Weekly cisplatin plus radiotherapy (RT) should be considered standard care in patients with locally advanced head and neck squamous cell carcinoma (HNSCC), according to researchers.
In a phase 3 trial, weekly cisplatin plus RT proved no less effective than RT with cisplatin given every 3 weeks. Weekly cisplatin was better tolerated as well, with decreased treatment interruptions, hospitalizations, and toxicity.
These results were presented at the 2022 ASCO Annual Meeting by Atul Sharma, MD, of All India Institute of Medical Sciences in New Delhi.
Dr Sharma and colleagues studied patients with treatment-naïve, locally advanced, non-nasopharyngeal HNSCC treated at 6 centers across India. Patients were randomly assigned to receive standard cisplatin at 100 mg/m2 every 3 weeks (days 1, 22, and 43) or cisplatin given at 40 mg/m2 weekly (days 1, 8, 15, 22, 29, 36, and 43).
RT was similar between the treatment arms, and there were no significant differences in baseline characteristics. The final analysis included 133 patients in each arm (131 who were treated).
At a median follow-up of 25.7 months, there were no significant differences in efficacy outcomes between the treatment arms.
The 2-year locoregional control rate was 60.9% in the weekly arm and 56.4% in the standard arm, for an absolute difference of 4.5%, which met criteria for non-inferiority.
The median progression-free survival was 20.8 months in the weekly arm and 21.3 months in the standard arm (P =.377). The median overall survival was 25.5 months and 30 months, respectively (P =.751).
Weekly cisplatin was associated with a significantly lower rate of mucositis (40.6% vs 54.1%; P =.039), renal toxicity (3.7% vs 18%; P <.0001), vomiting (4.5% vs 12.7%; P =.019), and hyponatremia (21.8% vs 37.5%; P =.004).
In addition, patients receiving weekly cisplatin were significantly less likely to be hospitalized (20% vs 36.8%; P =.004), require treatment interruptions (57.8% vs 61.6%; P =.035), or need IV fluids (34.5% vs 62.4%; P =.0001).
A limitation of this study was that the COVID-19 pandemic affected cancer treatment delivery, and this may have impacted outcomes, according to Dr Sharma.
Nevertheless, he concluded that weekly cisplatin at 40 mg/m2, plus RT, should be considered a standard treatment in locally advanced HNSCC.
Sharma A, Kumar M, Bhasker S, et al. An open-label, noninferiority phase III RCT of weekly versus three weekly cisplatin and radical radiotherapy in locally advanced head and neck squamous cell carcinoma (ConCERT trial). Presented at ASCO 2022; June 3-7, 2022. Abstract 6004.