NAPLESNearly 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
All Patients Age 70 and Up
The study, known as ELVIS (Elderly Lung Cancer Vinorelbine Italian
Study Group) randomized 191 patientsall 70 years of age or
older with stage IIIb/IV NSCLC unsuitable for curative radiotherapy
and no previous chemotherapyto 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.