As a result of an increasing life expectancy, the incidence of lung cancer diagnosed in the elderly population is rising. Despite the high frequency of NSCLC in this population, elderly pts are frequently underrepresented in clinical trials since aging is associated with a significant prevalence of comorbid diseases. The purpose of this analysis is to focus on treatment with nivolumab in the elderly population (≥75 years) with advanced Sq-NSCLC from the EAP in Italy, namely in the real word setting representing a more realistic picture of clinical practice.
Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg is administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events.
Of 372 Italian pts with advanced Sq-NSCLC participating in the EAP in Italy, 70 (18.8%) were ≥75 years; of these, 68 pts were evaluable for response. With a median number of doses of 7 (range, 1–20) and a median follow-up of 4.7 months, the disease control rate was 42.9%, including 13 pts with a partial response and 17 with stable disease. Sixteen pts were treated beyond RECIST defined progression, with 5 of these who achieved a disease control. As of April 2016, median progression-free survival and median overall survival among all elderly pts were 3.2 and 7.6 months, respectively. Among 70 pts, 41 pts (58.6%) discontinued treatment for any reason except toxicity; 8 out of 70 discontinued due to AE (11.4%).
These results suggest that elderly population can benefit from nivolumab treatment with safety results consistent to what previously reported, supporting the use of nivolumab in this subpopulation.
Clinical trial identification
Legal entity responsible for the study
Bristol Myers Squibb
Bristol Myers Squibb
F. Grossi: Advisory boards of BMS during the conduct of the study. P. Bidoli: Advisory role for BMS on the Nivolumab EAP board and in other occasions. All other authors have declared no conflicts of interest.