A phase II trial of vinorelbine plus gemcitabine in previously untreated inoperable (stage IIIb/IV) non-small-cell lung cancer patients aged 80 or older

Vinorelbine and gemcitabine are two active single agents with mild toxicity profiles that are used in the treatment of non-small-cell lung cancer (NSCLC). Whether or not very old NSCLC patients, such as those aged 80 years or older, should still be considered for chemotherapy is unknown, since their response to the treatment is also unknown. A phase II clinical trial was conducted to evaluate the efficacy and toxicity of vinorelbine plus gemcitabine in very old patients with inoperable (stage IIIb or IV) NSCLC. Vinorelbine 20 mg/m² was given as a 10-min intravenous infusion, followed by a 30-min intravenous infusion of gemcitabine 800 mg/m² on days 1, 8, and 15 of each 28-day cycle. From March 1998 to December 2001, 20 patients (16 males, four females) were enrolled in the study. The median age was 83 years, within the range 80-88 years. The median number of treatment cycles per patient was four. With the exception of one, all patients received at least two cycles of treatment. Thirteen patients achieved a partial response, with an overall response rate of 65% (95% confidence interval, 44.1-85.9%). Median survival was 10 months. The significant (WHO grade 3/4) toxicities were myelosuppression, including leukopenia in five (25%) patients, neutropenia in eight (40%), anaemia in six (30%), and thrombocytopenia in three (15%) patients. Febrile neutropenia occurred in two patients and accounted for one treatment-related death. Non-haematological toxicity was generally mild, except one patient who suffered from grade 3 interstitial pneumonitis. Another patient suffered from a cerebral infarction after three cycles of treatment. In conclusion, the combination of vinorelbine and gemcitabine in very old patients with advanced NSCLC is a highly active regimen with an acceptable toxicity profile.