ELVIS Favors Vinorelbine for Elderly With NSCLC

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 group."

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.