dc.contributor.author | Forster, MD | |
dc.contributor.author | Dillon, MT | |
dc.contributor.author | Kocsis, J | |
dc.contributor.author | Remenár, É | |
dc.contributor.author | Pajkos, G | |
dc.contributor.author | Rolland, F | |
dc.contributor.author | Greenberg, J | |
dc.contributor.author | Harrington, KJ | |
dc.date.accessioned | 2020-04-03T11:07:03Z | |
dc.date.issued | 2019-12-01 | |
dc.identifier.citation | European journal of cancer (Oxford, England : 1990), 2019, 123 pp. 36 - 47 | |
dc.identifier.issn | 0959-8049 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3582 | |
dc.identifier.eissn | 1879-0852 | |
dc.identifier.doi | 10.1016/j.ejca.2019.08.017 | |
dc.description.abstract | BACKGROUND: The fully human monoclonal antibody patritumab blocks HER3 activation, a resistance mechanism to cetuximab, induced by heregulin (HRG). A phase Ib study in recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) demonstrated tolerability and tumour response of patritumab + cetuximab + platinum. METHODS: This was a randomised, double-blind, phase II study of patritumab + cetuximab with platinum-based therapy for first-line treatment of R/M SCCHN (Clinicaltrials.gov identifier: NCT02633800). Patients aged ≥18 years received patritumab or placebo, both combined with cetuximab + cisplatin or carboplatin. Co-primary end-points were progression-free survival (PFS) in the intent-to-treat (ITT) and the high-expression HRG (HRG high) populations. RESULTS: Eighty-seven patients (n = 43 in the patritumab group; n = 44 in placebo group) enrolled. A median (range) of 6.5 (1-24) patritumab cycles were completed. Median PFS was similar between the patritumab group and placebo group in the ITT population (5.6 versus 5.5 months; hazard ratio [HR] 0.99 [95% confidence interval [CI], 0.6-1.7]; P = 0.96) and HRG-high subgroup (n = 51; 5.6 versus 5.6 months; HR 0.93 [95% CI, 0.5-1.8]; P = 0.82). Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69-2.29]; P = 0.46). All patients experienced ≥1 treatment-emergent adverse event (TEAE). Grade ≥III TEAEs were more frequent in the patritumab than the placebo group (84.1% versus 60.5%). The most common grade ≥III patritumab-related TEAE in the patritumab group (20.5% overall) was rash (6.8%). CONCLUSION: Patritumab + cetuximab + platinum was tolerable but not superior to cetuximab + platinum. | |
dc.format | Print-Electronic | |
dc.format.extent | 36 - 47 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCI LTD | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Head and Neck Neoplasms | |
dc.subject | Neoplasm Metastasis | |
dc.subject | Neoplasm Recurrence, Local | |
dc.subject | Cisplatin | |
dc.subject | Carboplatin | |
dc.subject | Receptor, erbB-3 | |
dc.subject | Neuregulin-1 | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Double-Blind Method | |
dc.subject | Drug Resistance, Neoplasm | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Intention to Treat Analysis | |
dc.subject | Antibodies, Monoclonal, Humanized | |
dc.subject | Cetuximab | |
dc.subject | Squamous Cell Carcinoma of Head and Neck | |
dc.subject | Progression-Free Survival | |
dc.subject | Broadly Neutralizing Antibodies | |
dc.title | Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2019-08-26 | |
rioxxterms.versionofrecord | 10.1016/j.ejca.2019.08.017 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2019-12 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European journal of cancer (Oxford, England : 1990) | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Cancer Biology | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Cancer Biology | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy | |
pubs.publication-status | Published | |
pubs.volume | 123 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Targeted Therapy | |
dc.contributor.icrauthor | Dillon, Magnus | |
dc.contributor.icrauthor | Harrington, Kevin | |