Vinorelbine, ifosfamide and cisplatin in advanced non-small cell lung cancer

Between September 1994 and July 1997, 78 patients with advanced/metastatic, non-small cell lung cancer (NSCLC) were selected for the NIP (vinorelbine, ifosfamide, and cisplatin) protocol. The study group included 43 males; age range 34-74 years; median age 56 years; median follow-up for all patients was 14 months and for surviving patients, 30 months. Histological distribution included 55 adenocarcinomas (70.5%), 8 squamous cell carcinomas, and 9 large cell carcinomas. Stage distribution was 14 stage IIIB (malignant effusions) and 64 stage IV or recurrent metastatic; sites of metastasis were lungs, -26; liver-19; bones-27; brain-7; adrenals-3; distant nodes-2; skin-2. The NIP regimen was well tolerated by most of the patients but nausea/vomiting was noted in 55% of the cycles administered, most of them of grade 1-2 severity. Fifteen neutropenic episodes (5%) were encountered. Response to NIP was: 44 partial responses (56%); 1 complete response (1%); overall response, 58%. For stage IIIB, overall response was 36%, while for stage IV/metastatic, overall response was 63%. The median time to progression was 7 months for stage IIIB and 8 months for stage IV/metastatic disease and the overall median survival achieved was 14 months, with 60% of patients alive after one year. No significant difference in survival outcome was noted between patients with metastatic disease and those with stage IIIB (malignant effusion) disease. The NIP regimen has produced encouraging results in advanced NSCLC, as well as a favourable toxicity profile. The efficacy of NIP as a palliative tool should be assessed. A randomized trial to compare NIP with a two-drug combination of vinorelbine and cisplatin has been initiated.