Quality of life in patients with locally advanced head and neck cancer treated with concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin alone – Additional data from a phase 3 trial

尼妥珠单抗 医学 生活质量(医疗保健) 头颈部癌 随机对照试验 内科学 顺铂 放射治疗 肿瘤科 临床试验 癌症 外科 化疗 表皮生长因子受体 护理部
作者
Nandini Menon,Vijay Patil,Vanita Noronha,Amit Joshi,Atanu Bhattacharjee,Balajirao J Satam,Vijayalakshmi Mathrudev,Sarbani Ghosh Laskar,Kumar Prabhash
出处
期刊:Oral Oncology [Elsevier BV]
卷期号:122: 105517-105517 被引量:15
标识
DOI:10.1016/j.oraloncology.2021.105517
摘要

The addition of Nimotuzumab to radical chemoradiation (CRT) improved outcomes in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing radical CRT in a phase 3 randomized trial. The current study focuses on the quality of life (QoL) of patients in this trial. In this phase III randomized trial, patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx were randomized to receive cisplatin 30 mg/m2 or cisplatin 30 mg/m2 with nimotuzumab once a week with curative radiotherapy. The primary end point of the trial was PFS. The aim of the current study was to compare the QoL between the two arms. QoL was assessed using the EORTC QLQ-C30 (v3.0) and HN-35 (v1.0). The linear mixed-effects model was used for longitudinal analysis of QoL. 536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis. There was a significant change in the global health status QoL scores over time (p = 0.0016) with no difference between the two arms (p = 0.396). On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms. QoL scores for most symptom scales worsened during treatment and improved thereafter in both arms. The addition of nimotuzumab to cisplatin based chemoradiation in LAHNSCC improved PFS, LRC and DFS without negatively impacting QoL.
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