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. 2020 Nov 29:2020:9246758.
doi: 10.1155/2020/9246758. eCollection 2020.

Real-World Safety and Efficacy of Nivolumab in Advanced Squamous and Nonsquamous Non-Small-Cell Lung Cancer: A Retrospective Cohort Study in Croatia, Hungary, and Malta

Eduard Vrdoljak  1 , Marko Jakopović  2   3 , Lajos Geczi  4 , Krisztina Bogos  5 , Lidija Bošković  1 , Claude Magri  6 , Lela Bitar  2 , Žarko Bajić  7 , Miroslav Samaržija  2   3
Affiliations

Real-World Safety and Efficacy of Nivolumab in Advanced Squamous and Nonsquamous Non-Small-Cell Lung Cancer: A Retrospective Cohort Study in Croatia, Hungary, and Malta

Eduard Vrdoljak et al. J Oncol. .

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.

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Conflict of interest statement

Eduard Vrdoljak received support for clinical trials and scientific projects from Pfizer, Roche, BMS, and AZ; speaker fees and consulting from Amgen, Astellas, Astra Zeneca, Boehringer Ingelheim, Johnson & Johnson, Novartis, Pharmaswiss, Pfizer, Roche, Sanofi, MSD, and Merck. Marko Jakopović received speaker fees and traveler grants from Roche, MSD, Boehringer Ingelheim, Astra Zeneca, BMS, Pfizer, Novartis, and Eli Lilly and advisory boards of Roche, MSD, Boehringer Ingelheim, Astra Zeneca, BMS, and Pfizer. Lajos Geczi declares no conflicts of interest. Krisztina Bogos received speaker and travel fees from Astra Zeneca, MSD, BMS, Pfizer, and Boehringer Ingelheim. Lidija Bošković received speaker fees and consulting from Amgen, Boehringer Ingelheim, MSD, Astra Zeneca, Roche, Novartis, Merck, and Sanofi. Claude Magri received financial support for conferences/symposia from BMS, Lilly, MSD, Pfizer, Sanofi, and Servier. Lela Bitar declares no conflicts of interest. Žarko Bajić has been giving workshops in clinical trials' critical appraisals and has done study designs, data analysis, and marketing research for Abbott, Abbvie, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Eli Lilly, Fresenius Kabi, GlaxoSmithKline, Janssen Cilag, Merck, MSD, Mylan, Novartis, Novo Nordisk, Pfizer, Reckitt Benckiser, Roche, Sanofi, Servier, Takeda, and Teva. Miroslav Samaržija received speaker fees and traveler grants from Roche, MSD, Boehringer Ingelheim, Astra Zeneca, BMS, Pfizer, Novartis, and Eli Lilly and advisory boards of Roche, MSD, Boehringer Ingelheim, Astra Zeneca, BMS, and Pfizer.

Figures

Figure 1
Figure 1
Kaplan–Meier curves of the progression-free and overall survival.
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