Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
VINO+TRAS; VINO
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
For the treatment of metastatic breast cancer
trastuzumab
New Drug Funding Program
(Trastuzumab (Biosimilar) in combination with Vinorelbine - Metastatic Breast Cancer)
(NDFP Website
)
trastuzumab
New Drug Funding Program
(Trastuzumab (Biosimilar) - Second Line - Metastatic Breast Cancer)
(NDFP Website
)
Note: Different trastuzumab products are NOT INTERCHANGEABLE.
vinorelbine | 25-30 mg /m² | IV | Days 1, 8 and 15 |
For patients with HER2 positive tumours, trastuzumab may be given concurrently and then as a single agent. |
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trastuzumab | 4 mg /kg | IV loading dose | Day 1, cycle 1 only |
THEN, |
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trastuzumab | 2 mg /kg | IV maintenance dose | Weekly (Q7 Days) |
Alternative Schedule: |
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vinorelbine | 25-30 mg /m² | IV | Days 1 and 8 |
trastuzumab | 8 mg /kg | IV loading dose | Day 1, cycle 1 only |
THEN, |
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trastuzumab | 6 mg /kg | IV maintenance dose | Every 21 days |
Standard schedule: REPEAT EVERY 28 DAYS
Alternative schedule: REPEAT EVERY 21 DAYS
Until disease progression or unacceptable toxicity
Minimal
Other Supportive Care:
• Trastuzumab: Refer to Trastuzumab drug monograph for full details.
Doses should be modified according to the protocol by which the patient is being treated.
See TRAS (Breast - Advanced) regimen for details on trastuzumab dose modifications.
Dosage with toxicity
Worst toxicity in previous cycle |
Vinorelbine Dose (% previous dose) |
Febrile neutropenia Thrombocytopenic bleeding ANC < 0.5 and/or grade 4 thrombocytopenia for ≥ 5 to 7 days |
|
Grade 2 peripheral neuropathy |
Discontinue |
Grade 3 peripheral neuropathy |
Discontinue |
Grade 3 related organ/ non-hematological toxicity |
75 %* |
Grade 4 related organ/ non-hematological toxicity, OR delay > 3 weeks |
Discontinue |
*Do not start new cycle until platelets ≥ 100 x 109/L, neutrophils ≥ 1.5 x 109/L, hemoglobin > 80 g/L and major toxicity has recovered to ≤ grade 2 (may consider administering if neutrophils 1-1.5 x 109/L at 50% of planned dose). |
Dose on Day 8, 15 of cycle
Toxicity on Day 8 (or 15) of cycle |
Vinorelbine Day 8 (or 15) |
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Non–hematologic |
|
Hematologic |
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ANC |
|
Platelets |
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≤ grade 2 |
and |
≥ 1.5 |
and |
≥ 100 |
100% |
≤ grade 2 |
and |
1-1.49 |
and/or |
≥ 100 |
50% |
Grade 3 or 4 related organ |
or |
< 1 |
or |
<100 |
Omit |
Hepatic Impairment
As vinorelbine undergoes hepatobiliary metabolism and excretion, administer with caution in hepatic insufficiency. Consider adjusting doses with hyperbilirubinemia.
Suggested adjustments for increases in total bilirubin:
Total Bilirubin (micromol/L) | Vinorelbine (% Usual dose) |
< 1.5 x ULN |
100% |
1.5 to 2 x ULN |
50% |
> 2 x ULN |
25% |
Renal Impairment
No dose adjustment required
Dosage in the Elderly
No dosage adjustments are required for increased age.
Refer to vinorelbine (± trastuzumab) drug monograph(s) for additional details of adverse effects.
See TRAS (Breast - Advanced) regimen for details on trastuzumab adverse effects.
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
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Refer to vinorelbine (± trastuzumab) drug monograph(s) for additional details.
Note: Different trastuzumab products are NOT INTERCHANGEABLE.
See TRAS (Breast - Advanced) regimen for details on trastuzumab monitoring.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Vinorelbine:
Recommended Clinical Monitoring
- CBC; Baseline and at each dose
- Liver function tests; Baseline and before each cycle
- Clinical toxicity assessment for signs of neurotoxicity, local toxicity, bleeding, infection, hypersensitivity, thromboembolism, lung or GI toxicity, radiation recall; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Local site toxicity ratings, if incidence of phlebitis
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Jones S, Winer E, Vogel C, et al. Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. J Clin Oncol 1995 Oct; 13(10): 2567-2574.
Zelek L, Barthier S, Riofrio M, et al. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 2001; 92: 2267-72.
Keller AM, Mennel RG, Georgoulias VA, et al. Randomized Phase III Trial of Pegylated Liposomal Doxorubicin Versus Vinorelbine or Mitomycin C Plus Vinblastine in Women With Taxane-Refractory Advanced Breast Cancer. J Clin Oncol 2004; 22:3893-901.
Vinorelbine drug monograph, Cancer Care Ontario.
August 2021 Modified Rationale and Uses section
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.