Endostar combined with intensity-modulated radiotherapy in low-risk local advanced nasopharyngeal carcinoma: A phase II, randomized, multicentric clinical trial.

Authors

null

Min Kang

Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China

Min Kang , Shaomin Lin , Haisheng Zhu , Sihui Liao , Haixin Huang , Bin Yu , Hongqian Wang , Meilian Liu , Jinxian Zhu , Guang Huang , Tingting Zhang , Zhendong Yang , Pingting Zhou , Ziyan Zhou , Yutao Qin , Zhuxin Wei , Qinghua Du , Changhong Zhao , Mingjun Shen , Rensheng Wang

Organizations

Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China, Department of Radiation Oncology, People’s Hospital of Hainan Province, Haikou, China, Department of Radiation Oncology, First People’s Hospital of Yulin City, Yulin, China, Department of Radiation Oncology, People’s Hospital of Beihai City, Beihai, China, Department of Radiation Oncology, Liuzhou Worker Hospital, Liuzhou, China, Department of Radiation Oncology, People’s Hospital of Liuzhou City, Liuzhou, China, Department of Radiation Oncology, Yulin Red Cross Hospital, Yulin, China, Guilin Medical College, Guilin, China, The Red Cross Hospital of Wuzhou, Wuzhou, China, Simcere, Nanjing, China, The First Affiliated Hospital of Guangxi Medical University, Nanning, China

Research Funding

Other Foundation
National Natural Science Foundation of China

Background: A Phase II, randomized, prospective, multicentric trial was conducted to evaluate the efficacy and safety of Endostar plus radiotherapy in patients with low-risk local advanced nasopharyngeal carcinoma (NPC). This study reported the preliminary results of NCT02237924. 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 OS rate, progression free survival (PFS) rate, loco-regional recurrence free survival (LRRFS) rate and distance metastasis free survival (DMFS) rate. Results: After a median follow-up of 47 months, 3-year OS rate were 93.2% and 79.3% (p=0.032), 3-year PFS rate were 89.8% and 70.6% (p=0.011), 3-year DMFS rate were 93.2% and 80.7%, in two groups, respectively (P=0.042). 3-year LRRFS rate were 96.6% and 92.0% in two groups, respectively (but P=0.565). For short-term curative effects, CR rate were 71.2% and 60.0% for primary tumor, 74.6%and 63.3%for cervical lymph nodes, in two groups, respectively (P < 0.05). Moreover, the incidences of adverse events were significantly lower in ERT group compared with in CCRT group. The grade 3/4 Hyponatraemia (0 [0%] vs 3 [5%], p=0·04), the grade 1/2 vomiting (10 [16.7%] vs 52 [86.7%], p=0.000), dry mouth (45 [75.0%] vs 56 [93.3%], p=0.012), leukopenia (22 [36.7%] vs 42 [70.0%], p=0.000) and weight loss (30 [50.0%] vs 45 [75.0%], p=0.005). No patients died of treatment-related causes. Conclusions: 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. Clinical trial information: NCT02237924

Survival outcomes to treatment.


Endostar + radiotherapy

(n = 60)
Chemo-radiotherapy

(n = 60)
Hazard ratio*

(95% CI)
P value†
Overall survival
 Deaths5(8.3%)13(21.7%)
 patients with 3 years OS93.2% (86.8-99.6)79.3% (68.9-89.7)0.342 (0.122-0.960)0.032
Progression-free survival
 Failures7(11.7%)17(28.3%)
 patients 3 years PFS rate89.8% (82.2-97.4)70.6% (58.8-82.4)0.362 (0.150-0.873)0.018
Locoregional failure-free survival
 Locoregional failures3(5.0%)4(6.7%)
 without locoregional failure at 3 years96.6% (91.9-99.9)92.0% (84.4-99.6)0.651 (0.146-2.911)0.572
Distant failure-free survival
 Distant failures4(6.7%)11(18.3%)
 without distant failures at 3 years93.2% (86.7-99.7)80.7% (70.5-90.9)0.325 (0.103-1.021)0.042

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Head and Neck Cancer

Track

Head and Neck Cancer

Sub Track

Local-Regional Disease

Clinical Trial Registration Number

NCT02237924

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 6050)

DOI

10.1200/JCO.2021.39.15_suppl.6050

Abstract #

6050

Poster Bd #

Online Only

Abstract Disclosures