Background: There were approximately 12,500 cases of esophageal carcinoma d
iagnosed in the US in 1992 and 12,200 deaths. The impact of chemotherapy on
patients with metastatic disease is marginal with a median survival of onl
y five months. Gemcitabine (LY188011,2,2,-difluorodeoxycytidine: dFdC), an
analog of cytosine arabinoside (ara-C), is a pyrimidine antimetabolite. Gem
citabine has shown interesting clinical activity in initial phase II clinic
al trials in a variety of malignancies, including the aerodigestive maligna
ncies, squamous-cell carcinoma of the head/neck and both non-small-cell and
small-cell lung cancer.
Patients and methods: A total of 21 patients with chemotherapy-naive metast
atic esophageal carcinoma were entered. Nineteen patients were evaluable fo
r toxicity and seventeen patients were evaluable for response. Gemcitabine
was administered intravenously at 1250 mg/m(2) over 30-60 minutes on days 1
, 8, and 15 followed by 1 week of rest. This four-week schedule defined a c
ycle of treatment. Patients may have received a maximum of six cycles.
Results: Gemcitabine was well tolerated with minimal non-hematologic toxici
ty and grade 3-4 anemia, granulocytopenia, and thrombocytopenia occurring i
n 10.5%, 21%, and 0% of patients, respectively. No responses were seen in t
he seventeen evaluable patients.
Conclusions: At the dose and schedule studied it would appear that gemcitab
ine has no activity in patients with chemotherapy-naive esophageal carcinom