Background: Published phase III non-small-cell lung cancer (NSCLC) literature has demonstrated minimal activity for salvage vinorelbine (response rate [RR], 0.8% in 1 published study); however, our clinical experience has been discordant with such reports.
Patients and methods: All patients with NSCLC who had received vinorelbine at Fox Chase Cancer Center from June 2002 to June 2005 were identified. Evaluable patients had biopsy-proven, measurable, recurrent or metastatic NSCLC, had full medical records and imaging available, and had received >or= 1 cycle of single-agent vinorelbine after first-line therapy. The primary endpoint was RR; secondary endpoints included safety, overall survival (OS), and time to progression.
Results: Of 52 patients, 39 were evaluable. Median age was 63 years and 59% of patients were women. The Eastern Cooperative Oncology Group performance status was 0 in 12.8% of patients, 1 in 53.8%, 2 in 25.6%, and 3 in 7.7%. Nearly 80% of patients underwent 2 lines of previnorelbine therapy; 38.4% underwent 3 lines, and 7.7% underwent 4 lines. Approximately, 28.2% had received previous epidermal growth factor receptor tyrosine kinase inhibitor therapy; 23% had brain metastases; and 84.6% had significant comorbidities. The most common dosing schedules were 25-30 mg/m(2) on days 1 and 8 every 3 weeks. The median number of vinorelbine cycles was 3. The partial RR was 7.7%; 25.6% had stable disease; 43.6% had disease progression, and 23.1% were not radiographically assessed for response (but were included in the OS analysis). Approximately, 20.5% required dose reductions, predominantly for hematologic toxicities; nonhematologic toxicities were generally mild, and there were no treatment-related deaths. Nearly 31% received subsequent therapy after vinorelbine. Median OS was 5 months (n = 39), median time to progression was 3 months (n = 30), 1-year OS was 25.6%, and 2-year OS was 7.7%.
Conclusion: Salvage vinorelbine is active and well tolerated in patients with NSCLC. The RR exceeds that reported in the literature.