NAPLES, ItalyIn elderly non-small-cell lung cancer (NSCLC)
patients, gemcitabine (Gemzar) combined with vinorelbine (Navelbine)
was associated with significantly better survival in comparison to
treatment with vinorelbine alone, Giuseppe Frasci, MD, reported at
the 36th ASCO Annual Meeting.
Increasing interest in the treatment of elderly NSCLC cancer
patients is mainly due to the demographic changes that are taking
place in Western countries, said Dr. Frasci, Division of
Medical Oncology A, National Tumor Institute, Naples, Italy. For lung
cancer, more than 50% of cases occur in people over age 60 and 30% in
people over 70.
This population is characterized by several features that must be
considered when selecting a chemotherapy regimen, Dr. Frasci said.
These include physiologic changes in the functions of the main organs
and a higher prevalence of concomitant disease that may impair the
tolerability of the disease or of treatment.
Dr. Frasci reported that this Southern Italy Cooperative Oncology
Group (SICOG) phase III trial was conducted to compare survival and
quality of life with the gemcitabine plus vinorelbine regimen (GV) vs
that of vinorelbine (V) alone.
In this study, NSCLC patients with stage IIIB or IV disease, between
71 and 85 years of age with an ECOG performance status of 2 or below,
were randomized to receive either gemcitabine 1,200 mg/m² plus
vinorelbine 30 mg/m² on days 1 and 8, every 3 weeks or
vinorelbine 30 mg/m² on days 1 and 8, every 3 weeks.
Survival was the main end point, Dr. Frasci said. We expected
to prolong the median survival time by 50%.
He said that the researchers did not exclude patients with CNS
involvement provided that they were asymptomatic. The number and
weight of comorbidities was assessed using the Charlson probability scale.
The total sample size planned was 120 patients per arm, with an
interim analysis after half of the patients had been enrolled. Early
termination of the study was planned if the experimental regimen
showed better survival at a P level of less than .01.
When at least 12 weeks had elapsed from the accrual of the last
patient, survival data of the first 120 eligible patients (V = 60, GV
= 60) were analyzed.
The median survival in the whole population was 24 weeks, 25 weeks in
stage IIIB disease, and 21 in stage IV disease.
Median survival was 29 weeks in the combination arm, compared with 18
weeks in the control arm.
There was also a significant difference in time to symptom
deterioration, 21 weeks for GV vs 13 weeks for V alone, and there
were no major differences in toxicity between the groups.
The response rate to the GV regimen was 22%, and for the V regimen,
it was 15%.
Quality of life differed between the groups. We had 62% of
patients with the score improved or stable in the combination arm, as
compared to 40% improved or stable in the standard treatment
arm, Dr. Frasci said.
Among the nonhematologic toxicities, vomiting, fatigue, constipation,
and loss of appetite were the most frequent causes of patient
complaints, and they are occurred in almost half of the patients, Dr.
The number and weight of concomitant diseases, together with
the performance status, have a major role in impairing the tolerance
of the treatment, Dr. Frasci said. A more accurate
selection of patients, and a personalized drug dosing could be
advisable in future trials.
As planned, the study was closed early, since the null
hypothesis can be rejected at the P = .01 significance
level, Dr. Frasci said. The gemcitabine/vinorelbine combination
regimen is now considered the SICOG reference first-line treatment
for elderly NSCLC patients.