Phase II Trial of Atezolizumab Combined With Carboplatin and Pemetrexed for Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Untreated Brain Metastases (Atezo-Brain, GECP17/05)
Nadal, Ernest (Hospital Universitari de Bellvitge)
Rodríguez-Abreu, Delvys (Universidad de Las Palmas de Gran Canaria)
Simó, Marta (Hospital Universitari de Bellvitge)
Massutí, Bartomeu (Hospital General Universitari d'Alacant)
Juan, Óscar (Hospital Universitari i Politècnic La Fe (València))
Huidobro, G. (Complexo Hospitalario Universitario de Vigo)
Lopez Castro, Rafael (Hospital Clínico Universitario de Valladolid)
De Castro, Javier (Hospital Universitario La Paz (Madrid))
Estival, Anna (Institut Català d'Oncologia)
Mosquera, J. (Complejo Hospitalario Universitario de A Coruña)
Sullivan, Ivana (Institut d'Investigació Biomèdica Sant Pau)
Felip, Enriqueta (Vall d'Hebron Institut d'Oncologia)
Blasco Cordellat, Ana (Hospital General de València)
Guirado, Maria (Hospital General Universitario de Elche)
Pereira, Eva (Grupo Español de Cáncer de Pulmón)
Vilariño, Noelia (Hospital Universitari de Bellvitge)
Navarro, Valentín (Institut Català d'Oncologia)
Bruna, Jordi (Hospital Universitari de Bellvitge)
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	The Atezo-Brain study evaluated atezolizumab combined with chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) with untreated brain metastases, a population traditionally excluded from trials. This single-arm phase II clinical trial enrolled patients with advanced nonsquamous NSCLC with untreated brain metastases without neurologic symptoms or asymptomatic with medical treatment. Dexamethasone was allowed up to 4 mg once daily. Atezolizumab plus carboplatin and pemetrexed was given for four to six cycles followed by atezolizumab plus pemetrexed until progression for a maximum of 2 years. The primary end points were to determine the progression-free survival (PFS) rate at 12 weeks and the incidence of grade 3 adverse events during the first 9 weeks. Intracranial outcomes were assessed using response assessment in neuro-oncology brain metastases criteria. Forty patients were enrolled and 22 (55%) were receiving corticosteroids at baseline. The overall 12-week PFS rate was 62. 2% (95% credibility interval [CrI], 47. 1 to 76. 2). The rate of grade 3/4 adverse events during the first 9 weeks was 27. 5%. Most neurologic events were grade 1 and 2 but five patients (12. 5%) experienced grade 3-4 neurologic events. With a median follow-up of 31 months, intracranial median PFS was 6. 9 months and response rate was 42. 7% (95% CrI, 28. 1 to 57. 9). Systemic median PFS was 8. 9 months and response rate was 45% (95% CrI, 28. 1 to 57. 9). The median overall survival (OS) was 11. 8 months (95% CI, 7. 6 to 16. 9) and the 2-year OS rate was 27. 5% (95% CI, 16. 6 to 45. 5). Atezolizumab plus carboplatin and pemetrexed demonstrates activity in patients with advanced nonsquamous NSCLC with untreated brain metastases with an acceptable safety profile.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	Journal of clinical oncology, Vol. 41 Núm. 28 (january 2023) , p. 4478-4485, ISSN 1527-7755

DOI: 10.1200/JCO.22.02561
PMID: 37603816

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