The non-platinum regimen of Navelbine® (vinorelbine) and Gemzar® (gemcitabine) followed by Taxotere® (docetaxel) appears to be as effective as the standard regimen of Paraplatin® (carboplatin) and Taxol® (paclitaxel), but with less toxicity, for patients with advanced non–small cell lung cancer (NSCLC). The details of this study were published in the December 2008 issue of the Lancet Oncology.
Non–small cell lung cancer (NSCLC) accounts for roughly 85% of all lung cancer. In advanced NSCLC cancer has spread outside the lung; standard therapy for this stage of disease includes chemotherapy. Initial treatment for patients with advanced NSCLC often includes two-drug combinations that contain a platinum compound (such as Paraplatin); however, several more recent studies have indicated that other two-drug combinations that do not contain a platinum compound are equally effective and less toxic.
Researchers in Japan conducted a Phase III study comparing the standard Paraplatin/Taxol regimen with an experimental regimen of Navelbine/Gemzar followed by Taxotere. The study included 401 patients with Stage IIIB or IV NSCLC who were randomized to receive one of the regimens. The primary endpoint of the study was overall survival, with secondary endpoints of progression-free survival, response to treatment, and toxicity.
The results indicated that the experimental regimen was equally as effective as the standard regimen, with a different toxicity profile. The median overall survival in the experimental group was 13.6 months compared with 14.1 months in the standard group. Twenty-five percent of patients in the experimental group experienced a partial response compared with 37% in the standard group. The median progression-free survival was similar in both groups: 5.5 months in the experimental group versus 5.8 months in the standard group.
The toxicity profiles were different for the two regimens. Patients who received the standard regimen experienced more grade 3-4 neutropenia, central nervous system symptoms, and joint and muscle pain than those in the experimental group; however, patients in the experimental group experienced more pulmonary toxicity.
The researchers concluded that non-platinum regimens might be equally effective for patients with advanced NSCLC and provide a different toxicity profile.
 Kubota K, Kawahara M, Ogawara M, et al. Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-cmall-cell lung cancer: A randomized, open-label, phase III study. Lancet Oncology. 2008; 9: 1135-1142.
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