Nonplatinum Doublet Effective in Non-Small-Cell Lung Cancer

January 1, 2003

NEW YORK- A combination of vinorelbine (Navelbine) and gemcitabine (Gemzar) showed similar efficacy to the standard platinum-based regimen for advanced non-small-cell lung cancer (NSCLC) and a different toxicity profile in a phase II study presented at the Mount Sinai School of Medicine Chemotherapy Foundation Symposium XX.

NEW YORK— A combination of vinorelbine (Navelbine) and gemcitabine (Gemzar) showed similar efficacy to the standard platinum-based regimen for advanced non-small-cell lung cancer (NSCLC) and a different toxicity profile in a phase II study presented at the Mount Sinai School of Medicine Chemotherapy Foundation Symposium XX.

Rogerio C. Lilenbaum, MD, clinical associate professor of medicine, University of Miami School of Medicine, and director, Thoracic Oncology Program, Mount Sinai Comprehensive Cancer Center, Miami Beach, presented preliminary results from a multicenter randomized trial that enrolled 164 lung cancer patients.

All patients had histologically proven stage IIIB or IV non-small-cell lung cancer and had not previously received chemotherapy. Patients with brain metastases were eligible for the trial, provided they were neurologically stable.

"Most patients had stage IV disease," Dr. Lilenbaum said, "and most patients had performance status 0 to 1. About 15% had performance status 2."

Patients were randomized to receive carboplatin (Paraplatin) at a dose of AUC 6 and paclitaxel (Taxol) at 200 mg/m2 on the first day of each cycle or vinorelbine 25 mg/m2 and gemcitabine 1,000 mg/m2 on days 1 and 8 of each cycle. For both regimens, the cycles were 21 days and were repeated up to a maximum of six times. The median number of cycles completed was approximately four, Dr. Lilenbaum said.

Outcome were similar in both arms, with no significant differences. Partial responses were achieved in 14.6% of patients in the vinorelbine/gemcitabine arm and 17.1% in the carboplatin/paclitaxel arm. Stable disease was recorded in 37.8% and 35.4%, and disease progression was seen in 34.1% and 31.7%, respectively. The median time to progression was 2.1 months in both groups.

Median survival was 7.3 months with vinorelbine/gemcitabine and 8.4 months with the platinum-based therapy.

Toxicity

Grade 3-4 hematologic toxicity was more common in the platinum-based arm, occurring in 11% of the vinorelbine/gemcitabine patients vs 28% of the carboplatin/paclitaxel group. The difference in neutropenia, but not throm-bocytopenia, was statistically significant, Dr. Lilenbaum noted.

Among nonhematologic toxicities, alopecia (grade 1-4) was significantly less common in the vinorelbine/gemcitabine arm, 7.5% vs 36.6% for the platinum-based regimen.

"There was less peripheral neuropathy in the vinorelbine/gemcitabine arm, compared with the carboplatin/paclitaxel regimen," he said. Quality of life was similar in both arms.

As a result of the findings in the phase II trial, Dr. Lilenbaum now sees vinorel-bine/gemcitabine as "an attractive alternative" to carboplatin/paclitaxel in patients with advanced NSCLC who, in the physician’s judgment, are not likely to tolerate such therapy well.

"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," Dr. Lilenbaum commented.