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Randomized Controlled Trial
. 2022 Nov;11(21):3939-3948.
doi: 10.1002/cam4.4715. Epub 2022 Mar 28.

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

Nandini S Menon  1 , Vanita Noronha  1 , Vijay Maruti Patil  1 , Amit Joshi  1 , Atanu Bhattacharjee  2 , Devanshi Kalra  1 , Sarbani Ghosh Laskar  3 , Vijayalakshmi Mathrudev  1 , Kavita Nawale  1 , Arati S Bhelekar  1 , Kumar Prabhash  1
Affiliations
Randomized Controlled Trial

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

Nandini S Menon et al. Cancer Med. 2022 Nov.

Abstract

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.

Keywords: chemoradiation; cisplatin; head and neck cancer; quality of life.

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Conflict of interest statement

Vanita Noronha reports grants from Dr. Reddy's Laboratories, Amgen, and Sanofi, outside of the submitted work. Kumar Prabhash reports grants from Tata Memorial Center Research Administration Council, the Indian Cooperative Oncology Network, and Glenmark Pharmaceuticals, during the conduct of the study; grants from Dr. Reddy's Laboratories, Fresenius Kabi India, and Roche Holding, outside of the submitted work. All other authors declare no conflict of interest.

Figures

FIGURE 1
FIGURE 1
CONSORT diagram
FIGURE 2
FIGURE 2
QoL scores in the various scales of the EORTC QLQ‐C30 and H&N 35. (A): Global Health status, (B): Physical Function, (C–F): Symptom scales for decreased sexuality, nausea & vomiting, constipation, and financial difficulty respectively. D1‐ day 1, D22‐ day 22, D 43‐ day 43, 6 m‐ 6 months, 12 m‐ 12 months, 24 m‐ 24 months. p values for the difference between the treatment arms from the linear mixed model
See this image and copyright information in PMC

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