Emerging role of gefitinib in the treatmentof non-small-cell lung cancer (NSCLC)

M. Tiseo, M. Bartolotti, F. Gelsomino, P. Bordi

Research output: Contribution to journalArticlepeer-review


Most patients with non-small-cell lung cancer (NSCLC) present with advanceddisease and their long-term prognosis remains poor. Epidermal growth factor receptor (EGFR)-targeted therapies, such as gefitinib, have been subjected to comprehensive clinical development.Several phase II and III trials evaluated the clinical efficacy of gefitinib as monotherapyin pretreated patients with advanced NSCLC, as well as both monotherapy and combined withchemotherapy in chemotherapy-naive patients. A phase III trial (ISEL) in heavily pretreatedadvanced NSCLC patients demonstrated some improvement in survival with gefitinib comparedwith placebo; however, the difference was not statistically significant within the overall population.A large phase III trial in pretreated patients (INTEREST) demonstrated the non-inferiorityof gefitinib in comparison with docetaxel for overall survival, together with an improved qualityof life and tolerability profiles. In a large phase III trial (IPASS) in Asian chemotherapy-naive,never or former light-smoker patients with adenocarcinoma, gefitinib was more effective thancarboplatin-paclitaxel in prolonging progression-free survival, particularly in patients harboringEGFR gene mutations. Gefitinib was a generally well tolerated treatment, with skin rash anddiarrhea being the most common treatment adverse events. As a result, gefitinib is expectedto have a large impact on the management of patients with advanced NSCLC, in particular inEGFR mutated patients.

Original languageEnglish
Pages (from-to)81-98
Number of pages18
JournalDrug Design, Development and Therapy
Publication statusPublished - 2010


  • EGFR
  • Gefitinib
  • Non-small-cell lung cancer

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology
  • Drug Discovery


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