Second-Line Treatment for Advanced or Inoperable Biliary Tract Cancer (Cholangiocarcinoma) with Adequate Performance Status
Clinical Scenario
This protocol applies to patients with advanced or inoperable biliary tract cancer (cholangiocarcinoma) who retain adequate performance status and require further management after first-line chemotherapy has failed to achieve durable disease control.
Indication
Combination chemotherapy is recommended in patients with adequate performance status following failure of first-line chemotherapy, particularly in the absence of a targetable molecular alteration. Where molecular testing identifies an actionable alteration, a targeted approach may be preferred.
Treatment Approach — partial overview
Second-line management involves either combination chemotherapy or, where molecular profiling reveals a specific actionable alteration, a targeted agent matched to that finding. The complete regimen selection, sequencing criteria, and full evidence base are available in the structured protocol below.
References
DOI: 10.1136/gutjnl-2023-330029
- CisGem chemotherapy is recommended as the first-line treatment in patients with advanced BTC.
- Combination chemotherapy is recommended in patients with adequate performance status following failure of first-line chemotherapy, particularly in the absence of a targetable molecular alteration.
- In the phase III ABC-06 study, patients were randomised to active symptom control alone or with FOLFOX (5-FU and oxaliplatin) chemotherapy.
- Several agents, such as pemigatinib and infigratinib (among others), are likely to have a similar efficacy, affording a progression-free survival in second and subsequent line therapy of 7–9 months.
- Ivosidenib has been shown to have progression-free survival advantage for patients with IDH1 mutations and is now adopted as standard of care in several countries, also after prior treatment with chemotherapy.
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