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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.

A - Regimen Name

PENT+ALEM Regimen
Pentostatin-Alemtuzumab


Disease Site
Hematologic - Lymphoma - T-cell
Hematologic - Rare Diseases

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.

This 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). 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.


Rationale and Uses

For the treatment of T-Cell neoplasms.

 
B - Drug Regimen

pentostatin
4 mg /m² IV Day 1; Q7 Days x 4 doses
(This drug is not currently publicly funded for this regimen and intent)

 

THEN

pentostatin
4 mg /m² IV Days 1 and 15
(This drug is not currently publicly funded for this regimen and intent)

 

Q28 Days

AND

Week 1:

alemtuzumab

a, b, c

3 mg IV / Subcut * (first dose)
alemtuzumab

a, b, c

10 mg IV / Subcut * (second dose)
alemtuzumab

a, b, c

30 mg IV / Subcut * (third dose)
(This drug is not publicly funded. Universal compassionate access program is available. )


Weeks 2+:

alemtuzumab

a, b, c

30 mg IV / Subcut * 3 times per week
(This drug is not publicly funded. Universal compassionate access program is available. )

a. Although not approved by Health Canada, alemtuzumab has been given subcutaneously instead of intravenously; the incidence of infusion reactions may be lower.

b. Gradual dose escalation is required at the initiation of therapy and after treatment interruptions of 7 days or more. In most patients, escalation to 30mg can be accomplished in 3-7 days.  Initial doses can be administered in various ways; sequentially (daily on days 1 to 3) and on alternate days (i.e. days 1, 3, and 5).  Both schedules were used in clinical trials.

c. Single doses of alemtuzumab greater than 30 mg or cumulative weekly doses of greater than 90 mg should not be administered since higher doses are associated with an increased incidence of pancytopenia.

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C - Cycle Frequency

Alemtuzumab: Until CR or best response, for a usual total of up to 13 weeks, unless disease progression or unacceptable toxicity occurs. 

Pentostatin: Until CR or best response, for a usual total of up to 14 doses (weekly for 4 weeks then every 2 weeks for up to 10 doses), unless disease progression or unacceptable toxicity occurs. 

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal (Alemtuzumab)
Low (Pentostatin)

Other Supportive Care:

Premedication (prophylaxis for infusion reactions):

Administer 30 minutes prior to IV/SC alemtuzumab*:

  • H1-receptor antagonist (e.g. diphenhydramine 50 mg IV)
  • Acetaminophen 650 mg PO

*Can consider corticosteroids (methylprednisolone 1g) on the first 3 days

Other supportive care:

  • Trimethoprim/sulfamethoxazole DS twice daily three times per week and famciclovir (or equivalent) 250mg bid during treatment and for 2 months after or until CD4+ count is ≥ 200 cells/microL.
  • Consider antifungal prophylaxis (e.g. fluconazole)
  • Allopurinol and hydration to reduce the risk of tumour lysis syndrome are recommended.
  •  Irradiated blood products should be used.
 
J - Administrative Information

Approximate Patient Visit
PENT: 1.5 to 2.5 hours; ALEM (IV): 2.5 to 3 hours; ALEM (SC): 0.5 to 1 hour
Pharmacy Workload (average time per visit)
8.33 minutes
Nursing Workload (average time per visit)
32.33 minutes
 
K - References

Alemtuzumab drug monograph, Cancer Care Ontario.

Ravandi F, Aribi A, O'Brien S, et al. Phase II study of alemtuzumab in combination with pentostatin in patients with T-cell neoplasms. J Clin Oncol 2009;27:5425-5430.


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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.