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
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.
First-line treatment of advanced non-small cell lung cancer in patients who cannot tolerate combination therapy, due to elderly age, toxicity, or other considerations
| vinorelbine | 25-30 mg /m² | IV | Days 1, 8 and 15 |
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Alternative schedule:
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| vinorelbine | 25-30 mg /m² | IV | Days 1 and 8 |
Standard schedule: REPEAT EVERY 28 DAYS
Alternative schedule: REPEAT EVERY 21 DAYS
For a usual total of 4 to 6 cycles in responding patients, unless disease progression or unacceptable toxicity
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.
Dosage with toxicity
|
Worst toxicity in previous cycle |
Dose (% previous dose) |
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Febrile neutropenia Thrombocytopenic bleeding ANC < 0.5 and/or grade 4 thrombocytopenia for ≥ 5 to 7 days |
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Grade 2 peripheral neuropathy
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Discontinue
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Grade 3 peripheral neuropathy
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Discontinue
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Grade 3 related organ/ non-hematological toxicity |
75 %* |
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Grade 4 related organ/ non-hematological toxicity, OR delay > 3 weeks |
Discontinue
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*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). |
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Dose on Day 8, 15 of cycle
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Toxicity on Day 8, 15 of cycle |
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Non–hematologic |
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Hematologic |
Day 8 (or 15) |
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ANC |
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Platelets |
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≤ grade 2 |
and |
≥ 1.5 |
and |
≥ 100 |
100% |
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≤ grade 2 |
and |
1-1.49 |
and/or |
≥ 100 |
50% |
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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) |
% Usual dose |
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< 1.5 x ULN |
100% |
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1.5 to 2 x ULN |
50% |
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> 2 x ULN |
25% |
Renal Impairment
No adjustment required
Dosage in the Elderly
No dosage adjustments are required for increased age
Refer to vinorelbine drug monograph(s) for additional details of 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 drug monograph(s) for additional details
- Use CYP3A4 inhibitors with caution; consider vinorelbine dose adjustment (reduction) when used with azole antifungals.
Refer to vinorelbine drug monograph(s) for additional details
Administration
FOR INTRAVENOUS USE ONLY.
Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled “WARNING – FOR INTRAVENOUS USE ONLY. FATAL if given intrathecally.”
- Mix in 50mL minibag (D5W, NS) to a final concentration 0.5 - 2mg/mL; infuse over 6-10 minutes through free-flowing IV.
- Or may push (at final concentration of 1.5 – 3mg/mL) through sidearm of free-flowing IV (D5W, NS); inject over 6-10 minutes.
- After administration is completed, the manufacturer recommends flushing IV line with at least 75 to 125mL of D5W or NS.
- Flushing the line before and after administration of vinorelbine may reduce injection site reactions and phlebitis risk.
- Discontinue the injection if extravasation occurs and the remaining dose should be given into another vein. Warm compresses applied for 15 to 20 minutes 4 times per day for 1-2 days and elevation of affected area for 2-3 days may help disperse the drug and minimize discomfort.
- Refrigerate unopened vials (2-8°C); protect from light and do not freeze.
Contraindications
- Patients with known hypersensitivity to vinorelbine
- Patients who have drug-induced severe myelosuppression
- Intrathecal administration is absolutely contraindicated
Precautions
- Use with extreme caution in patients with compromised marrow reserve
- May result in radiosensitizing effects with prior or concomitant radiation therapy
- Patients with pre-existing neuropathy or prior treatment with other neurotoxic drugs may have increased potential for neurotoxicity
Pregnancy/Lactation
- Vinorelbine is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment, and for at least 6 months after the last dose.
- Breastfeeding is not recommended.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
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
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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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Depierre A, Chastang Cl, Quoix E, et al. Vinorelbine versus vinorelbine plus cisplatin in advanced non-small cell lung cancer: a randomized trial. Ann Oncol 1994;5:37-42.
Gridelli C, Perrone F, Gallo C, et al. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003;95:362-72.
Kudoh S, Takeda T, Nakagawa K, et al. Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904). J Clin Oncol. 2006;24:3657-63.
LeChevalier T, Brisgand D, Douillard J-Y, et al, Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small cell cancer: Results of a European Multicentre trial including 612 patients. J Clin Oncol, 1994; 12: 360-367
Vinorelbine drug monograph, Cancer Care Ontario.
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.
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