An out-patient second-line chemotherapy with gemcitabine and vinorelbine in patients with non-small cell lung cancer previously treated with cisplatin-based chemotherapy. A phase II study of the Hellenic Co-Operative Oncology Group

Thirty-nine patients with advanced non-small cell lung cancer, refractory o r resistant to platinum or taxanes derivatives were treated on an out-patie nt basis with vinorelbine 25mg/m(2) intravenous (I.V.) on days 1 and 8 foll owed by gemcitabine 800mg/m(2) L V. on days 1 and 8. Chemotherapy was repea ted every 3 weeks. The patients were evaluated for response every two cycle s of treatment. All 39 patients were assessable for toxicity and 35 were as sessable for response, On an intent to treat analysis, only 1 (2.6%) patien t achieved a partial response (PR) (95% CI 0.09% to 17.6%); fourteen patien ts (35.9%, 95% CI 29.45% to 67.4%) had stable disease (SD) and 24 (61.5%) h ad progressive disease (PD). The median time to tumor progression (TTP) was 4.7 months (range 0.13 to 18.9 months), the median survival time was 7.3 m onths (range 0.6 to 18.9 months) and the 1-year survival rate was 35%. Clin ical benefit response including improvement of PS, dyspnea and anorexia, pa in and cough reduction and cessation of hemoptysis and fever was observed i n 10% to 50% of patients. Grade 3/4 neutropenia occurred only in 2 (5.2%) p atients. Five patients experienced febrile neutropenia, which was successfu lly treated with G-CSF and broad-spectrum antibiotics. No patient experienc ed grade 3/4 anaemia or thrombocytopenia. One patient experienced grade 4 f atigue and stopped the treatment. Nausea / vomiting, fatigue, neurotoxicity , diarrhea and fever were mild in the majority of patients and did not resu lt in any clinically, significant problem. There were no treatment-related deaths. In conclusion, the combination of gemcitabine and vinorelbine showe d low objective response rate in patients previously treated with CDDP/taxa nes-containing regimens. This regimen was relatively, well- tolerated and w as associated with prolonged 1-year survival and improvement in cancer rela ted symptoms. To validate these findings a randomized trial of gemcitabine and vinorelbine versus taxotere or best supportive care is required.