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
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
Endostar + radiotherapy (n = 60) | Chemo-radiotherapy (n = 60) | Hazard ratio* (95% CI) | P value† | |
---|---|---|---|---|
Overall survival | ||||
Deaths | 5(8.3%) | 13(21.7%) | ||
patients with 3 years OS | 93.2% (86.8-99.6) | 79.3% (68.9-89.7) | 0.342 (0.122-0.960) | 0.032 |
Progression-free survival | ||||
Failures | 7(11.7%) | 17(28.3%) | ||
patients 3 years PFS rate | 89.8% (82.2-97.4) | 70.6% (58.8-82.4) | 0.362 (0.150-0.873) | 0.018 |
Locoregional failure-free survival | ||||
Locoregional failures | 3(5.0%) | 4(6.7%) | ||
without locoregional failure at 3 years | 96.6% (91.9-99.9) | 92.0% (84.4-99.6) | 0.651 (0.146-2.911) | 0.572 |
Distant failure-free survival | ||||
Distant failures | 4(6.7%) | 11(18.3%) | ||
without distant failures at 3 years | 93.2% (86.7-99.7) | 80.7% (70.5-90.9) | 0.325 (0.103-1.021) | 0.042 |
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Abstract Disclosures
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