(Erbitux) improves the efficacy
of cisplatin/vinorelbine (Navelbine)
for first-line treatment of advanced
non-small-cell lung cancer (NSCLC)
in patients whose tumors express epidemal
growth factor receptor (EGFR),
according to Rafael Rosell, MD, of the
Catalan Institute of Oncology, Barcelona,
Spain. Dr. Rosell reported that
data from a randomized phase II study
also showed that development of a
skin rash is predictive of response and
that the toxicity of the regimen was
not increased substantially by adding
cetuximab (abstract 7012).
Cetuximab is an IgG1 monoclonal
antibody targeting the EGFR. Dr.
Rosell said that combinations of cetuximab
and chemotherapy have been
shown to be effective and safe in other
EGFR-expressing tumors such as
colorectal and head and neck cancers.
The primary study endpoint was
objective response rate. Ninety percent
of the patients in this study had
stage IV disease.
All patients were treated with three
cycles of cisplatin 80 mg/m2 on day 1
and vinorelbine 25 mg/m2 on days 1
and 8. Patients were then randomized
to receive either additional treatment
with cetuximab 400 mg/m2 on week 1
and 250 mg/m2 weekly thereafter (arm
A, n = 43), or no additional treatment
(arm B, n = 43). Ninety percent (101
of 122 patients screened) had EGFRexpressing
tumors. A total of 86 patients
were enrolled, 43 in each of the
two treatment arms.
One-year survival was 32% with
cetuximab plus chemotherapy vs 29%
with placebo plus chemotherapy, but
Dr. Rosell emphasized that only five
patients are still alive. Survival at 18
months was 14% with cetuximab vs 0
on the comparison arm. "The longest
survival was 24 months," he said.
The patients who were treated with
cetuximab had more grade 3 or 4 asthenia
and fatigue (19% vs 2%).
For patients under age 60 years, the
unconfirmed complete response/partial
response rate was 63% for patients
treated with cetuximab vs 2% for controls.
In the same population, confirmed
were 14% with cetuximab, 0 without
cetuximab. For patients over age 60
years, the unconfirmed complete response/
partial response rate was 31%
with cetuximab vs 36% without cetuximab.
Dr. Rosell said that the response
rate was 25% in patients who developed
any type of skin toxicity.
"Cetuximab can safely be added to
the regimen of cisplatin and vinorelbine,
with evidence suggesting enhancement
of activity," Dr. Rosell