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Phase III Randomized Trial of Docetaxel Plus Cisplatin Versus Vindesine Plus Cisplatin in Patients With Stage IV Non-Small-Cell Lung Cancer: The Japanese Taxotere Lung Cancer Study Group

From the National Cancer Center Hospital E, Kashiwa; Yokohama Municipal Citizen’s Hospital; Kanagawa Cancer Center, Yokohama; National Cancer Center Hospital; Nippon Medical School; Tokyo University; Tokyo Cooperative Oncology Group, Tokyo; National Kyushu Cancer Center, Fukuoka; Kobe City General Hospital, Kobe; Aichi Cancer Center, Nagoya; National Kinki Central Hospital for Chest Disease, Sakai; Niigata Cancer Center, Niigata; Toneyama National Hospital, Toyonaka; Saitama Cancer Center, Kitaadachi; Osaka Prefectural Habikino Hospital, Habikino; Osaka City University Hospital, Osaka; Hiroshima University, Hiroshima; National Shikoku Cancer Center, Matsuyama; National Cancer Center Hospital E, Kashiwa, Japan; and the Japanese Taxotere Lung Cancer Study Group (other members of the study group are listed in the Appendix)

Address reprint requests to Kaoru Kubota, MD, Thoracic Oncology Division, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan; e-mail: kkubota{at}east.ncc.go.jp.

PURPOSE: Few randomized trials have demonstrated survival benefit of combination chemotherapy involving new agents plus cisplatin compared with classic combination chemotherapy in advanced non-small-cell lung cancer (NSCLC). The primary aim of this study was to test whether docetaxel plus cisplatin (DC) improves survival compared with vindesine plus cisplatin (VdsC) in patients with previously untreated stage IV NSCLC.

PATIENTS AND METHODS: Eligible, stage IV, chemotherapy-naive patients (n = 311) were randomly assigned to receive docetaxel 60 mg/m² intravenously on day 1 plus cisplatin 80 mg/m² intravenously on day 1 of a 3- or 4-week cycle, or vindesine 3 mg/m² intravenously on days 1, 8, and 15 plus cisplatin 80 mg/m² intravenously on day 1 of a 4-week cycle. Cross-over administration of docetaxel and vindesine was prohibited for both treatment groups.

RESULTS: Overall, 302 patients were eligible for evaluation. The DC arm demonstrated significant improvements compared with the VdsC arm in overall response rates (37% v 21%, respectively; P < .01) and median survival times (11.3 v 9.6 months, respectively; P = .014). Two-year survival rates were 24% for the DC arm compared with 12% for the VdsC arm. The physical domain of the Quality of Life for Cancer Patients Treated with Anticancer Drugs measure was significantly better in the DC arm than in the VdsC arm (P = .020). Toxicity was predominantly hematologic and was more severe in the VdsC arm.

CONCLUSION: As first-line treatment for stage IV NSCLC, DC resulted in greater clinical benefit in terms of response rate (with marked improvements in overall and 2-year survival rates) and quality of life than did treatment with VdsC.

Supported by a grant from Aventis Pharma Ltd, Tokyo, Japan.

Previously presented in part at the Annual Meetings of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001, and Orlando, FL, May 18-21, 2002.

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

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