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A - Regimen Name

PCV Regimen
Procarbazine-CCNU (Lomustine)-VinCRIStine


Disease Site
Central Nervous System

(Malignant Glioma, Recurrent Malignant Glioma)


Intent
Adjuvant
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

procarbazine
ODB - General Benefit (procarbazine)

lomustine
ODB - General Benefit (lomustine)

 
B - Drug Regimen

procarbazine
60 mg /m² PO Days 8 to 21
(*Outpatient prescription in multiples of 50mg capsules)
lomustine
100-110 mg /m² PO Day 1
(*Outpatient prescription in multiples of 10, 40 & 100mg capsules)
vinCRIStine
1.4 mg /m² IV (maximum 2 mg) Day 8 and 29
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C - Cycle Frequency

REPEAT EVERY 42 DAYS

Adjuvant: For a usual total of 4 to 6 cycles unless disease progression or unacceptable toxicity occurs

Palliative: Until disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal (D29)
Consider prophylaxis daily for procarbazine
Consider prophylaxis daily for lomustine


Febrile Neutropenia Risk:

Low

Other Supportive Care:

If vomiting not controlled during procarbazine treatment, escalate antiemetic treatment – vomiting may increase intracranial pressure with larger brain tumours

Also refer to CCO Antiemetic Recommendations.

 
E - Dose Modifications

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

 

 

Dosage with toxicity

Hematologic Toxicities: 
 
Toxicity Type / Counts x 109 /L previous cycle
 
Procarbazine*
(% previous dose)
Lomustine*
(% previous dose)
Vincristine*
(% previous dose)
Febrile Neutropenia
Thrombocytopenic bleeding, grade 4 neutropenia or ≥ grade 3 thrombocytopenia
 
 
75%
 
               75%
 
No change
Grade 2 neuropathy
 
75 %
No change
67%
Grade 3 neuropathy
 
Discontinue
Other Grade 3 related organ
 
75%
Grade 4 related organ  or neurotoxicity
 
 
Discontinue
Hypersensitivity, pneumonitis, renal failure, bronchospasm
Discontinue
 
* Do not start new cycle until organ toxicity ≤ grade 2, platelets ≥ 100 x 109/L and ANC ≥ 1.5 x 109/L.



Hepatic Impairment

Bilirubin
 
AST/ALT
Procarbazine
Lomustine
Vincristine
(% previous dose)
2-4 x ULN
or
2-5 x ULN
Omit
Monitor
50%
> 4 x ULN
>5 x ULN
Omit
Monitor, consider ↓
25%

 

 


Renal Impairment

Creatinine Clearance (mL/min)
Procarbazine
(% previous dose)
Lomustine
(% previous dose)
Vincristine
(% previous dose)
>50
100%
100%
No change
10-50
75%
75%
<10
50% or Discontinue
50% or Discontinue

Dosage in the Elderly

Older patients may have more neurotoxicity with vincristine. No specific dosage adjustment recommended. 


 
F - Adverse Effects

Refer to procarbazine, lomustine, vinCRIStine drug monograph(s) for additional details of adverse effects


Most Common Side Effects

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

  • Nausea and vomiting
  • Myelosuppression (cumulative) ± bleeding, infection
  • CNS depression, nightmares, insomnia, hallucinations
  • Rash, pigmentation, radiation recall, photosensitivity
  • Diarrhea and stomatitis, anorexia
  • Neurotoxicity (cranial, peripheral ,autonomic neuropathy, disorientation, ataxia; may be severe)
  • Constipation, cramps (may be severe)
  • Fatigue, flu-like symptoms
  • Reproductive risks
  • Vesicant
  • Pneumonitis / pulmonary fibrosis (may be acute or delayed)
  • Nephrotoxicity
  • Secondary leukemia, MDS
  • Hypersensitivity and serum sickness like reactions
  • Hemolytic anemia
  • Thromboembolism
  • MI, SIADH
  • Perforation, pancreatitis

 

 
G - Interactions

Refer to procarbazine, lomustine, vinCRIStine drug monograph(s) for additional details

 
H - Drug Administration and Special Precautions

Refer to procarbazine, lomustine, vinCRIStine drug monograph(s) for additional details

 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Clinical toxicity assessment (including neurotoxicity, skin, CNS, local and pulmonary toxicity).
  • CBC before each cycle. 
  • Baseline and regular hepatic and renal function tests
  • Pulmonary function tests with prolonged (> 6month) therapy or cumulative doses > than 1,100 mg/m2
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
Vincristine: 0.5 hour
Pharmacy Workload (average time per visit)
15.99 minutes
Nursing Workload (average time per visit)
35 minutes
 
K - References

Buckner JC, Shaw EG, Pugh SL, et al.  Radiation plus Procarbazine, CCNU, and Vincristine in Low-Grade Glioma.  N Engl J Med. 2016;374(14):1344-55.

Cairncross G, Berkey B, Shaw E, et al Phase III Trial of Chemotherapy Plus Radiotherapy Compared With Radiotherapy Alone for Pure and Mixed Anaplastic Oligodendroglioma: Intergroup Radiation Therapy Oncology Group Trial 9402. J Clin Oncol 2006; 24: 2707-14.
 
Cairncross G, Macdonald D, Ludwin S, et al, Chemotherapy for anaplastic oligodendroglioma. J Clin Oncol 1994; 12: 2013-21.
 
Levin VA, Hess KR, Choucair A, et al. Phase III Randomized Study of Postradiotherapy Chemotherapy with Combination Difluoromethylornithine-PCV versus PCV for Anaplastic Gliomas. Clinical Cancer Research 2003; 9: 981–0.
 
Levin VA, Silver P, Hannigan J, et al. Superiority of post-radiotherapy adjuvant chemotherapy with CCNU, procarbazine, and vincristine over BCNU for anaplastic gliomas: NCOG 6G61 final report. Int J Radiat Oncol Biol Phys, 1990; 18: 321-4.
 
Medical Research Council Brain Tumor Working Party. Randomized trial of procarbazine, lomustine, and vincristine in the adjuvant treatment of high-grade astrocytoma: a Medical Research Council trial. J Clin Oncol 2001;19:509-18.
 
Murphy C, Pickles T, Knowling M, et al. Concurrent modified PCV chemotherapy and radiotherapy in newly diagnosed grade IV astrocytoma. Journal of Neuro-Oncology 2002; 57: 215–20.
 
van den Bent MJ, Carpentier AF, Brandes AA, et al. Adjuvant Procarbazine, Lomustine, and Vincristine Improves Progression-Free Survival but Not Overall Survival in Newly Diagnosed Anaplastic Oligodendrogliomas and Oligoastrocytomas: A Randomized European Organisation for Research and Treatment of Cancer Phase III Trial. J Clin Oncol 2006; 24: 2715-22.

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.
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