Published 2024
| Version v1
Publication
Sotorasib in KRASp.G12C mutated advanced NSCLC: Real-world data from the Italian expanded access program
Creators
- Passiglia, Francesco
- Lucia Reale, Maria
- Lo Russo, Giuseppe
- Pasello, Giulia
- Minuti, Gabriele
- Bulotta, Alessandra
- Galetta, Domenico
- Pelizzari, Giacomo
- Sini, Claudio
- Bria, Emilio
- Roca, Elisa
- Pilotto, Sara
- Genova, Carlo
- Metro, Giulio
- Citarella, Fabrizio
- Chiari, Rita
- Cortinovis, Diego
- Delmonte, Angelo
- Russo, Alessandro
- Tiseo, Marcello
- Cerea, Giulio
- Carta, Annamaria
- Scotti, Vieri
- Vavalà, Tiziana
- Brambilla, Marta
- Buffoni, Lucio
- Buosi, Roberta
- Catania, Chiara
- Gori, Stefania
- Grisanti, Salvatore
- Agustoni, Francesco
- Garbo, Edoardo
- Malapelle, Umberto
- Novello, Silvia
Contributors
Others:
- Passiglia, Francesco
- Lucia Reale, Maria
- Lo Russo, Giuseppe
- Pasello, Giulia
- Minuti, Gabriele
- Bulotta, Alessandra
- Galetta, Domenico
- Pelizzari, Giacomo
- Sini, Claudio
- Bria, Emilio
- Roca, Elisa
- Pilotto, Sara
- Genova, Carlo
- Metro, Giulio
- Citarella, Fabrizio
- Chiari, Rita
- Cortinovis, Diego
- Delmonte, Angelo
- Russo, Alessandro
- Tiseo, Marcello
- Cerea, Giulio
- Carta, Annamaria
- Scotti, Vieri
- Vavalà, Tiziana
- Brambilla, Marta
- Buffoni, Lucio
- Buosi, Roberta
- Catania, Chiara
- Gori, Stefania
- Grisanti, Salvatore
- Agustoni, Francesco
- Garbo, Edoardo
- Malapelle, Umberto
- Novello, Silvia
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.
Additional details
Identifiers
- URL
- https://hdl.handle.net/11567/1171656
- URN
- urn:oai:iris.unige.it:11567/1171656
Origin repository
- Origin repository
- UNIGE