Advanced or Metastatic Gallbladder Carcinoma (ECOG 0–1): Treatment After First-Line Therapy Failure
This protocol addresses patients with advanced or metastatic gallbladder carcinoma and an ECOG performance status of 0–1 whose disease has progressed following first-line systemic treatment.
Clinical scenario: Advanced or metastatic gallbladder carcinoma with preserved performance status (ECOG 0–1), requiring a structured approach to second-line therapy following first-line failure.
First-line failure
First-line systemic therapy with cisplatin plus gemcitabine (with or without durvalumab) did not achieve adequate disease control. Efficacy had been assessed by CT or MRI imaging every 8–12 weeks; CA 19-9 or CEA tumour markers were used as supplementary monitoring where applicable. Progression under or after this regimen is the trigger for escalation to the protocol below.
For patients in this situation, the evidence supports a second-line systemic combination regimen involving an oxaliplatin-based multi-drug backbone — an approach evaluated in a randomised UK study that demonstrated an overall survival advantage over active symptom control alone.
The complete regimen, eligibility criteria, substitution rules, and monitoring schedule are detailed in the full protocol.
References
DOI: 10.1016/j.annonc.2022.10.506
Cisplatinegemcitabine 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 cisplatinegemcitabine doublet demonstrated an OS benefit over gemcitabine mono-therapy in the UK ABC-02 study and the Japanese BT22 study.
FOLFOX is the SoC in the second-line setting after cisplatinegemcitabine.
The UK ABC-06 study demonstrated a modest OS (primary endpoint) advantage with 5-fluorouracileleucovorineoxaliplatin (FOLFOX) compared with active symptom control (HR 0.69).
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