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

[[abstract]]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-naïve non-small cell lung cancer (NSCLC) patients aged 70 or older. Patients and methods: Patients were randomized into vinorelbine (V) or vinorelbine plus cisplatin (VP) treatment arms. Treatment consisted of vinorelbine 25 mg/m2 intravenous infusion (IV) on days 1 and 8 every 3 weeks (V arm), or vinorelbine 22.5 mg/m2 IV on days 1 and 8 plus cisplatin 50 mg/m2 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