title: Efficacy of trastuzumab beyond progression in HER2 positive advanced gastric cancer: a multicenter prospective observational cohort study.
abstract: BACKGROUND
  Trastuzumab plus chemotherapy is the standard first-line regimen in HER2 positive advanced gastric cancer (AGC), but lack of data in post-progression treatment. So, it is worth evaluating the efficacy of continuing trastuzumab after failure of the first-line trastuzumab based treatment.
  
  
  METHODS
  59 patients were enrolled from Zhongshan Hospital Fudan University, Sun Yat-sen University Cancer Center and Peking University Cancer Hospital between September 2012 and Oct 2015. Patients were divided into two groups according to the second line regimens: with or without trastuzumab. The primary endpoint was progression free survival of second line therapy (PFS2). Secondary end points included overall survival (OS), response rate, and adverse events (AEs).
  
  
  RESULTS
  Baseline factors were well balanced between two groups. 32 patients treated with trastuzumab plus second line chemotherapy (group A) and 27 patients received chemotherapy alone (group B). The median follow-up time was 7.60 months (range 1.50-32.50). Longer median PFS2 was observed in group A than in group B (3.1 vs 2.0 months, P=0.008). There was no significant differences of median OS2 calculating from the second line therapy (10.5 vs 6.5 months, P=0.172) between two groups. Response rate was 9.3% in group A compared with 3.7% in group B (P=0.617). AEs were similar in two groups including cardiac safety. Subgroup analysis showed that factors of male, age<65, good performance status, HER2 immunohistochemical (IHC) 2+ and poor response to first line indicated superior PFS2 in patients continuing trastuzumab to those treated with chemotherapy alone.
  
  
  CONCLUSIONS
  Continuing treatment of trastuzumab beyond first line therapy progression showed effective and safe in AGC.
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Qian
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Huiqin
authors.initials: H
authors.lastname: Jiang
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Medical Oncology, Sun Yat-Sen University Cancer Center; State Key Laboratory of Oncology in South China, Guangzhou, China.
authors.forename: Ruihua
authors.initials: R
authors.lastname: Xu
authors.affiliation: Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Shen
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Yiyi
authors.initials: Y
authors.lastname: Yu
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Yuehong
authors.initials: Y
authors.lastname: Cui
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Shan
authors.initials: S
authors.lastname: Yu
authors.affiliation: Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Tianshu
authors.initials: T
authors.lastname: Liu
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D000068878:Trastuzumab / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: HER2; advanced gastric cancer; trastuzumab; treatment beyond progression