Concurrent chemoradiotherapy plus anlotinib vs. concurrent chemoradiotherapy alone in locally advanced nasopharyngeal carcinoma: An interim analysis of a multicenter randomized controlled trial<strong><br /></strong>

Chen,Kequan; Xu,Guoding; Liang,Yong; Liang,Ping; Gao,Weiwei; Li,Zhou; Liang,Weichao; Tao,Zheng; Chen,Jiaxin; Hu,Xiaohua; Xu,Yaocan

doi:10.3892/ol.2023.13978

Concurrent chemoradiotherapy plus anlotinib vs. concurrent chemoradiotherapy alone in locally advanced nasopharyngeal carcinoma: An interim analysis of a multicenter randomized controlled trial

Authors:
- Kequan Chen
- Guoding Xu
- Yong Liang
- Ping Liang
- Weiwei Gao
- Zhou Li
- Weichao Liang
- Zheng Tao
- Jiaxin Chen
- Xiaohua Hu
- Yaocan Xu
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Affiliations: Department of Oncology, Guiping People's Hospital, Guiping, Guangxi Zhuang Autonomous Region 537200, P.R. China, Department of Oncology, The First People's Hospital of Nanning, The Fifth Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi Zhuang Autonomous Region 530022, P.R. China, Department of Oncology and Radiotherapy, Guangxi Academy of Medical Sciences, The People's Hospital of Guangxi Zhuang, Nanning, Guangxi Zhuang Autonomous Region 530021, P.R. China, Department of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi Zhuang Autonomous Region 530021, P.R. China
Published online on: July 27, 2023 https://doi.org/10.3892/ol.2023.13978
Article Number: 392
Copyright: © Chen et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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Abstract

Despite the use of intensity‑modulated radiation therapy (IMRT) and concurrent chemotherapy (CCRT), the treatment of locoregionally advanced nasopharyngeal carcinoma (LA‑NPC) is not satisfactory. EGFR and VEGFR are highly expressed in 60‑80% of patients with LA‑NPC and this is associated with a poor prognosis, which suggests the potential effectiveness of an inhibitor targeting tumor angiogenesis for treating LA‑NPC. The present study aimed to assess the safety and effectiveness of CCRT combined with anlotinib in patients with LA‑NPC. The study involved patients with LA‑NPC (stage III‑IVA) from four institutions in Guangxi, China. Patients were randomized to receive CCRT + anlotinib (n=36) or CCRT alone (n=37). Acute toxicity and short‑term efficacy were evaluated. The most common grade 3 or 4 adverse events were leucopenia [10 (27.7%) vs. 8 (21.6%)], neutropenia [6 (16.7%) vs. 5 (13.5%)] and mucositis [13 (36.1%) vs. 11 (29.7%)] in the CCRT + anlotinib vs. CCRT cohort but there were no significant differences between the two cohorts (P=0.54, P=0.70 and P=0.56, respectively). Two patients (5.6%) displayed grade 1/2 hemorrhage in the CCRT + anlotinib cohort. No patient displayed grade 3/4 hemorrhages or adverse event‑associated deaths in any cohort. Complete response rates in the CCRT + anlotinib arm at 1 week and 3 and 6 months post‑radiotherapy were 60.0, 91.4, and 97.1%, respectively, compared with 40.5, 81.1 and 91.9% in the CCRT arm but there was no significant difference (P=0.10, P=0.35 and P=0.65, respectively). This interim analysis of the ongoing trial showed that administration of CCRT + anlotinib has acceptable toxicity profiles, good compliance and promising results in patients with LA‑NPC. A larger study cohort and a longer follow‑up period are needed to confirm therapeutic effectiveness and late toxicity.

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