Frontline Treatment of Advanced Gastric Cancer With Docetaxel and Granulocyte Colony-Stimulating Factor (G-CSF)

Abstract

We conducted a phase II study to evaluate the efficacy and tolerance of docetaxel monotherapy with granulocyte colony-stimulating factor (G-CSF) support in patients with advanced gastric cancer. Thirty patients with measurable advanced gastric cancer were enrolled. Twenty-four patients were chemotherapy-naive and six patients had previously received adjuvant chemotherapy after complete surgical resection. Docetaxel was administered at 100 mg/m2 IV during 1 hour every 3 weeks. G-CSF 5 microg/kg SC was also given on days 2 through 8 prophylactically to all patients. All patients were evaluable for response and toxicity. We observed one complete and five partial responses for an overall response rate of 20% (95% confidence interval: 6-34%). In addition, seven patients (23%) had stable disease. After a median follow-up time of 7 months, the median duration of response was 4.5 months, the median time of tumor progression was 6 months, and the median survival was 7 months. The estimated probability of 1-year survival was 28%. Toxicity was generally mild. Grade III/IV neutropenia occurred in 11 (36%) patients. Neutropenia with fever developed in three patients (10%). There were no toxic deaths. Docetaxel with G-CSF support is an active drug and well tolerated by patients with advanced gastric cancer. Docetaxel merits further investigation in combination with other active agents as frontline treatment in patients with advanced gastric cancer.

A phase II study of sequential chemotherapy with docetaxel after the weekly PELF regimen in advanced gastric cancer. A report from the Italian group for the study of digestive tract cancer

“…Recent phase II studies have established the role of docetaxel in first-line and second-line treatment of advanced gastric cancer (Sulkes et al, 1994;Furue and Taguchi, 1998;Mavroudis et al, 1999). As a consequence, the hope for more potent regimens prompted several investigators to evaluate docetaxel in multidrug regimens.…”

“…Docetaxel has been tested in advanced gastric cancer and it showed promising single-agent activity with 20% to 24% response rates in treated and chemotherapy-naive patients (Sulkes et al, 1994;Furue and Taguchi, 1998;Mavroudis et al, 1999;Vanhofer et al, 1999). A logical step of investigation consisted in the development of multi-drug schedules including docetaxel and other known active drugs.…”

Docetaxel, 5-fluorouracil, and leucovorin as treatment for advanced gastric cancer: results of a phase II study

“…Subsequent phase I and II clinical trials have confirmed that docetaxel is effective in advanced gastric cancer when used as monotherapy, yielding response rates of 20%-24% [11][12][13]. In addition, docetaxel given as first-line treatment, with granulocyte colony-stimulating factor (G-CSF) as support, has been shown to be both active and well tolerated [14].…”

Infusional 5-fluorouracil, cisplatin and mitomycin C in advanced gastric cancer: A low cost effective regimen

“…New cytotoxic agents, such as irinotecan, paclitaxel and docetaxel could be a more appealing approach for the treatment of advanced gastric cancer (Kollmannsberger et al, 2000;Mavroudis et al, 2000;Roth et al, 2000). Docetaxel obtained a 20% response rate as first-line treatment in 37 advanced gastric patients (Sulkes et al, 1994) with a median survival time of 7 months.…”