EVIDENCE-BASED ONCOLOGY
Gefitinib does not improve survival when
combined with paclitaxel and carboplatin
chemotherapy in people with advanced
non-small-cell lung cancer
Abstracted from: Herbst RS, Giaccone G, Schiller JH et al. Gefitinib in combination with paclitaxel and
carboplatin in advanced non-small-cell lung cancer: a phase III trial – INTACT 2. J Clin Oncol
2004;22:785–94.
Background
Evidence to support the use of gefitinib, an
epidermal growth factor receptor tyrosine
kinase inhibitor, in combination with paclitaxel
and carboplatin chemotherapy regimens in people
with advanced non-small-cell lung cancer is
limited.
Objective
To determine if gefitinib, in combination with
paclitaxel and carboplatin chemotherapy improves
survival outcomes in people with advanced non-
small-cell lung cancer.
Setting
This multicentre study was conducted mainly (80%)
in the United States.
Method
Multicentre randomised controlled trial.
Participants
1037 people (60% male, median age 61 years,
range 26–86 years) with histologically confirmed
non-small-cell lung cancer (NSCLC) and disease
stage IIIa (n = 30, 3%); IIIb without malignant
pleural effusion (n = 41, 4%); IIIb with malignant
pleural effusion (n = 127, 12%) or stage IV
(n = 834, 80%; note: information not available
from all participants) with a WHO performance
status of 0 (n = 367, 35%), 1 (n = 554, 53%) or 2
(n = 114, 11%). People were excluded if they:
had mixed NSCLC plus small-cell lung cancer;
had previously received chemotherapy; had brain
metastases that were newly diagnosed or had not
been treated with surgery or radiation; had
previously been treated for CNS metastases or
spinal-cord compression in the absence of clini-
cally stable disease; had received radiotherapy
within the preceding 2 weeks; had unresolved
toxicity from previous radiation therapy or had
not completely healed from previous surgery;
were hypersensitive to mannitol, corticosteroids,
H
2
-antagonists, antihistamines or agents formu-
lated with polyoxyethylated castor oil; had great-
er than trace blood or protein on repeat
urinalysis; had indications of severe or uncon-
trolled systemic disease; had an absolute neutro-
phil count of <2000/lL, a white blood cell count
0305-7372/$ - see front matter
c
2004 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ctrv.2004.08.002
CANCER TREATMENT REVIEWS (2004) 30, 655–659
www.elsevierhealth.com/journals/ctrv