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Clinical Drug Investigation

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01-01-2016 | Systematic Review

The Impact of Ramucirumab on Survival in Patients with Advanced Solid Tumors: A Systematic Review and Meta-Analysis of Randomized II/III Controlled Trials

Authors: Kai Wang, Xiao Qu, Ying Wang, Wei Dong, Hongchang Shen, Tiehong Zhang, Yang Ni, Qi Liu, Jiajun Du

Published in: Clinical Drug Investigation | Issue 1/2016

Abstract

Background and Objectives

Ramucirumab is a fully immunoglobulin G (lgG) monoclonal antibody targeting vascular endothelial growth factor receptor type 2 (VEGFR2). Previous clinical trials suggested ramucirumab could improve the survival and increase the risk of adverse effects. Here, we aimed to assess the efficacy and safety of ramucirumab in the treatment of advanced solid tumors.

Methods

Publications were searched from Pubmed, Embase database and clinicaltrials.gov. Hazard ratio (HR) and 95 % confidence interval (95 % CI) were calculated to evaluate efficacy, and the risk ratio (RR) for adverse effects.

Results

Ten relevant studies were included. Ramucirumab resulted in significant benefit in overall survival [OS, HR and 95 % CI 0.87 (0.82–0.93), I ²: 0.0 %] and progression-free survival [PFS, HR and 95 % CI 0.74 (0.66–0.82), I ²: 67.4 %]. Also the difference of time to progression (TTP) and objective response rate (ORR) between two groups were also significant [0.70 (0.57–0.88) and 1.78 (1.40–2.25), respectively]. Ramucirumab could increase the risk of total adverse effects (TAEs, of any grade) by 1 % (from 0 to 2 %) and severe adverse effects (SAEs, grade > 2) by 17 % (from 9 to 26 %). The most frequently occurring TAEs were fatigue (54.71 %), neutropenia (42.74 %), bleeding (37.55 %), nausea (34.63 %) and stomatitis (33.74 %). Most frequently occurring SAEs (grade ≥3) were neutropenia (33.43 %), fatigue (12.08 %), leukopenia (10.59 %), hypertension (8.99 %) and liver injury (8.74 %).

Conclusion

Ramucirumab could improve OS and PFS for patients suffering from advanced solid tumors. Ramucirumab could increase the risk of TAEs and SAEs.

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Title: The Impact of Ramucirumab on Survival in Patients with Advanced Solid Tumors: A Systematic Review and Meta-Analysis of Randomized II/III Controlled Trials
Authors: Kai Wang
Xiao Qu
Ying Wang
Wei Dong
Hongchang Shen
Tiehong Zhang
Yang Ni
Qi Liu
Jiajun Du
Publication date: 01-01-2016
Publisher: Springer International Publishing
Published in: Clinical Drug Investigation / Issue 1/2016
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.1007/s40261-015-0355-x

At a glance: The STEP trials

Springer Medicine

The Impact of Ramucirumab on Survival in Patients with Advanced Solid Tumors: A Systematic Review and Meta-Analysis of Randomized II/III Controlled Trials

Abstract

Background and Objectives

Methods

Results

Conclusion

At a glance: The STEP trials

Springer Medicine

Abstract

Background and Objectives

Methods

Results

Conclusion

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