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Safety and efficacy of PD-1/PD-L1 blockade in patients with preexisting antinuclear antibodies
T Sakakida1, T Ishikawa2,3, Y Chihara4,5
1Department of Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajiicho, Hirokoji agaru, Kawaramachi Street, Kamigyoku, Kyoto, 602-8566, Kyoto, Japan.
Purpose:
Immune checkpoint inhibitors (ICIs) show promising clinical activity in advanced cancers. However, the safety and efficacy of PD-1/PD-L1 blockade in patients with preexisting antinuclear antibodies (ANA) are unclear.
Methods:
191 patients treated with nivolumab, pembrolizumab, atezolizumab, or durvalumab for unresectable advanced cancers between September 2014 and December 2018 were identified retrospectively. Patients were divided into positive (ANA titers ≥ 1:160) and negative ANA groups (ANA titers < 1:160). Development of immune-related adverse events (irAEs), the overall response rate (ORR), and disease control rate (DCR) were monitored.
Results:
Positive ANA titers were seen in 9 out of 191 patients. Four patients in the positive ANA group and 69 patients in the negative group developed irAEs of any grade without a significant difference between the groups. The development of endocrine, pulmonary, and cutaneous irAEs was not significant, whereas positive ANA was significantly higher in patients who developed colitis (2/9) than in patients who did not (3/182, P = 0.0002). DCR in the positive and negative ANA group was 37.5% and 67.5%, respectively, and was not statistically significant, but had better efficacy in patients without ANA (P = 0.08). ANA-related autoimmune diseases such as SLE, Sjögren's syndrome, MCTD, scleroderma, dermatomyositis, and polymyositis was not induced in either group. However, one patient with preexisting dermatomyositis had a flare up after initiation of atezolizumab.
Conclusion:
Further studies to identify predictive factors for the development of irAEs are required to provide relevant patient care and maximize the therapeutic benefits of ICIs.
Insights
Immune checkpoint inhibitors (ICIs) are effective for advanced cancers. Preexisting antinuclear antibodies (ANA) did not significantly increase overall immune-related adverse events (irAEs), but were linked to higher colitis risk.
Area of Science:
- Oncology
- Immunology
- Rheumatology
Background:
- Immune checkpoint inhibitors (ICIs) targeting PD-1/PD-L1 pathways offer significant clinical benefits in advanced cancers.
- The impact of preexisting antinuclear antibodies (ANA) on ICI safety and efficacy remains largely undetermined.
Purpose of the Study:
- To investigate the safety and efficacy of PD-1/PD-L1 blockade in advanced cancer patients with and without preexisting antinuclear antibodies (ANA).
Main Methods:
- Retrospective analysis of 191 patients treated with nivolumab, pembrolizumab, atezolizumab, or durvalumab.
- Patients were stratified into ANA-positive (titer ≥ 1:160) and ANA-negative (titer < 1:160) groups.
- Monitoring included immune-related adverse events (irAEs), overall response rate (ORR), and disease control rate (DCR).
Main Results:
- Of 191 patients, 9 were ANA-positive. No significant difference in overall irAEs was observed between ANA-positive and ANA-negative groups.
- ANA-positive patients showed a significantly higher incidence of colitis (2/9) compared to ANA-negative patients (3/182; P=0.0002).
- Disease control rate (DCR) was lower in ANA-positive patients (37.5%) versus ANA-negative patients (67.5%), though not statistically significant (P=0.08).
Conclusions:
- Preexisting ANA did not increase the overall risk of irAEs but was associated with a higher risk of developing colitis.
- While not statistically significant, efficacy (DCR) appeared lower in ANA-positive patients.
- Further research is needed to identify predictive factors for irAEs to optimize patient care and maximize ICI benefits.
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