Long-Term Update of a Phase 3 Randomized Study Comparing Once-a-Week Versus Once-Every-3-Weeks Cispl

Long-Term Update of a Phase 3 Randomized Study Comparing Once-a-Week Versus Once-Every-3-Weeks Cisplatin Along With Radiation in Head and Neck Cancer

Vanita Noronha, Vijay Patil, Nandini Menon, Ajaykumar Singh, Minit Shah, Ankush Shetake, Zoya Peelay, Vijayalakshmi Mathrudev, Kavita Nawale, Srushti Shah, Kumar Prabhash

Int J Radiat Oncol Biol Phys. 2024 Jul 27:S0360-3016(24)03139-0.

doi: 10.1016/j.ijrobp.2024.07.2315.

PMID: 39074566

Abstract

Purpose: In the weekly-3-weekly study, cisplatin at 100 mg/m² once-every-3-weeks led to superior locoregional control compared with cisplatin 30 mg/m² once-a-week in combination with radical radiation for locally advanced head and neck squamous cell carcinoma (LAHNSCC). We report the updated analysis of the study.

Methods and materials: In this phase 3 open-label noninferiority study conducted between 2013 and 2017, 300 patients with LAHNSCC were randomly assigned to receive cisplatin 100 mg/m² once-in-every-weeks or cisplatin 30 mg/m² once-a-week, concurrently with radiation. The primary endpoint was locoregional control. Secondary outcomes were overall survival, progression-free survival, and late adverse events.

Results: The median follow-up was 6.91 years (95% CI, 6.12-7.36). The updated 2-year and 5-year locoregional control rates for the once-a-week cisplatin arm were 58.75% (95% CI, 51.08-67.58) and 48.09% (95% CI, 40.26-57.43), whereas for the once-every-3-weeks, cisplatin arm were 73.95% (95% CI, 66.93-81.70) and 56.76% (95% CI, 48.46-66.48), respectively, hazard ratio = 1.44 (95% CI, 1.03-2.03), P = .034. The 5-year overall survival was 43.60% (95% CI, 36.29-52.37) in the once-a-week cisplatin arm and 50.55% (95% CI, 43.06-59.35) in the once-every-3-weeks cisplatin arm; P = .19. There was no difference in any grade or grade ≥3 late adverse events between the 2 arms, except for hearing dysfunction, which was significantly more common in patients who received high-dose cisplatin.

Conclusions: Long-term follow-up confirms that cisplatin at 100 mg/m² administered once-every-3-weeks concurrently with radical radiation for LAHNSCC leads to superior locoregional control compared with cisplatin 30 mg/m² once-a-week and should remain one of the standard treatment options.