Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metas
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ORIGINAL RESEARCH
Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the Phase 3 FRESCO Trial Jin Li . Weijian Guo . Yuxian Bai . Yanhong Deng . Lei Yang . Zhendong Chen . Haijun Zhong . Ruihua Xu . Hongming Pan . Yongqian Shu . Ying Yuan . Jianfeng Zhou . Nong Xu . Tianshu Liu . Dong Ma . Changping Wu . Ying Cheng . Jianming Xu . Donghui Chen . Wei Li . Sanyuan Sun . Zhuang Yu . Peiguo Cao . Lin Shen . Haihui Chen . Shubin Wang . Hongbing Wang . Songhua Fan . Xiaojun Guo . Ning Wang . Rubing Han . Bin Zhang . Shukui Qin Received: March 4, 2020 Ó Springer Healthcare Ltd., part of Springer Nature 2020
ABSTRACT Introduction: In FRESCO (Fruquintinib Efficacy and Safety in 3? Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful
Jin Li and Weijian Guo contributed equally to this manuscript.
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overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI), is not well known. The present analysis evaluated the safety profile and AESIs for fruquintinib in the FRESCO trial. Methods: In FRESCO, eligible Chinese patients were randomized (2:1) to receive fruquintinib (5 mg once daily for 3 weeks, followed by 1 week off in 28-day cycles) or placebo plus best
Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s12325020-01477-w) contains supplementary material, which is available to authorized users. J. Li Department of Medical Oncology, Tongji University East Hospital, Shanghai, China
Y. Deng Department of Medical Oncology, The Sixth Hospital Affiliated to Sun Yat-sen University, Guangzhou, China
W. Guo Department of Medical Oncology, Shanghai Medical College, Fudan University Shanghai Cancer Center, Shanghai, China
L. Yang Department of Medical Oncology, Nantong Cancer Hospital, Nantong, China
Y. Bai Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China
Z. Chen Department of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei, China
Adv Ther
10, 21, and 20 days, respectively. Subgroup analysis by age, sex, and BMI revealed that the frequencies of treatment-related TEAEs were similar across all subgroups, and were consistent with the overall safety profile of fruquintinib. Conclusions: The most common treatment-related grade C 3 AEs were hypertension, HFSR, and proteinuria. The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population. Trial Registration: Clinical Trials identifier NCT02314819.
supportive care. Treatment-related AESIs a
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