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A - Regimen Name

CVP Regimen
Cyclophosphamide-VinCRIStine-Prednisone


Disease Site
Hematologic - Leukemia - Chronic Lymphocytic (CLL)

Intent
Palliative

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

prednisone
ODB - General Benefit (prednisone)

 
B - Drug Regimen

cyclophosphamide
750 mg /m² IV Day 1
vinCRIStine
1.4 mg /m² IV (maximum 2 mg) Day 1
prednisone
100 mg PO daily Days 1 to 5
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

For 6 to 8 cycles unless disease progression or unacceptable toxicity occurs

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate

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

Hematologic Toxicities: 
 
Toxicity Vincristine1 (% previous dose) Cyclophosphamide1 (% previous dose)
Grade 4 hematological ≥ 7 d, febrile neutropenia, bleeding 100% 75% or G-CSF for low ANC
Grade 3 non-hematological toxicity 100% 75%
Grade 4 organ toxicity Discontinue Discontinue
Neurotoxicity Mild: 67%
Moderate:  Hold until  recovery, then ↓ 50%
Severe:  Discontinue
100%
1Prior to retreatment, major organ toxicity should have recovered to ≤ grade 2 and ANC to ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L.



Hepatic Impairment

Also consider dose modification for vincristine for severe increase in transaminases.

Bilirubin Vincristine
(% previous dose)
Cyclophosphamide
(% previous dose)

1 – 2 X ULN

50%
100%

2 – 4 x ULN

25%
Caution

> 4 ULN

OMIT
Caution
 

Renal Impairment

Creatinine Clearance (mL/min) Vincristine
(% previous dose)
Cyclophosphamide
(% previous dose)
>30-50

No dose adjustment required.

100%
10-30
50-75%

< 10

50% or Omit


 
F - Adverse Effects

Refer to cyclophosphamide, vinCRIStine, prednisone drug monograph(s) for additional details of adverse effects


Most Common Side Effects

Less Common Side Effects, but may be Severe

  • Alopecia
  • Nausea and vomiting
  • Myelosuppression ± infection and bleeding (may be severe)
  • Constipation
  • Anorexia
  • Peripheral neuropathy
  • Steroid effects (e.g. weight gain, GI irritation, hyperglycemia, insomnia)
  • ↑ Antidiuretic hormone
  • ↑ LFTs
  • Arterial or venous thromboembolism
  • Cardiotoxicity
  • Hemolytic uremic syndrome
  • Nephrotoxicity
  • Pancreatitis
  • Pneumonitis
  • GI perforation
  • Tumor lysis syndrome
  • Steroid effects (e.g. myopathy, cataracts, osteoporosis)
 
G - Interactions

Refer to cyclophosphamide, vinCRIStine, prednisone drug monograph(s) for additional details

 
H - Drug Administration and Special Precautions

Refer to cyclophosphamide, vinCRIStine, prednisone drug monograph(s) for additional details

 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • CBC; baseline and before each cycle. Interim counts should be done in first cycle and repeated if dose modification necessary.
  • Blood glucose testing; baseline and regular
  • Baseline and regular liver & renal function tests and urinalysis.
  • Clinical toxicity assessment (including gastrointestinal, neurotoxicity, constipation and cystitis); at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
1 hour
Pharmacy Workload (average time per visit)
30.139 minutes
Nursing Workload (average time per visit)
41.667 minutes
 
K - References

Raphael B, Andersen JW, Silber R, et al. Comparison of chlorambucil and prednisone versus cyclophosphamide, vincristine, and prednisone as initial treatment for chronic lymphocytic leukemia: long-term follow-up of an Eastern Cooperative Oncology Group randomized clinical trial. J Clin Oncol 1991;9(5):770-6.

July 2019 Updated hyperlink to vincristine drug monograph


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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.