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Steroid Use Independently Predicts for Poor Outcomes in Patients With Advanced NSCLC and High PD-L1 Expression Receiving First-Line Pembrolizumab Monotherapy
- Publication Year :
- 2021
-
Abstract
- Real-world data have suggested a detrimental effect of steroid use in patients with advanced non-small-cell lung cancer (NSCLC) receiving immunotherapy. However, previous studies included heterogeneous cohorts of patients receiving different lines of treatment with several immuno-oncology agents and various combinations of chemotherapy and immuno-oncology agents.A comprehensive clinicopathologic database of patients with NSCLC and programmed cell death ligand 150% treated with frontline pembrolizumab monotherapy was constructed in 14 centers in Italy, Spain, Greece, and Switzerland. A multivariate analysis adjusting for the established prognostic factors was performed using a Cox regression model.For the 265 eligible patients, the median age at diagnosis was 67 years, 66% were male, 90% were current or former smokers, 18% had had an Eastern Cooperative Oncology Group performance status of 2 or 3. Of the NSCLC subtypes, 64% were adenocarcinoma and 25% were squamous cell. Of the patients, 18% had had brain metastases at diagnosis and 24% had received steroids before or during pembrolizumab treatment. The median time to progression was 4.4 months with and 13.7 months without steroid use (hazard ratio [HR], 2.55; 95% confidence interval [CI], 1.69-3.85; log-rank P .001). The median survival was 22.5 months for the whole cohort, 7.7 months for the steroid group, and not reached for the non-steroid group (HR, 3.64; 95% CI, 2.34-5.68; log-rank P .001). On multivariate analysis accounting for all established prognostic variables, steroid use was still independently associated with a high risk of progression (HR, 1.864; 95% CI, 1.179-2.949; P = .008) and death (HR, 2.292; 95% CI, 1.441-3.644; P .001) CONCLUSIONS: In patients with advanced NSCLC and programmed cell death ligand 1 expression50% receiving frontline pembrolizumab monotherapy, any use of steroids before or during treatment was associated with an 86% increase in the risk of progression and a 2.3-fold increase in the risk of death, even accounting for palliative indication-related bias, including the presence of central nervous system metastasis. The use of steroids for palliative indications should be restricted to absolutely necessary for patients receiving immuno-oncology monotherapy.
- Subjects :
- 0301 basic medicine
Oncology
Male
Cancer Research
Lung Neoplasms
medicine.medical_treatment
Pembrolizumab
B7-H1 Antigen
Metastasis
Cohort Studies
0302 clinical medicine
Antineoplastic Agents, Immunological
Carcinoma, Non-Small-Cell Lung
Monoclonal
Non-Small-Cell Lung
Humanized
Hazard ratio
Middle Aged
Prognosis
Progression-Free Survival
Europe
Survival Rate
Immunological
030220 oncology & carcinogenesis
Adenocarcinoma
Steroids
Female
Immunotherapy
Pulmonary and Respiratory Medicine
medicine.medical_specialty
Antineoplastic Agents
Antibodies, Monoclonal, Humanized
Antibodies
03 medical and health sciences
Internal medicine
medicine
Humans
Lung cancer
Aged
Chemotherapy
business.industry
Proportional hazards model
Non–small-cell lung cancer
Carcinoma
Brain metastases
medicine.disease
Confidence interval
030104 developmental biology
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....e8a5aa7649250ca8a5967556c4307652