title: Phase II study of docetaxel and cisplatin as first-line chemotherapy in patients with recurrent or metastatic gastric cancer.
abstract: OBJECTIVE
  Palliative chemotherapy for patients with recurrent or metastatic gastric cancer has been shown to have a survival benefit. Docetaxel monotherapy has achieved appreciable results for treating gastric cancer. We investigated the clinical efficacy and feasibility of a docetaxel and cisplatin combination regimen for patients suffering with recurrent or metastatic gastric cancer.
  
  
  METHODS
  Patients with histologically proven, bidimensionally measurable lesions of recurrent or metastatic gastric cancer, and they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and no prior palliative chemotherapy were eligible for this study. The combination chemotherapy regimen consisted of docetaxel 75 mg/m(2) plus cisplatin 75 mg/m(2) on day 1, and this was repeated every 3 weeks until disease progression.
  
  
  RESULTS
  32 patients were enrolled from 2002 to 2005. The objective response rate was 31.3% (95% confidence interval (CI): 14.2 approximately 48.2%) with no CR. The disease control rate was 59.4%. At a median follow up of 38.9 months, the median overall survival was 7.4 months (95% CI: 6.3 approximately 8.5). The median time to progression was 4.7 months (95% CI: 3.1 approximately 6.3). During a total of 106 cycles, grade 3 or 4 hematological toxicities were observed as follows: neutropenia (39 of 106 cycles) and anemia (3 of 106 cycles). The grade 3 or 4 non-hematological toxicities included anorexia (18.9%) and nausea/vomiting (21.7%).
  
  
  CONCLUSIONS
  Docetaxel and cisplatin combination chemotherapy showed promising anti-tumor activity and this was well tolerated as a first-line treatment for patients with recurrent or metastatic gastric cancer. Further large, randomized phase III studies are warranted.
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
authors.forename: Kyung-Ha
authors.initials: KH
authors.lastname: Kim
authors.forename: Ki-Ju
authors.initials: KJ
authors.lastname: Jeung
authors.forename: Hyun-Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Sang-Byung
authors.initials: SB
authors.lastname: Bae
authors.forename: Chan-Kyu
authors.initials: CK
authors.lastname: Kim
authors.forename: Nam-Su
authors.initials: NS
authors.lastname: Lee
authors.forename: Kyu-Taek
authors.initials: KT
authors.lastname: Lee
authors.forename: Sung-Kyu
authors.initials: SK
authors.lastname: Park
authors.forename: Jong-Ho
authors.initials: JH
authors.lastname: Won
authors.forename: Dae-Sik
authors.initials: DS
authors.lastname: Hong
authors.forename: Hee-Sook
authors.initials: HS
authors.lastname: Park