A phase II randomized, multicentric clinical trail comparing recombinant human endostatin plus intensity-modulated radiotherapy versus concurrent chemoradiotherapy in locally advanced low-risk nasopharyngeal carcinoma.

作者：Kang, Min; Lin, Shaomin; Zhu, Haisheng; Liao, Sihui; Huang, Haixin; Yu, Bin; Wang, Hongqian; Liu, Meilian; Zhu, Jinxian; Huang, Guang; Qin, Yutao; Wei, Zhuxin; Du, Qinghua; Hu, Kai; Zhang, Tingting; Zhou, Pingting; Liao, Xueyin; Wang, Rensheng

来源：53rd Annual Clinical Science Meeting of the American-Society-of-Clinical-Oncology (ASCO) / Symposium on Old Targets, New Drugs - Her2 and MET, Chicago, IL, 2017-06-02 To 2017-06-07.

DOI：10.1200/JCO.2017.35.15_suppl.6063

<jats:p> 6063 </jats:p><jats:p> Background: A prospective, randomized, and multicentric phase II study was performed to evaluate the short-term efficacy and safety of Endostar plus intensity-modulated radiotherapy (IMRT) versus concurrent chemoradiotherapy(CCRT) in locally advanced low-risk nasopharyngeal carcinoma(NPC). Methods: From September 2014 to August 2016, 120 patients with low-risk NPC at stages III-IVa from 9 centers were randomly divided into experimental group (Endostar plus radiotherapy (ERT); n = 60) and control group (CCRT; n = 60). ERT patients were given Endostar (7.5 mg/m<jats:sup>2</jats:sup>/day) by continuous intravenous infusion (CIV) from 5 days before radiotherapy for consecutive 10 days for 2 cycles with an interval of 14 days. Then, ERT patients received 2 cycles of 10 days of maintenance treatment with Endostar after radiotherapy. The CCRT patients were given cisplatin (100 mg/m<jats:sup>2</jats:sup>) on days 1, 22, and 43 for 3 cycles. Immediate and 3-month efficacy and adverse effects were evaluated between the two groups. ClinicalTrials registration number was NCT02237924. Results: All patients were eligible for toxicity and response analysis. Regarding immediate efficacy, the complete response(CR) rates were 45.0% for ERT arm and 33.3% for CCRT arm in nasopharynx (P = 0.190), and 43.3% for ERT arm and 36.7% for CCRT arm in regional nodes (P = 0.456). Three months after RT, the CR rates were 71.2% for ERT arm and 60.0% for CCRT arm in nasopharynx (P = 0.151), and 74.6% for ERT arm and 63.3% for CCRT arm in regional nodes (P = 0.172). The rate and severity of leukopenia, hemoglobin reduction and thrombocytopenia in ERT arm were significantly lower than CCRT arm (P &lt; 0.01). The occurrence rates of Xerostomia, oral mucositis, nausea / vomiting, constipation and weight loss in ERT arm were significantly lower than those in CCRT arm (P &lt; 0.01). Conclusions: The present study demonstrates that ERT has similar short-term efficacy on locally advanced low-risk NPC compared with CCRT, but the acute adverse effects of ERT are fewer, and the compliance and tolerability of patients are better. Clinical trial information: NCT02237924. </jats:p>

• 出版日期2017-5-20
• 单位海南省人民医院; 桂林医学院; 广西医科大学; 北海市人民医院; 柳州市人民医院; 梧州市红十字会医院; 柳州市工人医院