In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 6050-6050
Abstract:
6050 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. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2021.39.15_suppl.6050
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2021
detail.hit.zdb_id:
2005181-5
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