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Association details:
| Biomarker: | HER-2 amplification |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial
Published date:
08/28/2010
Excerpt:
Trastuzumab, a monoclonal antibody against human epidermal growth factor receptor 2 (HER2; also known as ERBB2), was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer...Median follow-up was 18.6 months (IQR 11-25) in the trastuzumab plus chemotherapy group and 17.1 months (9-25) in the chemotherapy alone group. Median overall survival was 13.8 months (95% CI 12-16) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months (10-13) in those assigned to chemotherapy alone (hazard ratio 0.74; 95% CI 0.60-0.91; p=0.0046).
Secondary therapy:
cisplatin + capecitabine; cisplatin + 5-fluorouracil
DOI:
10.1016/S0140-6736(10)61121-X
Trial ID:
Source:
Title:
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy
Excerpt:
...HER-2 amplification by fluorescent in situ hybridization or HER-2 score of at least at least 1+ by Immunohistochemistry in more than 10% of the cells....
Trial ID:
Source:
Title:
NK Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer
Excerpt:
...Histologically confirmed diagnosis of HER2-positive breast or gastric cancer (defined as IHC 3+ or HER2 FISH amplification ratio >2.2) 3....
Trial ID:
More C2 evidence
Source:
Title:
Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or Stomach
Excerpt:
...- Detection of an adenocarcinoma with HER2 3+ (IHC) or HER2 2+ (IHC) with amplification proven by FISH, SISH or CISH by an accredited local pathologist (for quality assurance tumor samples have to be available for a subsequent central review)...
Trial ID:
Source:
Title:
Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System
Excerpt:
...- Detection of a carcinoma with HER2 3+ (IHC) or HER2 2+ (IHC) with amplification proven by fluorescence in situ hybridization(FISH), silver in situ hybridization（SISH） or chromogenic in situ hybridization（CISH） using gastric cancer criteria by an accredited local pathologist....
Trial ID:
Source:
Title:
PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer
Excerpt:
...HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH (≥2.0)...
Trial ID:
Less C2 evidence
Source:
Title:
Trastuzumab combined with irinotecan in patients with HER2-positive metastatic colorectal cancer: A phase II single-arm study and exploratory biomarker analysis
Published date:
12/23/2022
Excerpt:
Twenty-one HER2-positive mCRC patients were enrolled in this study. Seven (33.3%) patients achieved an objective response, and 11 (52.4%) patients had stable disease as their best response. The median progression-free survival (PFS) was 4.3 months (95% CI: 2.7 - 5.9 m)....Trastuzumab combined with chemotherapy is a potentially effective and well-tolerated therapeutic regimen in mCRC with a high HER2 copy number.
Secondary therapy:
irinotecan
DOI:
10.4143/crt.2022.1058
Trial ID:
Source:
Title:
Predictive Roles of HER2 Gene Amplification and Neutrophil-to-Lymphocyte Ratio on Survival in HER2-Positive Advanced Gastric Cancer Treated With Trastuzumab-Based Chemotherapy
Published date:
03/12/2021
Excerpt:
We retrospectively reviewed medical records of 112 patients between 28 and 91 years old (median of 66 y) with AGC treated with first-line trastuzumab-based chemotherapy….Objective response rate in both high HER2/CEP17 ratio (59.4% vs. 28.1%, P=0.012) and HER2 GCN groups (62.1% vs. 33.3%, P=0.032) was higher than that of each group.
DOI:
10.1097/COC.0000000000000810
Source:
Title:
HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer
Published date:
07/20/2014
Excerpt:
Patients with advanced gastric or gastroesophageal junction cancer displaying HER2 overexpression or amplification were randomized to trastuzumab plus chemotherapy...or 5-fluorouracil plus cisplatin (XP/FP)] or to chemotherapy alone....HER2 testing was performed in a central laboratory (Targos Molecular Pathology GmbH, Kassel, Germany) by IHC [HercepTest™ (Dako, Glostrup, Denmark)] and FISH [HER2 FISH pharmDx™ (Dako)] in parallel...The addition of trastuzumab to chemotherapy significantly prolongs survival compared with chemotherapy alone in patients with advanced gastric or gastroesophageal junction tumors that show HER2 overexpression or gene amplification (median overall survival: 13.8 months vs. 11.1 months, respectively; HR 0.74; 95 % CI, 0.60–0.91)
Secondary therapy:
cisplatin + 5-fluorouracil; capecitabine
DOI:
10.1007/s10120-014-0402-y
Trial ID:
