Treatment of Advanced or Metastatic Gallbladder Carcinoma in Patients with ECOG Performance Status 0–1
This protocol applies to patients with unresectable advanced or metastatic gallbladder carcinoma who have a preserved performance status — ECOG 0 or 1 — making them candidates for active systemic treatment.
Clinical Setting
ECOG performance status 0–1 is a key eligibility criterion in this setting. Chemotherapy is the established standard of care for first-line treatment of advanced biliary tract cancer in this performance group, with overall survival benefit demonstrated over best supportive care alone.
Treatment Approach
Where tumour genomic profiling identifies specific alterations, molecularly targeted therapy can be selected for eligible patients. The protocol defines distinct options matched to particular biomarker profiles — the selection of which depends on the individual tumour's genomic findings.
The complete regimen — including full biomarker-matched agent selection, sequencing criteria, and all applicable options — is available in the structured protocol below.
References
DOI: 10.1016/j.annonc.2022.10.506
- Cisplatin–gemcitabine is recommended as SoC in the first-line setting for patients with a PS of 0–1.
- ChT is the current SoC for first-line treatment of advanced BTC; OS is improved when compared with best supportive care alone and the cisplatin–gemcitabine doublet demonstrated an OS benefit over gemcitabine mono-therapy in the UK ABC-02 study and the Japanese BT22 study.
- Pembrolizumab is recommended in patients with MSI-H/dMMR who have progressed on or are intolerant to prior treatment.
- HER2-directed therapies can be considered in patients with the respective genetic alterations who have progressed on or are intolerant to prior treatment.
- In the MyPathway basket trial, the combination of pertuzumab–trastuzumab achieved an ORR of 23%, median PFS of 4 months and median OS of 10.9 months.
- Dabrafenib–trametinib is recommended for the treatment of patients with BRAF V600E mutations who have progressed after 1 prior line of systemic therapy.
- NTRK inhibitors are recommended in patients with NTRK fusions who have progressed on or are intolerant to prior treatment.
- They are targetable with specific inhibitors such as larotrectinib or entrectinib.
- Patients with BRCA1/2 or PALB2 mutations responding to platinum-based therapy can be considered for treatment with PARP inhibitors.
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