Efficacy and Safety Evaluation of Sintilimab for Cancer Treatment: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Ye, Ziqi; Yang, Wenchao; Xuan, Bixia; Li, Xiaofang; He, Jiana; Si, Haiyan; Ma, Wei

doi:10.3389/fphar.2022.895187

Cited by 5 publications

(4 citation statements)

References 13 publications

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“…However, its side effects have also been found. [2–6] The current study reported a case of Sintilima-caused adverse reaction in the form of swelling along the vascular direction at the intravenous injection site. However, determining the nature of adverse reactions is still a focus of discussion.…”

Section: Introductionmentioning

confidence: 90%

A rare presentation of Sintilimab-induced swelling along the vessels: Case report

Liu

Xia

et al. 2023

Medicine

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Rationale: Immune-related adverse events are occasionally reported in Sintilimab treatment. This study reports a forward and reverse swelling case along the vein after infusion of Sintilimab. At present, swelling along the vascular direction during peripheral infusion are limitedly reported at home and abroad, especially when choosing a vein with thick, elastic, and good blood return.Patient concerns: A 56-year-old male who suffered from esophageal cancer and liver cancer and received albumin-bound paclitaxel and nedaplatin chemotherapy in combination with Sintilimab immunotherapy appeared swelling along the vessel after infusion of Sintilimab. The patient was punctured 3 times.Diagnoses: Sintilimab-induced vascular edema may be a side effect resulted from a combination of variables such as relatively poor vascular function of the patient, chemical extravasation, allergic skin reactions, venous valves, vascular intima, and diameter stenosis. Sintilimab rarely causes vascular edema only when drug allergic reaction is the underlying factor. As only a few cases of vascular edema caused by Sintilimab have been reported, causes to such a drug-induced vascular edema remained unclear.Interventions: The swelling was controlled by an intravenous specialist nurse according to delayed extravasation treatment and the doctor anti-allergy treatment, but the uncertainty of repeated puncture and symptom diagnosis caused pain and anxiety to the patient and his family.Outcomes: The symptom of swelling was gradually relieved after the anti-allergic treatment. The patient completed the following drug infusion without discomfort after the third puncture. When the patient was discharged the next day, swelling in his both hands disappeared, and the patient had no anxiety or discomfort.Lessons: The side effects of immunotherapy may accumulate over time. Early identification and appropriate nursing management are the keys to minimizing patients' pain and anxiety. To effectively treat symptoms, nurses could benefit from quickly identifying the source of swelling.

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Section: Introductionmentioning

confidence: 90%

A rare presentation of Sintilimab-induced swelling along the vessels: Case report

Liu

Xia

et al. 2023

Medicine

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“…The adverse events induced by sintilimab include, but are not limited to, pneumonitis, hepatitis, endocrinopathies, colitis and myocarditis. [ 7 ] Here we report a case of ICI-induced lethal myocarditis overlapping with MG secondary to sintilimab therapy for a thymoma patient. We present the following case in accordance with the CARE reporting checklist.…”

Section: Introductionmentioning

confidence: 99%

Immune checkpoint inhibitor sintilimab-induced lethal myocarditis overlapping with myasthenia gravis in thymoma patient: A case report

Wang

Bing-di

et al. 2023

Medicine

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Rationale: Immune checkpoint inhibitors have been extensively used and significantly improved the clinical outcomes in multiple types of cancer. But the immune-related adverse events occur frequently, particularly in thymoma. The cardiac immune-related adverse, which is relatively rare but fatal, have been increasing reported. Patient concerns: A 45-year-old thymoma patient was admitted to our hospital after receiving anti-programmed cell death-1 treatment with sintilimab 14 days later, accompanied by abdominal pain, intermittent chest tightness and dizziness. Diagnoses: The laboratory tests revealed elevated serum troponin I. Electrocardiogram reported the prolongation of QTc interval. Echocardiography showed small amount of pericardial effusion, a left ventricular ejection fraction of 71%. Coronary artery computed tomography angiography revealed localized noncalcified plaque in the middle of the left anterior descending artery and mild stenosis of the lumen. Enhanced computed tomography scanning of the whole abdomen showed no abnormal signs in the parenchyma organs. Combining the results of the examinations, the Immune checkpoint inhibitor induced myocarditis was diagnosed. Interventions: The patient was treated with glucocorticoids (120 mg/day, IV, methylprednisolone) within 24 hours of admission. Seven days later, the patient experienced tachy ventricular arrhythmia and cardiogenic shock and was transferred to intensive care unit after electrical cardioversion, tracheal intubation and cardiopulmonary resuscitation. Intravenous immunoglobulin therapy at 25 g/day was given and methylprednisolone was reduced to 40 mg/day for the next 3 days. Intravenous esmolol and lidocaine were used for correcting arrhythmias. Ventilator positive pressure ventilation was used for respiratory support. She was administrated with plasmapheresis when the electrocardiogram monitoring showed ventricular arrhythmia storms. Outcome: The patient progressed to ventricular arrhythmia storms and cardiac failure, which eventually resulted in death. Lessons: The case aims to raise awareness of immune-mediated cardiotoxicity and bring thoughts to the prospects of immunotherapy in thymoma.

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“…To the best of our knowledge, in the domestic and foreign literature to date, there are no meta-analyses on the use of sintilimab for advanced NSCLC. Meta-analyses of PD-1/PD-L1 receptor inhibitors for advanced NSCLC treatment have only included a small number of sintilimab-related studies ( 15 , 16 ). A meta-analysis was performed in in the present study to assess the safety and effectiveness of sintilimab in the treatment of advanced NSCLC, in order to serve as a model for the therapeutic use of sintilimab in advanced NSCLC.…”

Section: Introductionmentioning

confidence: 99%

Meta‑analysis of the efficacy and safety of sintilimab for treating advanced non‑small cell lung cancer

Xie

et al. 2022

Oncol Lett

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Lung cancer is the leading cause of death from malignant tumors in China, and non-small cell lung cancer (NSCLC) accounts for >80% of all types of lung cancer. Novel immunotherapeutic agents targeting programmed death protein-1 (PD-1) and its ligands [programmed death ligands (PD-L)1 and 2] have emerged as important therapeutic measures and trends in the treatment of advanced NSCLC. Sintilimab (trade name, Daboshu) is a humanized IgG4 monoclonal antibody targeting PD-1 that was developed by Innovent Biologics and Eli Lilly and Company. Studies have shown that sintilimab has the characteristics of high affinity, long-lasting stability and an increased target occupancy rate, and that it is a broad-spectrum drug. The present study uses a meta-analysis to evaluate the safety and efficacy of sintilimab in treating advanced NSCLC. The PubMed, Cochrane Library, Embase, Chinese Biomedical Literature, China National Knowledge Infrastructure, VIP Chinese Science and Technology Journal and Wanfang Medical databases were searched from their establishment until October 2021. Randomized controlled trials of patients with NSCLC who were treated with conventional chemotherapy (chemotherapy) plus sintilimab treatment or sintilimab alone, compared with a chemotherapy group, were included, and a meta-analysis was performed using RevMan 5.3 software. The findings revealed that there was no significant difference between the conventional chemotherapy group and the sintilimab group in terms of the overall incidence of adverse drug reactions (ADR) or grade 3-5 ADRs (risk ratio, 1.04; 95% confidence interval, 0.96-1.14; P=0.33), respectively. Sintilimab coupled with chemotherapy outperformed standard chemotherapy in treating advanced NSCLC. The ADRs did not differ considerably from those of conventional chemotherapy, which will help in the assessment of the clinical efficacy of sintilimab combined with chemotherapy and conventional chemotherapy in treating advanced NSCLC.

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Efficacy and Safety Evaluation of Sintilimab for Cancer Treatment: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Cited by 5 publications

References 13 publications

A rare presentation of Sintilimab-induced swelling along the vessels: Case report

A rare presentation of Sintilimab-induced swelling along the vessels: Case report

Immune checkpoint inhibitor sintilimab-induced lethal myocarditis overlapping with myasthenia gravis in thymoma patient: A case report

Meta‑analysis of the efficacy and safety of sintilimab for treating advanced non‑small cell lung cancer

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