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    Association details:
    Biomarker:MSI-H/dMMR
    Cancer:Cholangiocarcinoma
    Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    ESMO.org
    Title:

    Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up☆

    Excerpt:
    Pembrolizumab is recommended in patients with MSI-H/dMMR who have progressed on or are intolerant to prior treatment [III, A; ESMO-MCBS v1.1 score: 3; ESCAT score: I-C].
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Small Intestinal Carcinoma)
    New
    Title:

    European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) Tumors in Five Different Types of Cancer

    Excerpt:
    Merck...announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors in adults with...unresectable or metastatic gastric, small intestine or biliary cancer, who have disease progression on or following at least one prior therapy.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

    Excerpt:
    ...- Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H) OR...
    Trial ID:
    KEYNOTE-158
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    Springer
    Title:

    Efficacy of pembrolizumab in microsatellite instability-high locally advanced cholangiocarcinoma: a case report

    Published date:
    06/03/2021
    Excerpt:
    ...Here, we report the use of PEM for MSI-high locally advanced cholangiocarcinoma. A 57-year-old man presented to our department with jaundice...After 15 cycles of PEM were administered over about 10 months, size of tumor was reduced and tumor marker dramatically decreased. We experienced the rare case which PEM has been successfully used for MSI-high double primary cancers.
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    JGH Open
    Title:

    Success rate of microsatellite instability examination and complete response with pembrolizumab in biliary tract cancer

    Published date:
    05/21/2021
    Excerpt:
    The study included 24 intrahepatic cholangiocarcinomas, 12 hilar cholangiocarcinomas, 4 distal cholangiocarcinomas, 16 gallbladder carcinomas...a case in which pembrolizumab resulted in a complete response to MSI-H BTC. Since pembrolizumab for MSI-H BTC could prolong survival time...
    DOI:
    https://doi.org/10.1002/jgh3.12576
    Evidence Level:
    Sensitive: C4 – Case Studies
    New
    Source:
    Nihon Shokakibyo Gakkai Zasshi
    Title:

    [A case of unresectable intrahepatic cholangiocarcinoma receiving sustainable pembrolizumab therapy]

    Excerpt:
    A 65-year-old man had unresectable intrahepatic cholangiocarcinoma...We had a re-biopsy with EUS-FNA and tested for microsatellite instability, which came back as MSI-high. We administered pembrolizumab, which resulted in a significant reduction of tumor size....He has maintained partial response for more than 20 months after receiving pembrolizumab.
    DOI:
    10.11405/nisshoshi.119.360
    Evidence Level:
    Sensitive: C4 – Case Studies
    New
    Source:
    J Transl Med
    Title:

    Comprehensive molecular profiling of intrahepatic cholangiocarcinoma in the Chinese population and therapeutic experience

    Excerpt:
    Two patient samples (1.6%) had MSI-H signatures...a 57-year-old male with a history of hepatitis B virus (HBV) infection, and he was diagnosed with local advanced left lobe cholangiocarcinoma with intrahepatic metastasis...The patient was treated with pembrolizumab for 8 months...The patient exhibited a partial response...
    DOI:
    https://dx.doi.org/10.1186%2Fs12967-020-02437-2