title: Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy.
abstract: Capturing the patient experience during treatment is important to both regulatory authorities and to patients starting treatment. We identified the symptoms and side effects experienced by patients with advanced non-small-cell lung cancer during osimertinib treatment, to understand treatment expectations, satisfaction, and the level of difficulty coping with the side effects experienced during treatment.
  
  
  
  Qualitative interviews (approximately 4-6 weeks after treatment initiation and again after approximately 4 months of treatment) were conducted during the phase I/II AURA clinical trial of osimertinib, a tyrosine kinase inhibitor of epidermal growth factor receptor-sensitizing and T790M resistance mutations.
  
  
  
  During the first interview (23 patients), the most commonly reported symptoms/side effects were coughing, itching, tiredness (each reported by 56.5% of patients), and rash (43.5%). During the second interview (21 patients), compared with the first interview, shortness of breath and diarrhea were reported by more patients (57.1 and 38.1%, respectively; both increased from 34.8%); tiredness remained predominant (42.9%); and itching (38.1%), coughing (38.1%), and rash (14.3%) were reported by fewer patients. At both interviews, the most frequently reported symptoms/side effects were also those most often rated by patients for bothersomeness and severity, and generally received mean scores in the low-to-moderate range. However, several rarely expressed symptoms/side effects (e.g., abdominal pain, frequent day time urination) received high bothersomeness ratings. At the second interview, patients were highly satisfied with osimertinib and had a low level of difficulty in coping with side effects during treatment.
  
  
  
  These data enhance our understanding of patients' experiences of symptoms/side effects, which could increase the accuracy of the osimertinib benefit-risk assessment, guide management of adverse events, and improve the information given to patients receiving the drug.
authors.affiliation: AstraZeneca Gothenburg, Mölndal, Sweden. Anna.Ryden@astrazeneca.com.
authors.forename: Anna
authors.initials: A
authors.lastname: Rydén
authors.affiliation: Division of Molecular and Clinical Cancer Sciences, University of Manchester, Manchester, UK.|The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Blackhall
authors.affiliation: Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Hye Ryun
authors.initials: HR
authors.lastname: Kim
authors.affiliation: Department of Hematology and Medical Oncology, School of Medicine, Winship Cancer Institute of Emory University, Atlanta, GA, 30345, USA.
authors.forename: Rathi N
authors.initials: RN
authors.lastname: Pillai
authors.affiliation: Health Research Associates Inc., Seattle, WA, USA.
authors.forename: Lauren
authors.initials: L
authors.lastname: Braam
authors.affiliation: Health Research Associates Inc., Seattle, WA, USA.
authors.forename: Mona L
authors.initials: ML
authors.lastname: Martin
authors.affiliation: AstraZeneca R&D, Alderley Park, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Walding
mesh_terms: D000178:Acrylamides; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000814:Aniline Compounds; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D006801:Humans; D007407:Interviews as Topic; D008175:Lung Neoplasms / Q000188:drug therapy*; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D007211:Indoles; D011743:Pyrimidines
chemical_list: D000178:Acrylamides; D000814:Aniline Compounds; D000970:Antineoplastic Agents; D010879:Piperazines; D047428:Protein Kinase Inhibitors; C000596361:osimertinib; D007211:Indoles; D011743:Pyrimidines
keywords: Bothersome Symptom; Epidermal Growth Factor Receptor; Initial Interview; Poor Appetite; Transcript Database