^
    Evidence Level:
    Sensitive: A1 - Approval

    [HER-2 overexpression-Gastric Cancer-trastuzumab-anns]

    Source:
    FDA
    Test:

    HercepTest, HER2 IQFISH pharmDx

    Published date:
    06/13/2019
    Excerpt:
    KANJINTI is a HER2/neu receptor antagonist indicated for:...the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma….Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product...
    Secondary therapy:
    XP; FP
    Evidence Level:
    Sensitive: A1 - Approval

    [HER-2 overexpression-Gastroesophageal Junction Adenocarcinoma-trastuzumab-anns]

    Source:
    FDA
    Test:

    HercepTest, HER2 IQFISH pharmDx

    Published date:
    06/13/2019
    Excerpt:
    KANJINTI is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
    Secondary therapy:
    FP; XP
    Evidence Level:
    Sensitive: A1 - Approval

    [HER-2 overexpression-Breast Cancer-trastuzumab-anns]

    Source:
    FDA
    Test:

    HercepTest, HER2 IQFISH pharmDx

    Excerpt:
    KANJINTI is a HER2/neu receptor antagonist indicated for: the treatment of HER2 overexpressing breast cancer.
    Secondary therapy:
    paclitaxel; paclitaxel + doxorubicin hydrochloride + cyclophosphamide; carboplatin + docetaxel; docetaxel + doxorubicin hydrochloride + cyclophosphamide
    Evidence Level:
    Sensitive: C3 – Early Trials

    [HER-2 amplification-HER2 Positive Breast Cancer-trastuzumab]

    Source:
    ASCO 2020
    Test:

    HER2 IQFISH pharmDx

    Title:
    Correlation between HER2 amplification level and response to neoadjuvant treatment with trastuzumab and chemotherapy in HER2 positive breast cancer.
    Published date:
    05/28/2020
    Excerpt:
    Pathological Complete Response (pCR) (Miller-Payne grading system) was obtained in 58% of the patients whose tumors showed amplification. No pCR was obtained in the 8 patients whose tumors were negative by FISH (not amplified)....We also demonstrated an association between the HER2 amplification level (both ratios and numbers of HER2 signals) and a trend toward improved disease free survival (DFS) (p = 0.451 and p= 0.619, respectively).
    DOI:
    10.1200/JCO.2020.38.15_suppl.e12641
    Evidence Level:
    Sensitive: C3 – Early Trials

    [HER-2 amplification-Lung Adenocarcinoma-ado-trastuzumab emtansine]

    Source:
    J Clin Oncol
    Test:

    HER2 IQFISH pharmDx, PathVysion HER-2 DNA Probe Kit

    Title:
    Ado-Trastuzumab Emtansine for Patients With HER2-Mutant Lung Cancers: Results From a Phase II Basket Trial
    Excerpt:
    We treated 18 patients with advanced HER2-mutant lung adenocarcinomas...The partial response rate was 44% (95% CI, 22% to 69%), meeting the primary end point...Responses were seen in patients with HER2 exon 20 insertions and point mutations in the kinase, transmembrane, and extracellular domains...Concurrent HER2 amplification was observed in two patients...HER2 immunohistochemistry ranged from 0 to 2+ and did not predict response, and responders had low HER2 protein expression measured by mass spectrometry...The median progression-free survival was 5 months (95% CI, 3 to 9 months).
    DOI:
    10.1200/JCO.2018.77.9777
    Trial ID:
    NCT02675829