Phase II study of gefitinib in combination with docetaxel as first-line therapy in metastatic breast cancer.
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).
Ciardiello
F
F
Cattedra di Oncologia Medica, Dipartimento Medico-Chirurgico di Internistica Clinica e Sperimentale 'F Magrassi e A Lanzara', Seconda Università degli Studi di Napoli, Via S Pansini 5, 80131 Naples, Italy. fortunato.ciardiello@unina2.it
Troiani
T
T
Caputo
F
F
De Laurentiis
M
M
Tortora
G
G
Palmieri
G
G
De Vita
F
F
Diadema
M R
MR
Orditura
M
M
Colantuoni
G
G
Gridelli
C
C
Catalano
G
G
De Placido
S
S
Bianco
A R
AR