title: Docetaxel as salvage therapy in advanced gastric cancer: a phase II study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.).
abstract: BACKGROUND
  Docetaxel (DCT), a semisynthetic taxoid, has demonstrated cytotoxic activity against gastric cancer in early phase II studies producing an overall response rate of 17-24%. The Gruppo Oncologico Italia Meridionale (G.O.I.M.) started a confirmatory multicenter phase II trial to evaluate the clinical activity and toxicity of single agent TXT in the treatment of advanced gastric cancer patients who had failed a first-line chemotherapy.
  
  
  METHODS
  Thirty patients with advanced gastric carcinoma refractory to first-line ECF or PELF chemotherapy were treated with DCT administered at the dosage of 100 mg/mq given as a 1-hour i.v. infusion every three weeks. All patients received a premedication with dexamethasone 8 mg i.v. 12 hours and 1 hour before, and 12 hours after DCT administration. Granulocyte colony stimulating factor was employed in case of febrile neutropenia as needed. The first evaluation of disease status was planned after three cycles.
  
  
  RESULTS
  We observed 5 partial responses without any complete response for an overall response rate of 17% (95% CI = 6-36%, intent-to-treat analysis). Nine patients showed stable disease and 14 patients progressed. The duration of objective partial responses were 5, 6, 6, 9 and 12 months, respectively. The median overall survival was 6 months and the 1-year survival rate was 20.6%. No chemotherapy-related toxic death was observed. Haematological grade 3-4 side-effects were respectively: anemia (7%), leucopenia (7%) and neutropenia (18%); in 13 patients (45%) G-CSF was employed to avoid severe leukopenia.
  
  
  CONCLUSIONS
  This multinstitutional single-step phase II study confirms that single-agent docetaxel is active in advanced gastric cancer progressing after first-line chemotherapy. The most frequent toxicity is neutropenia, which may be managed by G-CSF and/or dose adjustments. Docetaxel is therefore worthy of further study in combination with other active drugs.
authors.affiliation: Medical and Experimental Oncology Unit, Oncology Institute, Bari, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giuliani
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Francesco
authors.initials: F
authors.lastname: De Vita
authors.forename: Evaristo
authors.initials: E
authors.lastname: Maiello
authors.forename: Maurizio
authors.initials: M
authors.lastname: Di Bisceglie
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Catalano
authors.forename: Nicolo
authors.initials: N
authors.lastname: Gebbia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016879:Salvage Therapy; D013274:Stomach Neoplasms / Q000188:drug therapy*; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel