Cancer medicine · 2022
Quality of life in patients with locally advanced head and neck squamous cell carcinoma undergoing concurrent chemoradiation with once-a-week versus once-every-3-weeks cisplatin.
Рандомизированное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Menon Nandini S, Noronha Vanita, Patil Vijay Maruti, Joshi Amit, Bhattacharjee Atanu, Kalra Devanshi, Laskar Sarbani Ghosh, Mathrudev Vijayalakshmi, Nawale Kavita, Bhelekar Arati S, Prabhash Kumar
Аннотация
INTRODUCTION: This trial was conducted to compare the efficacy of low dose once-a-week cisplatin and once-every-3-weeks cisplatin with radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). The current analysis focuses on the quality of life (QoL) of patients in this trial.
METHODS: In this phase III randomized trial, patients with nonmetastatic LAHNSCC were randomized to receive cisplatin 30 mg/m2 once-a-week or 100 mg/m2 once every- 3-weeks concurrently with radiotherapy. The primary endpoint was locoregional control. QoL was a key secondary endpoint. QoL was assessed using EORTC QLQ-C30 and QLQ-H&N35. QoL data were assessed at baseline, days 22 and 43 during treatment; and at 6, 12, 24 months. The linear mixed-effects model was used for longitudinal analysis of QoL to determine the impact of treatment (arm) and time on QoL.
RESULTS: Three hundred patients were enrolled, data of 150 patients with available baseline QoL were analyzed. There was no significant difference in the global health status/QoL of the two treatment arms (p = 0.8664). There was no significant difference in the longitudinal QoL scores between the two treatment arms in all scales except constipation (p = 0.0096), less sexuality (p = 0.0002,), and financial difficulty (p = 0.0219). There was a worsening of the QoL scores in all scales in both arms during treatment, which improved after treatment completion in most scales.
CONCLUSION: The use of once-every-3-weeks cisplatin did not adversely impact QoL as compared to once-a-week cisplatin in combination with radiotherapy in LAHNSCC.
METHODS: In this phase III randomized trial, patients with nonmetastatic LAHNSCC were randomized to receive cisplatin 30 mg/m2 once-a-week or 100 mg/m2 once every- 3-weeks concurrently with radiotherapy. The primary endpoint was locoregional control. QoL was a key secondary endpoint. QoL was assessed using EORTC QLQ-C30 and QLQ-H&N35. QoL data were assessed at baseline, days 22 and 43 during treatment; and at 6, 12, 24 months. The linear mixed-effects model was used for longitudinal analysis of QoL to determine the impact of treatment (arm) and time on QoL.
RESULTS: Three hundred patients were enrolled, data of 150 patients with available baseline QoL were analyzed. There was no significant difference in the global health status/QoL of the two treatment arms (p = 0.8664). There was no significant difference in the longitudinal QoL scores between the two treatment arms in all scales except constipation (p = 0.0096), less sexuality (p = 0.0002,), and financial difficulty (p = 0.0219). There was a worsening of the QoL scores in all scales in both arms during treatment, which improved after treatment completion in most scales.
CONCLUSION: The use of once-every-3-weeks cisplatin did not adversely impact QoL as compared to once-a-week cisplatin in combination with radiotherapy in LAHNSCC.