Endostar Combined with Intensity-Modulated Radiotherapy in Low-Risk Local Advanced Nasopharyngeal Carcinoma: A Phase II, Randomized, Multicentric Clinical Trial

Background: A Phase II, randomized, prospective, multicentric trial (NCT02237924) was conducted to evaluate the efficacy and safety of Endostar plus radiotherapy in patients with low-risk local advanced nasopharyngeal carcinoma (NPC). Methods: From 09/2014 to 08/2016, patients with low-risk local advanced NPC were randomly treated with Endostar plus radiotherapy (ERT group, n=60) and concurrent chemoradiotherapy (CCRT group, n=60). Primary endpoint was the 5-year overall survival (OS) rate. The secondary endpoints were 3-year progression free survival (PFS) rate, OS rate, loco-regional recurrence free survival (LRRFS) rates and distance metastasis free survival (DMFS) rates. Findings: After a median follow-up of 47 months, 3-year OS rates were 93.2% and 79.3%, 3-year PFS rates were 89.8% and 70.6%, 3-year DMFS rates were 93.2% and 80.7%, in two groups, respectively (P 0.05). Moreover, the incidences of complications were significantly lower in ERT group. For short-term curative effects, CR rates were 70.0% and 60.0% for primary tumor, 73.3%and 65.0% for cervical lymph nodes, in two groups, respectively (P 0.05). Interpretation: OS, PFS, and DMFS rates can be improved, adverse events be reduced, with better tolerability, by Endostar plus radiotherapy, when compared to concurrent chemoradiotherapy for local advanced low-risk NPC. Trial Registration: (NCT02237924). Funding Statement: This work was supported by National Natural Science Foundation of China (No. 81760542), the Projects for Research and Development of Medical and Health Appropriate Technology of Guangxi Zhuang Autonomous Region (No. S2018087), the Key Research and Development Program of Guangxi (No. Guike AB18281003), Guangxi Medical University Training Program for Distinguished Young Scholars, and Medical Excellence Award Funded by the Creative Research Development Grant from the First Affiliated Hospital of Guangxi Medical University, “139” Program for high-level medical talents in Guangxi, Innovation Team of the First Affiliated Hospital of Guangxi Medical University. Guangxi Science and Technology Program Project (GK AD17129013), Simcere. Declaration of Interests: The authors declare that they have no competing interests. Ethics Approval Statement: This study was approved by the Ethics Committee of Guangxi Medical University. All procedures performed in the study involving human participants were in accordance with the ethical standards of the 1964 Helsinki declaration and its later amendments. Written informed consent was obtained from the patient and his/her immediate families.