In this study, people with advanced or spreading cancer of the bile ducts were treated either with the drug gemcitabine alone or with a combination of cisplatin and gemcitabine. People who had the two-drug combination lived longer on average (11.7 months versus 8.1 months). Side effects were similar in the two groups; only a drop in white blood cells (neutropenia) was seen more often in the combination group.
Advanced biliary tract or gallbladder cancer, first line
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Phase 1: up to 8 cycles | |||
| Gemcitabine | 1000 mg/m² | IV | Days 1 and 8 |
| Cisplatin | 25 mg/m² | IV | Days 1 and 8 |
| Durvalumab | 1500 mg | IV | Day 1 every 21 days |
| Phase 2 | |||
| Durvalumab | 1500 mg | IV | Every 28 days |
Doses as in TOPAZ-1; gemcitabine-cisplatin is the same regimen as ABC-02.
Dose source:.
On the page “Gemcitabine-cisplatin with durvalumab in biliary tract cancer”
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Cisplatin (25 mg/m² body surface area) followed by gemcitabine (1000 mg/m²) on days 1 and 8, every 3 weeks, for eight cycles.
Gemcitabine (1000 mg/m²) on days 1, 8 and 15, every 4 weeks, for six cycles.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with cholangiocarcinoma, gallbladder cancer or ampullary cancer whose disease was locally advanced or metastatic.
The primary endpoint was overall survival. Progression-free survival and tumour control rate were also reported. Treatment continued for up to 24 weeks.
Adverse events were similar in the two groups, except for neutropenia, which was more frequent in the cisplatin-gemcitabine group. The number of neutropenia-associated infections was similar in the two groups.
On the basis of this trial, cisplatin plus gemcitabine is an appropriate option for the treatment of patients with advanced biliary cancer. The status of this regimen in clinical guidelines and drug approvals should be checked separately, as the abstract does not address it.
The abstract does not explicitly state the study's limitations. This trial was extended from a phase 2 study to phase 3. Further details are available in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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