ◽  
Corinne Brillant ◽  
Michael Clarke ◽  
Sabine Kluge ◽  
Maryann Napoli ◽  
...  

Abstract Background: Erythropoiesis stimulating agents (ESAs) consistently have been shown to decrease transfusions in anemic oncology patients. However, whether they increase mortality in cancer patients is under debate. Results from individual studies conflict, and results from literature based meta-analyses are inconclusive. We conducted a meta-analysis based on individual patient data (IPD) from all available randomized controlled trials (RCTs). Meta-analyses with individual patient data offer several advantages over study-level analysis, including the ability to gain statistical power and increase validity using time-to-event analyses, to adjust for prognostic variables that may have confounded the original treatment comparisons and to investigate subgroups in which treatment may be either more or less effective or harmful. Methods: An international collaboration conducted an individual patent data meta-analysis of ESA effects on mortality in cancer patients. With guidance from an independent steering committee of international experts in hematology, oncology, radiotherapy, epidemiology, medical statistics and a consumer representative, we developed a detailed protocol and statistical analysis plan. Independent RCT investigators and representatives from pharmaceutical companies who submitted data provided additional input through the project’s advisory board. IPD from RCTs of ESA plus red blood cell transfusion (RBCT) (as needed) versus placebo or no ESA plus RBCT (as needed), for prophylaxis or treatment of anemia in cancer patients with or without concurrent antineoplastic therapy, were included. Hazard ratios and 95% confidence intervals (CIs) were calculated per study and meta-analyzed with fixed-effects and random-effects models. Primary endpoints were overall survival (during active study phase and for the longest follow-up available) for patients receiving chemotherapy, and for all cancer patients regardless of anticancer treatment. Stratified multivariable Cox-regression analyses were conducted to assess the impact of baseline imbalances and to identify potential effect modifiers. Duplicate main statistical analyses were conducted independently at two academic statistical departments. Results: Data on 13933 patients enrolled in 53 studies were included in the analysis. Data were provided by the companies Amgen Inc., Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and F. Hoffmann-La Roche Ltd.; and by five independent investigators. Results are currently undergoing internal verification and final evaluation and will be presented at the meeting. Conclusion: Final conclusions will be presented at the meeting. Future analyses using IPD will be conducted to estimate the risks (clots, tumor progression) and potential benefits (transfusion needs and quality of life/fatigue) from other outcomes.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20725-e20725
Author(s):  
A. T. Samaras ◽  
S. Y. Lai ◽  
B. Kim ◽  
D. P. West ◽  
J. M. McKoy ◽  
...  

e20725 Background: Erythropoiesis stimulating agents (ESAs) have transformed the treatment of cancer-associated anemia worldwide. However, recent reports of venous thromboembolism (VTE), tumor progression, and mortality risks associated with ESA administration to cancer patients have resulted in reassessments of the safety and appropriate usage of these agents. The present study investigated the disparate factors that contributed to the transformation of ESA policies. Methods: We reviewed meta-analyses, advisory committee recommendations, manufacturer label revisions, clinical guidelines, reimbursement policies from the Centers for Medicare and Medicaid Services (CMS), updated clinical guidelines, and ESA usage trends. Results: See Table . Conclusions: The risks and benefits of ESAs for cancer patients have been reassessed, resulting in increasingly restrictive guidelines and labels in the U.S. and Europe. In response to the 2008 ESA labeling change mandated by the U.S. Food and Drug Administration (FDA), the European advisory committee, Committee for Medicinal Products for Human Use (CHMP), convened to reassess the risk-benefit profile of ESAs and determined that for patients with reasonably long life expectancies, the benefits of ESAs do not outweigh the risks. Additionally, the U.S. National Comprehensive Cancer Network (NCCN) revised clinical guidelines in accordance with the FDA labeling change. Therefore, FDA actions combined with the CMS reimbursement policy have provided the impetus for increasingly restrictive use of ESAs. [Table: see text] [Table: see text]


2011 ◽  
Vol 138 (2) ◽  
pp. 179-187 ◽  
Author(s):  
Fausto Petrelli ◽  
Karen Borgonovo ◽  
Mary Cabiddu ◽  
Veronica Lonati ◽  
Sandro Barni

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18600-e18600
Author(s):  
Maryam Alasfour ◽  
Salman Alawadi ◽  
Malak AlMojel ◽  
Philippos Apolinario Costa ◽  
Priscila Barreto Coelho ◽  
...  

e18600 Background: Patients with coronavirus disease 2019 (COVID-19) and cancer have worse clinical outcomes compared to those without cancer. Primary studies have examined this population, but most had small sample sizes and conflicting results. Prior meta-analyses exclude most US and European data or only examine mortality. The present meta-analysis evaluates the prevalence of several clinical outcomes in cancer patients with COVID-19, including new emerging data from Europe and the US. Methods: A systematic search of PubMED, medRxiv, JMIR and Embase by two independent investigators included peer-reviewed papers and preprints up to July 8, 2020. The primary outcome was mortality. Other outcomes were ICU and non-ICU admission, mild, moderate and severe complications, ARDS, invasive ventilation, stable, and clinically improved rates. Study quality was assessed through the Newcastle–Ottawa scale. Random effects model was used to derive prevalence rates, their 95% confidence intervals (CI) and 95% prediction intervals (PI). Results: Thirty-four studies (N = 4,371) were included in the analysis. The mortality prevalence rate was 25.2% (95% CI: 21.1–29.7; 95% PI: 9.8-51.1; I 2 = 85.4), with 11.9% ICU admissions (95% CI: 9.2-15.4; 95% PI: 4.3-28.9; I 2= 77.8) and 25.2% clinically stable (95% CI: 21.1-29.7; 95% PI: 9.8-51.1; I 2 = 85.4). Furthermore, 42.5% developed severe complications (95% CI: 30.4-55.7; 95% PI: 8.2-85.9; I 2 = 94.3), with 22.7% developing ARDS (95% CI: 15.4-32.2; 95% PI: 5.8-58.6; I 2 = 82.4), and 11.3% needing invasive ventilation (95% CI: 6.7-18.4; 95% PI: 2.3-41.1; I 2 = 79.8). Post-follow up, 49% clinically improved (95% CI: 35.6-62.6; 95% PI: 9.8-89.4; I 2 = 92.5). All outcomes had large I 2 , suggesting high levels of heterogeneity among studies, and wide PIs indicating high variability within outcomes. Despite this variability, the mortality rate in cancer patients with COVID-19, even at the lower end of the PI (9.8%), is higher than the 2% mortality rate of the non-cancer with COVID-19 population, but not as high as what other meta-analyses conclude, which is around 25%. Conclusions: Patients with cancer who develop COVID-19 have a higher probability of mortality compared to the general population with COVID-19, but possibly not as high as previous studies have shown. A large proportion of them developed severe complications, but a larger proportion recovered. Prevalence of mortality and other outcomes published in prior meta-analyses did not report prediction intervals, which compromises the clinical utilization of such results.


2021 ◽  
Vol 1 (2) ◽  
pp. 35-40
Author(s):  
Putu Yogi Pramana ◽  
Anak Agung Gede Kesuma Yudha

The development of health science, with the discovery of a type of treatment to reduce mortality due to cancer, namely using chemotherapy agents such as anthracycline and trastuzumab. From the number of studies that have been done, the types of drugs such as anthracycline and trastuzumab have a cardiotoxic effect which is often associated with decreased heart-lung function and the incidence of cardiomyopathy. Exercise is reported to have a pleiotropic effect. Therefore, this study aims to synthesize evidence from the application of pleiotropic exercise in cancer patients undergoing chemotherapy with cardiotoxic agents. The search was performed according to the recommended reporting items for systematic review and meta-analyses (PRISMA). Obtained an accumulation of 2397 articles from PubMed and Google Scholar (2016-2020), which were assisted by the PICO search engine. The article was reviewed by the author within sorting using inclusion and exclusion criteria and obtained 28 articles accordingly. Aerobic exercise has pleiotropic effects by stimulating antioxidants and reducing reactive oxygen species (ROS) levels, reducing pro-apoptosis molecular signaling, stimulating myofilament, facilitating concentric cardia hypertrophy remodeling, and changing cardiac metabolism via adenosine monophosphate (amp) with kinase-mediated. Pretreatment aerobic exercise with minimal supervised 30-min exercise sessions 3 times/week for ≥12 weeks effectively reduce the risk of chemotherapy-induced cardiomyopathy (CRC). Aerobic exercise has a significant pleiotropic effect in patients undergoing chemotherapy with cardiotoxic agents.


2021 ◽  
Author(s):  
Xu Tian ◽  
Yan-Fei Jin ◽  
Zhao-Li Zhang ◽  
Hui Chen ◽  
Wei-Qing Chen ◽  
...  

Abstract Background: Enteral immunonutrition (EIN) has been extensively applied in cancer patients, however its role in esophageal cancer (EC) patients receiving esophagectomy remains unclear. We performed this network meta-analysis to investigate the impact of EIN on patients undergoing surgery for EC and further determine the optimal time of applying EIN.Methods: We searched PubMed, EMBASE, Cochrane library, and China National Knowledgement Infrastructure (CNKI) to identify eligible studies. Categorical data was expressed as the odds ratio with 95% confidence interval (CI), and continuous data was expressed as mean difference (MD) with 95% CI. Pair-wise and network meta-analysis was performed to evaluate the impact of EIN on clinical outcomes using RevMan 5.3 and ADDIS V.1.16.8 softwares. The surface under the cumulative ranking curve (SUCRA) was calculated to rank all nutritional regimes.Results: Total 14 studies involving 1071 patients were included. Pair-wise meta-analysis indicated no difference between EIN regardless of the application time and standard EN (SEN), however subgroup analyses found that postoperative EIN was associated with decreased incidence of total infectious complications (OR=0.47; 95%CI=0.26 to 0.84; p=0.01) and pneumonia (OR=0.47; 95%CI=0.25 to 0.90; p=0.02) and shortened LOH (MD=-1.01; 95%CI=-1.44 to -0.57; p<0.001) compared to SEN, which were all supported by network meta-analyses. Ranking probability analysis further indicated that postoperative EIN has the highest probability of being the optimal option in terms of these three outcomes.Conclusions: Postoperative EIN should be preferentially utilized in EC patients undergoing esophagectomy because it has optimal potential of decreasing the risk of total infectious complications and pneumonia and shortening LOH.OSF registration number: 10.17605/OSF.IO/KJ9UY.


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