Association of hepatitis B virus infection status with outcomes of non-small cell lung cancer patients undergoing anti-PD-1/PD-L1 therapy
Zhang, Xuanye (Sun Yat-sen University Cancer Center)
Tian, Dan (Guangdong Academy of Medical Sciences)
Chen, Yue (The Eighth Affiliated Hospital of Sun Yat-sen University)
Chen, Chen (Sun Yat-sen University Cancer Center)
He, Li-Na (Sun Yat-sen University Cancer Center)
Zhou, Yixin (Sun Yat-sen University Cancer Center)
Li, Haifeng (Sun Yat-sen University Cancer Center)
Lin, Zuan (Sun Yat-sen University Cancer Center)
Chen, Tao (Sun Yat-sen University Cancer Center)
Wang, Yuhong (Sun Yat-sen University Cancer Center)
Russo, Alessandro (A.O. Papardo)
Nadal, Ernest (Hospital Universitari de Bellvitge)
Passiglia, Francesco (S. Luigi Gonzaga Hospital)
Soo, Ross Andrew (National University Health System)
Watanabe, Satoshi (Niigata University Graduate School of Medical and Dental Sciences)
Morán, Teresa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Oh, In-Jae (Hwasun Hospital)
Fu, Sha (Sun Yat-sen University)
Hong, Shaodong (Sun Yat-sen University Cancer Center)
Zhang, Li (Sun Yat-sen University Cancer Center)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	The aim of this study was to evaluate the safety and survival outcomes of anti-programmed cell death (PD)-1/programmed cell death-ligand 1 (PD-L1) monotherapy in patients with advanced non-small cell lung cancer (NSCLC) and different hepatitis B virus (HBV) infection status. Patients with advanced NSCLC and both chronic and/or resolved HBV infection who were treated with anti-PD-(L)1 monotherapy were retrospectively enrolled. The primary endpoint was the safety of PD-1/PD-L1 monotherapy, while the secondary endpoints included the survival outcomes. Of the 62 eligible patients, 10 (16. 1%) were hepatitis B surface antigen (HBsAg) positive [chronic hepatitis B (CHB) infection] and 52 (83. 9%) were HBsAg negative and HBcAb positive [resolved hepatitis B (RHB) infection]; 42 (67. 7%) patients had at least 1 treatment-related adverse event (AE), with 4 patients (6. 5%) developing grade 3 AEs and 6 (9. 7%) developing hepatic AEs. One CHB patient experienced HBV reactivation during anti-PD-1 immunotherapy due to the interruption of antiviral prophylaxis. The objective response rate and durable clinical benefit (DCB) rate were 17. 7% and 29. 0%, respectively. Median overall survival (OS) and progression-free survival (PFS) were 23. 6 months [95% confidence interval (CI): 14. 4-32. 8] and 2. 1 months (95% CI: 1. 2-3. 0), respectively. The DCB rate was significantly higher in the CHB group than in the RHB group (60% vs. 23. 1%; P=0. 048). Patients with CHB experienced a longer PFS (8. 3 vs. 2. 0 months; P=0. 103) and OS (35. 0 vs. 18. 2 months, P=0. 119) than did RHB patients. Anti-PD-(L)1 monotherapy was safe and effective in patients with NSCLC and HBV infection. This population should not be excluded from receiving immunotherapy in routine clinical practice or within clinical trials if HBV biomarkers are monitored and antiviral prophylaxis is properly used.
Drets:	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.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Hepatitis B virus infection (HBV infection) ; Immunotherapy ; Non-small cell lung cancer (NSCLC) ; Programmed cell death 1 (PD-1) ; Programmed cell death-ligand 1 (PD-L1)
Publicat a:	Translational Lung Cancer Research, Vol. 10 (july 2021) , p. 3191-3202, ISSN 2226-4477

DOI: 10.21037/tlcr-21-455
PMID: 34430357

12 p, 843.6 KB

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