title: Nutritional Status, Body Surface, and Low Lean Body Mass/Body Mass Index Are Related to Dose Reduction and Severe Gastrointestinal Toxicity Induced by Afatinib in Patients With Non-Small Cell Lung Cancer.
abstract: BACKGROUND
  The main reason for dose reduction of afatinib is gastrointestinal toxicity (GT). In a phase II study, we analyzed anthropometrical, nutritional, and biochemical factors associated with GT induced by afatinib.
  
  
  METHODS
  Patients diagnosed with non-small cell lung cancer who progressed to prior chemotherapy received 40 mg of afatinib. Malnutrition was determined by Subjective Global Assessment, and lean body mass (LBM) was determined by computed tomography scan analysis using a pre-established Hounsfield unit threshold. Toxicity was obtained during four cycles by Common Terminology Criteria for Adverse Events.
  
  
  RESULTS
  Eighty-four patients were enrolled. Afatinib was administered as the second, third, and fourth line of treatment in 54.8%, 38.1%, and 7.12% of patients, respectively. Severe diarrhea, mucositis, and overall severe GT were present in 38.9%, 28.8%, and 57.5%, respectively. Of the patients, 50% developed dose-limiting toxicity (DLT). Patients with malnutrition have higher risk for severe GT. Patients with lower LBM and body mass index developed more DLT (71.4% vs. 18.8%).
  
  
  CONCLUSIONS
  Malnutrition is associated with a higher risk of severe GT induced by afatinib. Determination of nutritional status and body composition are helpful in identifying patients at higher risk of severe GT and could allow initiating treatment with lower doses according to tolerance.
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada ogar@unam.mx.
authors.forename: Oscar
authors.initials: O
authors.lastname: Arrieta
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Martha
authors.initials: M
authors.lastname: De la Torre-Vallejo
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Diego
authors.initials: D
authors.lastname: López-Macías
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Orta
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Jenny
authors.initials: J
authors.lastname: Turcott
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Eleazar-Omar
authors.initials: EO
authors.lastname: Macedo-Pérez
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Karla
authors.initials: K
authors.lastname: Sánchez-Lara
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Laura-Alejandra
authors.initials: LA
authors.lastname: Ramírez-Tirado
authors.affiliation: Thoracic Oncology Unit, Instituto Nacional de Cancerología, Mexico City, Mexico; Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Vickie E
authors.initials: VE
authors.lastname: Baracos
mesh_terms: D000077716:Afatinib; D015992:Body Mass Index; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D009752:Nutritional Status; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D011799:Quinazolines; D000077716:Afatinib
keywords: Afatinib; Gastrointestinal toxicity; Malnourishment; Non-small cell lung cancer; Nutritional status; Phase II trial