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Meily Arevalo, Myo H. Zaw, Anita Sultan, Sriman Swarup, Nay N. Yee, Wai L. Thein, Myet M. Zin, Nusrat Jahan and Kyaw Z. Thein

Background: Ibrutinib targets Bruton’s tyrosine kinase, a kinase involved in signaling of B-cell and chemokine receptors, which are implicated in the pathogenesis of hematologic malignancies. Ibrutinib has been shown to improve survival in hematologic malignancies, and yet the tolerability has not been elucidated. We undertook systematic review and pooled analysis of randomized controlled trials (RTCs) to determine the risk of gastrointestinal toxicities and the rate of treatment discontinuation due to adverse events. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts through September 2018. Phase 3 RCTs that mention gastrointestinal toxicities and the rate of treatment discontinuation due to adverse events were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% CI. Random effects model was applied. Results: 6 phase III RCTs with a total of 1,811 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, and Waldenstrom’s macroglobulinemia were included. Studies comparing ibrutinib vs ofatumumab, ibrutinib vs chlorambucil, ibrutinib + bendamustine + rituximab vs placebo + bendamustine + rituximab, ibrutinib vs temsirolimus, and ibrutinib vs rituximab were included in the analysis. The incidence of treatment discontinuation due to adverse events was 9.30% in the ibrutinib group vs 13.13% in the control arm. The relative risk (RR) for treatment discontinuation was 0.740 (95% CI: 0.385–1.423; P=.367). The pooled RR of all-grade side effects were as follows: diarrhea, 1.955 (95% CI: 1.304–2.933; P=.001); nausea, 1.038 (95% CI: 0.702–1.534; P=.852); vomiting, 1.048 (95% CI: 0.547–2.007; P=.888); and stomatitis, 1.262 (95% CI: 0.112–14.173; P=.850). The RR of high-grade adverse effects were as follows: diarrhea, 1.749 (95% CI: 0.866–3.530; P=.119); nausea, 2.237 (95% CI: 0.478–10.471; P=.306); vomiting, 0.429 (95% CI: 0.111–1.659; P=.220); and stomatitis, 0.309 (95% CI: 0.028–3.440; P=.340). Conclusion: Our study demonstrated that patients on ibrutinib arm noted increased risk of all-grade diarrhea. Nevertheless, other GI toxicities as well as treatment discontinuation due to adverse events were not statistically significant in the ibrutinib group compared with the control arm.

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Kyaw Z. Thein, Sriman Swarup, Anita Sultan, Subhanudh Thavaraputta, Myo H. Zaw, Nicholas D’Cunha, Sanjay Awasthi, Fred Hardwicke and Lukman Tijani

Background: Tyrosine kinases such as VEGFR, KIT, RET, MET are implicated in development and progression of several solid tumors. Cabozantinib is an oral multiple tyrosine kinase inhibitor and has shown survival benefits in several solid tumors. Yet, there are notable toxicities. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of palmar-plantar erythrodysesthesia (PPE) and hypertension in patients with metastatic solid tumors treated with cabozantinib. Methods: We systematically conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 2018. Phase III RCTs that mention PPE and hypertension as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR), and risk difference (RD) with 95% CI. Random effects model was applied. Heterogeneity was assessed using I2 statistic. Results: 4 phase III RCTs with total of 2,703 patients, comparing cabozantinib (C) vs everolimus, C vs placebo, C vs prednisone, were included. I2 statistic was 70.70, suggesting some heterogeneity among RCTs. All grade-PPE incidence was 666 (39.3%) in cabozantinib arm vs 38 (3.76%) in control arm with a RR of 11.378 (95% CI: 6.545–19.782; P<.0001). The absolute RD was 0.383 (95% CI: 0.294–0.473; P<.0001). High-grade PPE was reported in 172 (10.15%) in cabozantinib group vs 3 (0.29%) in control group with a RR of 19.077 (95% CI: 5.733–63.476; P<.0001). The RD was 0.105 (95% CI: 0.049–0.160; P<.0001). The overall incidence of hypertension was noted at 524 (30.95%) in cabozantinib arm vs 84 (8.31%) in control arm. The pooled RR of hypertension was 4.131 (95% CI: 2.656–6.425; P<.0001) and RD was 0.240 (95% CI: 0.186–0.295; P<.0001). High-grade hypertension was reported in 276 (16.30%) in cabozantinib group vs 41 (4.05%) in control group with a RR of 4.324 (95% CI: 2.484–7.525; P<.0001) and RD was 0.115 (95% CI: 0.085–0.144; P<.0001). Conclusion: Our meta-analysis demonstrated that cabozantinib contributed to significant toxicity of any-grade and high-grade PPE as well as hypertension, with a RR of 19.07 for grade 3 and 4 PPE. Recognizing these toxicities and prompt intervention with proper supportive care may enhance patients’ quality of life, ultimately leading to better compliance.

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Sriman Swarup, Anita Sultan, Somedeb Ball, Francis Mogollon-Duffo, Nimesh Adhikari, Yin M. Myat, Myo H. Zaw, Catherine Jones and Kyaw Z. Thein

Background: Breast cancer is the most common cancer in women, and the majority of breast cancers express the estrogen receptor or progesterone receptor. Inhibition of CDK4/6 signaling pathway has shown survival benefit in advanced breast cancer by overcoming endocrine therapy resistance. Yet, there are considerable hematologic toxicities associated with CDK 4/6 inhibitors and hence, we performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk. Methods: MEDLINE, EMBASE databases, and meeting abstracts from inception through September 2018 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 (RR) and risk difference (RD) with 95% CI. Random effects model was applied. Results: 8 RCTs (7 phase III and 1 phase II studies) with a total of 4,557 patients were eligible. The study arms used palbociclib/ribociclib/abemaciclib with letrozole or anastrozole or fulvestrant or other hormonal agent while the control arms utilized placebo in combination with letrozole or anastrozole or fulvestrant or other hormonal agent. The RR of all-grade side effects were as follows: anemia, 3.494 (95% CI: 2.535–4.814; P<.0001); thrombocytopenia, 6.066 (95% CI: 3.055–12.046; P<.0001); leukopenia, 10.376(95% CI: 7.236–14.879; P<.0001); and neutropenia, 14.387 (95% CI: 10.877–19.031; P<.0001). The RR of high-grade adverse effects were as follows: anemia, 2.251 (95% CI: 1.393–3.637; P=.001); thrombocytopenia, 3.696 (95% CI: 1.417–9.642; P=.008); leukopenia, 22.083(95% CI: 12.126–40.217; P<.0001); neutropenia, 33.527(95% CI: 17.271–65.082; P<.001). Neutropenic fever was noted in 71 (3.73%) in CDK 4/6 inhibitors group vs 28 (2.18%) in control arm. The pooled RR was statistically significant at 12.056 (95% CI: 1. 352–3.127; P=.001) and RD was 0.014 (95% CI: −0.002–0.029; P=.078) Conclusion: CDK 4/6 inhibitors–based regimen significantly contributed to all hematologic toxicities as well as febrile neutropenia. The improved efficacy outcomes and manageable toxicities with CDK 4/6 inhibitors are observed with proper supportive care and close monitoring.

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Kyaw Z. Thein, Somedeb Ball, Sriman Swarup, Anita Sultan, Myo H. Zaw, Lukman Tijani, Sanjay Awasthi, Fred Hardwicke and Catherine Jones

Introduction: Ribociclib, a cyclin-dependent kinase 4/6 inhibitor, has improved survival in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER 2)-negative advanced breast cancer. Despite remarkable efficacy, potential cardiac toxicities remain a concern. We undertook a combined analysis of randomized controlled trials (RCT) to estimate the incidence of prolongation of corrected QT interval (QTcF) associated with ribociclib. Methods: We performed systematic search of Embase, MEDLINE, and meeting abstracts till September 30, 2018, to find all phase 3 RCTs comparing ribociclib with other agents or placebo in patients with advanced breast cancer and reporting QTc prolongation as adverse event. Mantel-Haenszel method was used to calculate the pooled risk ratio (RR) and absolute risk difference (RD) with 95% CI. Fixed effects model was applied. Heterogeneity was assessed using I2 statistic. Results: Three phase III studies with 2,062 participants were included. Randomization ratio was 1 to 1 in MONALEESA-2 and 7 studies and 2 to 1 in MONALEESA-3 study. I2 statistic was 0, suggesting homogeneity across studies. Prolongation of QTcF >60 msec from baseline was observed in 72 patients (61 had post-baseline QTcF >480 msec) in ribociclib arm, compared to 7 in control arm. Pooled RR for prolongation of QTcF was 7.956 (95%CI: 3.683–17.187; P<.001) and RD was 0.055 (95%CI: 0.040–0.070; P<.001). The risk of having a post-baseline QTcF >480 msec was significantly higher with ribociclib vs control (pooled RR, 4.002; 95%CI: 2.161–7.412; P<.001; and RD, 0.039; 95%CI: 0.024–0.055; P<.001). A total of 16 (1.38%) patients in the ribociclib arm had dose reduction, interruption, or discontinuation due to QTcF prolongation, as opposed to 3 (0.33%) in control arm. Pooled RR and RD were statistically significant at 4.204 (95%CI: 1.333–3.260; P=.014) and 0.012 (95%CI: 0.004–0.021; P=.006), respectively. Conclusion: Advanced breast cancer patients may have cardiac dysfunction due to prior cardiotoxic chemotherapies. In our meta-analysis, ribociclib was associated with significantly higher risk of QTc prolongation and the resultant dosing inconsistencies and discontinuation. Early detection of this potential adverse event and timely intervention are critical.

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Anita Sultan, Sriman Swarup, Somedeb Ball, Miguel Quirch, Meily Arevalo, Yin M. Myat, Ye Aung, Myo H. Zaw and Kyaw Z. Thein

Background: CDK4 and CDK6 are cyclin-dependent kinases that control transition between G1 and S phases of the cell cycle, hence controlling cell cycle progression by reversible combination with cyclin D1. In cancer cell, CDK4/6 activity is overexpressed, which can lead to amplification or overexpression of the genes encoding for CDK 4/6 or the cyclin D. Additionally, loss of endogenous INK4 inhibitors can also lead to over activity of CDK4 and CDK6. We undertook a meta-analysis of randomized controlled trials (RCT) to determine the risk of gastrointestinal (GI) and hepatic toxicities associated with CDK 4/6 inhibitors. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts from inception through September 2018. In our analysis, we incorporated RCTs that mention GI toxicities and elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) as adverse effects. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% CI. Random effects model was applied. Results: A total of 4,557 patients with advanced breast cancer from 7 phase III and 1 phase II RCTs were eligible. The study arms used were palbociclib/ribociclib/abemaciclib or placebo in combination with letrozole or anastrozole or fulvestrant or other hormonal agents. The RR of all-grade side effects were as follows: diarrhea, 1.691 (95% CI: 1.220–2.345; P=.002); nausea, 1.632 (95% CI: 1.447–1.840; P<.001); vomiting, 1.684 (95% CI: 1.256–2.259, P=.001); stomatitis, 2.160 (95% CI: 1.332–3.503; P=.002); elevated AST, 1.832 (95% CI: 1.312–2.558; P<.001); and elevated ALT, 2.150 (95% CI: 1.649–2.803; P<.001). The RR of high-grade side effects were as follows: diarrhea, 2.592 (95% CI: 0.853–7.877; P=.093); nausea, 1.326 (95% CI: 0.589–2.988; P=.496); vomiting, 1.089 (95% CI: 0.479–2.476; P=.839); stomatitis, 2.097 (95% CI: 0.502–0.753; P=.310); elevated AST, 2.274 (95% CI: 1.173–4.410; P=.015); and elevated ALT, 3.988 (95% CI: 2.387–6.663; P<.001). Conclusions: Our study demonstrated that the risk of developing all grade GI toxicities and all grades of hepatic side effects including grade 3 and 4, was high in CDK 4/6 inhibitors group, compared to control arm, and prompt intervention with good supportive care is required.

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Rachana Yendala, Kyaw Thein, Sriman Swarup, Anita Sultan, Somedeb Ball, Miguel Quirch, Myo H. Zaw, Yin M. Myat and Catherine Jones

Background: Pain, fatigue, hot flushes, and rash significantly contribute to quality of life in breast cancer patients undergoing chemotherapy. Hormone receptor-positive breast cancer is a common entity among women worldwide. In cancer cells, CDK4/6 activity is over expressed, which can lead to amplification or overexpression of the genes encoding for CDK 4/6 or the cyclin D, ultimately leading to endocrine therapy resistance. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of health-related quality of life (HRQOL) events associated with CDK 4/6 inhibitors. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts from inception through September 2018. RTCs that mention HRQOL events as adverse effects were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95%CI. Random effects model was applied. Results: 8 RCTs (7 phase III and 1 phase II) with a total of 4,557 patients were eligible. The study arms used palbociclib/ribociclib/abemaciclib with letrozole or anastrozole or fulvestrant or other hormonal agent while the control arms utilized placebo in combination with letrozole or anastrozole or fulvestrant or other hormonal agent. The RR of all-grade side effects were as follows: fatigue, 1.226 (95% CI: 1.079–1.393; P=.002); back pain, 0.971 (95% CI: 0.844–1.117; P=.681); arthralgia, 0.978 (95% CI: 0.830–1.152; P=.790); headache, 1.046 (95% CI: 0.928–1.179; P=.459); alopecia, 2.635 (95% CI: 1.966–3.533; P<.001); hot flushes, 0.901 (95% CI: 0.766–1.060; P=.210); and rash, 2.068 (95% CI: 1.604–2.666; P<.001). The RR of high-grade side effects were as follows: fatigue, 3.487 (95% CI: 1.765–6.889; P<.001); back pain, 1.364 (95% CI: 0.695–2.679; P=.367); arthralgia, 1.148 (95% CI: 0.509–2.593; P=.740); headache, 0.807 (95% CI: 0.303–2.147; P=.667); and rash, 3.018(95% CI: 0.954–9.554; P=.060). Conclusions: Our study showed that the risk of developing all grades of fatigue and any-grade alopecia and rash was significantly with CDK 4/6 inhibitors. Prompt intervention with good supportive care is required.

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Sriman Swarup, Anita Sultan, Nusrat Jahan, Upama Sharma, Nimesh Adhikari, Yin M. Myat, Ye Aung, Myo H. Zaw and Kyaw Z. Thein

Background: VEGFR, KIT, RET, and MET pathways are implicated in several solid tumors. Cabozantinib is an oral inhibitor of these kinase pathways, and hence has found its use in treatment of multiple malignancies. However, it has several side effects that can limit tolerance amongst patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of health-related quality of life (HRQOL) events in patients with advanced solid tumors treated with cabozantinib. Methods: We systematically conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 30, 2018. Phase 3 trials that mention HRQOL events like pain, arthralgia, fatigue, and reduced appetite as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR) with 95% CI. Random effects model was applied. Results: 4 phase 3 RCTs with a total of 2,703 patients with medullary thyroid cancer, prostate cancer, renal cell carcinoma, and hepatocellular carcinoma were eligible. Studies comparing cabozantinib (C) vs everolimus, C vs placebo, C vs prednisone were included in the analysis. The relative risks of all-grade side effects were as follows: fatigue, 1.378 (95% CI: 1.236–1.536; P<.0001); asthenia, 1.704 (95% CI: 1.190–2.441; P=.004); reduced appetite, 2.088 (95% CI: 1.471–2.964; P<.0001); back pain, 1.047 (95% CI: 0.871–1.259; P=.626); pain in limbs, 1.444 (95% CI: 1.128–1.847; P=.004); arthralgia, 0.982 (95% CI: 0.707–1.363; P=.912). The RR of high-grade side effects were as follows: fatigue, 1.937 (95% CI: 1.483–2.528; P<.0001); asthenia, 2.211 (95% CI: 1.536–3.184; P<.0001); reduced appetite, 4.329 (95% CI: 2.372–7.900; P<.0001); back pain, 1.227 (95% CI: 0.738–2.040; P=.431); pain in limbs, 2.933 (95% CI: 1.127–7.635; P=.028); arthralgia, 0.820 (95% CI: 0.394–1.709; P=.597). Conclusion: Our meta-analysis showed that cabozantinib contributed to significant toxicity of all grades of fatigue, asthenia, pain in limbs, and reduced appetite. Identifying and addressing these toxicities will be important in improving quality of life for these patients.

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Miguel Quirch, Sriman Swarup, Anita Sultan, Wai L. Thein, Zayar M. Oo, Nyein H. Yu, Myo H. Zaw, Donald P. Quick and Kyaw Z. Thein

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 the risk of hematologic toxicities and health-related quality of life (HRQOL) events associated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 2018. Phase III RCTs that mention hematologic toxicities and HRQOL events as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% CI. Random effects model was applied. Results: 6 phase III RCTs with a total of 1,811 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle-cell lymphoma, and Waldenstrom’s macroglobulinemia were eligible. Studies compared Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B) + rituximab (R) vs placebo + B+ R, I vs temsirolimus and I vs R were included in the analysis. The relative risks (RR) of all-grade side effects were as follows: anemia, 0.812 (95% CI: 0.565–1.168; P=.261); neutropenia, 0.956 (95% CI: 0.720–1.268; P=.754); thrombocytopenia, 1.054 (95% CI: 0.450–2.470; P=.904); fatigue, 0.896 (95% CI: 0.761–1.056; P=.192); pyrexia, 1.123 (95% CI: 0.893–1.413; P=.322); and arthralgia, 1.863 (95% CI: 1.101–3.152; P=.020). The RR of high-grade adverse effects were as follows: anemia, 0.522 (95% CI: 0.371–0.733; P<.0001); neutropenia, 0.969 (95% CI: 0.751–1.249; P=.807); thrombocytopenia, 0.608 (95% CI: 0.252–1.470; P=.270); fatigue, 0.618 (95% CI: 0.396–0.964; P=.034); pyrexia, 1.165 (95% CI: 0.534–2.542; P=.701); and arthralgia, 3.623 (95% CI: 0.743–17.663; P=.111). Conclusion: Ibrutinib increased the risk of all-grade arthralgia whereas the risks of high-grade anemia and fatigue were significantly lower in the study arm, favoring ibrutinib.

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Anita Sultan, Sriman Swarup, Francis Mogollon-Duffo, Ye Aung, Yin M. Myat, Myo H. Zaw, Rachana Yendala, Nicholas D’Cunha and Kyaw Z. Thein

Background: Cabozantinib is an oral inhibitor of multiple tyrosine kinases and is used in treatment of multiple solid tumors, targeting several pathways such as vascular endothelial growth factor signaling pathway and proto-oncogenes MET, KIT, RET. These pathways are implicated in several tumor development and progression. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of gastrointestinal (GI) and hepatic toxicities among patients with metastatic solid tumors treated with cabozantinib. Methods: MEDLINE, EMBASE databases, and meeting abstracts from inception to September 2018 were queried. Phase 3 RCTs that mention GI and elevation of liver enzymes as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR) with 95% CI. Random effects model was applied. Results: We included 4 phase 3 RCTs with a total of 2,703 patients with various solid tumors. The study arm used cabozantinib while the control arm utilized everolimus or placebo or prednisone. The relative risks of all-grade side effects were as follows: diarrhea, 2.495 (95% CI: 2.149–2.897, P<.0001); nausea, 1.849 (95% CI: 1.649–2.072; P<.0001); vomiting, 2.335 (95% CI: 1.724–3.163; P<.0001); stomatitis, 4.541 (95% CI: 0.908–22.696; P=.065); dysgeusia, 4.428 (95% CI: 2.67–7.343; P<.0001); elevated AST, 2.002 (95% CI: 1.331–3.011; P=.001); and elevated ALT, 1.988 (95% CI: 0.936–4.222; P=.074). The RR of high-grade side effects were as follows: diarrhea, 5.913 (95% CI: 3.655–9.566; P<.0001); nausea, 3.098 (95% CI: 1.266–7.581; P=.013); vomiting, 1.298 (95% CI: 0.395–4.265; P=.668); stomatitis, 3.837 (95% CI: 0.749–19.665; P=.107); dysgeusia, 1.522 (95% CI: 0.159–14.574; P=.716); elevated AST, 1.733 (95% CI: 1.101–2.728; P=.018); and elevated ALT, 2.489 (95% CI: 1.164–5.326; P=.019). Conclusion: The risk of developing all grades of diarrhea, nausea, elevated AST, and any-grade vomiting, dysgeusia as well as high-grade elevated ALT, was high in cabozantinib group. Timely recognition and providing good supportive care will enhance patients’ quality of life.

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Nimesh Adhikari, Myo H. Zaw, Sriman Swarup, Anita Sultan, Upama Sharma, Wai P. Thi, Nay N. Yee, Khaing K. Htwe, Tun W. Naing and Kyaw Z. Thein

Background: Bruton’s tyrosine kinase (BTK), a kinase downstream of the B-cell receptor, involves in the B cell survival and proliferation and has become an attractive therapeutic target. Ibrutinib is an oral potent, covalent inhibitor of BTK and hence employed in many hematologic malignancies. We performed a systematic review and pooled analysis of randomized controlled trials (RCTs) to determine the risk of atrial fibrillation (AF) and pulmonary toxicities among patients treated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 2018. Phase 3 RCTs that mention AF and pulmonary toxicities as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% CI. Random effects model was applied. Results: 4 phase III RCTs with a total of 1,383 patients with chronic lymphocytic leukemia or small lymphocytic lymphoma were eligible. Studies comparing Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B)+ rituximab (R) vs placebo + B+ R, and I vs R were included in the analysis. The AF incidence was 41 (5.686%) in the ibrutinib group vs 8 (1.208%) in the control arm. The relative risk (RR) for AF was statistically significant at 3.825 (95% CI: 1.848–7.917; P<.0001) and RD was 0.041 (95% CI: 0.023–0.059; P<.0001). The RR of all-grade side effects was as follows: cough, 1.133 (95% CI: 0.724–1.773; P=.584); edema, 1.375 (95% CI: 0.943–2.006; P=.098); pneumonia, 1.227 (95% CI: 0.884–1.703; P=.221); and upper respiratory infections (URI), 1.075 (95% CI: 0.809–1.429; P=.616). The RR of high-grade side effects was as follows: cough, 0.373 (95% CI: 0.063–2.209; P=.277); edema, 1.232 (95% CI: 0.199–7.649; P=.822); pneumonia, 1.277 (95% CI: 0.847–1.926; P=.243); and URI, 1.555 (95% CI: 0.239–10.127; P=.644). Conclusion: Our meta-analysis demonstrated that patients on ibrutinib noted a significant increase in the risk of atrial fibrillation with a relative risk of 3.825. However, the risk of pulmonary toxicities was not statistically increased in the ibrutinib group.