Once-a-week versus once-every-3-weeks cisplatin in patients receiving chemoradiation for locally advanced head-and-neck cancer: A survey of practice in India

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.

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Quality of life in patients with locally advanced head and neck squamous cell carcinoma undergoing concurrent chemoradiation withonce‐a‐weekversusonce‐every‐3‐weekscisplatin

Menon

Noronha

Patil

et al. 2022

Cancer Medicine

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A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer

Patil

Noronha

Joshi

et al. 2019

Cancer

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BACKGROUND:Because the addition of nimotuzumab to chemoradiation in patients with locally advanced head and neck cancer improved outcomes in a phase 2 study, the authors conducted a phase 3 study to confirm these findings. METHODS: This openlabel, investigator-initiated, phase 3, randomized trial was conducted from 2012 to 2018. Adult patients with locally advanced head and neck cancer who were fit for radical chemoradiation were randomized 1:1 to receive either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m 2 ) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT). The primary endpoint was progression-free survival (PFS); key secondary endpoints were disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS). An intent-to-treat analysis also was performed. RESULTS: In total, 536 patients were allocated equally to both treatment arms. The median follow-up was 39.13 months. The addition of nimotuzumab improved PFS (hazard ratio [HR], 0.69; 95% CI, 0.53-0.89; P = .004), LRC (HR, 0.67; 95% CI, 0.50-0.89; P = .006), and DFS (HR, 0.71; 95% CI, 0.55-0.92; P = .008) and had a trend toward improved OS (HR, 0.84; 95% CI, 0.65-1.08; P = .163). Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01). CONCLUSIONS: The addition of nimotuzumab to concurrent weekly CRT improves PFS, LRC, and DFS. This combination provides a novel alternative therapeutic option to a 3-weekly schedule of 100 mg/m 2 cisplatin in patients with locally advanced head and neck cancer who are treated with radical-intent CRT. Cancer 2019;125:3184-3197.

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Salvage surgery in head and neck cancer: Does it improve outcomes?

Patil

Noronha

Thiagarajan

et al. 2020

European Journal of Surgical Oncology

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Once-a-week versus once-every-3-weeks cisplatin in patients receiving chemoradiation for locally advanced head-and-neck cancer: A survey of practice in India

Cited by 8 publications

References 19 publications

Quality of life in patients with locally advanced head and neck squamous cell carcinoma undergoing concurrent chemoradiation withonce‐a‐weekversusonce‐every‐3‐weekscisplatin

Quality of life in patients with locally advanced head and neck squamous cell carcinoma undergoing concurrent chemoradiation withonce‐a‐weekversusonce‐every‐3‐weekscisplatin

A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer

Salvage surgery in head and neck cancer: Does it improve outcomes?

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