Originally published as JCO Early Release 10.1200/JCO.2005.04.016 on February 22 2005

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Vinorelbine Plus Cisplatin Versus Docetaxel Plus Gemcitabine in Advanced Non-Small-Cell Lung Cancer: A Phase III Randomized Trial

From the Department of Medical Oncology, University General Hospital, Heraklion, Crete; 1st Department of Medical Oncology, Agios Savas Anticancer Hospital, Athens; 1st and 2nd Departments of Pulmonary Diseases, Sismanoglio General Hospital, Athens; 1st, 3rd, 6th, 7th, and 8th Departments of Pulmonary Diseases; Medical Oncology Unit; 3rd Department of Internal Medicine of University of Athens, Sotiria General Hospital, Athens; 2nd Department of Pulmonary Diseases, Papanicolaou General Hospital, Thessaloniki; Medical Oncology Unit, Department of Propedeutic Medicine of University of Athens, Laiko General Hospital, Athens, Greece

Address reprint requests to Vassilis Georgoulias MD, PhD, Department of Medical Oncology, University General Hospital of Heraklion, PO Box 1352, 711 10 Heraklion, Crete, Greece; e-mail: georgoul{at}med.uoc.gr

PURPOSE: To compare the activity and tolerability of docetaxel/gemcitabine (DG) and vinorelbine/cisplatin (VC) combinations in chemotherapy-naïve non-small-cell lung cancer (NSCLC) patients.

PATIENTS AND METHODS: Patients with advanced NSCLC were randomly assigned to receive either DG (gemcitabine 1,000 mg/m² [days 1 and 8] plus docetaxel 100 mg/m² [day 8]) or VC (vinorelbine 30 mg/m² [days 1 and 8] plus cisplatin 80 mg/m² [day 8]) and prophylactic recombinant human granulocyte colony-stimulating factor (150 µg/m² subcutaneously [day 9 through 15]) every 3 weeks.

RESULTS: A total of 413 randomly assigned patients were analyzed for response and toxicity (DG, n = 197; VC, n = 192). Median survival was 9.0 and 9.7 months (P = .965) for DG and VC arms, respectively; the corresponding 1-year survival rates were 34.3% and 40.8%, respectively. Overall response rate was 30% (95% CI, 23.9% to 36.3%) and 39.2% (95% CI, 32.5% to 45.9%; P = .053) for DG and VC, respectively. Toxicity was as follows (DG v VC): grade 2 to 4 anemia, 34% v 55% (P = .0001); grade 3 to 4 neutropenia, 16% v 37% (P = .0001); febrile neutropenia, 6% v 11% (P = .009); and grade 3 to 4 nausea and vomiting, 1% v 15% (P = .003). Nephrotoxicity occurred in 8% and ototoxicity in 2% of VC-treated patients. There were five and six treatment-related deaths in the DG and VC arms, respectively. Quality of life was improved in DG but not in VC patients.

CONCLUSION: Although the two regimens produced comparable overall survival, the DG regimen had a better toxicity profile. Therefore, DG could be used in the first-line setting of advanced NSCLC, especially for patients who cannot tolerate cisplatin.

Supported in part by a research grant From the Cretan Association for Biomedical Research (CABR).

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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