title: Multicenter phase II study of trastuzumab in combination with capecitabine and oxaliplatin for advanced gastric cancer.
abstract: BACKGROUND
  Trastuzumab has been approved for use in combination with fluoropyrimidine plus cisplatin for the treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Although capecitabine plus oxaliplatin (XELOX) is a standard first-line regimen for AGC, combination trastuzumab plus XELOX has not been studied.
  
  
  METHODS
  Patients with metastatic or unresectable HER2-positive AGC were diagnosed by either HER2 immunohistochemistry (IHC) 3+ or IHC 2+/fluorescence in-situ hybridisation (FISH)+ received intravenous trastuzumab (8mg/m(2) for first cycle and 6mg/m(2) for subsequent cycles on day 1) plus oral capecitabine (1000mg/m(2) twice daily on days 1-14) and intravenous oxaliplatin (130mg/m(2) on day 1), every 3 weeks. The primary end-point was the objective response rate, and secondary end-points included progression-free survival (PFS), overall survival (OS) and toxicity profiles.
  
  
  RESULTS
  Fifty-five HER2-positive AGC patients were enrolled between August 2011 and February 2013. The median age was 57years (range=29-74). The confirmed objective response rate was 67% (95% confidence interval (CI)=54-80%). After a median follow-up period of 13.8 months (range=6.1-23.9), the median PFS and OS were 9.8 months (95% CI=7.0-12.6) and 21.0 months (95% CI=6.4-35.7), respectively. Frequently encountered grade 3-4 toxicities included neutropenia (18%), anaemia (11%), and peripheral neuropathy (11%). There was a treatment-related death caused by severe diarrhoea and complicated sepsis.
  
  
  CONCLUSIONS
  Combination of trastuzumab and XELOX is well tolerated and highly effective in patients with HER2-positive AGC.
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Min-Hee
authors: MH
authors: Ryu
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Changhoon
authors: C
authors: Yoo
authors: Department of Oncology/Hematology, Kyungpook National University Medical Center, Daegu, South Korea.
authors: Jong Gwang
authors: JG
authors: Kim
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Baek-Yeol
authors: BY
authors: Ryoo
authors: Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Young Soo
authors: YS
authors: Park
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Sook Ryun
authors: SR
authors: Park
authors: Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea.
authors: Hye-Suk
authors: HS
authors: Han
authors: Department of Internal Medicine, Chonnam National University Medical School, Gwangju, South Korea.
authors: Ik Joo
authors: IJ
authors: Chung
authors: Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, South Korea.
authors: Eun-Kee
authors: EK
authors: Song
authors: Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, South Korea.
authors: Kyung Hee
authors: KH
authors: Lee
authors: Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
authors: Seok Yun
authors: SY
authors: Kang
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: ykkang@amc.seoul.kr.
authors: Yoon-Koo
authors: YK
authors: Kang
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D013274:Stomach Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000401:mortality; D000068878:Trastuzumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: Capecitabine; Gastric cancer; HER2; Oxaliplatin; Trastuzumab