title: A multiple-center phase II study of weekly docetaxel and oxaliplatin as first-line treatment in patients with advanced gastric cancer.
abstract: BACKGROUND
  Docetaxel and oxaliplatin are active agents for advanced gastric cancer (GC). The combination of these two drugs in a triweekly schedule is an active and attractive regimen for gastric cancer but with significant hematological toxicities. A multicenter phase II study was designed to establish an active regimen with good tolerability by using a weekly docetaxel-oxaliplatin (DO) combination in GC patients.
  
  
  METHODS
  Eligible patients had histologically confirmed stage IV gastric cancer without previous palliative chemotherapy; age ≥18 years; Eastern Cooperative Oncology Group (ECOG) performance status ≤2; at least one measurable lesion; and adequate hematological, renal, and liver functions. All patients received premedications with dexamethasone and 5-HT3 antagonist before the chemotherapy. Docetaxel (Taxotere®; Sanofi-Aventis) 30 mg/m(2) followed by oxaliplatin (Eloxatin®; Sanofi-Aventis) 65 mg/m(2) were administered on days 1 and 8 of each 21-day cycle. Treatment continued until disease progression, intolerable toxicity, or consent withdrawal. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0. Tumor responses were evaluated every 2 cycles by the Response Evaluation Criteria in Solid Tumors Guidelines.
  
  
  RESULTS
  From May 2007 to December 2008, a total of 47 patients were enrolled. There were 8 females and 39 males with a median age of 57 years (range 26-76). Forty-three patients were evaluable for response. Two patients obtained a complete response (4.7%) and 12 patients had a partial response (27.9%), with an overall response rate of 32.6% (95% confidence interval [CI] 19.1-48.5); 20 patients experienced stable disease (46.5%), and the disease progressed in 9 patients (20.9%). Median time to disease progression was 4.2 months and median overall survival was 8.3 months. All 47 patients were assessable for toxicity. Major grade 3/4 hematological toxicities were anemia (5 patients, 10.6%), neutropenia (2 patients, 4.3%), and leukopenia (1 patient, 2.1%). The most common grade 3/4 non-hematological toxicities were fatigue (3 patients, 6.4%) and aspartate aminotransferase (AST) elevation in 3 patients (6.4%).
  
  
  CONCLUSIONS
  The combination of weekly DO demonstrated a well-tolerated profile with moderate activity in the treatment of advanced gastric cancer. Further studies of the combination together with a fluoropyrimidine are warranted.
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan. js1101@adm.cgmh.org.tw
authors.forename: Jen-Shi
authors.initials: JS
authors.lastname: Chen
authors.forename: Yen-Yang
authors.initials: YY
authors.lastname: Chen
authors.forename: Jen-Sheng
authors.initials: JS
authors.lastname: Huang
authors.forename: Kun-Yun
authors.initials: KY
authors.lastname: Yeh
authors.forename: Ping-Tsung
authors.initials: PT
authors.lastname: Chen
authors.forename: Wen-Chi
authors.initials: WC
authors.lastname: Shen
authors.forename: Hung-Chih
authors.initials: HC
authors.lastname: Hsu
authors.forename: Yung-Chung
authors.initials: YC
authors.lastname: Lin
authors.forename: Hung-Ming
authors.initials: HM
authors.lastname: Wang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel