Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Patients With Stage IIB-IVA Cervical Cancer: A Randomized Phase III Trial

Frontiers in Oncology

Oncology

Xinping Cao¹  Yufeng Ren²  Yulin Lai²  Yan Wang²  Yong Chen²  Shasha He² 

[1] Department of Radiation Oncology, Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou, China;Department of Radiation Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China;

关键词: cervical carcinoma;    nedaplatin;    cisplatin;    toxicity;    survival;   

DOI  :  10.3389/fonc.2021.798617

 received in 2021-10-20, accepted in 2021-12-21,  发布年份 2022

来源: Frontiers

【 摘 要 】

BackgroundIn this trial, we aimed to assess the efficacy and safety of radiotherapy with nedaplatin or cisplatin in patients with locally advanced cervical cancer.MethodsWe conducted an open-label, non-inferiority, phase III, randomized, controlled trial. Eligible patients with stage IIB-IVA cervical carcinoma were randomly assigned to receive either nedaplatin or cisplatin for two cycles concurrently with radiotherapy. We reported the therapy-associated harms and survival. The study was registered with chictr.org.cn, number ChiCTR1800020527.ResultsWe randomly assigned 68 patients to nedaplatin-based or cisplatin-based concurrent chemoradiotherapy. Study treatment was stopped early after a data analysis found a higher number of patients suffered severe hematologic harms in the nedaplatin group than in the cisplatin group. Patients in the nedaplatin group had a significantly higher frequency of grade 3-4 neutropenia (19·4% vs. 13%; P < 0·001), severe thrombocytopenia (16·1% vs. 4·3%), and grade 1-2 anemia (51·6% vs. 43·5%) than patients in the cisplatin group. The 1-year PFS and OS in the nedaplatin and cisplatin groups were similar.ConclusionOur findings showed that nedaplatin-based concurrent chemoradiotherapy expressed remarkably higher severe hematologic harms which were mortal. Though the results were negative, the experiences and lessons we learned from it were important.

【 授权许可】

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Copyright © 2022 He, Wang, Lai, Cao, Ren and Chen