NEW YORK- A combination
of vinorelbine (Navelbine) and
gemcitabine (Gemzar) showed similar
efficacy to the standard platinumbased
regimen for advanced non-small-cell lung cancer (NSCLC) and a
different toxicity profile in a phase II
study presented at the Mount Sinai
School of Medicine Chemotherapy
Foundation Symposium XX.
Rogerio C. Lilenbaum, MD, clinical
associate professor of medicine,
University of Miami School of Medicine,
and director, Thoracic Oncology
Program, Mount Sinai Comprehensive
Cancer Center, Miami Beach,
presented preliminary results from a
multicenter randomized trial that enrolled
164 lung cancer patients.
Patients With Brain
All patients had histologically proven
stage IIIB or IV NSCLC and had
not received chemotherapy. Patients
with brain metastases were eligible if
they were neurologically stable.
"Most patients had stage IV disease,"
Dr. Lilenbaum said, "and most
had performance status 0 to 1. About
15% had performance status 2."
Patients were randomized to receive
carboplatin (Paraplatin) at a dose
of AUC 6 and paclitaxel (Taxol) at
200 mg/m2 on the first day of each
cycle or vinorelbine at 25 mg/m2 and
gemcitabine at 1,000 mg/m2 on days 1
and 8 of each cycle. For both regimens,
the cycles were 21 days and were
repeated up to a maximum of six
times. The median number of cycles
completed was approximately four.
Results and Toxicity
Outcomes were similar in both
arms, with no significant differences.
Partial responses were achieved in
14.6% of patients in the vinorelbine/
gemcitabine arm and 17.1% in the
carboplatin/paclitaxel arm. Stable disease
was recorded in 37.8% and 35.4%,
and disease progression was seen in
34.1% and 31.7%, respectively. The
median time to progression was 2.1
months in both groups.
Median survival was 7.3 months
with vinorelbine/gemcitabine and
8.4 months with the platinum-based
Grade 3/4 hematologic toxicity was
more common in the platinum-based
arm, occurring in 11% of the
vinorelbine/gemcitabine patients vs
28% of the carboplatin/paclitaxel group. The difference in neutropenia,
but not thrombocytopenia, was statistically
significant, Dr. Lilenbaum
Among nonhematologic toxicities,
alopecia (grade 1 to 4) was significantly
less common in the vinorelbine/
gemcitabine arm, 7.5% vs 36.6% for
the platinum-based regimen.
'There was less peripheral neuropathy
in the vinorelbine/gemcitabine
arm, compared with the carboplatin/
paclitaxel regimen," Dr. Lilenbaum
said. Quality of life was similar in both
As a result of the findings in the
phase II trial, Dr. Lilenbaum now sees
vinorelbine/gemcitabine as "an attractive
alternative" to carboplatin/
paclitaxel in patients with advanced
NSCLC who, in the physician's judgment,
are not likely to tolerate such
"Just as we work to extend the lives of
people with late-stage disease, we will also
continue to investigate new approaches
that improve the tolerability of treatment
for these patients," he said.