Gemcitabine/vinorelbine/cisplatin in patients with advanced non-small cell lung cancer

Triplet chemotherapy containing new drugs might improve outcome of palliative chemotherapy in advanced non-small cell lung cancer (NSCLC). To further pursue this, we evaluated cisplatin/gemcitabine/vinorelbine in a phase 11 trial in advanced NSCLC. Thirty-three patients (76% stage IV; 25 chemo-naive, 8 previously pretreated) received 1000 mg/m(2) gemcitabine, 20 mg/m(2) vinorelbine and 40 mg/m(2) cisplatin i.v. on days I and 8 of a three-week cycle. Patients received 1-6 (median 4) cycles of chemotherapy. In chemo-naive patients, partial responses were seen in 20%, stable disease in 44% patients and progressive disease in 36% patients. The median overall survival time was 8.9 months and the 1-year survival rate was 36%. Three (38%) pre-treated patients showed a partial response. Hematotoxicity was the major side effect. Other side effects included nausea/vomiting and peripheral neuropathy. Thus gemcitabine/vinorelbine/cisplatin showed activity both as first- and second-line chemotherapy with an acceptable toxicity profile in patients with advanced NSCLC.