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    Association details:
    Biomarker:HER-2 amplification
    Cancer:Gastric Cancer
    Drug:lapatinib (EGFR inhibitor, HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations: TyTAN--a randomized, phase III study

    Published date:
    07/01/2014
    Excerpt:
    TyTAN was a two-part, parallel-group, phase III study in Asian patients. An open-label, dose-optimization phase (n = 12) was followed by a randomized phase (n = 261), in which patients who were HER2 positive by fluorescence in situ hybridization (FISH) received lapatinib 1,500 mg once per day plus once-per-week paclitaxel 80 mg/m(2) or paclitaxel alone...ORR was higher with lapatinib plus paclitaxel versus paclitaxel alone (odds ratio, 3.85; P < .001). Better efficacy with lapatinib plus paclitaxel was demonstrated in IHC3+ compared with IHC0/1+ and 2+ patients and in Chinese compared with Japanese patients.
    Secondary therapy:
    paclitaxel
    DOI:
    10.1200/JCO.2013.53.6136
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery

    Excerpt:
    ...HER2-positive is defined as HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or fluorescence in situ hybridization (FISH) (>= 2.0)...
    Trial ID:
    NCT01705340
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists

    Excerpt:
    ...Duration of Response`Progression-free Survival (PFS)`Time to Disease Progression (TTP)`Number of Participants With the Indicated Change in Cancer Antigen-125 (CA-125) Levels From Day 1`Incidence of MET Amplification in Gastric Cancer`Incidence of ErbB2-positive Participants...
    Trial ID:
    NCT00447226
    Less C2 evidence
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    AACR-II 2020
    Title:

    Abstract LB-326: The role of HER3 in HER2-amplified cancers other than breast cancers

    Published date:
    05/15/2020
    Excerpt:
    Lapatinib induced apoptosis correlated with HER3 activation. Tumor growth was reduced upon HER3 knockdown in HER2-amplified cancers other than breast cancers, particularly cancers with constitutive HER3 phosphorylation. Many HER2-amplified cancers of the breast (HCC1569, HCC1954, HCC1419, UACC732, SUM190), bladder (CLS-439), stomach (N87, OE19), esophagus (TE4, KYSE410), lung (Calu3), and endometrium (USPC-ARC1, USPC-ARC2) showed HER3 activation...
    DOI:
    10.1158/1538-7445.AM2020-LB-326