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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
- Source :
- 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)
- Publication Year :
- 2019
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- 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)
- Accession number :
- edsair.doi.dedup.....e05b41cab3691e3d2caaa5c2660937cb