THU0154 Adverse effects of glucocorticoid therapy in rheumatoid arthritis (RA): A systematic review and meta-analysis of randomized controlled trials:

2013 ◽  
Vol 71 (Suppl 3) ◽  
pp. 207.3-208 ◽  
Author(s):  
S. Tarp ◽  
E.M. Bartels ◽  
J.R. Kirwan ◽  
D.E. Furst ◽  
M. Boers ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Glucocorticoid Therapy ◽  
Controlled Trials ◽  
Randomized Controlled

Risk of hematological toxicities and febrile neutropenia in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with CDK 4/6 inhibitors: A systematic review and meta-analysis of randomized controlled trials.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 207-207
Author(s):  
Myo Zaw ◽  
Kyaw Zin Thein ◽  
Aung Tun ◽  
Myat M. Han ◽  
Saba Radhi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Effects ◽  
Febrile Neutropenia ◽  
Randomized Controlled Trials ◽  
Financial Burden ◽  
Meta Analysis ◽  
Neutropenic Fever ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Impact

207 Background: Majority of breast cancers express the estrogen receptor or progesterone receptor. CDK4/6 signaling plays a role in endocrine therapy resistance and the benefit of inhibition of these pathways has been proven in studies. Yet the impact of these agents on hematological toxicities and febrile neutropenia is a considerable safety concern. Hence, we performed a systematic review and meta-analysis of randomized controlled trials (RCT). Methods: MEDLINE, EMBASE databases and meeting abstracts from inception through June 2017 were queried. RCTs that mention anemia, thrombocytopenia, leukopenia, neutropenia and neutropenic fever as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Random effects model was applied. Results: Five RCTs (four phase 3 and one phase 2 studies) with a total of 2671 patients were eligible for analysis. The study arm used palbociclib-letrozole, palbociclib-fulvestrant, ribociclib-letrozole and abemaciclib-fulvestrant while the control arm utilized placebo in combination with letrozole or fulvestrant. The relative risks (RR) of all-grade side effects were as follows: anemia, 3.77 (95% CI: 2.47 – 5.75, p < 0.0001); thrombocytopenia, 9.69 (95% CI: 4.26 – 22.04, p < 0.0001); leukopenia, 11.68 (95% CI: 8.19–16.65; p < 0.0001); and neutropenia, 14.09 (95% CI: 10.73–18.49; p < 0.0001). The RR of high-grade adverse effects were as follows: anemia, 2.66 (95% CI: 1.29 – 5.45, p = 0.008); thrombocytopenia, 7.08 (95% CI: 1.95 – 25.74, p = 0.003); leukopenia, 33.58 (95% CI: 14.49–77.77; p < 0.0001); and neutropenia, 40.33 (95% CI: 19.34–84.10; p < 0.001). The pooled risk of neutropenic fever was statistically significant at 4.26 (95% CI: 1.11–16.26; p = 0.034). Conclusions: CDK 4/6 inhibitors based regimen significantly contributed to all hematological toxicities as well as febrile neutropenia. These toxicities affect patients’ quality of life, add financial burden and may lead to drug dosing inconsistencies.

Risk of infectious, hematological, and gastrointestinal side effects in patients treatedwith ibrutinib: A systematic review and meta-analysis of randomized controlled trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18265-e18265
Author(s):  
Myo Zaw ◽  
Kyaw Zin Thein ◽  
Aung Tun ◽  
Lukman Tijani ◽  
Elizabeth Guevara
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Chemokine Receptors ◽  
Meta Analysis ◽  
Controlled Trials ◽  
High Grade ◽  
Randomized Controlled ◽  
Gastrointestinal Side Effects

e18265 Background: Bruton’s tyrosine kinase (BTK) is essential for signaling of B-cell and chemokine receptors. Ibrutinib targets BTK and has become frontier in many hematologic malignancies. We undertook systematic review and pooled analysis of randomized controlled trials (RCTs) to determine infectious, hematological and gastrointestinal risks associated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts through December 31, 2016. The RCTs that mention infectious, hematological and gastrointestinal side effects as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Results: Four RCTs with a total of 1505 patients were eligible for the analysis. Studies compared Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B)+ rituximab (R) vs placebo + B+ R and I vs temsirolimus were included in the analysis. The relative risks (RR) of all-grade side effects were as follows: infection, 1.34 (95% CI: 1.04 – 1.74; p = 0.02); pneumonia, 1.16 (95% CI: 0.82–1.66; p = 0.38); anemia, 0.77 (95% CI: 0.64 – 0.93; p = 0.007); neutropenia, 0.99 (95% CI: 0.87 – 1.14; p = 0.98); thrombocytopenia, 0.86 (95% CI: 0.71 – 1.04; p = 0.12); diarrhea, 1.74 (95% CI: 1.48 – 2.05; p < 0.0001); nausea, 0.94 (95% CI: 0.80 – 1.10; p = 0.45); and vomiting, 0.98 (95% CI 0.74 – 1.30; p = 0.93). The RR of high-grade adverse effects were as follows: febrile neutropenia, 1.32 (95% CI: 0.84 – 2.08; p = 0.21); infection, 1.20 (95% CI: 0.73 – 1.98; p = 0.45); pneumonia, 1.22 (95% CI: 0.76–1.95; p = 0.39); anemia, 0.48 (95% CI: 0.33 – 0.71; p < 0.0001); neutropenia, 0.99 (95% CI: 0.86 – 1.15; p = 0.94); thrombocytopenia, 0.61 (95% CI: 0.47 – 0.81; p = 0.001); diarrhea, 1.72 (95% CI: 0.88 – 3.34;p = 0.10); nausea, 2.56 (95% CI: 0.59 – 10.99; p = 0.20); and vomiting, 0.42 (95% CI 0.11 – 1.63; p = 0.21). Conclusions: Ibrutinib increased the risk of all-grade diarrhea and infection whereas the risks of all-grade anemia, high-grade anemia and thrombocytopenia were significantly lower in the study arm, favoring ibrutinib.

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