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Br J Cancer
2006 Jun 05;9411:1604-9. doi: 10.1038/sj.bjc.6603141.
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Phase II study of gefitinib in combination with docetaxel as first-line therapy in metastatic breast cancer.
Ciardiello F
,
Troiani T
,
Caputo F
,
De Laurentiis M
,
Tortora G
,
Palmieri G
,
De Vita F
,
Diadema MR
,
Orditura M
,
Colantuoni G
,
Gridelli C
,
Catalano G
,
De Placido S
,
Bianco AR
.
Abstract
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).
Baselga,
Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer.
1996, Pubmed
Baselga,
Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer.
1996,
Pubmed
Baselga,
Phase II and tumor pharmacodynamic study of gefitinib in patients with advanced breast cancer.
2005,
Pubmed
Bissery,
Docetaxel (Taxotere): a review of preclinical and clinical experience. Part I: Preclinical experience.
1995,
Pubmed
Bonneterre,
Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure.
2002,
Pubmed
Burris,
Docetaxel (Taxotere) plus trastuzumab (Herceptin) in breast cancer.
2001,
Pubmed
Ciardiello,
Antitumor effect and potentiation of cytotoxic drugs activity in human cancer cells by ZD-1839 (Iressa), an epidermal growth factor receptor-selective tyrosine kinase inhibitor.
2000,
Pubmed
Ciardiello,
A novel approach in the treatment of cancer: targeting the epidermal growth factor receptor.
2001,
Pubmed
Ciardiello,
ZD1839 (IRESSA), an EGFR-selective tyrosine kinase inhibitor, enhances taxane activity in bcl-2 overexpressing, multidrug-resistant MCF-7 ADR human breast cancer cells.
2002,
Pubmed
Esteva,
Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer.
2002,
Pubmed
Fleming,
One-sample multiple testing procedure for phase II clinical trials.
1982,
Pubmed
Fox,
The epidermal growth factor receptor as a prognostic marker: results of 370 patients and review of 3009 patients.
1994,
Pubmed
Greenberg,
Long-term follow-up of patients with complete remission following combination chemotherapy for metastatic breast cancer.
1996,
Pubmed
Grünwald,
Developing inhibitors of the epidermal growth factor receptor for cancer treatment.
2003,
Pubmed
Herbst,
Gefitinib--a novel targeted approach to treating cancer.
2004,
Pubmed
Hortobagyi,
Can we cure limited metastatic breast cancer?
2002,
Pubmed
Klijn,
The prognostic value of epidermal growth factor receptor (EGF-R) in primary breast cancer: results of a 10 year follow-up study.
1994,
Pubmed
Klijn,
The clinical significance of epidermal growth factor receptor (EGF-R) in human breast cancer: a review on 5232 patients.
1992,
Pubmed
Knowlden,
Elevated levels of epidermal growth factor receptor/c-erbB2 heterodimers mediate an autocrine growth regulatory pathway in tamoxifen-resistant MCF-7 cells.
2003,
Pubmed
Luetteke,
Targeted inactivation of the EGF and amphiregulin genes reveals distinct roles for EGF receptor ligands in mouse mammary gland development.
1999,
Pubmed
Marty,
Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group.
2005,
Pubmed
Matsui,
Development of mammary hyperplasia and neoplasia in MMTV-TGF alpha transgenic mice.
1990,
Pubmed
Mendelsohn,
Status of epidermal growth factor receptor antagonists in the biology and treatment of cancer.
2003,
Pubmed
Mincey,
Advances in screening, diagnosis, and treatment of breast cancer.
2004,
Pubmed
Montemurro,
A phase II study of three-weekly docetaxel and weekly trastuzumab in HER2-overexpressing advanced breast cancer.
2004,
Pubmed
Montero,
Docetaxel for treatment of solid tumours: a systematic review of clinical data.
2005,
Pubmed
Nabholtz,
Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group.
1999,
Pubmed
Nabholtz,
Docetaxel in the treatment of breast cancer: current experience and future prospects.
2005,
Pubmed
Nicholson,
Modulation of epidermal growth factor receptor in endocrine-resistant, estrogen-receptor-positive breast cancer.
2002,
Pubmed
O'Shaughnessy,
Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results.
2002,
Pubmed
Polychronis,
Preoperative gefitinib versus gefitinib and anastrozole in postmenopausal patients with oestrogen-receptor positive and epidermal-growth-factor-receptor-positive primary breast cancer: a double-blind placebo-controlled phase II randomised trial.
2005,
Pubmed
Ringel,
Studies with RP 56976 (taxotere): a semisynthetic analogue of taxol.
1991,
Pubmed
Riou,
Effects of Taxotere on murine and human tumor cell lines.
1992,
Pubmed
Salomon,
Epidermal growth factor-related peptides and their receptors in human malignancies.
1995,
Pubmed
Sandgren,
Overexpression of TGF alpha in transgenic mice: induction of epithelial hyperplasia, pancreatic metaplasia, and carcinoma of the breast.
1990,
Pubmed
Shou,
Mechanisms of tamoxifen resistance: increased estrogen receptor-HER2/neu cross-talk in ER/HER2-positive breast cancer.
2004,
Pubmed
Sirotnak,
Efficacy of cytotoxic agents against human tumor xenografts is markedly enhanced by coadministration of ZD1839 (Iressa), an inhibitor of EGFR tyrosine kinase.
2000,
Pubmed
Sjöström,
Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group.
1999,
Pubmed
Tabernero,
A multicentre, randomised phase II study of weekly or 3-weekly docetaxel in patients with metastatic breast cancer.
2004,
Pubmed
Tedesco,
Docetaxel combined with trastuzumab is an active regimen in HER-2 3+ overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: a multi-institutional phase II trial.
2004,
Pubmed
Therasse,
New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada.
2000,
Pubmed
von Minckwitz,
A multicentre phase II study on gefitinib in taxane- and anthracycline-pretreated metastatic breast cancer.
2005,
Pubmed
