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Systemic Anti-Cancer Therapy Regimen Library

Home > UGI BIL AND GBC Advanced/Metastatic - cISplatin, gemcitabine and durvalumab

UGI BIL AND GBC Advanced/Metastatic - cISplatin, gemcitabine and durvalumab

Treatment Overview

Usually up to 8 cycles of cISplatin, gemcitabine and durvalumab [Q3W].

durvalumab [Q4W] may continue until disease progression or unacceptable toxicity.

Cycles 1 to 8 - 21 days - cISplatin, gemcitabine and durvalumab [Q3W]

Cycle length:
21

Cycle 9 (and all further cycles) - 28 days - durvalumab [Q4W] continuation

Cycle length:
28

Cycle details

Cycles 1 to 8 - 21 days - cISplatin, gemcitabine and durvalumab [Q3W]

Medication Dose Route Days Max Duration
durvalumab 1500 mg flat dosing intravenous 1 60 minutes
aprepitant 125 mg oral administration 1, 8
aprepitant 80 mg oral administration 2, 3, 9,
10
dexamethasone * 8 mg oral administration 1, 8
dexamethasone * 4 mg oral administration 2, 3, 9,
10
ondansetron 8 mg oral administration 1, 8
gemcitabine * 1000 mg/m² intravenous 1, 8 30 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 1, 8 60 minutes
cISplatin * 25 mg/m² intravenous 1, 8 60 minutes
sodium chloride 0.9 % intravenous 1, 8 60 minutes
ondansetron 8 mg oral administration 1, 8
domperidone 10 mg Three times daily oral administration 1

Cycle 9 (and all further cycles) - 28 days - durvalumab [Q4W] continuation

Medication Dose Route Days Max Duration
durvalumab 1500 mg flat dosing intravenous 1 60 minutes

Full details

Cycles 1 to 8 - 21 days - cISplatin, gemcitabine and durvalumab [Q3W]

Day: 1

Medication Dose Route Max duration Details
durvalumab 1500 mg flat dosing intravenous 60 minutes
Instructions:
Administer via a sterile, low protein binding 0.2 or 0.22 micron in-line filter.
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
gemcitabine * 1000 mg/m² intravenous 30 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin * 25 mg/m² intravenous 60 minutes
Instructions:
  • In 500 - 1000 mL of sodium chloride 0.9%, depending on stability.
  • Ensure patient has passed urine as per institutional policy.
  • Hypersensitivity risk increases with number of cycles of cISplatin.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:

After cISplatin infusion.

  • If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
domperidone 10 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.

Day: 2

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 4 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • This dose may be reduced or omitted at clinician’s discretion.

Day: 3

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 4 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • This dose may be reduced or omitted at clinician’s discretion.

Day: 8

Medication Dose Route Max duration Details
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
gemcitabine * 1000 mg/m² intravenous 30 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin * 25 mg/m² intravenous 60 minutes
Instructions:
  • In 500 - 1000 mL of sodium chloride 0.9%, depending on stability.
  • Ensure patient has passed urine as per institutional policy.
  • Hypersensitivity risk increases with number of cycles of cISplatin.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:

After cISplatin infusion.

  • If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.

Day: 9

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 4 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • This dose may be reduced or omitted at clinician’s discretion.

Day: 10

Medication Dose Route Max duration Details
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 4 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • This dose may be reduced or omitted at clinician’s discretion.

Cycle 9 (and all further cycles) - 28 days - durvalumab [Q4W] continuation

Day: 1

Medication Dose Route Max duration Details
durvalumab 1500 mg flat dosing intravenous 60 minutes
Instructions:
Administer via a sterile, low protein binding 0.2 or 0.22 micron in-line filter.

Supportive Care Factors

Factor Value
Emetogenicity: Variable
Hydration: Variable

Hydration: Routine hydration recommended with cISplatin (cycles 1 to 8).


Emetogenicity:

  • cISplatin, gemcitabine and durvalumab: HIGH (cISplatin ≤ 40 mg/m2).
  • durvalumab alone: MINIMAL.

References

Oh DY, Ruth He A, Qin S, et al. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2022 Aug;1(8): EVIDoa2200015., PMID: 38319896

Rimini M, Fornaro L, Lonardi S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real-world data. Liver Int. 2023 Aug;43(8):1803-1812., PMID: 37452505

Burris, H.A., T. Okusaka, A. Vogel, et al. 2022. "Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer." J Clin Oncol 40:4070-4070.

Boulanger J, Boursiquot JN, Cournoyer G, et al. Management of hypersensitivity to platinum- and taxane-based chemotherapy: cepo review and clinical recommendations. Curr Oncol. 2014;21(4):e630-e641. , PMID: 25089112

Castells, M.C., Matulonis, U.A., and Horton, TM. Infusion reactions to systemic chemotherapy. Savarese DMF and Feldweg AM, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/infusion-reactions-to-systemic-chemotherapy (Accessed 26 March 2021).

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.