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CRBPVINO

Cancer Type: Lung, Non-Small Cell  Intent: Adjuvant
Regimen Category: Evidence-Informed
Funding:
New Drug Funding Program
    Vinorelbine - Adjuvant Treatment of Completely Resected Stage II or IIIa Non-Small Cell Lung Cancer
A - Regimen Name

CRBPVINO Regimen
Vinorelbine-CARBOplatin


Disease Site
Lung - Non-Small Cell

Intent
Adjuvant

Regimen Category
Evidence-Informed :

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.


Supplementary Public Funding

vinorelbine
New Drug Funding Program (Vinorelbine - Adjuvant Treatment of Completely Resected Stage II or IIIa Non-Small Cell Lung Cancer)

 
B - Drug Regimen

vinorelbine
25 mg /m² IV Days 1 and 8
CARBOplatin
AUC 5 IV Day 1

Adjust Carboplatin dose to AUC target (using Calvert formula) as outlined in "Other Notes" section.

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C - Cycle Frequency

REPEAT EVERY 21 DAYS

For 4 cycles (up to 6 for neoadjuvant) unless disease progression or unacceptable toxicity occurs

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate + NK1 antagonist (Carboplatin AUC ≥ 5) (D1)
Minimal (D8)


Febrile Neutropenia Risk:

Low

Other Supportive Care:

Also refer to CCO Antiemetic Summary

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated.

 

Dosage with toxicity

 
Dosage for subsequent cycle
Worst Toxicity / Counts in the Previous Cycle
Carboplatin
(% previous dose)
Vinorelbine
(% previous dose)
 Febrile neutropenia,
Thrombocytopenic bleeding,
ANC < 0.5 x 109/L for ≥ 5 to 7 days and/or
Grade 4 thrombocytopenia
75%*
75%*
Grade 2 or 3 peripheral neuropathy
n/a
Discontinue
Grade 3 non-hematologic toxicity
75%*
75%*
Grade 4 non-hematologic toxicity
Discontinue
Discontinue
 * Do not retreat until non-hematologic/ organ toxicity ≤ grade 2, platelets ≥ 100 x 109/L and ANC ≥ 1.5 x 109/L
 
 Dose on day 8 of cycle
 
Toxicity on day 8 of cycle
 
 
Non–hematologic
(related organ)
 
Hematologic
Day 8 Vinorelbine
(% day 1 dose)
ANC
(x 109/L)
 
 
 Platelets
(x 109/L)
-
 
≤ grade 2
and
 
≥ 1.5
 
and
≥ 100
100%
≤ grade 2
and
1-1.49
and/or
75-99
50%
Grade 3 or 4 related organ
or
< 1
or
< 75
Omit

 

 

 

 



Hepatic Impairment

Total bilirubin
vinorelbine (% usual dose)
2-3 X ULN
50%
>3 X ULN
25%

No dosage adjustment required for carboplatin.


Renal Impairment

As creatinine clearance changes, adjust dosage of Carboplatin using the Calvert Formula . (See "Other Notes" section).

No adjustment needed for vinorelbine.

Dosage in the Elderly

No dosage adjustments are required for vinorelbine increased age. Caution should be exercised and dose reduction considered for carboplatin as elderly patients may have more severe myelosuppression and neuropathy.

 

 

 


 
F - Adverse Effects

Refer to vinorelbine, CARBOplatin drug monograph(s) for additional details of adverse effects


Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

  • Myelosuppression +/- infection, bleeding (may be severe)
  • Nausea, vomiting
  • Fatigue
  • Constipation
  • Injection site reaction
  • Increased LFTs
  • Nephrotoxicity
  • Diarrhea
  • Neuropathy (may be severe)
  • Anorexia
  • Mucositis
  • Hearing impaired
  • Alopecia
  • Abnormal electrolytes
  • Hypersensitivity
  • Aterial thromboembolism
  • Venous thromboembolism
  • Hemolytic uremic syndrome
  • Pneumonitis
  • Radiation recall reaction

 

 
G - Interactions

Refer to vinorelbine, CARBOplatin drug monograph(s) for additional details

 
H - Drug Administration and Special Precautions

Refer to vinorelbine, CARBOplatin drug monograph(s) for additional details

 
I - Recommended Clinical Monitoring

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 before each cycle. Interim counts should be done in first cycle and repeated if dose modifications necessary.
  • Renal and liver function tests; baseline and before each cycle
  • Clinical toxicity asessment (including neuropathy, ototoxicity, local toxicity, infection, bleeding); at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • INR; Baseline and as clinically indicated
     

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J - Administrative Information

Approximate Patient Visit
Day 1: 1.5 hours; Day 8: 0.5 hours
Pharmacy Workload (average time per visit)
22.018 minutes
Nursing Workload (average time per visit)
42.917 minutes
 
K - References

Carboplatin and vinorelbine drug monographs, Cancer Care Ontario.

Kenmotsu H, Ohde Y, Shukuya T, et al. Feasibility of postoperative adjuvant chemotherapy of cisplatin plus vinorelbine for completely resected non-small-cell lung cancer: a retrospective study in Japan. Respir Investig. 2012 Dec;50(4):157-61.

Kris MG, Gaspar LE, Chaft JE, et al. Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I to IIIA Completely Resected Non-Small-Cell Lung Cancers: American Society of Clinical Oncology/Cancer Care Ontario Clinical Practice Guideline Update. J Clin Oncol 2017;35(25):2960- 74.

Shukuya T, Takahashi T, Tamiya A, et al.  Evaluation of the safety and compliance of 3-week cycles of vinorelbine on days 1 and 8 and cisplatin on day 1 as adjuvant chemotherapy in Japanese patients with completely resected pathological stage IB to IIIA non-small cell lung cancer: a retrospective study.  Jpn J Clin Oncol 2009;39(3):158-62.


May 2019 Updated emetic risk category and cycle frequency section; added PEBC guideline link


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L - Other Notes

Calvert Formula

DOSE (mg) = target AUC X (GFR + 25)

  • AUC = product of serum concentration (mg/mL) and time (min)
  • GFR (glomerular filtration rate) expressed as measured Creatinine Clearance or estimated from Serum Creatinine (by Cockcroft and Gault method or Jelliffe method)

(Calvert AH, Newell DR, Gumbrell LA, et al, Carboplatin dosage: Prospective evaluation of a simple formula based on renal function. J Clin Oncol, 1989; 7: 1748-1756)

 
M - Disclaimer

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.