• Miriana d'Alessandro, Laura Bergantini, Paolo Cameli, Maria Pieroni, Rosa Metella Refini, Piersante Sestini, and Elena Bargagli.
• Respiratory Diseases and Lung Transplantation Unit, Department of Medical and Surgical Sciences & Neurosciences, Siena University Hospital, 53100 Siena, Italy.
• Cancers (Basel). 2021 Feb 9; 13 (4).

BackgroundKrebs von den Lungen-6 (KL-6) was suggested as ILD biomarker including idiopathic pulmonary fibrosis (IPF). Lung cancer is one of the most severe comorbidity of IPF patients. This study aims to serially analyze KL-6 in IPF patients after 24 months of Nintedanib and to first investigate the biomarker behavior in IPF associated with adenocarcinoma.Materials And MethodsOne hundred and forty-two ILD patients (median (IQR), 69 (63-75) years; 86 males) were retrospectively enrolled. Serial serum samples were collected from IPF patients before starting antifibrotic therapy and after 12 months. Serum KL-6 levels were measured by KL-6 reagent assay (Fujirebio Europe, UK).ResultsIncreased KL-6 concentrations were identified in IPF-LC patients than IPF, fibrotic hypersensitivity pneumonitis, and pulmonary fibrosis associated with autoimmune disease groups. A cut-off value was calculated to distinguish IPF and IPF-LC patients. IPF patients monitored for 24 months with Nintedanib showed persisted increased levels of KL-6 with a progressive decline of FVC percentages.ConclusionThis preliminary study offers a first demonstration that very high serum concentrations of KL-6 in IPF-LC patients are associated with poor prognosis. Moreover, serial evaluation of serum KL-6 in IPF patients over 24 months of Nintedanib treatment revealed that most patients experienced a stabilization of lung function parameters and of serum concentrations of KL-6.

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