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Systemic Anti-Cancer Therapy Regimen Library

Home > BR Metastatic - trastuzumab Q3W and vinORELBine [oral]

BR Metastatic - trastuzumab Q3W and vinORELBine [oral]

Treatment Overview

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 - Loading Dose

Cycle length:
21

Cycle 2 (and all further cycles) - 21 days - Maintenance Dose

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 - Loading Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 2, 3,
8, 9, 10
ondansetron 8 mg oral administration 1, 8
trastuzumab * 8 mg/kg intravenous 1 90 minutes
vinORELBine * 60 mg/m² oral administration 1, 8
ondansetron 8 mg oral administration 1, 8
domperidone 10 mg Three times daily oral administration 1
docusate sodium + sennoside B 2 Tablet(s) oral administration 1

Cycle 2 (and all further cycles) - 21 days - Maintenance Dose

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1, 2, 3,
8, 9, 10
ondansetron 8 mg oral administration 1, 8
trastuzumab * 6 mg/kg intravenous 1 90 minutes
vinORELBine * 60 mg/m² oral administration 1, 8
ondansetron 8 mg oral administration 1, 8
domperidone 10 mg Three times daily oral administration 1
docusate sodium + sennoside B 2 Tablet(s) oral administration 1

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

Full details

Cycle 1 - 21 days - 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.
trastuzumab * 8 mg/kg intravenous 90 minutes
vinORELBine * 60 mg/m² oral administration
Instructions:
Take with food. Swallow whole, do not crush or chew. Round dose to closest multiple of 20 mg and/or 30 mg capsules.
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.
docusate sodium + sennoside B 2 Tablet(s) oral administration
Instructions:
At night when required for constipation. Each tablet contains docusate sodium 50 mg + sennoside B 8 mg.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 8

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.
vinORELBine * 60 mg/m² oral administration
Instructions:
Take with food. Swallow whole, do not crush or chew. Round dose to closest multiple of 20 mg and/or 30 mg capsules.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.

Day: 9

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 10

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Cycle 2 (and all further cycles) - 21 days - 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.
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.
vinORELBine * 60 mg/m² oral administration
Instructions:
Take with food. Swallow whole, do not crush or chew. Round dose to closest multiple of 20 mg and/or 30 mg capsules.
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.
docusate sodium + sennoside B 2 Tablet(s) oral administration
Instructions:
At night when required for constipation. Each tablet contains docusate sodium 50 mg + sennoside B 8 mg.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 8

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.
vinORELBine * 60 mg/m² oral administration
Instructions:
Take with food. Swallow whole, do not crush or chew. Round dose to closest multiple of 20 mg and/or 30 mg capsules.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.

Day: 9

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Day: 10

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:
ONCE daily in the morning with food.

Supportive Care Factors

Factor Value
Constipation risk: laxatives are usually prescribed
Emetogenicity: Medium

References

1. Pegram, M. D., G. E. Konecny, C. O'Callaghan, et al. 2004. "Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer." J Natl Cancer Inst 96(10):739-749., PMID: 15150302

2. Mano, M. 2006. "Vinorelbine in the management of breast cancer: New perspectives, revived role in the era of targeted therapy." Cancer Treat Rev 32(2):106-118, PMID: 16473470

3. Gralla, R. J., U. Gatzemeier, V. Gebbia, et al. 2007. "Oral vinorelbine in the treatment of non-small cell lung cancer: rationale and implications for patient management." Drugs 67(10):1403-1410., PMID: 17600389

4. Wargin, W. A. and V. S. Lucas. 1994. "The clinical pharmacokinetics of vinorelbine (Navelbine)." Semin Oncol 21(5 Suppl 10):21-27, PMID: 7973765

5. Jassem, J., R. Ramlau, H. Karnicka-Mlodkowska, et al. 2001. "A multicenter randomized phase II study of oral vs. intravenous vinorelbine in advanced non-small-cell lung cancer patients." Ann.Oncol. 12(10):1375-1381., PMID: 11762807

6. Chan, A. 2007. "A review of the use of trastuzumab (Herceptin) plus vinorelbine in metastatic breast cancer." Ann Oncol 18(7):1152-1158., PMID: 17264064

7. Andersson, M., E. Lidbrink, K. Bjerre, et al. 2011. "Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: the HERNATA study." J Clin Oncol 29(3):264-271., PMID: 21149659

8. Burstein, H. J., A. Keshaviah, A. D. Baron, et al. 2007. "Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbine or taxane study." Cancer 110(5):965-972., PMID: 17614302

9. Chan, A., P. F. Conte, L. Petruzelka, et al. 2013. "Phase II study of a triple combination of oral vinorelbine, capecitabine and trastuzumab as first-line treatment in HER2-positive metastatic breast cancer." Anticancer Res 33(6):2657-2664, PMID: 23749924

10. Farhat, F., J. G. Kattan and M. Ghosn. 2016. "Oral vinorelbine in combination with trastuzumab as a first-line therapy of metastatic or locally advanced HER2-positive breast cancer." Cancer Chemother Pharmacol 77(5):1069-1077., PMID: 27059339

11. Heinemann, V., D. Di Gioia, U. Vehling-Kaiser, et al. 2011. "A prospective multicenter phase II study of oral and i.v. vinorelbine plus trastuzumab as first-line therapy in HER2-overexpressing metastatic breast cancer." Ann Oncol 22(3):603-608., PMID: 20724574

12. Bartsch, R., C. Wenzel, U. Pluschnig, et al. 2006. "Oral vinorelbine alone or in combination with trastuzumab in advanced breast cancer: results from a pilot trial." Cancer Chemother Pharmacol 57(5):554-558., PMID: 16133525

13. Bergen, E., A. S. Berghoff, M. Rudas, et al. 2014. "Taxanes Plus Trastuzumab Compared To Oral Vinorelbine Plus Trastuzumab in HER2-Overexpressing Metastatic Breast Cancer." Breast Care (Basel) 9(5):344-348., PMID: 25759615

14. 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)

15. 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. doi: 10.1136/esmoopen-2016-000142. , PMID: 28848668

16. 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. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14. , PMID: 29443651

* 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.