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

F. Ciardiello, T. Troiani, F. Caputo, M. De Laurentiis, G. Tortora, G. Palmieri, F. De Vita, M. R. Diadema, M. Orditura, G. Colantuoni, C. Gridelli, G. Catalano, S. De Placido, A. R. Bianco

Research output: Contribution to journalArticlepeer-review


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).

Original languageEnglish
Pages (from-to)1604-1609
Number of pages6
JournalBritish Journal of Cancer
Issue number11
Publication statusPublished - Jun 5 2006


  • Combination therapy
  • Metastatic breast cancer
  • Small-molecule EGFR tyrosine kinase inhibitors
  • Taxanes

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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