Efficacy and safety of PD-1 immune checkpoint inhibitors in locally
advanced and advanced non-small cell lung cancer patients with chronic
viral infection
Abstract
Abstract Immune checkpoint inhibitors (ICIs) have become new research
hotspots in the treatment of non-small cell lung cancer, but the
efficacy and safety of immunotherapy for patients with chronic viral
infection are still unclear, because existing clinical trials often
exclude those patients. Materials and Methods We identified 78 locally
advanced or advanced NSCLC patients with chronic viral infection treated
with PD-1/PD-L1 inhibitors alone or combined with the
chemotherapy/bevacizumab therapy, of whom 60 with hepatitis B, 2 with
hepatitis C, and 16 with syphilis. Objective response rates were
assessed using the RECIST v1.1. Adverse events were graded following the
National Cancer Institute Common Terminology Criteria for Adverse Events
v5.0. Results Objective responses were observed in 19 out of 78(24.36%)
patients, and the disease control rate (DCR) was 69.23% (54/78). No
patient achieved a complete response. The median progression-free
survival (PFS) was 6.49 months (95% CI:3.71-9.27). PFS was 1.44 months
(95%CI:0.00-4.34) for monotherapy versus 7.34 months
(95%CI:4.50-10.18) for combination therapy (P=0.053). Patients in the
first-line treatment group revealed relatively higher ORR and longer PFS
(ORR: 48.00% vs. 13.20%, P = 0.001; PFS: 7.67 months vs. 5.57 months,
P = 0.129). Patients with combined radiotherapy showed longer PFS than
those without combined radiotherapy (14.07 vs.4.62, P=0.027). The
incidence of adverse events of any grade was 73.07% (57/78), among
which there were 7 cases of grade 4 adverse events. The incidence of
leukopenia in any grade of adverse reactions was the highest (57.69%),
followed by anemia (25.64%), elevated alanine aminotransferase or
aspartate aminotransferase (24.36%) and fatigue (21.79%). Hepatic
transaminase increased in 26.7% (16/60) of HBV-infected patients, and
remained unchanged in 63.3% (38/60) patients. Conclusions The PD-1
inhibitor showed an acceptable toxicity profile and moderate efficacy on
NSCLC patients with chronic viral infection, but still has the potential
to increase the incidence of hepatitis.