© 2005 European Society for Medical Oncology
Original article |
Phase II randomized trial of vinorelbine and gemcitabine versus carboplatin and paclitaxel in advanced non-small-cell lung cancer
1 The Mount Sinai Comprehensive Cancer Center, Miami Beach, FL; 2 Loma Linda University Medical Center, Loma Linda, CA; 3 Mid-Ohio Oncology & Hematology Inc, Columbus, OH; 4 Stanley S. Scott Cancer Center, New Orleans, LA; 5 Maryland Hematology Oncology Associates, Baltimore MD; 6 GlaxoSmithKline, Research Triangle Park, NC; 7 GlaxoSmithKline, Upper Providence, PA, USA
* Correspondence to: Dr R. C. Lilenbaum, The Mount Sinai Comprehensive Cancer Center, 4306 Alton Road, Miami Beach, FL 33140, USA. Tel: +1-305-535-3310; Fax: +1-305-535-7128; Email: rlilenba{at}salick.com
Background: The purpose of this study was to compare quality of life and overall toxicity in patients with advanced non-small-cell lung cancer (NSCLC) treated with vinorelbine–gemcitabine (VG) or carboplatin–paclitaxel (Taxol) (CP).
Patients and methods: A total of 165 previously untreated patients were randomized to the two regimens. Quality of life was assessed by the Lung Cancer Symptom Scale (LCSS). Overall toxicity and secondary efficacy end points were evaluated by standard WHO criteria.
Results: There was no significant difference in overall quality of life between the two treatments. Neutropenia, thrombocytopenia, peripheral neuropathy, and alopecia, were more common in the CP arm, whereas constipation was more frequent in the VG arm. Response rates were 14.6% in the VG arm and 16.9% in the CP arm. Median survival times were 7.8 and 8.6 months, and 1 year survival rates were 38.4% and 31.9%, respectively.
Conclusions: Patients treated with VG experienced lower toxicity, but overall quality of life was similar in both arms. Efficacy seemed comparable between VG and CP. Our study shows that VG is a viable alternative to platinum-based chemotherapy in patients with advanced NSCLC.
Key words: advanced non-small-cell lung cancer, carboplatin–paclitaxel, vinorelbine–gemcitabine
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