Primary results from TAIL: a global single-arm safety study of atezolizumab monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer
| Autor: | Jorge Arturo Alatorre-Alexander, Hina Patel, Kerstin Trunzer, Delvys Rodriguez-Abreu, Jinming Yu, T. Newsom-Davis, Andrea Ardizzoni, Konstantinos N. Syrigos, A. Cardona, Pablo D Perez-Moreno, Jonathan Tolson, Sergio J. Azevedo, Hans J.M. Smit, Belen Rubio-Viqueira |
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| Přispěvatelé: | Ardizzoni A., Azevedo S., Rubio-Viqueira B., Rodriguez-Abreu D., Alatorre-Alexander J., Smit H.J.M., Yu J., Syrigos K., Trunzer K., Patel H., Tolson J., Cardona A., Perez-Moreno P.D., Newsom-Davis T. |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
Cancer Research Lung Neoplasms Time Factors medicine.medical_treatment B7-H1 Antigen 0302 clinical medicine Carcinoma Non-Small-Cell Lung Immunology and Allergy Medicine Prospective Studies 030212 general & internal medicine subgroup analysis Immune Checkpoint Inhibitors PD-L1 inhibitor phase IIII clinical trial RC254-282 Clinical/Translational Cancer Immunotherapy Aged 80 and over education.field_of_study Neoplasms. Tumors. Oncology. Including cancer and carcinogens clinical trial Middle Aged Progression-Free Survival metastatic Oncology 030220 oncology & carcinogenesis Disease Progression Molecular Medicine Female immunotherapy Human Adult medicine.medical_specialty Time Factor Immune Checkpoint Inhibitor Immunology Population Subgroup analysis Antibodies Monoclonal Humanized 03 medical and health sciences Young Adult Atezolizumab Internal medicine Humans Lung cancer Adverse effect education Aged Neoplasm Staging Pharmacology clinical trials Chemotherapy business.industry medicine.disease lung neoplasm Clinical trial Prospective Studie checkpoint inhibitor subgroup analysi business |
| Zdroj: | Journal for ImmunoTherapy of Cancer, Vol 9, Iss 3 (2021) Journal for Immunotherapy of Cancer |
| ISSN: | 2051-1426 |
| Popis: | BackgroundAtezolizumab treatment improves survival, with manageable safety, in patients with previously treated advanced/metastatic non-small cell lung cancer. The global phase III/IV study TAIL (NCT03285763) was conducted to evaluate the safety and efficacy of atezolizumab monotherapy in a clinically diverse population of patients with previously treated non-small cell lung cancer, including those not eligible for pivotal trials.MethodsPatients with stage IIIB/IV non-small cell lung cancer whose disease progressed after 1–2 lines of chemotherapy were eligible for this open-label, single-arm, multicenter study, including those with severe renal impairment, an Eastern Cooperative Oncology Group performance status of 2, prior anti-programmed death 1 (PD-1) therapy, and autoimmune disease. Atezolizumab was administered intravenously (1200 mg every 3 weeks). Coprimary endpoints were treatment-related serious adverse events and immune-related adverse events.Results619 patients enrolled and 615 received atezolizumab. At data cutoff, the median follow-up was 12.6 months (95% CI 11.9 to 13.1). Treatment-related serious adverse events occurred in 7.8% and immune-related adverse events in 8.3% of all patients and as follows, respectively, in these subgroups: renal impairment (n=78), 11.5% and 12.8%; Eastern Cooperative Oncology Group performance status of 2 (n=61), 14.8% and 8.2%; prior anti–PD-1 therapy (n=39), 5.1% and 7.7%; and autoimmune disease (n=30), 6.7% and 10.0%. No new safety signals were reported. In the overall population, the median overall survival was 11.1 months (95% CI 8.9 to 12.9), the median progression-free survival was 2.7 months (95% CI 2.1 to 2.8) and the objective response rate was 11%.ConclusionsThis study confirmed the benefit–risk profile of atezolizumab monotherapy in a clinically diverse population of patients with previously treated non-small cell lung cancer. These safety and efficacy outcomes may inform treatment decisions for patients generally excluded from checkpoint inhibitor trials. |
| Databáze: | OpenAIRE |
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