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Abstract Quality improvement of care for patients with head and neck cancer remains a constant objective for the multidisciplinary team of physicians managing these patients. The purpose of quality assurance (QA) for head and neck surgical oncology and surgical trials however differs. While QA for the general head and neck patient aims to improve global outcome through structural changes of health-care systems, QA for surgical trials pursues the goal to help providing meaningful results from a clinical trial through the definition of structure, process and outcome measures within the trial. Establishing a QA program for surgical trials is challenging largely due to the variation in the execution of surgical techniques. Within this article, we describe the surgical QA program, which was developed for the phase III European Organisation for Research and Treatment of Cancer (EORTC) 1420 study, a trial assessing swallowing function after transoral surgery compared with radiation therapy. We propose based on our experience to further develop surgical QA for surgical clinical trials by introducing two separate components, one adaptable and one non-adaptable. The adaptable is tailored to the scientific question and specific procedure; the non-adaptable consists of minimal structural requirements of the clinical unit to participate in surgical trials at EORTC as well as guidelines and incentives for protocol adherence based on our experience in EORTC 24954. Finally, we strongly believe that surgical QA designed for clinical trials may serve as a basis for the development of QA surgical guidelines in clinical practice. Highlights • Quality assurance (QA) programs for surgical trials are challenging. • We propose a QA framework consisting of an adaptable and a non-adaptable component. • The adaptable is tailored to the scientific question and specific procedure. • The non-adaptable consists of minimal structural requirements of the clinical unit. • Surgical QA within clinical trials may serve as the basis for guidelines in clinical practice. [ABSTRACT FROM AUTHOR]

Personalised medicine tumour boards, which leverage genomic data to improve clinical management, are becoming standard for the treatment of many cancers. This paper is designed as a primer to assist clinicians treating head and neck squamous cell carcinoma (HNSCC) patients with an understanding of the discovery and functional impact of recurrent genetic lesions that are likely to influence the management of this disease in the near future. This manuscript integrates genetic data from publicly available array comparative genome hybridization (aCGH) and next-generation sequencing genetics databases to identify the most common molecular alterations in HNSCC. The importance of these genetic discoveries is reviewed and how they may be incorporated into clinical care decisions is discussed. Considerations for the role of genetic stratification in the clinical management of head and neck cancer are maturing rapidly and can be improved by integrating data sets. This article is meant to summarise the discoveries made using multiple genomic platforms so that the head and neck cancer care provider can apply these discoveries to improve clinical care. [ABSTRACT FROM AUTHOR]

Abstract: Background: Cetuximab is an epidermal growth factor receptor (EGFR)-blocking antibody that has been approved for the treatment of patients with head and neck squamous cell carcinoma (HNSCC) and metastatic colorectal cancer, but no predictive biomarkers of activity have been yet identified. Establishment of such biomarkers will help identify a subset of patients that will benefit from cetuximab therapy. Methods: In this paper, we report on a patient with HNSCC who had a complete tumour regression following treatment with cetuximab given as a single agent after initial surgery and radiation therapy. The EGFR protein expression level, the EGFR gene copy number and the EGFR gene sequence were assessed from both normal and tumour tissues. Results: Besides protein overexpression and gene amplification in the tumour tissue, sequencing of the EGFR gene from the patient revealed the presence of two somatic mutations, one in the kinase domain (R705G) and the other in the ligand binding domain (P546S). Cells that stably express these EGFR mutants were treated with cetuximab and their sensitivity to the drug was compared to cells expressing the wildtype gene. While P546S mutation sensitised NIH-3T3 cells to cetuximab, R705G had a marginal effect. The double mutant (P546S/R705G) behaved like the P546S mutant, indicating that the mutation in the kinase domain does not contribute to the increased sensitivity to cetuximab. No mutations were found in K-RAS or B-RAF genes and no HPV protein or DNA was detected in the tumour. This is the first report of a somatic mutation in the EGFR ligand binding domain that may contribute to increased sensitivity to cetuximab. Conclusions: Our results support a role for the P546S mutation in cetuximab sensitivity. Other factors including EGFR protein high copy number and protein overexpression may have also contributed to the observed response. The severity of a skin rash developed by this patient and its correlation with the antitumour activity does not exclude the involvement of the immune system (i.e. complement-mediated immune response) as well. The occurrence of the P546S mutation needs to be evaluated in HNSCC, as a well as a prospective evaluation of cetuximab anti-tumour activity in patients with tumours harbouring the mutation. [Copyright &y& Elsevier]

Abstract: The RARECARE project has proposed a different and more detailed grouping of cancers, based on localisation and histological type, in order to identify rare entities with clinical meaning. RARECARE gathered data on cancer patients diagnosed from 1978 to 2002 and archived in 76 population-based cancer registries, all of which had vital status information available up to at least 31st December 2003. This study provides incidence, prevalence and survival rates for rare head and neck epithelial (H&N) cancers. Among the rare H&N cancers, those of oral cavity had the highest annual crude incidence rate of 48 per million, followed by oropharynx and ‘major salivary glands and salivary gland type tumours’ (28 and 13 per million, respectively). Incidence rates of epithelial tumours of nasal cavities, nasopharynx, eye and adnexa and middle ears were all lower than 5 per million. The prevalence for all investigated entities was lower than 35 per 100,000. The 5-year relative survival rates ranged from 40% for epithelial cancer of oropharynx to 85% for epithelial cancer of eye and adnexa. Survival rates were lower for men and for patients aged ⩾65years. With few exceptions, the lowest and highest survival figures were observed for Eastern Europe and Northern Europe, respectively. According to the definition for rare tumours by RARECARE (incidence<6 per 100,000), as well as according to the definition for rare diseases by the European Commission (prevalence<50 per 100,000) the H&N cancers described in this paper should be considered rare and diagnosis and treatment of these cancers should therefore be centralised. [Copyright &y& Elsevier]