Ken Kato, MD
As reported in The Lancet Oncology by Ken Kato, MD, and colleagues, the phase III ATTRACTION-3 trial conducted in predominantly Asian patients has shown a survival benefit with nivolumab vs paclitaxel or docetaxel in patients with advanced esophageal squamous cell carcinoma who were refractory to or intolerant of prior fluoropyrimidine-based and platinum-based chemotherapy.
The open-label trial included 419 patients from 90 sites in eight countries; 96% of patients in each group were Asian. Patients were randomly assigned between January 2016 and May 2017 to receive nivolumab at 240 mg every 2 weeks (n = 210), or investigator’s choice of paclitaxel at 100 mg/m2 once per week for 6 weeks then 1 week off or docetaxel at 75 mg/m2 every 3 weeks (n = 209). Treatment continued until investigator-assessed disease progression on Response Evaluation Criteria in Solid Tumors, version 1.1, or unacceptable toxicity.
The primary endpoint was overall survival in the intention-to-treat population. Median overall survival was 10.9 months in the nivolumab group vs 8.4 months in the chemotherapy group (hazard ratio [HR] = 0.77, P = .019). Survival was 47% vs 34% at 12 months and 31% vs 21% at 18 months. Median progression-free survival was 1.7 vs 3.4 months (HR = 1.08, 95% confidence interval = 0.87–1.34).
Among 171 patients in the nivolumab group and 158 in the chemotherapy group with baseline measurement of target lesions, objective response was observed in 19% vs 22%. The median duration of response was 6.9 vs 3.9 months.
Treatment-related grade 3 or 4 adverse events occurred in 18% of the nivolumab group and 63% of the chemotherapy group. The most common event in the nivolumab group was anemia (2%); the most common events in the chemotherapy group were decreased neutrophil count (28%) and decreased white blood cell count (22%). Treatment-related serious adverse events occurred in 16% vs 23% of patients. Treatment-related adverse events led to discontinuation of treatment in 9% of patients in each group. Two deaths in the nivolumab group and three in the chemotherapy group were considered related to treatment.
The investigators concluded, “Nivolumab was associated with a significant improvement in overall survival and a favorable safety profile compared with chemotherapy in previously treated patients with advanced esophageal squamous cell carcinoma, and might represent a new standard second-line treatment option for these patients.” ■
Kato K, et al: Lancet Oncol. September 30, 2019 (early release online).