title: Multi-center Randomized Phase II Study of Weekly Docetaxel Versus Weekly Docetaxel-plus-Oxaliplatin as a Second-line Chemotherapy for Patients with Advanced Gastric Cancer.
abstract: OBJECTIVE
  The current phase II clinical study was conducted to evaluate the efficacy and safety of weekly docetaxel alone, and weekly docetaxel-plus-oxaliplatin, as a second-line chemotherapy in patients with cisplatin-refractory advanced gastric cancer.
  
  
  METHODS
  We enrolled patients with histologically confirmed gastric adenocarcinoma whose disease had progressed after cisplatin-based regimens. Patients were randomly assigned to receive docetaxel alone (36 mg/m(2), days 1 and 8) or docetaxel (36 mg/m(2), days 1 and 8) and oxaliplatin (80 mg/m(2), day 1) combination therapy every three weeks.
  
  
  RESULTS
  This trial was terminated early due to poor patient accrual rate. From January 2009 to January 2012, a total of 52 patients were enrolled in the current study from six centers: 27 patients in the docetaxel monotherapy arm and 25 patients in the docetaxel/oxaliplatin combination arm. Fifty-two patients were assessable for efficacy, and response rates as follows (response rate: 14.8% in the monotherapy arm, 24.0% in the combination arm; disease control rate: 48.1% in the monotherapy arm, 76.0% in the combination arm. The median progression-free survival was 2.0 (95% confidence interval=1.2-2.9) months in the monotherapy arm and 4.9 (95% confidence interval=3.6-6.6) months in the combination arm (p=0.002). The most common grade 3 or 4 adverse event was neutropenia (14% for monotherapy versus 32% for combination). No treatment-related mortality was observed.
  
  
  CONCLUSIONS
  Weekly docetaxel and weekly docetaxel-plus-oxalipaltin regimens were found to be well-tolerated and effective as a second-line chemotherapy for patients with advanced gastric cancer.
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
authors.forename: Jin Young
authors.initials: JY
authors.lastname: Kim
authors.affiliation: Department of Oncology/Hematology, Daegu Catholic University Hospital, Daegu, Republic of Korea.
authors.forename: Hun Mo
authors.initials: HM
authors.lastname: Ryoo
authors.affiliation: Department of Oncology/Hematology, Daegu Catholic University Hospital, Daegu, Republic of Korea.
authors.forename: Sung Hwa
authors.initials: SH
authors.lastname: Bae
authors.affiliation: Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors.forename: Byung Woog
authors.initials: BW
authors.lastname: Kang
authors.affiliation: Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors.forename: Yee Soo
authors.initials: YS
authors.lastname: Chae
authors.affiliation: Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors.forename: Shinkyo
authors.initials: S
authors.lastname: Yoon
authors.affiliation: Department of Hematology/Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.
authors.forename: Jin Ho
authors.initials: JH
authors.lastname: Baek
authors.affiliation: Department of Oncology/Hematology, Yeungnam University Medical Cener, Daegu, Republic of Korea.
authors.forename: Min Kyoung
authors.initials: MK
authors.lastname: Kim
authors.affiliation: Department of Oncology/Hematology, Yeungnam University Medical Cener, Daegu, Republic of Korea.
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Department of Hematology/Oncology, Daegu Fatima Hospital, Daegu, Republic of Korea.
authors.forename: Sun Ah
authors.initials: SA
authors.lastname: Lee
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea jkk21c@knu.ac.kr shs7436@dsmc.or.kr.
authors.forename: Hong Suk
authors.initials: HS
authors.lastname: Song
authors.affiliation: Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Republic of Korea jkk21c@knu.ac.kr shs7436@dsmc.or.kr.
authors.forename: Jong Gwang
authors.initials: JG
authors.lastname: Kim
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel; D002945:Cisplatin
keywords: Docetaxel; chemotherapy; gastric cancer; oxaliplatin