Phase II study of gefitinib in combination with docetaxel as first-line therapy in metastatic breast cancer

Br J Cancer. 2006 Jun 5;94(11):1604-9. doi: 10.1038/sj.bjc.6603141.


We have evaluated the activity and safety of gefitinib, a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with docetaxel as first-line treatment of women with metastatic breast cancer (MBC). In total, 41 patients with MBC were enrolled in a first-line combination therapy study with oral gefitinib (250 mg day(-1)) and intravenous docetaxel (75 mg m(-2), the first 14 patients; or 100 mg m(-2), the following 27 patients, on day 1 of a 3-week cycle). Out of 41 patients, 38 received at least one cycle of therapy. There were no differences in activity or tolerability between the two docetaxel doses. G3/4 toxicities were neutropenia (49%), diarrhoea (10%), acne-like rash (5%), and anaemia (2%). Complete plus partial responses (CR+PR) were observed in 22 out of 41 patients with a 54% response rate (95% confidence interval (CI) 45-75%). The 22 patients that achieved a response following six cycles of docetaxel plus gefitinib continued gefitinib monotherapy (median duration, 24 weeks; range, 2-108+ weeks). Two patients with PR following combination therapy achieved a CR during gefitinib monotherapy. Complete plus partial responses correlated with oestrogen receptor (ER) status, since they occurred in 19 out of 27 (70%) patients with ER-positive tumours as compared to three out of 14 (21%) patients with ER-negative tumours (P=0.01).

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / toxicity*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Disease Progression
  • Docetaxel
  • Female
  • Gefitinib
  • Humans
  • Middle Aged
  • Neoplasm Metastasis
  • Quinazolines / administration & dosage
  • Quinazolines / toxicity
  • Receptors, Estrogen / analysis
  • Taxoids / administration & dosage
  • Taxoids / toxicity
  • Treatment Outcome


  • Quinazolines
  • Receptors, Estrogen
  • Taxoids
  • Docetaxel
  • Gefitinib