He Shasha, Wang Yan, Lai Yulin, Cao Xinping, Ren Yufeng, Chen Yong
Department of Radiation Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Department of Radiation Oncology, Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou, China.
Front Oncol. 2022 Feb 2;11:798617. doi: 10.3389/fonc.2021.798617. eCollection 2021.
In this trial, we aimed to assess the efficacy and safety of radiotherapy with nedaplatin or cisplatin in patients with locally advanced cervical cancer.
We 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.
We 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%; < 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.
Our 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.
在本试验中，我们旨在评估奈达铂或顺铂同步放化疗治疗局部晚期宫颈癌患者的疗效和安全性。
我们开展了一项开放标签、非劣效性、III期随机对照试验。符合条件的IIB-IVA期宫颈癌患者被随机分配接受奈达铂或顺铂同步放化疗两个周期。我们报告了治疗相关的不良事件和生存率。该研究已在中国临床试验注册中心（chictr.org.cn）注册，注册号为ChiCTR1800020527。
我们将68例患者随机分配至奈达铂或顺铂同步放化疗组。数据分析发现奈达铂组严重血液学不良事件的患者数量高于顺铂组后，提前终止了研究治疗。奈达铂组3-4级中性粒细胞减少（19.4% 对13%；P<0.0_01）、严重血小板减少（16.1% 对4.3%）和1-2级贫血（51.6% 对43.5%）的发生率显著高于顺铂组。奈达铂组和顺铂组的1年无进展生存期和总生存期相似。
我们的研究结果表明，奈达铂同步放化疗的严重血液学不良事件明显更多，且可能致命。尽管结果为阴性，但我们从中吸取的经验教训很重要。
