Abstract
Background There is a lack of real-world data on the safety and efficacy of nivolumab in patients with previously treated advanced non-small-cell lung cancer (NSCLC) especially in South East Europe, a region with particularly high incidence and an unfavorable mortality-to-incidence ratio for lung cancer. Objectives To evaluate the real-world safety and efficacy of nivolumab in patients with previously treated advanced squamous and nonsquamous NSCLC in South East Europe. Methods This is a multicenter, retrospective cohort study on patients with stage IIIB or IV disease with at least one previous systemic treatment who received nivolumab through an expanded-access program between 2015 and 2017 in Croatia, Malta, and Hungary. The primary endpoint was the proportion of patients whose therapy was discontinued because of toxicity. Secondary endpoints were the incidence of adverse events (AEs), objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Results We analyzed data on 239 patients with a median (IQR) age of 62 (57–68), and 33% of them were women. Treatment was discontinued because of toxicity in 11.6% (95% CI 7.8% to 16.5%) of patients. The PFS was 6.4 (95% CI 5.2 to 8.6) months, and the median OS was 14.1 (10.6 to 18.0) months. Conclusions The safety and efficacy of nivolumab in previously treated patients with advanced NSCLC in the real-world South East Europe clinical settings were consistent with the results of randomized clinical trials and comparable to the results from other countries.
Highlights
Despite the accelerated lowering of lung cancer mortality rates in the USA during the last decade, it still causes more deaths than breast, prostate, colorectal, and brain cancers together [1]
We did not specify the missing data for each variable in text, but we presented denominators for all percentages and declare missing data below the tables
We assessed for eligibility of all patients who were enrolled in the Named Patient Program (NPP) in Croatia, Hungary, and Malta from April 2015 to December 2016
Summary
Despite the accelerated lowering of lung cancer mortality rates in the USA during the last decade, it still causes more deaths than breast, prostate, colorectal, and brain cancers together [1]. Pemetrexed demonstrated a similar clinical response as docetaxel, but a better safety profile Both agents provided a median survival of approximately 7–8 months and a response rate
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