| Contributors: |
Passiglia, F.; Lucia Reale, M.; Lo Russo, G.; Pasello, G.; Minuti, G.; Bulotta, A.; Galetta, D.; Pelizzari, G.; Sini, C.; Bria, E.; Roca, E.; Pilotto, S.; Genova, C.; Metro, G.; Citarella, F.; Chiari, R.; Cortinovis, D.; Delmonte, A.; Russo, A.; Tiseo, M.; Cerea, G.; Carta, A.; Scotti, V.; Vavala, T.; Brambilla, M.; Buffoni, L.; Buosi, R.; Catania, C.; Gori, S.; Grisanti, S.; Agustoni, F.; Garbo, E.; Malapelle, U.; Novello, S. |
| Description: |
Background: Sotorasib showed a significant improvement of progression free survival (PFS), safety and quality of life over docetaxel in patients with KRASp.G12C–mutated advanced non–small-cell lung cancer (NSCLC) within the CodeBreak-200 study. Here we report real-world efficacy and tolerability data from NSCLC patients who received sotorasib within the Italian expanded access program (EAP). Methods: Sotorasib (960 mg, orally, once daily) was available on physician request for KRASp.G12C mutant advanced NSCLC patients. Clinical-pathological and molecular data were collected from the Italian ATLAS real-world registry. Patients underwent CT-scan and responses were evaluated by RECIST criteria. Efficacy and tolerability outcomes have been assessed. Results: A total of 196 advanced NSCLC patients were treated across 30 Italian centers. Median age was 69 years old (range 33–86). Most patients were male (61 %), former (49 %) or current smokers (43 %), with ECOG-PS 0/1 (84 %) and adenocarcinoma subtype (90 %). 45 % and 32 % of patients received sotorasib in 2nd and 3rd line, respectively. Overall, response rate was 26 % and the median duration of response was 5.7 months (95 % CI: 4.4–7.0). Median PFS and OS were 5.8 months (95 % CI: 5 – 6.5) and 8.2 months (95 % CI: 6.3 – 9.9). Grade 3–4 TRAEs occurred in 16.5 % of patients, with Grade ≥ 3 liver enzyme increase and TRAEs-related discontinuation reported in 12 % and 4.6 % of cases. Conclusion: Real-world data from the Italian EAP confirm the tolerability and effectiveness of sotorasib in patients with KRASp.G12C-mutated advanced NSCLC and highlight the value of the national ATLAS network as source of real-world evidence driving the clinical management of NSCLC patients. |