In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 6061-6061
Abstract:
6061 Background: Concurrent chemoradiotherapy (CCRT) is currently considered to be the standard treatment for locoregionally advanced nasopharyngeal carcinoma (LA-NPC), accompanied with non-neglectable toxicity and unsatisfactory compliance. Therefore, it is highly warranted to explore an alternative regimen for LA-NPC. This trial aimed to assess and investigate the efficacy and safety of recombinant human endostatin ( Rh-endostatin) with intensity-modulated radiotherapy (IMRT) for low-risk LA-NPC. Methods: Patients with low-risk LA-NPC were randomly assigned into ERT group (n=60, receiving Rh-endostatin plus radiotherapy) and CCRT group (n=60, receiving cisplatin plus radiotherapy). The primary endpoint was the 5-year overall survival (OS). Non-inferiority was shown if the upper limit of the 95% CI for the difference in 5-year OS between the ERT group and CCRT group did not exceed 15%. The secondary endpoint was 3-year progression-free survival (PFS). Results: A total of 120 patients were included in the trial. After a median follow-up of 71 months (IQR 62-75), the 5-year OS rate was 88.1% in the ERT group and 77.6% in the CCRT group, with a difference of 10.5% (95% CI: -0.03 to 0.24; P non -inferiority = 0.002). Patients in the ERT group had better 3-year PFS than that in the CCRT group (89.8% vs 70.6%; HR = 0.362; 95% CI: 0.150-0.873; P log-rank = 0.018). The overall all-grade toxicity burdens were heavier in CCRT group. No patients died of treatment-related causes. Conclusions: Rh-endostatin combined with IMRT had favorable efficacy, fewer toxic effects and more improved quality of life, which might be a promising alternative regimen to CCRT for low-risk LA-NPC in clinic. Clinical trial information: NCT02237924. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2022.40.16_suppl.6061
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2022
detail.hit.zdb_id:
2005181-5
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