Phase II trial of gemcitabine in patients with previously untreated metastatic cancer of the esophagus or gastroesophageal junction

Citation
Ab. Sandler et al., Phase II trial of gemcitabine in patients with previously untreated metastatic cancer of the esophagus or gastroesophageal junction, ANN ONCOL, 11(9), 2000, pp. 1161-1164
Citations number
20
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
ANNALS OF ONCOLOGY
ISSN journal
0923-7534 → ACNP
Volume
11
Issue
9
Year of publication
2000
Pages
1161 - 1164
Database
ISI
SICI code
0923-7534(200009)11:9<1161:PITOGI>2.0.ZU;2-M
Abstract
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 a.