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Journal of Clinical Oncology, Vol 18, Issue 13 (July), 2000: 2529-2536
© 2000 American Society for Clinical Oncology

Gemcitabine Plus Vinorelbine Versus Vinorelbine Alone in Elderly Patients With Advanced Non–Small-Cell Lung Cancer

By Giuseppe Frasci, Vito Lorusso, Nicola Panza, Pasquale Comella, Gianpaolo Nicolella, Andrea Bianco, Giuseppe De Cataldis, Annunziato Iannelli, Domenico Bilancia, Mario Belli, Bruno Massidda, Francovito Piantedosi, Giuseppe Comella, Mario De Lena, for the Southern Italy Cooperative Oncology Group and Interregional Association for the Study of Lung Carcinoma–Italy

From the Division of Medical Oncology, City Hospital, Avellino; Division of Medical Oncology, Oncology Institute, Bari; Division of Medical Oncology, University School of Medicine, Cagliari; Division of Medical Oncology A, National Tumor Institute, Division of Medical Oncology, Cardarelli Hospital, Division of Respiratory Diseases, 2nd University School of Medicine, and Division of Pneumology, Monaldi Hospital, Naples; and Divisions of Medical Oncology, Da Procida Hospital and General Hospital of Salerno, Salerno, Italy.

Address reprint requests to Giuseppe Frasci, MD, Division of Medical Oncology A, National Tumor Institute, Via Mariano Semmola 80131, Naples, Italy; email GIFRASCI{at}SIRIO-ONCOLOGY.IT

PURPOSE: To evaluate whether the addition of gemcitabine (G) to vinorelbine (V) improves survival and quality of life (QoL) among elderly patients with advanced non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS: Patients with NSCLC aged >= 70 years with advanced disease were randomly allocated to receive V 30 mg/m2 on days 1 and 8 every 3 weeks or G 1,200 mg/m2 + V 30 mg/m2 on days 1 and 8 every 3 weeks. The estimated sample size was 120 patients per arm, but an interim analysis of survival was planned based on the first 60 patients per arm.

RESULTS: In May 1999, the survival data were analyzed of 120 eligible patients (V group = 60; G + V group = 60) who had been randomized from June 1997 to February 1999. Forty-nine patients had stage IIIB disease, and 71 had stage IV. At a median potential follow-up of 14 months (range, 3 to 22 months), 93 patients had died (G + V group = 41; V group = 52). In the G + V group, median survival time was 29 weeks and projected 1-year survival was 30%; these values were 18 weeks and 13% in the V group. According to multivariate Cox analysis, the risk of death in the G + V arm compared with the V arm was 0.48 (95% confidence interval, 0.29 to 0.79; P < .01). Combination therapy was also associated with a clear delay in symptom and QoL deterioration. The overall response rates were 22% and 15% in the G + V and V groups, respectively.

CONCLUSION: In elderly patients with NSCLC, G + V treatment is associated with significantly better survival than is V alone.


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