Biliary Tract Cancers Clinical Practice Guidelines (NCCN, 2023)

National Comprehensive Cancer Network (NCCN)

These are some of the highlights of the guidelines without analysis or commentary. For more information, go directly to the guidelines by clicking the link in the reference.

August 16, 2023

Recent updates to the National Comprehensive Cancer Network (NCCN) guidelines for the evaluation and management of patients with biliary tract cancers (BTCs) (gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma) were published in July 2023 in the Journal of the NCCN (JNCCN).[1] Select recommendations for molecular testing and for systemic therapy are outlined below.

Molecular Testing

Molecular testing

The NCCN recommends comprehensive molecular profiling for those with unresectable or metastatic BTCs, such as NTRK gene fusion, microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) status, tumor mutational burden-high (TMB-H) status, BRAF V600E mutation, FGFR2 fusion or rearrangement, IDH1 mutation, HER2 (ERBB2) overexpression and/or amplification, and/or RET gene fusion.

Consider cell-free DNA (cfDNA) to identify gene mutations.

Germline testing in hepatobiliary cancers

Insufficient evidence exists for definitive recommendations about specific criteria to guide genetic risk assessment in hepatobiliary cancers or for universal germline testing in these tumors.

Systemic Therapy

Primary treatment for unresectable and metastatic disease

Preferred regimen: Durvalumab plus gemcitabine plus cisplatin. This regimen is also recommended as an option for those with recurrent disease that develops longer than 6 months postoperatively with curative intent as well as longer than 6 months post adjuvant therapy completion.

Subsequent-line therapy for BTCs that progress

Preferred regimen: Folinic acid plus fluorouracil plus oxaliplatin (FOLFOX)

For more information, please go to Gallbladder Cancer and Cholangiocarcinoma.

For more Clinical Practice Guidelines, please go to Guidelines.


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