According to the results of the phase 3 trial, ATTRACTION-3, nivolumab significantly improves overall survival compared with chemotherapy in patients who have been previously treated for advanced esophageal squamous cell carcinoma.
For this study, results of which are published in The Lancet Oncology, researchers enrolled 419 patients from 90 hospital and cancer centers in Denmark, Germany, Italy, Japan, South Korea, Taiwan, the UK, and the USA. Patients with unresectable advanced or recurrent esophageal squamous cell carcinoma (regardless of PD-L1 expression) were eligible for the study if they were 20 years old or older, had at least one measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors, a baseline Eastern Cooperative Oncology Group performance status of 0-1, were refractory or intolerant to one previous fluoropyrimidine-based and platinum-based chemotherapy, and had a life expectancy of at least three months.
In a 1:1 ratio, patients were randomly assigned to receive either 240 mg of nivolumab for 30 minutes every two weeks or investigator's choice of chemotherapy which included the following two options: 100 mg/m2 of paclitaxel for at least 60 minutes once per week for six weeks then one week off or 75 mg/m2 of docetaxel for at least 60 minutes every three weeks.
The results revealed that nivolumab significantly improved overall survival compared with chemotherapy (10.5 vs 8.0 months). Grade 3/4 side effects occurred in 18% of patients in the nivolumab group and 63% of patients in the chemotherapy group. Anemia was the most common adverse event for patients in the nivolumab group, and decreased neutrophil count occurred most frequently in the chemotherapy group.
The study authors conclude, "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."
For More Information
Kato K, Cho BC, Takahashi M, et al (2019). Nivolumab versus chemotherapy in patients with advanced esophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicenter, randomized, open-label, phase 3 trial. Lancet Oncol. [Epub ahead of print] DOI:10.1016/S1470-2045(19)30626-6
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