Global named patient use program of afatinib in advanced non-small-cell lung carcinoma patients who progressed following prior therapies

Future Oncol. 2018 Jun;14(15):1477-1486. doi: 10.2217/fon-2017-0666. Epub 2018 Jan 29.

Abstract

Aim: A global afatinib named patient use program in non-small-cell lung carcinoma (NSCLC) commenced in 2010.

Materials & methods: Eligible NSCLC patients had progressed after clinical benefit on prior erlotinib/gefitinib and/or had activating EGFR/HER2 mutations, exhausted all other treatments, and were ineligible for afatinib trials.

Results: Data, as of January 2016, were reported on 3966 heavily pretreated NSCLC patients (41 countries; six continents). Among 2595/3966 (65.4%) patients with tumor EGFR status, 2407 (92.8%) were EGFR mutation positive. Median time to treatment failure (2862/3966 [72.2%] patients with available data) was 4.4 months. Among 1141/2862 (39.9%) patients with response reported, objective response rate was 23.4% (267/1141). Safety findings were as expected.

Conclusion: Time to treatment failure durations and objective response rates were encouraging.

Keywords: afatinib; compassionate use; non-small-cell lung carcinoma.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Afatinib
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / genetics
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Disease Progression
  • ErbB Receptors / genetics
  • Erlotinib Hydrochloride / therapeutic use
  • Female
  • Gefitinib
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Mutation
  • Patient Selection
  • Program Evaluation
  • Protein Kinase Inhibitors / therapeutic use*
  • Quinazolines / therapeutic use*
  • Time Factors
  • Treatment Failure

Substances

  • Protein Kinase Inhibitors
  • Quinazolines
  • Afatinib
  • Erlotinib Hydrochloride
  • EGFR protein, human
  • ErbB Receptors
  • Gefitinib