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Published on: September 25, 2018
PD-1 inhibitors for non-small cell lung cancer patients with special issues: Real-world evidence
Seonggyu Byeon1, Jang Ho Cho2, Hyun Ae Jung1
1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
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.
Insights
Immune checkpoint inhibitors (ICIs) are viable for non-small cell lung cancer (NSCLC) patients with conditions like viral hepatitis or tuberculosis. Outcomes were comparable to patients without these issues, with manageable adverse events.
Area of Science:
- Oncology
- Immunotherapy
- Pulmonology
Background:
- Immune checkpoint inhibitors (ICIs) offer new treatment avenues for non-small cell lung cancer (NSCLC).
- Clinical trials often exclude patients with comorbidities like viral hepatitis, tuberculosis (Tbc), interstitial lung disease (ILD), and autoimmune diseases due to safety concerns.
- These exclusions limit understanding of ICI efficacy and safety in diverse NSCLC patient populations.
Purpose of the Study:
- To evaluate the clinical outcomes and safety of immune checkpoint inhibitors (ICIs) in NSCLC patients with pre-existing special conditions.
- To compare the efficacy and adverse event profiles of ICIs in NSCLC patients with and without conditions such as viral hepatitis, Tbc, ILD, and autoimmune diseases.
Main Methods:
- Retrospective review of medical records for 237 NSCLC patients treated with ICIs between January 2015 and October 2018.
- Analysis of clinical outcomes, including overall response rate and progression-free survival.
- Assessment of immune-related adverse events (AEs), focusing on hepatitis, Tbc reactivation, ILD exacerbation, and autoimmune disease flares.
Main Results:
- 26% of patients had special issues, including hepatitis B virus (HBV) infection (32), Tbc (20), ILD (6), and autoimmune diseases (2).
- Severe hepatitis (grade 3+) was more frequent in HBV-infected patients (12.5% vs 1.9%), but AEs were manageable.
- Tbc reactivation occurred in 3/20 patients; no ILD aggravation was observed; one rheumatoid arthritis patient experienced a flare.
- No significant differences in overall response rate or progression-free survival were found between patients with and without special issues.
Conclusions:
- Immune checkpoint inhibitors (ICIs) can be a safe and effective treatment option for NSCLC patients with special issues.
- The incidence of severe immune-related adverse events is relatively low and manageable in this population.
- Comparable clinical outcomes support the use of ICIs in NSCLC patients with comorbidities, broadening therapeutic options.
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