BACKGROUND: Head and neck malignancies rank sixth in incidence as a group
of cancer. Within the histological types, squamous cell carcinoma is the most
prevalent one, and it is associated with risk factors such as tobacco or alcohol.
These tumours are characterized by their rapid lymphatic spread to regional
lymph nodes, frequently having to associate a cervical lymphadenectomy as a
part of the treatment. These neoplasms also have a high percentage of distant
metastases after treatment of the primary tumour. The lung is the most affected
organ, with a poor prognosis when pulmonary metastases develop. New clinical
and pathological markers are considered when establishing the prognosis. The
type of follow-up performed on patients affected by these neoplasms may be
modified by these factors. Extranodal extension (ENE) is an upstaging factor as
stated in the last TNM edition. Although TNM staging system suggests a division
into major and minor ENE subtypes, studies are lacking to conclude ENE’s role in
distant metastases. Moreover, none of them evaluate these subtyping
implications. OBJECTIVES: To determine if there is a direct association between
the HNSCC’s extranodal extension and the incidence of pulmonary metastases.
Also, as a secondary objective, to determine if this association is maintained in
both minor and major subtypes of extranodal extension. DESIGN: This study is
designed as a multicentre observational prospective cohort study with three-year
follow-up. SAMPLE: A non-probabilistic consecutive sampling method will be
performed, and the patients will be recruited in six hospitals around Catalonia.
The patients must have received a cervical lymphadenectomy as part of their
HNSCC’s treatment and be older than 18 years. METHODS: We will recruit 200
patients in 15 months, with a follow-up of three years. Two groups will be created,
one with extranodal extension stratified in ENEma and ENEmi, and another
without extranodal extension. We will observe if pulmonary metastases are
detected during the follow-up. We will use a Cox regression adjusted for the
covariates with a CI of 95%
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