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.
Resources from the same session
2108 - Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase 3 study.
Presenter: Michiel Van der Heijden
Session: Poster Display session 3
Resources:
Abstract
3090 - Comparison of Immuno-Oncology (IO) Biomarkers in Adenocarcinoma (ACB), Urothelial Carcinoma (UCB) and Squamous Cell Carcinoma (SCCB) of the Bladder, with interim results from PURE01
Presenter: Daniele Raggi
Session: Poster Display session 3
Resources:
Abstract
5211 - Potential role of a clinical, taxonomical classification and RNA expression integrated signature to predict response to neoadjuvant platinum-based chemotherapy in muscle-invasive bladder cancer (MIBC) patients
Presenter: Albert Font
Session: Poster Display session 3
Resources:
Abstract
3206 - Hyperphosphatemia due to Erdafitinib (a Pan-FGFR Inhibitor) and Anti-tumor Activity Among Patients (Pts) with Advanced Urothelial Carcinoma (UC)
Presenter: Scott Tagawa
Session: Poster Display session 3
Resources:
Abstract
3110 - Prognostic role of FGFR Mutations and FGFR mRNA expression in metastatic urothelial cancer treated with anti-PD(L1) inhibitors in first and second line setting
Presenter: Florian Roghmann
Session: Poster Display session 3
Resources:
Abstract
3564 - Circulating tumour DNA (ctDNA) utility as a biomarker for metastatic urothelial carcinoma (mUC)
Presenter: Jean-Michel Lavoie
Session: Poster Display session 3
Resources:
Abstract
2760 - Comparative analysis of tumor mutational burden (TMB) prediction methods and its association with determinants of the tumor immune microenvironment of urothelial bladder cancer (UBC)
Presenter: Markus Eckstein
Session: Poster Display session 3
Resources:
Abstract
2513 - The Immunoscore in patients with urothelial carcinoma treated with neoadjuvant chemotherapy: clinical significance for pathological response and survival
Presenter: Elise Nassif
Session: Poster Display session 3
Resources:
Abstract
2835 - Genomic analysis of urothelial cancer and associations with treatment choice and outcome
Presenter: David Sarid
Session: Poster Display session 3
Resources:
Abstract
5763 - cfDNA is an acceptable but insufficient means of characterizing FGFR3 mutation in patients with metastatic urothelial cancer (mUC)
Presenter: Sumanta Pal
Session: Poster Display session 3
Resources:
Abstract