Frontline treatment of advanced gastric cancer with docetaxel and granulocyte colony-stimulating factor (G-CSF) - A phase II trial

We conducted a phase II study to evaluate the efficacy and tolerance of doc etaxel monotherapy with granulocyte colony-stimulating factor (G-CSF) suppo rt in patients with advanced gastric cancer. Thirty patients with measurabl e advanced gastric cancer were enrolled. Twenty-four patients were chemothe rapy-naive and six patients had previously received adjuvant chemotherapy a fter complete surgical resection. Docetaxel was administered at 100 mg/m(2) IV during 1 hour every 3 weeks. G-CSF 5 mu g/kg SC was also given on days 2 through 8 prophylactically to all patients. All patients were evaluable f or response and toxicity. We observed one complete and five partial respons es for an overall response rate of 20% (95% confidence interval: 6-34%). In addition, seven patients (23%) had stable disease. After a median follow-u p time of 7 months, the median duration of response was 4.5 months, the med ian time of tumor progression was 6 months, and the median survival was 7 m onths. The estimated probability of 1-year survival was 28%. Toxicity was g enerally mild. Grade III/IV neutropenia occurred in 11 (36%) patients. Neut ropenia with fever developed in three patients (10%). There were no toxic d eaths. Docetaxel with G-CSF support is an active drug and well tolerated by patients with advanced gastric cancer. Docetaxel merits further investigat ion in combination with other active agents as frontline treatment in patie nts with advanced gastric cancer.