1. Effectiveness and safety of different amifostine regimens: Preliminary results of a phase II multicenter randomized controlled trial
- Author
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Song-Ran Liu, Wenwen Zhang, Chen Chen, Yun-Fei Xia, Weishu Song, Wei Yi, Jing Li, Xiaohui Wang, Xiaohui Li, Xin Yang, Shu Zhou, Yimin Liu, Xunfan Shao, Shirong Ding, Hui Chang, Yalan Tao, and Gong Li
- Subjects
0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Randomization ,medicine.medical_treatment ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Mucositis ,medicine ,Adverse effect ,business.industry ,Amifostine ,medicine.disease ,Radiation therapy ,stomatognathic diseases ,Regimen ,030104 developmental biology ,Nasopharyngeal carcinoma ,030220 oncology & carcinogenesis ,Original Article ,business ,medicine.drug - Abstract
Objective The radioprotective effects of amifostine remain uncertain in patients with nasopharyngeal carcinoma (NPC), and adverse effects and cost limit generalization of its classical everyday regimen. This phase II multicenter randomized controlled trial aimed to explore whether amifostine could ameliorate the toxicities of NPC patients in the era of intensity-modulated radiotherapy (IMRT), and to compare different regimens of amifostine on effectiveness and safety. Methods Patients with stage I-IVB NPC were involved prospectively from January 1st, 2013. All patients received radical treatment based on IMRT. After a randomization stratified by their stage, these patients were allocated into 3 groups: the group treated without amifostine, the group treated with the everyday regimen of amifostine, and the group treated with the every-other-day regimen. The 3 groups of patients were compared on radiotherapy-related acute toxicities, treatment effects of NPC, and amifostine-related complications. This trial was registered on the clinicaltrials.gov (ID: NCT01762514). Results Until August 31st, 2017, totally 187 patients completed experimental intervention. Only amifostine of everyday regimen appeared to reduce the patient proportion of mucositis (79.1% vs. 96.8%, P=0.002). Hypocalcemia was less common in patients treated without amifostine than in those treated with amifostine (22.6% vs. 53.4% vs. 41.8%, P=0.002). Neither complete remission rates nor the survivals were affected by amifostine. Conclusions Amifostine of everyday regimen could reduce mucositis in NPC patients who received IMRT, though it also had the possibility to cause more hypocalcemia.
- Published
- 2018
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