scholarly journals Development and prospective validation of a risk score model in guiding individualized concurrent chemoradiotherapy in stage II nasopharyngeal carcinoma in intensity‐modulated radiotherapy era

2021 ◽  
Author(s):  
Shan‐Shan Yang ◽  
Ya‐Jun Pang ◽  
Zhi‐Qiang Wang ◽  
Bao‐Yu Zhang ◽  
Zhi‐Qiao Liu ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Risk Score ◽  
Concurrent Chemoradiotherapy ◽  
Intensity Modulated Radiotherapy ◽  
Stage Ii ◽  
Intensity Modulated ◽  
Score Model

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.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6063-6063
Author(s):  
Min Kang ◽  
Shaomin Lin ◽  
Haisheng Zhu ◽  
Sihui Liao ◽  
Haixin Huang ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Adverse Effects ◽  
Phase Ii ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Intensity Modulated Radiotherapy ◽  
Low Risk ◽  
Short Term ◽  
Intensity Modulated ◽  
Term Efficacy

6063 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/m2/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/m2) 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 < 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 < 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.

Sign in / Sign up

Export Citation Format

Share Document