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Adverse Events and Efficacy of Cixutumumab in Phase II Clinical Trials: A systematic Review and Meta-Analysis

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Abstract

Background and Objectives

Cixutumumab is a monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF1R). We sought to evaluate the efficacy of cixutumumab in the treatment of cancer, and to comprehensively assess the associated adverse events in phase II clinical trials.

Methods

Data were collected from PubMed, Embase, and Clinicaltrials.gov. The improvement on progression-free survival (PFS) was evaluated by hazard ratio (HR) and 95% confidence intervals (95% CIs). We also carried a meta-analysis to comprehensively evaluate the incidence of adverse events.

Results

The adverse events that were mentioned most frequently were hyperglycemia, anemia, nausea, fatigue, and thrombocytopenia. The most frequent adverse events were hyponatremia (40.28%), fatigue (35.18%), and skin rash (35.11%). Results showed that cixutumumab treatments did not benefit PFS (HR 1.03, 95% CI 0.83–1.26, p = 0.979). The complete response (CR) was rarely seen in phase II trials.

Conclusions

Cixutumumab was well tolerated when used alone and in combination therapies, but its antitumor activity was low in the existing phase II clinical trials. An acceptable incidence of adverse effects supports further investigation of this drug, provided that it shows antitumor activity in combination with other drugs.

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    Authors and Affiliations

    1. Institute of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China

      Hongxin Cao, Lixuan Cui, Kai Wang & Jiajun Du

    2. Department of Chemotherapy, Cancer Center, Qilu Hospital of Shandong University, 8, Jinan, Shandong, 250012, People’s Republic of China

      Hongxin Cao

    3. Department of Thoracic Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China

      Wei Ma, Linhai Zhu & Jiajun Du

    4. Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China

      Yang Ni

    5. Department of Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, 250021, China

      Yibing Wang

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    1. Hongxin Cao
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    Correspondence to Yibing Wang or Jiajun Du.

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    This work was supported by Medicine and Health Science Technology Development Plan of Shandong Province (2013WS0103) and Natural Science Foundation of Shandong Province (ZR2014HQ028) and Provincial science and technology development plan of Shandong (2015GSF118063).

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    All authors have completed the Unified Competing Interest form (available on request from the corresponding author) and no support from any organization for the submitted work and no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years. No other relationships or activities that could appear to have influenced the submitted work.

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    H. Cao and L. Cui contributed equally to this work.

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    Cao, H., Cui, L., Ma, W. et al. Adverse Events and Efficacy of Cixutumumab in Phase II Clinical Trials: A systematic Review and Meta-Analysis. Clin Drug Investig 37, 135–153 (2017). https://doi.org/10.1007/s40261-016-0475-y

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