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FCM(PO)+R

Cancer Type: Hematologic, Lymphoma - Non-Hodgkin's Low Grade  Intent: Palliative
Regimen Category: Evidence-informed
Funding:
New Drug Funding Program
    Rituximab in Combination with Chemotherapy - Indolent B-cell Lymphoma
New Drug Funding Program
    Rituximab - Retreatment - Indolent Lymphoma
ODB - General Benefit
    cyclophosphamide - oral tablets
New Drug Funding Program
    Rituximab (SC) - Retreatment - Indolent Lymphoma
New Drug Funding Program
    Rituximab (SC) in Combination with Chemotherapy - Indolent B-cell Lymphoma
A - Regimen Name

FCM(PO)+R Regimen
Fludarabine (oral)-Cyclophosphamide (oral)-mitoXANTRONE-riTUXimab


Disease Site
Hematologic - Lymphoma - Non-Hodgkin's Low Grade

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

Treatment of follicular lymphoma or other indolent histology, CD20-positive B-cell lymphoma* after disease progression following first-line treatment, in patients who:

  • Have not received previous treatment with rituximab for indolent B-cell lymphoma
  • Have previously received rituximab (including combination rituximab-chemotherapy and/or rituximab monotherapy or maintenance rituximab) and have sustained a response and remained disease-free for at least 6 months after the last dose of rituximab

*excluding small lymphocytic lymphoma, CLL

Refer to the NDFP eligibility forms for detailed funding criteria.


Supplementary Public Funding

riTUXimab
New Drug Funding Program (Rituximab in Combination with Chemotherapy - Indolent B-cell Lymphoma) (NDFP Website)

riTUXimab
New Drug Funding Program (Rituximab - Retreatment - Indolent Lymphoma) (NDFP Website)

cyclophosphamide
ODB - General Benefit (cyclophosphamide - oral tablets) (ODB Formulary)

riTUXimab (subcut)
New Drug Funding Program (Rituximab (SC) - Retreatment - Indolent Lymphoma)

riTUXimab (subcut)
New Drug Funding Program (Rituximab (SC) in Combination with Chemotherapy - Indolent B-cell Lymphoma)

 
B - Drug Regimen

Cycle 1:  All patients must receive their first dose of rituximab by IV infusion.

riTUXimab
375 mg /m² IV Day 1
mitoXANTRONE
6 mg /m² IV Day 1
fludarabine
25 mg /m² PO Days 1 to 5
(This drug is not currently publicly funded for this regimen and intent)
cyclophosphamide
150 mg /m² PO Days 1 to 5

 

Cycle 2 and onwards [up to 6 cycles in total, including initial IV rituximab cycle(s)]:

riTUXimab
375 mg /m² IV Day 1


OR

Rituximab (subcut): 
The subcutaneous formulation must only be given at the second or subsequent cycles, and only after at least 1 full rituximab IV dose.

riTUXimab (subcut)
1400 mg Subcut Day 1

 

Plus FCM(PO) Chemotherapy

mitoXANTRONE
6 mg /m² IV Day 1
fludarabine
25 mg /m² PO Days 1 to 5
(This drug is not currently publicly funded for this regimen and intent)
cyclophosphamide
150 mg /m² PO Days 1 to 5
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C - Cycle Frequency

REPEAT EVERY 28 DAYS

For a usual total of 6 cycles in the absence of disease progression or unacceptable toxicity

For patients who responded to induction therapy, and were rituximab-naïve prior to induction, refer to maintenance rituximab regimen - RITU(MNT) or RITU(MNT-SC).

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low
Consider prophylaxis daily for cyclophosphamide PO

Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

Rituximab premedication:

  • Acetaminophen 650mg PO
  • Diphenhydramine 50mg PO/IV
  • If high volume disease, consider steroids and prophylaxis for tumour lysis
  • HBsAg positive patients should receive antiviral prophylaxis during and after rituximab. HBsAg negative, but HBcAb positive patients should be considered for antiviral prophylaxis and be closely monitored for viral reactivation by a HBV expert.

• Consider antiviral and PCP prophylaxis

 
J - Administrative Information

Pharmacy Workload (average time per visit)
28.643 minutes
Nursing Workload (average time per visit)
84.167 minutes
 
K - References

Bosch F, Abrisqueta P, Villamor N, et al. Rituximab, Fludarabine, Cyclophosphamide, and Mitoxantrone: A New, Highly Active Chemoimmunotherapy Regimen for Chronic Lymphocytic Leukemia. J Clin Oncol 2009; 27:4578-84.

Bosch F, Ferrer A, Villamor N, et al. Fludarabine, cyclophosphamide, and mitoxantrone as initial therapy of chronic lymphocytic leukemia: high response rate and disease eradication. Clin Cancer Res 2008; 14(1): 155-61.

Bosch F, Ferrer A, Lopez-Guillermo A et al. (2002) Fludarabine, cyclophosphamide and mitoxantrone in the treatment of resistant or relapsed chronic lymphocytic leukaemia. British Journal of Haematology 2002. 119: 976 –984.

Faderl S, Wierda W, O’Brien, S. Fludarabine, cyclophosphamide, mitoxantrone plus rituximab (FCM-R) in frontline CLL <70 Years. Leukemia Research 2010; 34: 284–8.

Fludarabine, cyclophosphamide, mitoxantrone, rituximab drug monographs, Cancer Care Ontario.

Hendry L, Bowen A, Matutes E, et al. Fludarabine, cyclophosphamide and mitoxantrone in relapsed or refractory chronic lymphocytic leukemia and low grade non-Hodgkin's lymphoma. Leuk Lymphoma 2004; 45(5): 945-50.

Hillmen P, Pocock C, Cohen D, Cocks K, Sayala H, et al. NCRI CLL201 Trial: A randomized phase II trial of fludarabine, cyclophosphamide, and mitoxantrone (FCM) with or without rituximab in previously treated CLL. (Abstract). Blood. 2007; 110:752.

Schmitt B, Franke A, Burkhard O, et al. ‘‘Fludarabine, Mitoxantrone and Cyclophosphamide combination therapy in relapsed chronic lymphocytic leukemia with or without G-CSF: results of the first interim analysis of a phase III study of the German CLL Group’’, Blood. 2002. 100: 364b (abstract 5015).

Davies A, Merli F, Mihaljević B, et al.  Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial.  Lancet Haematol. 2017 Jun;4(6):e272-e282.


PEBC Advice Documents or Guidelines

May 2019 Updated emetic risk category


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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.