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A - Regimen Name

MTRX Regimen
Methotrexate


Disease Site
Head and Neck

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.


Rationale and Uses

Treatment for recurrent and/or metastatic head and neck cancer

 
B - Drug Regimen

methotrexate
40 mg /m² IV Day 1

(If no toxicity at 40mg/m2, may increase by 10mg/m2 q2weeks (maximum 60 mg/m² IV on Day 1)

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C - Cycle Frequency

REPEAT EVERY 7 DAYS
Until evidence of disease progression or limited by toxicity to chemotherapy

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.

Dosage with toxicity

Toxicity
Action

Grade 4 neutropenia or thrombocytopenia, febrile neutropenia or thrombocytopenic bleeding

Hold until recovery* and then reduce by 25%

Grade 3 non-hematologic/organ

Hold until recovery* and then reduce by 25%

Grade 4 non-hematologic/organ

Discontinue
Suspected pneumonitis

Hold, investigate appropriately and discontinue of confirmed

Leucoencephalopathy, hepatic fibrosis, viral reactivation

Discontinue

* until ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and other toxicity ≤ grade 2

 

 



Hepatic Impairment

Bilirubin (µmol/L)

  Transaminases

% usual dose

2.5 - 4 x ULN

or > 3 x ULN

75%

> 4 x ULN

   

DISCONTINUE


Renal Impairment

Creatinine clearance (mL/min)

% usual dose*

>80

100%

80

75%

60

60%

50

50%

<50

Discontinue

Less conservative dose modifications could be considered for low dose regimens (<50mg/m2).

 
F - Adverse Effects

Refer to methotrexate drug monograph(s) for additional details on adverse effects.


Most Common Side Effects 

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

  • Mucositis
  • Diarrhea
  • Myelosuppression ± bleeding, infection
  • Nausea, vomiting
  • Rash (may be severe)
  • ↑ LFTs (may be severe)
  • Encephalopathy
  • Pneumonitis
  • Arterial thromboembolism
  • Venous thromboembolism
  • Hypersensitivity
  • GI perforation
  • Nephrotoxicity/Proteinuria
  • Pancreatitis
  • TLS
  • Secondary malignancies

 

 
G - Interactions
Refer to methotrexate drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions
Refer to methotrexate drug monograph(s) for additional details
 
I - Recommended Clinical Monitoring

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 regular
  • Liver function tests; baseline and regular
  • Renal function tests; baseline and regular
  • Clinical assessment of infection, bleeding, GI (stomatitis, diarrhea), skin, pulmonary, or CNS toxicity; 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
0.5 hour
Pharmacy Workload (average time per visit)
15.714 minutes
Nursing Workload (average time per visit)
36.667 minutes
 
K - References

Forastiere AA, Metch B, Schuller DE, et al, Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: A Southwest Oncology Study. J Clin Oncol, 1992; 10: 1245-1251.

Hong WK, Schaefer S, Issell B, et al. A prospective randomized trial of methotrexate versus cisplatin in the treatment of recurrent squamous cell carcinoma of the head and neck. Cancer 1983;52(2):206-10.

Methotrexate drug monograph, Cancer Care Ontario.

Stewart JS, Cohen EE, Licitra L, et al. Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck. J Clin Oncol 2009;27(11):1864-71.

 


PEBC Advice Documents or Guidelines

October 2017 Added PEBC guideline link


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L - Other Notes

Methotrexate regimen is associated with low toxicity risks and response rates of about 10-15% but no difference in survival when compared against 5FU and Cisplatin.

In patients with adequate performance status where standard chemotherapy would unlikely yield a good therapeutic index, consideration should be made for enrollment into a clinical trial of novel agent(s).

 
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.