Research Article

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

Table 1

Characteristics of the patients and treatment.

All patients (n = 239)Tumor histology
Squamous (n = 81)Nonsquamous (n = 158)

Demographic characteristics61 (56–66)62 (58–66)60 (55–66)
Age at nivolumab initiation (years), median (IQR)62 (57–68)64 (60–67)62 (57–68)

Sex
 Female78 (32.6)17 (21.0)61 (38.6)
 Male161 (67.4)64 (79.0)97 (61.4)

Clinical characteristics
Stage at introduction of nivolumab
 III (unresectable)10 (4.2)4 (5.0)6 (3.8)
 IV228 (95.8)76 (95.0)152 (96.2)

Treatment of metastatic disease
 Chemotherapy218 (95.2)74 (94.9)144 (95.4)
 Tyrosine kinase inhibitors60 (25.9)11 (13.9)49 (32.0)

Metastatic sites
 Mediastinal lymph nodes188 (81.0)68 (85.0)120 (78.9)
 Lung181 (78.4)67 (85.9)114 (74.5)
 Bone73 (31.9)18 (23.1)55 (36.4)
 Pleural effusion60 (26.2)23 (28.7)37 (24.8)
 Other sites44 (18.4)10 (12.3)34 (21.5)
 Brain39 (16.7)4 (4.9)35 (22.9)
 Liver37 (16.0)13 (16.5)24 (15.8)
 Pleural metastasis17 (7.4)2 (2.5)15 (10.0)
 Abdominal lymph nodes17 (7.4)5 (6.3)12 (8.0)
Number of metastatic sites, median (IQR)3 (2–4)2 (2–3)3 (2–4)

ECOG performance status
 0125 (52.3)43 (53.1)82 (51.9)
 1110 (46.0)37 (45.7)73 (46.2)
 ≥24 (1.7)1 (1.2)3 (1.9)

EGFR status positive (among those tested)15/145 (10.3)0/5 (0.0)15/140 (10.7)
ALK rearrangements present (among those tested)2/116 (1.7)0/2 (0.0)2/114 (1.8)
Time from diagnosis to introduction of nivolumab (months), median (IQR)18 (11–30)16 (11–26)19 (11–31)
Number of cycles, median (IQR)12 (4–28)13 (5–25)11 (4–29)
Treatment duration (months), median (IQR)5 (2–12)6 (2–11)5 (2–15)
Therapy after nivolumab83 (35.8)29 (35.8)54 (35.8)

Data are presented as the number (percentage) of patients if not stated otherwise. Abbreviations: IQR = interquartile range; EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase.