Vinorelbine, a first-line chemotherapy treatment for advanced non-small cell lung cancer, is not currently indicated for use in the U.S. in combination with gemcitabine.

"Platinum-based combinations, such as those containing carboplatin, are widely used in treating advanced non-small cell lung cancer," said principal investigator Rogerio C. Lilenbaum, M.D. "Because some patients cannot tolerate platinum therapy, we wanted to determine if the combination of two relatively well tolerated agents with known activity in this form of cancer, such as vinorelbine and gemcitabine, could produce similar outcomes."

The study enrolled 164 patients with advanced (stage IIIB or IV) non-small cell lung cancer. Patients were randomized to receive either the standard regimen, carboplatin AUC 6 IV plus paclitaxel 200 mg/m2 IV infusion on day 1 of each cycle, or the investigational combination of vinorelbine 25 mg/m2 IV plus gemcitabine 1,000 mg/m2 IV on days 1 and 8 of each cycle.

Treatment cycles were repeated every 21 days up to a maximum of 6 cycles. Both treatment arms showed comparable efficacy with no statistical difference between the two groups in median time to progression (2.1 months and 2.1 months, respectively) and overall survival (8.4 months versus 7.3 months).

The incidence of serious hematological toxicity (Grade 3 or 4) was lower in the vinorelbine/gemcitabine arm than in the carboplatin/paclitaxel arm (11 percent versus 28 percent, respectively). Furthermore, the non-hematological toxicity profile, including alopecia and peripheral neuropathy, appeared to favor the vinorelbine/gemcitabine combination. Overall quality of life measures were similar for the two groups.

"These results suggest that the vinorelbine/gemcitabine doublet is an attractive alternative to carboplatin/paclitaxel therapy in advanced non-small cell lung cancer patients," said Lilenbaum. "Just as we work to extend the lives of people with late stage disease, we will also continue to investigate new approaches that improve the tolerability of treatment for these patients."

According to the American Cancer Society, lung cancer represents about 13 percent of all new cancers that will be diagnosed in 2002, but it will be responsible for approximately 28 percent of cancer deaths (an estimated 154,900 this year). Only about 41 percent of all lung cancer patients survive longer than one year and the five-year survival rate across all stages of the disease is only 15 percent. Approximately 80 percent of lung cancers are classified as non-small cell. Patients with advanced stage non-small cell lung cancer have a particularly poor prognosis.