Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial.

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Abstract

In the phase III LUX-Head & Neck 1 (LHN1) trial, afatinib significantly improved progression-free survival (PFS) versus methotrexate in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients progressing on/after platinum-based therapy. This report evaluates afatinib efficacy and safety in prespecified subgroups of patients aged ≥65 and <65 years.

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Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy.

Jan B Vermorken, José Trigo, Ricardo Hitt … (2007)

To evaluate the efficacy and safety of the epidermal growth factor receptor-directed monoclonal antibody cetuximab administered as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who experience disease progression on platinum therapy. An open-label multicenter study in which patients with disease progression on two to six cycles of platinum therapy received single-agent cetuximab (initial dose 400 mg/m2 followed by subsequent weekly doses of 250 mg/m2) for > or = 6 weeks (single-agent phase). Patients who experienced disease progression could receive salvage therapy with cetuximab plus platinum (combination-therapy phase). From June 2001 to December 2002, 103 patients were enrolled and treated with cetuximab, 53 of whom subsequently received combination therapy. In the single-agent phase, response rate was 13%, disease control rate (complete response/partial response/stable disease) was 46%, and median time to progression (TTP) was 70 days. During the combination-therapy phase, the objective response rate was zero, disease control rate was 26%, and TTP was 50 days. Median overall survival was 178 days. Treatment was well tolerated. The most common cetuximab-related adverse events in the single-agent phase were skin reactions, particularly rash (49% of patients, mainly grade 1 or 2). There was one treatment-related death due to an infusion-related reaction. Single-agent cetuximab was active and generally well tolerated in the treatment of recurrent and/or metastatic SCCHN that progressed on platinum therapy. Response was comparable to that seen with cetuximab plus platinum combination regimens in the same setting.

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A systematic review of barriers to medication adherence in the elderly: looking beyond cost and regimen complexity.

Walid F Gellad, Jerry L. Grenard, Zachary Marcum (2011)

Medication nonadherence is a common problem among the elderly. To conduct a systematic review of the published literature describing potential nonfinancial barriers to medication adherence among the elderly. The PubMed and PsychINFO databases were searched for articles published in English between January 1998 and January 2010 that (1) described "predictors," "facilitators," or "determinants" of medication adherence or that (2) examined the "relationship" between a specific barrier and adherence for elderly patients (ie, ≥65 years of age) in the United States. A manual search of the reference lists of identified articles and the authors' files and recent review articles was conducted. The search included articles that (1) reviewed specific barriers to medication adherence and did not solely describe nonmodifiable predictors of adherence (eg, demographics, marital status), (2) were not interventions designed to address adherence, (3) defined adherence or compliance and specified its method of measurement, and (4) involved US participants only. Nonsystematic reviews were excluded, as were studies that focused specifically on people who were homeless or substance abusers, or patients with psychotic disorders, tuberculosis, or HIV infection, because of the unique circumstances that surround medication adherence for each of these populations. Nine studies met inclusion criteria for this review. Four studies used pharmacy records or claims data to assess adherence, 2 studies used pill count or electronic monitoring, and 3 studies used other methods to assess adherence. Substantial heterogeneity existed among the populations studied as well as among the measures of adherence, barriers addressed, and significant findings. Some potential barriers (ie, factors associated with nonadherence) were identified from the studies, including patient-related factors such as disease-related knowledge, health literacy, and cognitive function; drug-related factors such as adverse effects and polypharmacy; and other factors including the patient-provider relationship and various logistical barriers to obtaining medications. None of the reviewed studies examined primary nonadherence or nonpersistence. Medication nonadherence in the elderly is not well described in the literature, despite being a major cause of morbidity, and thus it is difficult to draw a systematic conclusion on potential barriers based on the current literature. Future research should focus on standardizing medication adherence measurements among the elderly to gain a better understanding of this important issue. Published by EM Inc USA.

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Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

V. Grégoire, J.-L. Lefebvre, L. Licitra … (2010)

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Author and article information

Journal

Journal ID (iso-abbrev): Ann. Oncol.

Title: Annals of oncology : official journal of the European Society for Medical Oncology

Publisher: Oxford University Press (OUP)

ISSN (Electronic): 1569-8041

ISSN (Print): 0923-7534

Publication date (Electronic): Aug 2016

Volume: 27

Issue: 8

Affiliations

[1 ] Department of Oncology, KU Leuven, Leuven Department of General Medical Oncology, UZ Leuven, Leuven, Belgium paul.clement@uzleuven.be.

[2 ] Department of Medicine (Cancer Research), West German Cancer Center, University Hospital Essen, Essen, Germany.

[3 ] Institut Roi Albert II, Service d'Oncologie Médicale, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Brussels, Belgium.

[4 ] Departmant of Medical Oncology, Dana-Farber Cancer Institute/Harvard Medical School, Boston, USA.

[5 ] Departmant of Medical Oncology, Léon Bérard Center, University of Lyon, Lyon, France.

[6 ] Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.

[7 ] Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

[8 ] Department of Medicine, University of California San Diego Moores Cancer Center, La Jolla, USA.

[9 ] Service d'Oncologie Médicale, Institut du Cancer de Montpellier Val d'Aurelle, Montpellier, France.

[10 ] Department of Medical Oncology, Hospital Clínic and University of Barcelona, Barcelona, Spain.

[11 ] Department of Medical Oncology, Gustave Roussy, Villejuif Centre Antoine Lacassagne, Nice, France.

[12 ] Department of Melanoma, Soft Tissues, Muscolo Scheletal, Head and Neck, Head and Neck Medical Oncology, National Tumor Institute of Naples, Naples, Italy.

[13 ] Oncologia Clinica, Instituto do Câncer do Estado de São Paulo, São Paulo.

[14 ] Department of Medical Oncology, Hospital de Câncer de Barretos, São Paulo, Brazil.

[15 ] Charité Comprehensive Cancer Center, Berlin, Germany.

[16 ] Department of Medical Oncology, Hospital Universitario Vall D'Hebron, Barcelona, Spain.

[17 ] Biometrics and Data Management, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, USA.

[18 ] Division of Oncology, Boehringer Ingelheim Danmark A/S, Copenhagen, Denmark.

[19 ] Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium.

Article

Publisher Item ID: mdw151

DOI: 10.1093/annonc/mdw151

PMC ID: 4959921

PubMed ID: 27084954

SO-VID: 8722803a-b20b-46eb-ac0e-591b5b108d2d

History

Keywords: HNSCC,afatinib,methotrexate,older,phase III,second-line

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Keywords: HNSCC, afatinib, methotrexate, older, phase III, second-line

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Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial.

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Most cited references 8

Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy.

A systematic review of barriers to medication adherence in the elderly: looking beyond cost and regimen complexity.

Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

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