OBJECTIVES:

Inhibition of KRAS, and particularly mutant KRAS p.G12C, has been the focus of extensive research in NSCLC but information on how these patients are managed in the real-world setting in Italy is limited. This study aimed to describe the clinical characteristics and treatment patterns in patients with locally advanced and unresectable or metastatic KRAS p.G12C mutant NSCLC in Italy.

METHODS:

Anonymized data were retrospectively collected by 40 oncologists in general/non-university (65%), university hospitals (25%) and other sites (7.5% oncology reference centers; 2.5% private hospital/clinic) contributing to the annually updated Italian Cancerology NSCLC database. Patients included were adult NSCLC patients with KRAS p.G12C mutant tumors without other onco-driver mutations (i.e. EGFR, ALK, ROS-1, BRAF, MET, RET, NTRK) receiving 2^nd (2L) or later lines of anti-tumor systemic treatment during July-December 2019.

RESULTS:

A total of 136 patients with a KRAS p.G12C mutation were included in the analysis. Nearly all patients were in 2L (n=130/136), on average 67.3 years old, male (70%), ever-smokers (80%), had one comorbidity (57%), ECOG PS 0–1 (86%), multiple metastases at diagnosis (85%; lung: 65%, bone: 46%, distant lymph nodes: 44%, liver: 39%, pleura: 29%, brain: 13%), non-squamous histology (84%), and PD-L1 expression 1–<50% (69%). The most commonly used 2L regimen was an anti-PD-L1 monotherapy (59%; 66% nivolumab, 22% pembrolizumab, 12% atezolizumab), followed by chemotherapy (33%; 12% docetaxel monotherapy). Prior (1L) treatment included chemotherapy (88%) and much less commonly anti-PD-L1 as monotherapy (6%) or combined with chemotherapy (3%).

CONCLUSIONS:

In 2019, the studied 2L patients with advanced KRAS p.G12C NSCLC received primarily anti-PD‑L1 monotherapy, after exposure to chemotherapy in 1L, reflecting the treatment choices common for that period and that given patient profile in the real-world setting in Italy. Follow-up observational research reflecting the fast-evolving treatment landscape in NSCLC would be of interest.