PD‐1 inhibitors for non‐small cell lung cancer patients with special issues: Real‐world evidence

Abstract

Background Immune checkpoint inhibitors (ICIs) have provided new therapeutic options for non‐small cell lung cancer(NSCLC) patients. However, due to concerning increases in immune‐related adverse events, clinical trials usually exclude patients with special issues such as viral hepatitis, tuberculosis (Tbc), interstitial lung disease (ILD) and autoimmune disease. Methods We retrospectively reviewed the medical records of NSCLC patients who received ICIs, and analyzed the clinical outcomes of patients with special issues. Results Between January 2015 and October 2018, 237 patients received ICIs. Of these patients, 26% (61/237) had special issues: 32 had hepatitis B viral (HBV) infections, 20 Tbc, six ILD, one HIV infection, one Behçet's disease and a past HBV infection, and one rheumatoid arthritis. The incidence of hepatitis tended to be higher in patients with HBV infections than in those without (18.8% vs 8.91%, P = .082). Severe hepatitis (grade 3 or higher) was more common in HBV‐infected patients (12.5% vs 1.9%, P = .0021), but the AEs were well‐managed. During ICI treatment, three of the 20 patients with a history of pulmonary Tbc developed active pulmonary Tbc, considered reactivations. No aggravation of ILD was noted. One RA patient experienced a disease flare and was treated with a low‐dose steroid. There was no significant difference in the overall response rate or progression‐free survival between patients with and without special issues. Conclusion Given the relatively low incidence of immune‐related AEs and the comparability of clinical outcomes, ICIs can be treatment option of NSCLC patients with special issues.

Association of hepatitis B virus infection status with outcomes of non-small cell lung cancer patients undergoing anti-PD-1/PD-L1 therapy

“…These results are shown in Table 3 and Figure 1. (14)(15)(16)(17)(18)(19)(20). Most of the relevant studies have enrolled a limited number of patients, impeding in-depth characterization of the safety and efficacy of immunotherapy.…”

“…Recently, some retrospective studies or prostective clinical trials have demonstrated that the efficacy and limited toxicity of PD-(L)1 inhibitors in patients with HIV infection and advanced NSCLC is similar to non-infected patients (9)(10)(11)(12)(13). However, data from the literature have been limited to case reports or small case series that have described the utilization of PD-1 pathway inhibitor (alone or in combination with ipilimumab or chemotherapy) for advanced NSCLC patients with chronic or previous HBV infection (14)(15)(16)(17)(18)(19)(20). Therefore, there is a paucity of information on the safety and efficacy of anti-PD-(L)1 monotherapy in this population.…”

Immune Checkpoint Inhibitors in Thoracic Malignancies: Review of the Existing Evidence by an IASLC Expert Panel and Recommendations

“…None of the patients had HCV reactivation or HCV-associated hepatitis. 225 In a study by Byeon et al 225 it was found that among 237 patients with NSCLC treated with anti-PD-1, 14% had HBV infection. The ORR was 23.1%.…”

Integrative and Comparative Genomic Analysis and the Immune Microenvironment Features of Lung Cancer Patients with Tuberculosis

“…Furthermore, the PD-1/PD-L1 pathway suppresses the accumulation of CD4 + T-cells and IFN-γ production, which is an essential part of the immune response to TB. However, treatment that targets PD-1/PD-L1 may cause CD4 + T-cells to overproduce IFN-γ, which can aggravate TB or cause TB recurrence (24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35). Another study has indicated that a TB antigen can inhibit the Th1 immune response and promote LC metastasis via the PD-1/PD-L1 signalling pathway (36).…”