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.
FC(PO)
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.
Treatment of recurrent follicular or other non-Hodgkin’s indolent B-cell lymphoma
cyclophosphamide
ODB - General Benefit
(cyclophosphamide - oral tablets)
(ODB Formulary)
fludarabine | 25 mg /m² | PO | Days 1 to 5 |
(This drug is not currently publicly funded for this regimen and intent) | |||
(Outpatient prescription in multiples of 10 mg tablets)
|
|||
cyclophosphamide | 150 mg /m² | PO | Days 1 to 5 |
(Outpatient prescription in multiples of 25 or 50 mg tablets) |
REPEAT EVERY 28 DAYS
For a usual total of 6 cycles unless disease progression or unacceptable toxicity occurs
Moderate – Consider prophylaxis daily
Other Supportive Care:
Also refer to CCO Antiemetic Recommendations.
Consider prophylactic growth factor support, antiviral and PCP prophylaxis (according to local practice).
If high volume disease, consider prophylaxis for tumour lysis
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.
Dosage with toxicity
Toxicity
|
Fludarabine
(% previous dose)
|
Cyclophosphamide
(% previous dose)
|
Febrile Neutropenia;
Grade 4 myelosuppression ≥ 7 days; Thrombocytopenic bleeding;
1-2 week delay prior cycle
|
75% or G-CSF (for isolated neutropenia*
|
75% or G-CSF (for isolated neutropenia)*
|
Grade 3 non-hematologic / organ
|
75%*
|
75%*
|
Any grade autoimmune, neurotoxicity, pneumonitis, pure red cell aplasia, > 2 week delay prior cycle, or progressive disease
|
Discontinue
|
Discontinue
|
*Do not retreat until non-hematologic / organ toxicity recovered to ≤ grade 2, ANC to ≥ 1 x 109/L and platelets ≥ 80 x 109/L (or to baseline levels)
|
Hepatic Impairment
Bilirubin |
|
AST / ALT |
Fludarabine (% usual dose) |
Cyclophosphamide (% usual dose) |
1-2 x ULN |
|
|
No data available; use with caution |
No change |
>2-4 X ULN |
and/or |
>2-4 X ULN |
Caution |
|
> 4 x ULN |
and/or |
> 4 x ULN |
Caution |
Renal Impairment
Creatinine Clearance (mL/min)
|
Fludarabine (% usual dose) |
Cyclophosphamide (% usual dose) |
>50 - 70 |
50% |
100% |
30 - 50 |
50% |
75% |
10 - <30 |
Discontinue
|
75% |
<10 |
Use with extreme caution or Discontinue |
Refer to fludarabine, cyclophosphamide drug monograph(s) for additional details of adverse effects.
Most Common Side Effects |
Less Common Side Effects, but may be Severe or Life-Threatening |
|
|
Refer to fludarabine, cyclophosphamide drug monograph(s) for additional details
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 visit
- Liver and renal function tests; baseline and at each visit
- Clinical toxicity assessment (including infection, bleeding, hypersensitivity, cystitis, pulmonary, skin, GI and CNS effects); at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Eve HE, Linch D, Qian W, et al. Toxicity of fludarabine and cyclophosphamide with or without rituximab as initial therapy for patients with previously untreated mantle cell lymphoma: results of a randomised phase II study. Leuk Lymphoma. 2009 Feb;50(2):211-5.
Fabbri A, Lenoci M, Gozzetti A, et al. Low-dose oral fludarabine plus cyclophosphamide as first-line treatment in elderly patients with indolent non-Hodgkin lymphoma. Br J Haematol. 2007 Oct;139(1):90-3.
Fludarabine and cyclophosphamide drug monographs, Cancer Care Ontario.
Tam CS, Wolf MM, Januszewicz EH, et al. Fludarabine and cyclophosphamide using an attenuated dose schedule is a highly effective regimen for patients with indolent lymphoid malignancies. Cancer 2004;100:2181–9.
Eucker J,Schille C,Schmid P, et al. The combination of fludarabine and cyclophosphamide results in a high remission rate with moderate toxicity in low-grade non-Hodgkin’s lymphomas. Anti-Cancer Drugs 2002;13:907–13.
June 2019 Updated emetic risk category
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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