Durvalumab for recurrent or metastatic head and neck squamous cell carcinoma : Results from a single-arm, phase II study in patients with ≥25% tumour cell PD-L1 expression who have progressed on platinum-based chemotherapy
| Autor: | Zandberg, D. P., Algazi, A. P., Jimeno, A., Good, J. S., Fayette, J., Bouganim, N., Ready, N. E., Clement, P. M., Even, C., Jang, R. W., Wong, S., Keilholz, Ulrich, Gilbert, J., Fenton, M., Braña, Irene, Henry, S., Remenar, E., Papai, Z., Siu, L. L., Jarkowski, A., Armstrong, Jon M., Asubonteng, K., Fan, J., Melillo, G., Mesía, R., Universitat Autònoma de Barcelona |
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| Přispěvatelé: | Institut Català de la Salut, [Zandberg DP] University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, PA, USA. [Algazi AP] University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. [Jimeno A] Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA. [Good JS] Institute of Head and Neck Studies and Education, Queen Elizabeth Hospital, Birmingham, UK. [Fayette J] Clinical Oncology, Cancer Center Centre Léon Bérard, University of Lyon, Lyon, France. [Bouganim N] Department of Oncology, McGill University Health Centre, Montreal, QC, Canada. [Braña I] Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universitat Autònoma de Barcelona, Barcelona, Spain, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, UCL - (MGD) Service d'oncologie médicale, UCL - SSS/IREC/MONT - Pôle Mont Godinne |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
0301 basic medicine Cancer Research Survival rate Durvalumab medicine.medical_treatment MULTICENTER Phases of clinical research Cap - Càncer neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma de células escamosas::carcinoma de células escamosas de cabeza y cuello [ENFERMEDADES] Other subheadings::Other subheadings::/drug therapy [Other subheadings] Gastroenterology B7-H1 Antigen Antineoplastic Agents Immunological 0302 clinical medicine Neoplasms::Neoplasms by Site::Head and Neck Neoplasms [DISEASES] Quimioteràpia Monoclonal Head and neck cancer Càncer de cap aminoácidos péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales [COMPUESTOS QUÍMICOS Y DROGAS] AGENT Aged 80 and over Antibodies Monoclonal Middle Aged Prognosis OPEN-LABEL CANCER CETUXIMAB METHOTREXATE Survival Rate Oncology Head and Neck Neoplasms Lymphatic Metastasis 030220 oncology & carcinogenesis Female Immunotherapy Life Sciences & Biomedicine Adult medicine.medical_specialty HPV Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] Antibodies GEFITINIB Head cancer Coll - Càncer Young Adult 03 medical and health sciences Internal medicine Biomarkers Tumor medicine Humans Chemotherapy neoplasias::neoplasias por localización::neoplasias de cabeza y cuello [ENFERMEDADES] Adverse effect PEMBROLIZUMAB Aged Salvage Therapy Science & Technology Recurrent or metastatic Squamous Cell Carcinoma of Head and Neck business.industry International Agencies medicine.disease Neck cancer Head and neck squamous-cell carcinoma Càncer de coll 030104 developmental biology Neoplasms::Neoplasms::Neoplasms by Site::Head and Neck Neoplasms::Squamous Cell Carcinoma of Head and Neck [DISEASES] Neoplasm Recurrence Local business Amino Acids Peptides and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies Monoclonal [CHEMICALS AND DRUGS] Anticossos monoclonals Follow-Up Studies |
| Zdroj: | Scientia Recercat. Dipósit de la Recerca de Catalunya instname Recercat: Dipósit de la Recerca de Catalunya Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) Dipòsit Digital de la UB Universidad de Barcelona Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona European journal of cancer, Vol. 107, p. 142-152 (2019) |
| Popis: | Anticossos; Immunoteràpia; Càncer de cap i coll Anticuerpos; Inmunoterapia; Cáncer de cabeza y cuello Antibodies; Immunotherapy; Head and neck cancer Background Patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) progressing on platinum-based chemotherapy have poor prognoses and limited therapeutic options. Programmed cell death-1 (PD-1) and its ligand 1 (PD-L1) are frequently upregulated in HNSCC. The international, multi-institutional, single-arm, phase II HAWK study ( NCT02207530 ) evaluated durvalumab monotherapy, an anti-PD-L1 monoclonal antibody, in PD-L1-high patients with platinum-refractory R/M HNSCC. Patients and methods Immunotherapy-naïve patients with confirmed PD-L1-high tumour cell expression (defined as patients with ≥25% of tumour cells expressing PD-L1 [TC ≥ 25%] using the VENTANA PD-L1 [SP263] Assay) received durvalumab 10 mg/kg intravenously every 2 weeks for up to 12 months. The primary end-point was objective response rate; secondary end-points included progression-free survival (PFS) and overall survival (OS). Results Among evaluable patients (n = 111), objective response rate was 16.2% (95% confidence interval [CI], 9.9–24.4); 29.4% (95% CI, 15.1–47.5) for human papillomavirus (HPV)-positive patients and 10.9% (95% CI, 4.5–21.3) for HPV-negative patients. Median PFS and OS for treated patients (n = 112) was 2.1 months (95% CI, 1.9–3.7) and 7.1 months (95% CI, 4.9–9.9); PFS and OS at 12 months were 14.6% (95% CI, 8.5–22.1) and 33.6% (95% CI, 24.8–42.7). Treatment-related adverse events were 57.1% (any grade) and 8.0% (grade ≥3); none led to death. At data cut-off, 24.1% of patients remained on treatment or in follow-up. Conclusion Durvalumab demonstrated antitumour activity with acceptable safety in PD-L1-high patients with R/M HNSCC, supporting its ongoing evaluation in phase III trials in first- and second-line settings. In an ad hoc analysis, HPV-positive patients had a numerically higher response rate and survival than HPV-negative patients. This study was supported by AstraZeneca. |
| Databáze: | OpenAIRE |
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