In a phase III trial, 191 patients aged over 70 with stage IIIB/IV
non-small cell lung cancer were randomized to receive best supportive care (BSC) alone or BSC plus
vinorelbine on days 1 and 8, q 21 days for up to six cycles. Increasing difficulties in recruitment meant that the investigators, blinded to the results, stopped the trial early. Data from 161 patients have been analyzed. The
vinorelbine regimen was well tolerated. Grade 3/4
neutropenia occurred in 10% of patients and grade 2/3
anemia in 16%. The principle nonhematological toxicities were
constipation and
fatigue. An objective response rate was recorded in 19.7% of the 76 patients treated with
vinorelbine. The survival experience of these patients was significantly superior to that among control patients. The median duration of survival was longer (28 versus 21 weeks) and patients receiving
vinorelbine were significantly more likely to survive to one year (32% versus 14%). The relative risk of death in the
vinorelbine group was 0.65 (95% confidence interval: 0.45-0.93). Quality of life was extensively investigated using European Organization for Research and Treatment of
Cancer scales. While aspects of quality-of-life issues that were directly related to
drug toxicity (such as
nausea and
constipation) were lower in the
vinorelbine group, patients who received
vinorelbine fared better than controls on measures related to
lung cancer symptoms and
pain and on social, cognitive, and physical functioning.