Real-World Data Determines Safety, Effectiveness of Second-Line NSCLC Treatment


A recently approved second-line therapy is reasonably effective in the treatment of advanced non-small cell lung cancer (NSCLC), according to a recent real-world study.

Although nivolumab was recently approved as a second-line treatment of NSCLC, little data exists on its safety and effectiveness in a real-life setting.

From January 2015 to March 2016, Elizabeth Dudnik, MD, Davidoff Cancer Center (Israel), and colleagues evaluated 260 patients with advanced NSCLC who were treated with nivolumab at 5 national cancer centers. Median patient age was 67 years, and 68% of patients were men. Median survival follow-up lasted 18.5 months.

Patients were assessed for overall survival (OS) and toxicity. The Cox proportional-hazards regression model was used to determine OS, and RECIST v.1.1 was used to analyze overall response rate (ORR) and progression-free survival (PFS).

A total of 155 (60%) patients died over the course of follow-up. Results of the study indicated that median OS was 5.9 months. According to univariate and multivariate analysis, ECOG PS was the only variable that significantly correlated with OS, with a median OS of 9.5 months among patients with ECOG PS 0/1 and 3.5 months in patients with ECOG PS 2 or higher.

Among 49 patients who were evaluable for response, ORR was found to be 35%, while median PFS was 2.8 months and the incidence of pseudo-progression was 9%. The researchers noted that safety data on nivolumab from this study had been consistent with its existing safety profile, except for 1 case of febrile neutropenia and 1 case of pericarditis.

“In a real life setting, the effectiveness of nivolumab is reasonable yet less prominent than it has been demonstrated in clinical trials,” the researchers concluded. “ECOG PS ≥2 is associated with poor prognosis.”—Christina Vogt