Phase II trial of gemcitabine plus cisplatin in non-small cell lung cancer: a Hoosier Oncology Group study.

Although non-small cell lung cancer accounts for a majority of lung cancer cases in the United States, overall response rates of only 20% have been obtained with cisplatin-based therapy. However, new agents such as the nucleoside analog gemcitabine have demonstrated single-agent response rates of approximately 20%. The synergistic growth inhibition of several tumor cell lines seen in vitro with cisplatin and gemcitabine has led to clinical trials incorporating this drug combination. Recent phase I trials revealed that administration of gemcitabine 1,000 mg/m2 weekly x 3, with cisplatin 100 mg/m2 on day 15, every 28 days, was well tolerated. This regimen was used in the present Hoosier Oncology Group phase II trial of patients with advanced non-small cell lung cancer, except that cisplatin was administered on day 1. Five patients had stage IIIB and 25 had stage IV disease, with a mean Karnofsky performance status of 90. Toxicity observed was primarily hematologic, notably, granulocytopenia and thrombocytopenia. Responses were seen in 10 of 27 patients, for an overall response rate of 37%. Median overall survival was 8.4 months; it was 10.2 months for patients with stage IV disease. These favorable results and manageable side effects suggest that future trials incorporating gemcitabine and cisplatin are indicated.