title: A randomized phase II study of weekly docetaxel/cisplatin versus weekly docetaxel/oxaliplatin as first-line therapy for patients with advanced gastric cancer.
abstract: BACKGROUND
  Docetaxel, in combination with cisplatin or oxaliplatin, has demonstrated efficacy in advanced gastric cancer (AGC). This randomized, non-comparative phase II trial evaluated two weekly docetaxel-based regimens to determine which is the most promising in terms of efficacy and safety as a front-line therapy in AGC.
  
  
  METHODS
  Chemotherapy-naïve patients with measurable unresectable and/or metastatic gastric adenocarcinoma were randomly assigned to receive docetaxel (35 mg/m(2)) weekly on days 1 and 8 of a 21-day cycle plus either cisplatin (60 mg/m(2) on day 1) (wDP) or oxaliplatin (120 mg/m(2) on day 1) (wDO).
  
  
  RESULTS
  Of the 77 randomly assigned patients, 76 patients (38 per arm) received one of the study treatments. Overall, response rate (ORR) was 37 % for wDP and 41 % for wDO. Median progression-free survival (PFS) was 4.9 and 4.4 months for wDP and wDO, respectively, and median overall survival (OS) was 9.7 and 12.3 months, respectively. Exploratory analyses showed no significant difference between wDP and wDO in terms of ORR (P = 0.707), PFS (P = 0.324), or OS (P = 0.581). The main grade 3 or 4 toxicity in the wDP and wDO groups was neutropenia (47 % in both groups). wDO was less associated with nausea (66 vs. 82 %) and vomiting (39 vs. 63 %), but more associated with peripheral neuropathy (68 vs. 39 %) than wDP. Rates of overall grade 3 or 4 adverse events were similar (wDP 66 vs. wDO 68 %).
  
  
  CONCLUSIONS
  wDP and wDO were found to be equally active and tolerable as front-line treatments in AGC.
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Hospital, 1198, Guwol-dong, Namdong-gu, Incheon, 405-706, Republic of Korea.
authors.forename: Young Saing
authors.initials: YS
authors.lastname: Kim
authors.forename: Sun Jin
authors.initials: SJ
authors.lastname: Sym
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Inkeun
authors.initials: I
authors.lastname: Park
authors.forename: Junshik
authors.initials: J
authors.lastname: Hong
authors.forename: Hee Kyung
authors.initials: HK
authors.lastname: Ahn
authors.forename: Jinny
authors.initials: J
authors.lastname: Park
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.forename: Woon Ki
authors.initials: WK
authors.lastname: Lee
authors.forename: Min
authors.initials: M
authors.lastname: Chung
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Lee
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel; D002945:Cisplatin