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.
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.
Hejna
Michael
M
Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria. michael.hejna@meduniwien.ac.at
Raderer
Markus
M
Zacherl
Johannes
J
Ba-Ssalamah
Ahmed
A
Püspök
Andreas
A
Schmidinger
Manuela
M
Pluschnig
Ursula
U
Brodowicz
Thomas
T
Zielinski
Christoph C
CC
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced / Q000517:prevention & control; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000627:therapeutic use; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel