Phase II study of docetaxel in combination with oxaliplatin in patients with metastatic or locally advanced esophagogastric cancer previously untreated with chemotherapy for advanced disease: results of the Central European Cooperative Oncology Group Study ESGAS.1.2.001

Anticancer Drugs. 2008 Jun;19(5):535-9. doi: 10.1097/CAD.0b013e3282fb178a.

Abstract

A phase II trial was performed to determine the efficacy and tolerance of docetaxel plus oxaliplatin with hematopoietic growth factor support in previously untreated patients with advanced gastroesophageal adenocarcinoma. Thirty-five patients were entered in this trial. Treatment consisted of 3-weekly docetaxel 80 mg/m2 and oxaliplatin 100 mg/m2 both infused on day 1. A prophylactic 5-day course of human granulocyte colony-stimulating factor 5 microg/kg/day was given subcutaneously, and erythropoietin (10,000 IU subcutaneously three times per week) was administered if hemoglobin was less than 12.0 mg/dl. The confirmed overall response rate was 34%, including two complete responses (6%) and 10 partial responses (28%). Fifteen patients (43%) had stable disease. The median time to response was 2.5 months (1-3.5), the median time to progression was 8.9 (4-42.5) months and the median overall survival time was 11.6 (2.5-51) months. Hematologic toxicity was common, though World Health Organization grade 3 or 4 neutropenia occurred only in six (17%) patients and anemia in six (17%) patients, respectively. Nonhematologic adverse reactions were usually mild-to-moderate. Our data suggest that the combination of docetaxel and oxaliplatin with granulocyte colony-stimulating factor and erythropoietin has a promising therapeutic index in patients with advanced gastroesophageal adenocarcinoma.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / mortality
  • Adenocarcinoma / secondary
  • Adult
  • Aged
  • Anemia / chemically induced
  • Anemia / prevention & control
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Docetaxel
  • Drug Administration Schedule
  • Erythropoietin / therapeutic use
  • Esophageal Neoplasms / drug therapy*
  • Esophageal Neoplasms / mortality
  • Esophageal Neoplasms / pathology
  • Female
  • Granulocyte Colony-Stimulating Factor / therapeutic use
  • Humans
  • Infusions, Intravenous
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Neutropenia / prevention & control
  • Organoplatinum Compounds / administration & dosage
  • Oxaliplatin
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / mortality
  • Stomach Neoplasms / pathology
  • Survival Rate
  • Taxoids / administration & dosage

Substances

  • Organoplatinum Compounds
  • Taxoids
  • Oxaliplatin
  • Erythropoietin
  • Granulocyte Colony-Stimulating Factor
  • Docetaxel