Clinical experience with single-agent gemcitabine chemotherapy in patients with non-small-cell lung cancer in whom previous chemotherapy has failed.

BACKGROUND In a phase II study, responses and toxicity to single-agent gemcitabine chemotherapy were evaluated in patients with non-small-cell lung cancer (NSCLC) who had failed previous cisplatin-based chemotherapy. METHODS Twenty patients were enrolled from December 2001 to December 2003: 17 of them had received first-line cisplatin-based regimens and second-line docetaxel treatment; and 3 had previously received cisplatin plus paclitaxel. Study treatment comprised an intravenous infusion of gemcitabine 1200 mg/m2 on days 1, 8, and 15 of each 4-week cycle. RESULTS Fifty-seven cycles of treatment were given (mean, 2.9 cycles per patient). All patients were evaluable for toxicity profile, and 16 were evaluable for response rate. The principal toxicity was myelosuppression: grade 3 neutropenia occurred in 2 patients (10%), thrombocytopenia in 3 (15%), and anemia in 1 (5%). Other toxicities were few and mild in severity. After 2 cycles of treatment, 2 of 16 patients (12.5%) had a partial response. The median time to disease progression was 2.1 months, and median survival time was 7.5 months. The 1-year survival rate was 36%. CONCLUSION Salvage, single-agent chemotherapy with gemcitabine has modest activity, is well tolerated, and yields good survival in NSCLC patients who have failed previous chemotherapy. Such single-agent therapy may therefore be suggested for use in patients with good performance status who ask for further chemotherapy, when disease progresses after cisplatin-based therapy, but especially after second-line docetaxel therapy.