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Phase III Study of Docetaxel Compared With Vinorelbine in Elderly Patients With Advanced Non–Small-Cell Lung Cancer: Results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904)

Shinzoh Kudoh, Koji Takeda, Kazuhiko Nakagawa, Minoru Takada, Nobuyuki Katakami, Kaoru Matsui, Tetsu Shinkai, Toshiyuki Sawa, Isao Goto, Hiroshi Semba, Takashi Seto, Masahiko Ando, Taroh Satoh, Naruo Yoshimura, Shunichi Negoro, Masahiro Fukuoka

From the Department of Respiratory Medicine, Osaka City University Medical School; Department of Medical Oncology, Osaka City General Hospital; Department of Medical Oncology, Kinki University Medical School; Department of Respiratory Medicine, Rinku General Medical Center; Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases; Department of Respiratory Medicine, Osaka Medical College, Osaka; Division of Respiratory Medicine, Kobe City General Hospital, Kobe; Department of Internal Medicine, Shikoku Cancer Center, Ehime; Department of Respiratory Medicine, Gifu Municipal Hospital, Gifu; Department of Internal Medicine, Kumamoto Regional Medical Center, Kumamoto; and the Health Service, Kyoto University, Kyoto, Japan

Address reprint requests to Shinzoh Kudoh, MD, Department of Respiratory Medicine, Osaka City University Medical School, 1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, Japan; e-mail: shinzohykudoh{at}med.osaka-cu.ac.jp

PURPOSE: Docetaxel has shown activity in elderly patients with advanced non–small-cell lung cancer (NSCLC). This randomized phase III trial evaluated the efficacy and safety of docetaxel versus vinorelbine (the current standard treatment) in elderly patients.

PATIENTS AND METHODS: Chemotherapy-naïve patients age 70 years or older with stage IIIB/IV NSCLC and performance status 2 or lower were eligible. Patients randomly received docetaxel 60 mg/m² (day 1) or vinorelbine 25 mg/m² (days 1 and 8) every 21 days for four cycles. The primary end point was overall survival. Overall disease-related symptom improvement was assessed using an eight-item questionnaire.

RESULTS: In total, 182 patients were enrolled. Median age was 76 years (range, 70 years to 86 years). There was no statistical difference in median overall survival with docetaxel versus vinorelbine (14.3 months v 9.9 months; hazard ratio, 0.780; 95% CI, 0.561 to 1.085; P = .138). There was a significant difference in median progression-free survival (5.5 months v 3.1 months; P < .001). Response rates were also significantly improved with docetaxel versus vinorelbine (22.7% v 9.9%; P = .019). The most common grade 3 to 4 toxicities were neutropenia (82.9% for docetaxel; 69.2% for vinorelbine; P = .031) and leukopenia (58.0% for docetaxel; 51.7% for vinorelbine). Other toxicities were mild and generally well tolerated. Docetaxel improved overall disease-related symptoms over vinorelbine (odds ratio, 1.86; 95% CI, 1.09 to 3.20).

CONCLUSION: Docetaxel improved progression-free survival, response rate, and disease-related symptoms versus vinorelbine. Overall survival was not statistically significantly improved at this time. Docetaxel monotherapy may be considered as an option in the standard treatment of elderly patients with advanced NSCLC.

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

Related Correspondence

• Docetaxel As Monotherapy in the Treatment of Advanced Non–Small-Cell Lung Cancer in Elderly Patients
  Ashok K. Malani, Rony M. Abou-Jawde, Jaswinder Singh, and Sarah A. Taylor
  JCO 2007 25: 1143-1144 [Full Text]
• Single-Agent Chemotherapy for the Treatment of Elderly Patients With Advanced Non–Small-Cell Lung Cancer: What Is the Best Drug?
  Cesare Gridelli, Paolo Maione, and Antonio Rossi
  JCO 2007 25: 1444-1445 [Full Text]

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