Hui Chang1, Wei Yi2, Xiaohui Wang1, Yalan Tao1, Xin Yang1, Chen Chen1, Wenwen Zhang1, Shu Zhou1, Songran Liu1, Xiaohui Li3, Shirong Ding1, Jing Li4, Gong Li5, Xunfan Shao6, Yimin Liu7, Weishu Song8, Yunfei Xia1. 1. Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou 510060, China. 2. Department of Radiation Oncology, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China. 3. Department of Oncology, People's Liberation Army 421 Hospital, Guangzhou 510318, China. 4. Department of Oncology, the Main Guangzhou Hospital of the Guangzhou Military Region, Guangzhou 510010, China. 5. Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510530, China. 6. Department of Radiation Oncology, the Affiliated Cancer Hospital of Guangzhou Medical College, Guangzhou 510095, China. 7. Department of Radiation Oncology, the Second Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510120, China. 8. Department of Oncology, Guangdong Second People's Hospital, Guangzhou 510317, China.
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.
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.
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