NAPLES, Italy--Platinum-based chemotherapy is often avoided in
elderly lung cancer patients due to concerns about tolerability.
Since about one-third of patients with non-small cell lung cancer
(NSCLC) are over age 70 at diagnosis, this presents a significant problem.
Most of these patients have been consigned to "best supportive
care," but, at ASCO, ELVIS (Elderly Lung Cancer Vinorelbine
Italian Study) investigators came out in favor of drug therapy for
this age group. Their study showed that vinorelbine (Navelbine) is
well tolerated in older patients and provides better survival and
quality of life than supportive care alone.
Francesco Perrone, MD, of the NCI-Naples, reporting for ELVIS, said
that 1-year survival was 27% in patients treated with vinorelbine vs
5% in those who received only best supportive care. This is similar
to the survival benefits reported with cisplatin-based chemotherapy
in advanced NSCLC, he said.
"We think that in clinical practice, vinorelbine should now be
proposed as the first choice when discussing treatment options with
elderly advanced NSCLC patients," Dr. Perrone said, "and
should be the control arm for future randomized clinical trials in
This phase III multicenter trial was designed to enroll 350 patients
aged 70 or more with stage IIIb/IV NSCLC unsuitable for curative
radiotherapy, and no previous chemotherapy. Accrual could not be
completed because of publication of a study showing efficacy for
single-agent vinorelbine in NSCLC.
"Our trial was stopped due to dwindling enrollment. Physicians
were not referring patients," he said. Three interim analyses
had been planned, but due to this unexpected problem, the second
interim analysis became the final one.
The researchers randomized 191 patients to vinorelbine plus best
supportive care or best supportive care only. Vinorelbine was given
at 30 mg/m2 IV on days 1 and 8, every 3 weeks for a maximum of 6 cycles.
Dr. Perrone reported survival data from 161 patients who had been
followed for at least 18 weeks. Median survival was 27 weeks with
vinorelbine vs 21 weeks with supportive care. Six-month survival was
54% vs 39%, respectively (a significant 37% reduction in death rate).
Patients on vinorelbine had a 20% response rate.
Toxicity was generally mild, with only 10% of patients on vinorelbine
reporting a grade 3/4 toxicity. This toxicity required stopping
treatment in five cases, he said.
Vinorelbine also appeared to improve quality of life, producing
significantly better scores on global health status, role function,
cognitive function, physical function, and fatigue. "Vinorelbine
prolongs survival without worsening, and for some items improving,
quality of life in elderly patients," he said.