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作者

Lu, Shun Wu, Jiong Jiang, Jin Guo, Qisen Yu, Yan Liu, Yu Zhang, Hua Qian, Ling Dai, Xiumei Xie, Yanyan Fu, Ting Lee, Tyson Lu, Yan Ma, Rui Eisner, Mark D.

作者单位

Harbin Medical University Cancer Hospital, Harbin, China Shandong First Medical University Cancer Hospital, Jinan, China The First People's Hospital of Foshan, Foshan, China Neijiang Second People's Hospital, Neijiang, China Cancer Hospital, Fudan University, Shanghai, China Xuzhou Central Hospital, Xuzhou, China 10 The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China 11 Zhuzhou Central Hospital, Zhuzhou, China 12 FibroGen, Inc, San Francisco, CA 13 FibroGen (China) Medical Technology Development Co, Ltd, Shanghai, China Shanghai Fifth People's Hospital, Shanghai, China The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

刊名

Journal of Clinical Oncology

年份

2024

页码

JCO2302742

ISSN

0732-183X

摘要

PURPOSE We evaluated the efficacy and safety of roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for chemotherapy-induced anemia in patients with nonmyeloid malignancies receiving multicycle treatments of chemotherapy. PATIENTS AND METHODS In this open-label, noninferiority phase III study conducted at 44 sites in China, 159 participants age ≥18 years with CIA nonmyeloid malignancy and CIA were randomly assigned to oral roxadustat or subcutaneous recombinant ...更多

PURPOSE We evaluated the efficacy and safety of roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for chemotherapy-induced anemia in patients with nonmyeloid malignancies receiving multicycle treatments of chemotherapy. PATIENTS AND METHODS In this open-label, noninferiority phase III study conducted at 44 sites in China, 159 participants age ≥18 years with CIA nonmyeloid malignancy and CIA were randomly assigned to oral roxadustat or subcutaneous recombinant human erythropoietin-α three times a week for 12 weeks. Roxadustat starting dosages were 100, 120, and 150 mg three times a week for participants weighing 40-60 kg, respectively. rHuEPO-α starting dosage for all participants was 150 IU/kg three times a week. Both roxadustat and rHuEPO-α dosages could be modified. The primary end point was least-squares mean change in hemoglobin concentration from baseline to the concentration averaged over weeks 9-13. RESULTS Of the 159 participants randomly assigned, 140 were included in the per-protocol set . The LSM change from baseline to weeks 9-13 in Hb concentration was 17.1 g/L with roxadustat and 15.4 g/L with rHuEPO-α . The lower bound of the one-sided 97.5% CI for the treatment difference was greater than the predefined noninferiority margin of ‒6.6 g/L, establishing noninferiority. Noninferiority was supported by five of six key secondary end points. Rates of adverse events were generally comparable between treatments and consistent with previous findings. CONCLUSION Roxadustat was noninferior to rHuEPO-α in treating CIA in participants with nonmyeloid malignancies receiving multicycle treatments of myelosuppressive chemotherapy. The oral formulation of roxadustat may potentially increase compliance.收起

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