Second-line nivolumab for advanced OSCC benefits Asian patients

Use of nivolumab for the second-line treatment of advanced oesophageal squamous cell carcinoma (OSCC) yields numerical gains in survival as compared with chemotherapy in Asian patients, according to a subgroup analysis of the phase III ATTRACTION-3 trial.

The analysis included 274 Japanese patients (63.5 percent male), of whom 136 received nivolumab (median age, 65 years) and 138 chemotherapy (paclitaxel or docetaxel; median age, 68 years). The minimum follow-up period was 17.6 months. Baseline characteristics of the patients were comparable between the treatment groups.

Overall survival (OS) was numerically longer in the nivolumab than the chemotherapy group (median, 13.4 vs 9.4 months; hazard ratio [HR], 0.77, 95 percent confidence interval [CI], 0.59–1.01), with the median duration of response being 7.6 and 3.6 months, respectively.

Objective response rates were similar in the treatment groups (22.4 percent vs 22.2 percent; odds ratio, 0.98, 95 percent CI, 0.52–1.87), although disease control rate was lower with nivolumab (41.1 percent vs 66.7 percent).

OS in the exploratory analysis consistently favoured nivolumab, and the drug showed an acceptable safety profile in the Japanese population. Treatment-related adverse events of any grade and grade 3–5 occurred with less frequency with nivolumab (68.1 percent and 17.0 percent vs 97.8 percent and 73.9 percent).

Nivolumab was administered at 240 mg over 30 min every 2 weeks (each cycle was 6 weeks long), paclitaxel at 100 mg/m² for ≥60 minutes once per week for 6 weeks followed by 1 treatment-free week (each cycle was 7 weeks long), and docetaxel at 75 mg/m² for ≥60 minutes every 3 weeks (each cycle was 3 weeks long). All treatments were administered intravenously and continued until disease progression or unacceptable toxicity.

Based on the subgroup data, nivolumab is poised to become a new standard second-line treatment option for Japanese patients with advanced OSCC refractory to fluoropyrimidine-based chemotherapy.