A multi-center phase II study of docetaxel plus cisplatin as first-line therapy in patients with metastatic squamous cell esophageal cancer.
OBJECTIVE
The objective of this study was to evaluate the efficacy and toxicity of docetaxel and cisplatin combination chemotherapy in patients with metastatic esophageal cancer.


METHODS
Patients with untreated metastatic squamous cell esophageal cancer, which was histologically proven with at least one measurable lesion, were eligible for the study. Docetaxel 70 mg/m(2) and cisplatin 70 mg/m(2) were intravenously given on day 1 of 21 days schedule.


RESULTS
From December 2004 to December 2007, total of 39 patients (M/F = 39/0) were enrolled. The median age was 65 years. Thirty-four patients were evaluable for response. There were 3 (7.7%) complete remission, 10 (25.6%) partial remission, 11 (28.2%) stable disease, and 10 (25.6%) progression disease. The objective tumor response rate was 33.3% in intention-to-treat (ITT). Median PFS was 5.0 months and median survival was 8.3 months. Median number of cycles administered was 3. The relative dose intensity of docetaxel and cisplatin was 92 and 91%, respectively. This treatment was comparatively tolerated with grade 3/4 neutropenia in 20.5%/10.3%, grade 3 infection in 2.6% of patients.


CONCLUSIONS
Docetaxel plus cisplatin combination chemotherapy showed promising antitumor activity with manageable toxicities in patients with metastatic squamous esophageal cancer.
Kim
Jin Young
JY
Division of Oncology-Hematology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University School of Medicine, 194 Dongsan-dong, Jung-gu, Daegu 700-712, Korea.
Do
Young Rok
YR
Park
Keon Uk
KU
Kim
Min Kyung
MK
Lee
Kyung Hee
KH
Bae
Sung Hwa
SH
Ryoo
Hun Mo
HM
Baek
Jin Ho
JH
Song
Hong Suk
HS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D018307:Neoplasms, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin