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AXIT

Cancer Type: Genitourinary, Renal cell / Kidney  Intent: Palliative
Regimen Category: Evidence-Informed
Funding:
Exceptional Access Program
    aXitinib - For the treatment of metastatic renal cell carcinoma of clear cell histology (second-line), according to clinical criteria
A - Regimen Name

AXIT Regimen
Axitinib


Disease Site
Genitourinary - Renal Cell / Kidney

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

For treatment of patients with metastatic renal cell carcinoma with clear cell histology after failure of prior therapy with a cytokine or sunitinib


Supplementary Public Funding

aXitinib
Exceptional Access Program (aXitinib - For the treatment of metastatic renal cell carcinoma of clear cell histology (second-line), according to clinical criteria)

 
B - Drug Regimen

aXitinib
5 mg PO BID

(Outpatient prescription in 1 mg, 3 mg, 5 mg and 7 mg tablets)

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Starting dose - may titrate according to table below: 

Current dose Titrated dose
Able to tolerate (≤ grade 2 toxicity) the current dose for 2 consecutive weeks, with no prior dose modification, normotensive and do not require antihypertensive medications ↑ 1 dose level (maximum 10mg BID) Refer to section E for dose levels

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C - Cycle Frequency

CONTINUOUS TREATMENT

Until disease progression, in the absence of unacceptable toxicity.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal – No routine prophylaxis; PRN recommended

Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

 
E - Dose Modifications

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.

Dose levels:  10mg BID, 7mg BID, 5mg BID, 3mg BID, 2mg BID

 

 

Dosage with toxicity

Toxicity
Action

Grade 3 related organ / non-hematologic

*Hold; ↓ 1 dose level

Moderate or severe proteinuria

* ↓ 1 dose level

Consider temporary discontinuation of therapy in severe proteinuria

Hypertension

Treat appropriately (refer to Appendix 8).  Reduce dose or hold as appropriate. 

Grade 4 related organ/ non-hematologic; uncontrolled hypertension/crisis; RPLS; heart failure

Discontinue
 
*Do not start new cycle until toxicities have recovered to ≤ grade 2, platelets ≥ 100 x 109/L, and ANC ≥ 1.5 x 109/L.
 



Hepatic Impairment

Axitinib exposure is increased in moderate hepatic impairment, but has not been studied in patients with severe impairment. 

Hepatic impairment

Starting dose

Moderate hepatic impairment (Child Pugh B)

↓ dose by approximately 50% rounded to nearest 1 mg

Severe hepatic impairment (Child Pugh C)

Discontinue / do not use (no data)


Renal Impairment

No dosage adjustments required for mild to moderate impairment.  Use with caution in patients with severe renal impairment.


 
F - Adverse Effects
Refer to axitinib drug monograph(s) for additional details of adverse effects

Most Common Side Effects 

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

  • Hypertension (may be severe)
  • Myelosuppression  ± infection, bleeding (may be severe)
  • Hand-Foot Syndrome (may be severe)
  • Hyperglycemia
  • Hypothyroidism
  • Proteinuria
  • Fatigue
  • ↑ Amylase/lipase (may be severe)
  • ↑ LFTs (may be severe)
  • Nausea, vomiting
  • Constipation
  • Darrhea
  • Mucositis
  • Hoarseness
  • Cough, dyspnea
  • Musculoskeletal pain
  • Anorexia
  • Electrolyte abnormalities
  • Increase in creatinine (may be severe)
  • Venous thromboembolism
  • Arterial thromboembolism
  • RPLS
  • Cardiotoxicity
  • GI perforation/fistula
 
G - Interactions

Refer to axitinib drug monograph(s) for additional details

 

 
H - Drug Administration and Special Precautions

Refer to axitinib drug monograph(s) for additional details

 

 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Blood pressure; baseline and regular; start within a week after beginning treatment, especially with any dose modifications
  • CBC; baseline and regular
  • Liver function tests (ALT, AST and bilirubin); baseline and periodic
  • Proteinuria; baseline and periodic
  • Renal function tests; baseline and regular
  • Thyroid function tests; baseline and periodic
  • Signs and symptoms of cardiotoxicity; baseline and periodically during treatment
  • Clinical toxicity assessment for hepatic, neurological, bleeding, GI symptoms and thromboembolism; baseline and regular
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

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J - Administrative Information

Outpatient prescription for home administration


 
K - References

Rini BI et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial.  Lancet 2011;378:1931-9.

Rini BI et al.  Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma.  J Clin Oncol 2009;27(27):4462-8.


August 2019 Removed archived PEBC guideline link


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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.