Gemcitabine plus vinorelbine in stage IIIB or IV non-small cell lung cancer (NSCLC): a multicentre phase II clinical trial

• Published in: Lung cancer (Amsterdam, Netherlands) Vol. 34; no. 1; pp. 115 - 123
• Main Authors: Palmeri, S., Leonardi, V., Gebbia, V., De Bella, M.Tamburo, Ferraù, F., Faillú, G., Spatafora, M., Valenza, R., Di Vita, G., Vitello, S., Carroccio, R., Sciortino, G., Vaglica, M., Accurso, V., Agostara, B., Licata, G.
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 01-10-2001; Elsevier Science
• Subjects: Adult; Advanced disease; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Female; Gemcitabine; Humans; Infusions, Intravenous; Injections, Intravenous; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Neutropenia - chemically induced; NSCLC; Phase II; Pneumology; Survival Analysis; Treatment Outcome; Tumors of the respiratory system and mediastinum; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives; Vinorelbine; Advanced disease; Phase II; Gemcitabine; NSCLC; Vinorelbine; Performance evaluation; Toxicity; Positivity; Activity; Male; Alkaloid; Number; Phase II trial; Pleurisy; Bronchus disease; Female; Pyrimidine nucleoside; Age; Non small cell carcinoma; Human; Lung disease; Respiratory disease; Malignant tumor; Normal; Clinic; Antimetabolic; Pleural disease; Fluorine Organic compounds; Performance; Day
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/S0169-5002(01)00206-9

A phase II study in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) was carried out to evaluate the clinical activity and toxicity of the chemotherapeutic combination of gemcitabine+vinorelbine (GEM/VNR). Forty-five patients (40 male, 5 female) with a median age of 67 years (range 37–73) and a median ECOG performance status of 1 (range 0–2) were enrolled into the trial. Twenty patients had stage IIIB (two positive supraclavicular nodes and 20 cytologically positive pleural effusion), and 25 had stage IV NSCLC. GEM 1000 mg/m
2 diluted in 250 cc
3 of normal saline was administered iv on days 1, 8, and 15, while VNR was given 30 mg/m
2 on days 1 and 8 every 4 weeks. The median number of courses/patient was 4 (range 3–7). According to an intent-to-treat analysis 2 (4%) patients had a complete response and 16 (36%; 95% CL 22–52%) had a partial response for an overall response rate of 40% (95% CL 26–56%)
. Twelve (27%) patients had stable disease and 15 (33%) were considered as treatment failures. Median overall survival of the whole series was 8+ months with 33% of patients alive at 1 year. Toxicity was generally mild. WHO grade 3–4 neutropenia was recorded in 22% of cases, grade 1–3 liver toxicity in 6% of patients and neutropenia-unrelated fever in 9%. This multicentre phase II study suggests that the GEM/VNR combination regimen is an active and well tolerated regimen in patients with stage IIIB/IV NSCLC. Larger studies comparing cisplatin-based regimens to new schedules without cisplatin are warranted.