Bi-weekly administration of gemcitabine plus vinorelbine in elderly patients with advanced non-small-cell lung cancer: Multicenter phase II trial

• Published in: Lung cancer (Amsterdam, Netherlands) Netherlands), 2007-06, Vol.56 (3), p.371-376
• Main Authors: Araya, Tomoyuki, Kasahara, Kazuo, Kimura, Hideharu, Shibata, Kazuhiko, Kita, Toshiyuki, Shirasaki, Hiroki, Hara, Johsuke, Yoshimi, Yuzo, Sone, Takashi, Oribe, Yoshitaka, Nobata, Kouichi, Nishi, Kouichi, Fujimura, Masaki, Nakao, Shinji
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antimetabolites, Antineoplastic - administration & dosage; Antineoplastic Agents, Phytogenic - administration & dosage; Bi-weekly schedule; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - pathology; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Drug Therapy, Combination; Elderly patients; Female; Follow-Up Studies; Gemcitabine; Hematology, Oncology and Palliative Medicine; Humans; Infusions, Intravenous; Japan - epidemiology; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Male; Medical sciences; Neoplasm Staging; Non-small-cell lung caner; Phase II trial; Pneumology; Pulmonary/Respiratory; Radiation-Sensitizing Agents - administration & dosage; Retrospective Studies; Ribonucleotide Reductases - antagonists & inhibitors; Severity of Illness Index; Survival Rate; Time Factors; Treatment Outcome; Tumors; Tumors of the respiratory system and mediastinum; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives; Vinorelbine
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2007.01.001

Summary Purpose Gemcitabine (GEM) and vinorelbine (VNR) have demonstrated activity as a first-line treatment in elderly patients with advanced non-small-cell lung cancer (NSCLC). We conducted a multicenter phase II trial to evaluate the efficacy and toxicity of bi-weekly administration of GEM plus VNR in elderly patients with advanced NSCLC. Patients and methods Forty-six chemotherapy-naive elderly (age: ≥70 years) NSCLC patients were enrolled. Patients were eligible if they had histologically or cytologically confirmed unresectable NSCLC with measurable and/or assessable disease. Patients received GEM (1000 mg/m2 ) and VNR (25 mg/m2 ) every 2 weeks. Results The objective response rate of this treatment was 22.7% (95% confidence interval (CI), 10.3–35.1%), median survival time was 310 days, and median time to progression was 133 days. The one-year survival rate was 40.9% (95% CI, 26.3–55.4%), and most adverse events were mild. Only three (6.8%) patients needed to omit GEM because of grade 4 neutropenia or due to physician judgment. No patients suffered treatment-related death. Conclusions Bi-weekly administration of GEM plus VNR in elderly patients was an effective, feasible and well-tolerated treatment schedule.