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Systemic Anti-Cancer Therapy Regimen Library

UGI GAST AND OES Metastatic - CAPOX [capecitabine and oxaliplatin], pembrolizumab and trastuzumab

Treatment Overview

Usually up to 8 cycles of CAPOX in combination with pembrolizumab and trastuzumab.

Continue pembrolizumab and trastuzumab for up to 2 years, or until disease progression or unacceptable toxicity.  


This regimen contains a biological anti-cancer medicine where one or more biosimilars may exist. These have been reviewed by the regulator (Medsafe) and by haematologists and/or oncologists nationally. Where haematologists and/or oncologists have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably. If a prescriber thinks there is a difference, then a specific brand will be named when prescribing. 

Cycle 1 - 21 days - CAPOX, pembrolizumab and trastuzumab loading dose

Cycle length:
21

Cycles 2 to 8 - 21 days - CAPOX, pembrolizumab and trastuzumab maintenance dose

Cycle length:
21

If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.

Cycles 9 to 35 - 21 days - pembrolizumab and trastuzumab continuation

Cycle length:
21

If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.

Cycle details

Cycle 1 - 21 days - CAPOX, pembrolizumab and trastuzumab loading dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 2, 3
ondansetron 8 mg oral administration 1
pembrolizumab 200 mg flat dosing intravenous 1 30 minutes
trastuzumab * 8 mg/kg intravenous 1 90 minutes
oxaliplatin * 130 mg/m² intravenous 1 120 minutes
capecitabine * 1000 mg/m² Twice daily oral administration 1 to 14
ondansetron 8 mg oral administration 1
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Cycles 2 to 8 - 21 days - CAPOX, pembrolizumab and trastuzumab maintenance dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 2, 3
ondansetron 8 mg oral administration 1
pembrolizumab 200 mg flat dosing intravenous 1 30 minutes
trastuzumab * 6 mg/kg intravenous 1 90 minutes
oxaliplatin * 130 mg/m² intravenous 1 120 minutes
capecitabine * 1000 mg/m² Twice daily oral administration 1 to 14
ondansetron 8 mg oral administration 1
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.

Cycles 9 to 35 - 21 days - pembrolizumab and trastuzumab continuation

Medication Dose Route Days Max Duration
pembrolizumab 200 mg flat dosing intravenous 1 30 minutes
trastuzumab * 6 mg/kg intravenous 1 90 minutes

If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.

Full details

Cycle 1 - 21 days - CAPOX, pembrolizumab and trastuzumab loading dose

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

pembrolizumab 200 mg flat dosing intravenous 30 minutes
Instructions:
Administer via a sterile, non-pyrogenic, low protein binding 0.2 to 5 micron in-line or add-on filter.
trastuzumab * 8 mg/kg intravenous 90 minutes
oxaliplatin * 130 mg/m² intravenous 120 minutes
Instructions:

Usual infusion time of two hours may be extended to up to 6 hours if needed to reduce likelihood and/or severity of adverse reactions.

Hypersensitivity risk increases with number of cycles of oxaliplatin.

capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

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.

loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 4

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 5

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 6

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 7

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 8

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 9

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 10

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 11

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 12

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 13

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 14

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Cycles 2 to 8 - 21 days - CAPOX, pembrolizumab and trastuzumab maintenance dose

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

pembrolizumab 200 mg flat dosing intravenous 30 minutes
Instructions:
Administer via a sterile, non-pyrogenic, low protein binding 0.2 to 5 micron in-line or add-on filter.
trastuzumab * 6 mg/kg intravenous 90 minutes
Instructions:
If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.
oxaliplatin * 130 mg/m² intravenous 120 minutes
Instructions:

Usual infusion time of two hours may be extended to up to 6 hours if needed to reduce likelihood and/or severity of adverse reactions.

Hypersensitivity risk increases with number of cycles of oxaliplatin.

capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

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.

loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 4

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 5

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 6

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 7

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 8

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 9

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 10

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 11

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 12

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 13

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Day: 14

Medication Dose Route Max duration Details
capecitabine * 1000 mg/m² Twice daily oral administration
Instructions:

Take each dose with food and a large glass of water.

Round dose to closest multiple of 150 mg and/or 500 mg tablets.

Cycles 9 to 35 - 21 days - pembrolizumab and trastuzumab continuation

Day: 1

Medication Dose Route Max duration Details
pembrolizumab 200 mg flat dosing intravenous 30 minutes
Instructions:
Administer via a sterile, non-pyrogenic, low protein binding 0.2 to 5 micron in-line or add-on filter.
trastuzumab * 6 mg/kg intravenous 90 minutes
Instructions:
If the initial loading dose of trastuzumab is well tolerated, subsequent doses may be administered over 30 minutes.

Supportive Care Factors

Factor Value
Diarrhoea risk: Variable
Emetogenicity: Variable
Hypersensitivity / Infusion related reaction risk: Low - routine premedication not recommended

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with CAPOX treatment.

Emetogenicity:

  • CAPOX, pembrolizumab and trastuzumab:
  • MEDIUM day 1.
  • MINIMAL to LOW day 2 to 14 (capecitabine). Antiemetics may be required with continuous dosing of oral anti-cancer medicines with MINIMAL to LOW emetic risk; an individualised approach is appropriate. 
  • pembrolizumab and trastuzumab continuation: MINIMAL.


References

Janjigian YY, Kawazoe A, Yañez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15., PMID: 34912120

Jatoi, A., B. R. Murphy, N. R. Foster, et al. 2006. "Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group." Ann Oncol 17(1):29-34., PMID: 16303863

Ryu, M. H., C. Yoo, J. G. Kim, et al. 2015. "Multicenter phase II study of trastuzumab in combination with capecitabine and oxaliplatin for advanced gastric cancer." Eur J Cancer 51(4):482-488., PMID: 25661103

Gong, J., T. Liu, Q. Fan, et al. 2016. "Optimal regimen of trastuzumab in combination with oxaliplatin/ capecitabine in first-line treatment of HER2-positive advanced gastric cancer (CGOG1001): a multicenter, phase II trial." BMC Cancer 16:68., PMID: 26857702

Rivera, F., C. Romero, P. Jimenez-Fonseca, et al. 2019. "Phase II study to evaluate the efficacy of Trastuzumab in combination with Capecitabine and Oxaliplatin in first-line treatment of HER2-positive advanced gastric cancer: HERXO trial." Cancer Chemother Pharmacol 83(6):1175-1181., PMID: 30927036

Pharmacy Retailing (NZ) limited t/a Healthcare Logistics. Oxaliplatin Accord New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/o/oxaliccordinf.pdf (Accessed 16 February 2021).

Dr Reddy’s New Zealand Ltd. Capercit New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/c/capercittab.pdf (Accessed 16 February 2021).

Roche Products (New Zealand) Limited. Herceptin (trastuzumab) New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/h/Herceptininf.pdf (Accessed 16 February 2021).

Celltrion Healthcare New Zealand Limited. Herzuma New Zealand Data Sheet. https://www.medsafe.govt.nz/profs/Datasheet/h/herzumainf.pdf (Accessed 16 February 2021).

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. "Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers." ESMO Open. 2017 Jan 16;1(6):e000142. , PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. "American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol." 2018 Apr 20;36(12):1260-1265. , PMID: 29443651

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

* 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.