Effective combination chemotherapy with bimonthly docetaxel and cisplatin with or without hematopoietic growth factor support in patients with advanced gastroesophageal cancer.
OBJECTIVE
A phase II trial was performed to determine the antitumor efficacy and tolerance of combined docetaxel and cisplatin with or without hematopoietic growth factor support in patients with advanced gastroesophageal cancer.


METHODS
Thirty-seven patients with histologically confirmed metastatic gastroesophageal cancer were entered in this trial. Treatment consisted of 4-weekly courses of docetaxel 50 mg/m(2) and cisplatin 50 mg/m(2) both given on day 1 and 15. Depending on absolute neutrophil counts on the days of scheduled chemotherapeutic drug administration (1,000-2,000/microl), a 5-day course of human granulocyte colony-stimulating factor (G-CSF) 5 microg/kg/day was given subcutaneously; in addition, if hemoglobin was <12.0 mg/dl, erythropoietin 10,000 IU was administered subcutaneously 3 times per week.


RESULTS
The confirmed overall response rate (intent-to-treat) was 46%, including 4 complete responses (11%) and 13 partial responses (35%). Eleven patients (30%) had stable disease and 9 (24%) progressed while on treatment. The median time to response was 3 months, the median time to progression was 7 months and the median overall survival time was 11.5 months with 16 (43%) patients currently alive. Hematologic toxicity was common, though WHO grade 4 neutropenia occurred only in 3 patients. Nonhematologic adverse reaction were usually mild to moderate; grade 3 toxicities included alopecia in 5 patients (14%), infection in 1 (3%), neutrotoxicity in 2 (5%) and anaphylaxis in 1 patient.


CONCLUSIONS
Our data suggest that the combination of docetaxel and cisplatin with or without G-CSF and/or erythropoietin has a promising therapeutic index in patients with advanced gastroesophageal cancer.
Schüll
Birgit
B
Department of Internal Medicine I, Vienna University Medical School, Vienna, Austria.
Kornek
Gabriela V
GV
Schmid
Katharina
K
Raderer
Markus
M
Hejna
Michael
M
Lenauer
Alfred
A
Depisch
Dieter
D
Lang
Fritz
F
Scheithauer
Werner
W
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004359:Drug Therapy, Combination; D004921:Erythropoietin / Q000008:administration & dosage*; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D004943:Esophagogastric Junction; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D043823:Taxoids; D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D002945:Cisplatin