A phase II randomized study of vinorelbine alone or with cisplatin against chemo-naive inoperable non-small cell lung cancer in the elderly

Purpose: Our aim here was to determine whether or not the addition of cisplatin into vinorelbine (V) treatment is an appropriate regimen for physically fit chemo-naive non-small cell lung cancer (NSCLC) patients aged 70 or older. Patients and methods: Patients were randomized into vinorelbine (V) or vinorelbine plus cis-platin (VP) treatment arms. Treatment consisted of vinorelbine 25 mg/m(2) intravenous infusion (IV) on days 1 and 8 every 3 weeks (V arm), or vinorelbine 22.5 mg/m(2) IV on days 1 and 8 plus cisplatin 50mg/m(2) IV on day 1 every 3 weeks (VP arm). Results: Sixty-five patients were enrolled from May 2005 to December 2006, including 31 who received V treatment and 34 who received VP treatment. Objective response rates were 16.1% in V and 32.4% in VP (p = 0.009). Control rates were 51.6% in V and 82.4% in VP (p = 0.008). Myelosuppression was more common and severe in the VP arm. Any grade of anemia and neutropenia was significantly higher in the VP arm (p = 0.001 and 0.009, respectively). Fatigue sensation was more common and severe in the VP arm (p = 0.032). Median time to disease progression was 3.1 months in the V arm and 5.2 months in the VP arm (p = 0.0303). The 1-year survival rate was 50.9% in the V arm and 47.2% in the VP arm. Conclusions: Adding cisplatin to vinorelbine treatment is feasible in elderly patients, and has a better response rate and longer median time to disease progression. However, both statistically significantly higher toxicity and no survival advantage for the combination treatment was observed. (C) 2007 Elsevier Ireland Ltd. All rights reserved.