ABSTRACT
OBJECTIVES: The S-REAL study aimed to assess the effectiveness of durvalumab as consolidation therapy after definitive chemoradiotherapy (CRT) in a real-world cohort of patients with locally advanced, unresectable stage III non-small cell lung cancer (LA-NSCLC) included in a Spanish early access program (EAP). METHODS: In this multicentre, observational, retrospective study we analysed data from patients treated in 39 Spanish hospitals, who started intravenous durvalumab (10 mg/kg every 2 weeks) between September 2017 and December 2018. The primary endpoint was progression-free survival (PFS). Secondary endpoints included patient characterization and adverse events of special interest (AESI). RESULTS: A total of 244 patients were followed up for a median of 21.9 months [range 1.2-34.7]. Median duration of durvalumab was 45.5 weeks (11.4 months) [0-145]. Median PFS was 16.7 months (95% CI 12.2-25). No remarkable differences in PFS were observed between patients with programmed cell death-ligand 1 (PD-L1) expression ≥ 1% or < 1% (16.7 versus 15.6 months, respectively). However, PFS was higher in patients who had received prior concurrent CRT (cCRT) versus sequential CRT (sCRT) (20.6 versus 9.4 months). AESIs leading to durvalumab discontinuation were registered in 11.1% of patients. CONCLUSIONS: These results are in line with prior published evidence and confirm the benefits of durvalumab in the treatment of LA-NSCLC patients in a real-world setting. We also observed a lower incidence of important treatment-associated toxicities, such as pneumonitis, compared with the pivotal phase III PACIFIC clinical study.
Subject(s)
Antibodies, Monoclonal , Carcinoma, Non-Small-Cell Lung , Chemoradiotherapy , Lung Neoplasms , Humans , Carcinoma, Non-Small-Cell Lung/therapy , Carcinoma, Non-Small-Cell Lung/pathology , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/mortality , Male , Female , Lung Neoplasms/therapy , Lung Neoplasms/pathology , Lung Neoplasms/drug therapy , Lung Neoplasms/mortality , Retrospective Studies , Aged , Middle Aged , Spain , Antibodies, Monoclonal/therapeutic use , Adult , Aged, 80 and over , Antineoplastic Agents, Immunological/therapeutic use , Neoplasm Staging , Progression-Free Survival , Consolidation Chemotherapy , B7-H1 Antigen/antagonists & inhibitorsABSTRACT
Immune checkpoint inhibitors (ICIs), including those targeting programmed cell death 1 (PD-1), its ligand 1 (PD-L1), or cytotoxic T-lymphocyte antigen 4 (CTLA-4) have become the standard treatment for several malignancies, including lung cancer. However, some patient populations have been routinely excluded from clinical trials or are underrepresented in these studies, as is the case of elderly patients or patients with poor performance status, brain metastases, solid organ transplant, autoimmune diseases, chronic viral infections (such as human immunodeficiency virus or chronic viral hepatitis B and C), or organ dysfunction. Thus, the safety and efficacy of ICIs in these special populations is still unclear, despite regulatory approval of these agents. This review analyzes and summarizes the available information on the efficacy and safety of ICIs in these special populations, focusing on patients with lung cancer.
Subject(s)
Brain Neoplasms , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Aged , B7-H1 Antigen , Carcinoma, Non-Small-Cell Lung/drug therapy , Humans , Immune Checkpoint Inhibitors , Lung Neoplasms/drug therapyABSTRACT
No disponible
Subject(s)
Humans , Male , Aged , Pancreatitis/diagnosis , Capecitabine/adverse effects , Adenocarcinoma/drug therapy , Colonic Neoplasms/pathologySubject(s)
Antimetabolites, Antineoplastic/adverse effects , Capecitabine/adverse effects , Pancreatitis/chemically induced , Abdomen, Acute/chemically induced , Adenocarcinoma/complications , Adenocarcinoma/drug therapy , Adenocarcinoma/surgery , Aged , Capecitabine/administration & dosage , Combined Modality Therapy , Fenofibrate/therapeutic use , Humans , Hypertriglyceridemia/chemically induced , Hypertriglyceridemia/complications , Hypertriglyceridemia/drug therapy , Hypolipidemic Agents/therapeutic use , Male , Oxaliplatin/administration & dosage , Pravastatin/therapeutic use , Sigmoid Neoplasms/complications , Sigmoid Neoplasms/drug therapy , Sigmoid Neoplasms/surgeryABSTRACT
No disponible
