Web of Science: 163 cites, Scopus: 181 cites, Google Scholar: cites,
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
Zandberg, Dan P. (University of Pittsburgh Medical Center. Hillman Cancer Center)
Algazi, Alain P. (University of California San Francisco Helen Diller Family Comprehensive Cancer Center)
Jimeno, Antonio (Division of Medical Oncology. University of Colorado School of Medicine)
Good, James S. (Institute of Head and Neck Studies and Education. Queen Elizabeth Hospital)
Fayette, Jérôme (Clinical Oncology. Cancer Center Centre Léon Bérard. University of Lyon)
Bouganim, Nathaniel (Department of Oncology. McGill University Health Centre)
Ready, Neal E. (Duke University Medical Center)
Clement, Paul M. (Department of Oncology. Leuven Cancer Institute)
Even, Caroline (Institut Gustave Roussy (Villejuif, França))
Jang, Raymond W. (Princess Margaret Cancer Centre. University of Toronto)
Wong, Stuart (Division of Hematology Oncology. Medical College of Wisconsin)
Keilholz, Ulrich (Charité Comprehensive Cancer Center)
Gilbert, Jill (Henry-Joyce Cancer Clinic)
Fenton, Moon (The West Cancer Center. University of Tennessee Health Science Center)
Braña, Irene (Vall d'Hebron Institut d'Oncologia)
Henry, Stephanie (Department of Oncology-Hematology. Radiotherapy. and Nuclear Medicine. CHU UCL Namur)
Remenar, Eva (National Institute of Oncology (Országos Onkológiai Intézet))
Papai, Zsuzsanna (State Health. Center Higatian Defanse Forses)
Siu, Lillian L. (Princess Margaret Cancer Centre. University of Toronto)
Jarkowski, Anthony (AstraZeneca)
Armstrong, Jon M. (AstraZeneca)
Asubonteng, Kobby (AstraZeneca)
Fan, Jean (AstraZeneca)
Melillo, Giovanni (AstraZeneca)
Mesía, Ricard (Institut d'Investigació Biomèdica de Bellvitge)
Universitat Autònoma de Barcelona

Data: 2019
Resum: 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.
Drets: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. Creative Commons
Llengua: Anglès
Document: Article ; recerca ; Versió publicada
Matèria: Antibodies ; HPV ; Head and neck cancer ; Immunotherapy ; Monoclonal ; Recurrent or metastatic ; Survival rate
Publicat a: European journal of cancer, Vol. 107 (january 2019) , p. 142-152, ISSN 1879-0852

DOI: 10.1016/j.ejca.2018.11.015
PMID: 30576970


11 p, 877.0 KB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats

 Registre creat el 2020-06-03, darrera modificació el 2023-08-31



   Favorit i Compartir