Abstract
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.
Highlights
Cervical cancer is one of the most common malignant carcinomas in women, is currently the fourth leading cancer in women worldwide, and resulted in approximately 570 000 cases of cervical cancer and 311 000 deaths from the disease in 2018
The results showed the 2-year PFS in the cisplatin group was 89·9% vs. 88·0% in the nedaplatin group, with no statistic difference; the results were similar for overall survival (OS) and local relapse-free survival (LRFS)
A total of 3 patients in the nedaplatin group and 11 patients in the cisplatin group withdrew from the trial before the initiation of trial treatment
Summary
Cervical cancer is one of the most common malignant carcinomas in women, is currently the fourth leading cancer in women worldwide, and resulted in approximately 570 000 cases of cervical cancer and 311 000 deaths from the disease in 2018. Compared with 40 years ago, the morbidity of cervical cancer has decreased due to the established screening program and available vaccines for human papilloma virus (HPV) in many countries, Chemotherapy Regimens in Cervical Cancer advanced cervical cancer cases remain prevalent, especially in developing countries [2]. The international standard treatment for advanced cervical cancer is platinum-based chemoradiotherapy [3]. While the main direction of current studies in concurrent chemoradiotherapy (CCRT) is still trying to improve efficacy and reduce adverse events. In this trial, we aimed to assess the efficacy and safety of radiotherapy with nedaplatin or cisplatin in patients with locally advanced cervical cancer
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