Meeting
2024 ASCO Breakthrough
Radiotherapy alone vs radiotherapy with concurrent chemoradiotherapy in patients with low-risk nasopharyngeal carcinoma: Updated results from a multicenter, open-label, non-inferiority, randomized phase III trial.
Authors
Rui Guo
Department of Radiation Oncology, Sun Yat-sen University Cancer Center; Collaborative Innovation Center for Cancer Medicine; State Key Laboratory of Oncology in South China; Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
Rui Guo , Yuan Zhang , Ning Zhang , Bin Deng , Zhi-Bin Cheng , Jing Huang , Fan Zhang , Yan-Ping Mao , Wen-Fei Li , Guan-Qun Zhou , Yu-Pei Chen , Cheng Xu , Li Lin , Wei-Wei Zhang , Xu Jiang , Qing Liu , Ying Sun , Jun Ma , Lei Chen
Organizations
Department of Radiation Oncology, Sun Yat-sen University Cancer Center; Collaborative Innovation Center for Cancer Medicine; State Key Laboratory of Oncology in South China; Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China, First People's Hospital of Foshan City, Foshan, China, Department of Radiation Oncology, the Wuzhou Red Cross Hospital, Wuzhou, Guangxi, China, Department of Radiation Oncology, the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China, Department of Oncology, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, Guangdong, China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, China, Clinical Trials Centre, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, Guangdong, China, Sun Yat-Sen University Cancer Center, Guangzhou, China, Sun Yat-Sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China
Research Funding
the National Natural Science Foundation of China
Natural Science Foundation of Guangdong Province, Key-Area Research and Development Program of Guangdong Province, Overseas Expertise Introduction Project for Discipline Innovation, Sun Yat-Sen University Clinical Research 5010 Program, the National Key Research and Development Program of China
Background: There is limited evidence for the role of concurrent chemotherapy with use of intensity-modulated radiation therapy (IMRT) in low-risk stage II/T3N0 Nasopharyngeal Carcinoma (NPC) patients. We previously reported comparable 3-year failure-free survival-free survival (FFS) using radiotherapy alone compared with concurrent chemoradiotherapy in the low-risk patients. Here, we present the 5-year overall survival (OS) analysis and additional analysis. Methods: This multicenter, open-label, randomized, phase 3, noninferiority clinical trial was conducted at 5 Chinese hospitals, including 341 adult patients with low-risk NPC, defined as stage II/T3N0M0 without adverse features (all nodes <3 cm, no level IV/Vb nodes; no extranodal extension; Epstein-Barr virus DNA <4000 copies/mL), with enrollment between November 2015 and August 2020. This trial is registered with ClinicalTrials.gov, number NCT02633202. Results: In this randomized trial, patients were assigned to be treated IMRT alone (n=172) or with concurrent chemoradiotherapy (IMRT with cisplatin, n=169). With a median follow-up of 70.1 months, the IMRT-alone group had a similar 5-year overall survival (95.2% vs. 98.2%, hazard ratio, 2.27 [95%CI:0.70-7.40]; P=0.16), failure-free survival (86.2% vs. 88.4%, hazard ratio, 1.16 [95%CI:0.64-2.07]; p = 0.63). Hearing impairment (HI) data (assessed by The Hearing Handicap Inventory for Adult- Screening version (HHIA-S)) were collected from 86 patients in the IMRT-alone group and 81 patients in the concurrent chemoradiotherapy group. Among the patients, 45(26.9%) developed HI (IMRT-alone vs. CCRT: 20 [23.3%] vs. 25 [30.9%]), among which 36 (21.6%) had mind HI (IMRT-alone vs. CCRT: 15 [17.4%] vs. 21 [25.9%]). Conclusions: Radiotherapy alone provides comparable survival or disease control and less toxicity compared to CCRT in low-risk nasopharyngeal carcinoma. Clinical trial information: NCT02633202.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session B
Track
Thoracic Cancers,Breast Cancer,Gynecologic Cancer,Head and Neck Cancer,Hematologic Malignancies,Genetics/Genomics/Multiomics,Healthtech Innovations,Models of Care and Care Delivery,Viral-Mediated Malignancies,Other Malignancies or Topics
Sub Track
Local Disease
Clinical Trial Registration Number
NCT02633202
Citation
J Clin Oncol 42, 2024 (suppl 23; abstr 142)
DOI
10.1200/JCO.2024.42.23_suppl.142
Abstract #
142
Poster Bd #
E7
Abstract Disclosures
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