title: Frontline treatment of advanced gastric cancer with docetaxel and granulocyte colony-stimulating factor (G-CSF): a phase II trial.
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.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, Crete, Greece.
authors.forename: D
authors.initials: D
authors.lastname: Mavroudis
authors.forename: C
authors.initials: C
authors.lastname: Kourousis
authors.forename: N
authors.initials: N
authors.lastname: Androulakis
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: S
authors.initials: S
authors.lastname: Agelaki
authors.forename: S
authors.initials: S
authors.lastname: Kakolyris
authors.forename: J
authors.initials: J
authors.lastname: Souglakos
authors.forename: E
authors.initials: E
authors.lastname: Sarra
authors.forename: N
authors.initials: N
authors.lastname: Vardakis
authors.forename: D
authors.initials: D
authors.lastname: Hatzidaki
authors.forename: G
authors.initials: G
authors.lastname: Sarmonis
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D016001:Confidence Intervals; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D005334:Fever / Q000139:chemically induced; D005500:Follow-Up Studies; D005743:Gastrectomy; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012074:Remission Induction; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery; D015996:Survival Rate; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D017239:Paclitaxel