Abstract 1929
Background
The impact of previous cumulative exposure to CS before treatment start is unknown, while its use for the treatment of immune-related adverse events during PD-(L)1 therapy does not seem to reduce efficacy. We used real-world data to evaluate the effect of CS immunosuppressive dose (cumulative dose of > 700 mg of prednisone equivalent) or CS delivery modality (prolonged, daily dose >10 mg of prednisone equivalent lasting >5 days, or pulsed, duration ≤5 days) over 3 months before treatment start.
Methods
Patients with advanced NSCLC treated at our Institution with single agent PD-(L)1 blockade after failure of platinum-based chemotherapy and on CS treatment in the previous 3 months were included. Clinical and pharmacy records were reviewed to identify CS dose and duration. According to the label, patients must not have received CS > 10 mg prednisone or equivalent over 10 days before start of anti-PD-(L)1 therapy and had PS ≤ 1. Patients must also have received >2 cycles of PD-(L)1 blockade to be eligible for efficacy analysis.
Results
We identified 62 patients fulfilling our inclusion criteria, 28 (45%) and 36 (58%) of them received a CS immunosuppressive dose and pulsed CS, respectively, 8 (13%) had brain metastases, and 20 (32%) had squamous histology. As of the general population, 36 (58%) patients achieved a durable clinical benefit (DCB, partial response or stable disease >6 months). The median PFS was 4.3 months, and the 1-year survival rate was 39%. CS immunosuppressive dose was not associated with decreased DCB (44% vs 55%; p-value 0.9), nor with shorter median PFS (3.7 vs 4.4 months; HR 1.2; p-value 0.2), nor with lower 1-year survival rate (31% vs 43%; p-value 0.6). CS prolonged exposure was significantly associated with either decreased DCB (30% vs 69%; p-value 0.01) and shorter median PFS (2.7 vs 4.5 months; HR 1.8; p-value 0.05), but not with lower 1-year survival rate (29% vs 41%; p-value 0.06).
Conclusions
Prolonged exposure to > 10 mg of prednisone equivalent through pretreatment 3 months was associated with poorer outcome in patients with advanced NSCLC treated with second-line PD-(L)1 blockade.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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