Hongxin Cao1,2, Lixuan Cui1, Wei Ma3, Linhai Zhu3, Kai Wang1, Yang Ni4, Yibing Wang5, Jiajun Du6,7. 1. Institute of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China. 2. Department of Chemotherapy, Cancer Center, Qilu Hospital of Shandong University, 8, Jinan, Shandong, 250012, People's Republic of China. 3. Department of Thoracic Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China. 4. Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China. 5. Department of Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, 250021, China. wyb0616@163.com. 6. Institute of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China. dujiajun@sdu.edu.cn. 7. Department of Thoracic Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China. dujiajun@sdu.edu.cn.
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.
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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