ELVIS Results Offer Hope to Elderly Lung Cancer Patients

NAPLES—Nearly one-third of the estimated 144,000 new non-small-cell lung cancer (NSCLC) patients diagnosed in the United States each year are over the age of 65, and these patients often do not have access to the range of treatment options available to younger patients. Platinum-based therapy is often avoided due to concerns about tolerability.

Now, an Italian study has shown that single-agent vinorelbine (Navelbine) is well tolerated in elderly patients and provides better survival and quality of life than supportive care alone.

“We feel the results of this trial show that vinorelbine may be a valuable treatment option for elderly NSCLC patients. This is the first treatment option we discuss with elderly patients,“ said principal investigator Cesare Gridelli, MD, of the Istituto Nazionale per lo Studio e la Cura del Tumori, Naples. Dr. Gridelli and his colleagues recommend that single-agent vinorelbine be used as the control arm for future studies exploring chemotherapy in elderly lung cancer patients.

All Patients Age 70 and Up

The study, known as ELVIS (Elderly Lung Cancer Vinorelbine Italian Study Group) randomized 191 patients—all 70 years of age or older with stage IIIb/IV NSCLC unsuitable for curative radiotherapy and no previous chemotherapy—to receive vinorelbine plus best supportive care or supportive care only. Vinorelbine was given at 30 mg/m² IV on days 1 and 8, every 3 weeks for up to six cycles.

The researcher noted a significant survival advantage for patients on the vin-orelbine arm: Median survival was 28 weeks with vinorelbine vs 21 weeks with supportive care. Six-month survival was 55% with vinorelbine vs 41% for best supportive care, and 1-year survival was 32% vs 14%, respectively (J Natl Cancer Institute 91:66-72, 1999).

Results of quality of life questionnaires showed functional scales consistently better for the vinorelbine patients, although significance was reached only for cognitive function. Vinorelbine patients scored clearly better than controls for some lung-cancer-specific items (pain and dyspnea) but scored significantly worse on some treatment toxicity-related items (constipation, nausea and vomiting, hair loss, and peripheral neuropathy). Treatment was stopped in five patients due to toxicity, either constipation or arrhythmia.