Phase-II randomized study of carboplatin plus capecitabine versus 3-weekly cisplatin in locally advanced head-and-neck cancer patients undergoing concurrent chemoradiation (CARCAP-HN).

Background: A substantial proportion of locally advanced head-and-neck squamous cell cancer (LAHNSCC) patients remain ineligible for cisplatin-based chemoradiation due to its frequent toxicities. The study was conducted to compare carboplatin plus capecitabine versus 3-weekly cisplatin in LAHNSCC patients undergoing definitive chemoradiation.

Materials and methods: In this phase II randomized trial, stage 3 or 4 laryngeal or pharyngeal cancer patients received radiation dose of 66-70 gray in 33-35 fractions and were randomized (1:1) to weekly carboplatin (AUC 1.5) plus capecitabine 850 mg/m2/day on the radiation days versus 3-weekly cisplatin (50 mg/m2 on day 1 and day 2). The primary endpoints were objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints included grade ≥ 3 treatment toxicities and treatment interruption rate (TIR). The study is registered with CTRI number CTRI/2020/11/029290.

Results: A total of 81 patients were studied, 40 in the experimental and 41 in the control arm. At a median follow-up of 12.5 months, the median PFS was 14 months versus 12.5 months (P = 0.715). The ORR was 97.5% versus 94.7%, whereas the complete response rate was 57.5% versus 42.1% in the experimental and control arm, respectively (P = 0.449). Significantly lower grade ≥3 toxicity was observed in the experimental arm, i.e., oral mucositis (P = 0.000), vomiting (P = 0.000), nephropathy (P = 0.014), dyselectrolytemia (P = 0.013), fatigue (P = 0.006), anorexia (P = 0.004). The TIR was significantly lower in the experimental arm (P = 0.000).

Conclusions: Carboplatin plus capecitabine-based chemoradiation shows similar efficacy with lesser toxicity compared to 3-weekly cisplatin-based chemoradiation in LAHNSCC.