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IMAT
(Dermatofibrosarcoma protuberans - DFSP)
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.
In patients with unresectable, recurrent and/or metastatic DFSP
iMAtinib
ODB - General Benefit
(iMAtinib - Refer to listed Health Canada indications for generic imatinib formulations. Patients must meet generic substitution policies for access to Gleevec.)
(ODB Formulary
)
| iMAtinib | 400* mg | PO | BID |
|
(Total daily dose = 800mg; Outpatient prescription in multiples of 100mg and 400mg tablets) |
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Continue treatment in the absence of unacceptable toxicity or disease progression.
Minimal – No routine prophylaxis; PRN recommended
Other Supportive Care:
- Patients at risk of tumour lysis syndrome should have appropriate prophylaxis and be monitored closely.
- Patients should be tested for HBV infection prior to initiating treatment. Carriers of HBV must be monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Also refer to CCO Antiemetic Recommendations.
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 are 200mg, 300mg, 400mg, 600mg, and 800mg.
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Indication
|
Daily Starting Dose |
Escalate?
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Hepatic Impairment |
Renal Impairment (Clcr, ml/min) |
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|
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Mild-Mod4
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Severe5
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20-59
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<20
|
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DFSP
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800mg
|
|
1
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2, 3 |
1
|
Discontinue
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Dosage with toxicity
| Toxicity | Action |
| Fluid retention (grade 3,4 ) | Hold until ≤ grade 1; resume with 1 dose level ↓ |
| Rash (grade 3, 4) | Hold until ≤ grade 1; resume with 1 dose level ↓ or discontinue |
| Hypotension / Hypersensitivity reaction | Hold, treat supportively, consider steroids |
| Bleeding | Hold; consider discontinuing if severe |
| Pneumonitis | Hold, investigate, consider discontinuing if confirmed |
| DRESS | Consider discontinuing |
Dosage with myelosuppression:
|
|
ANC (x 109/L) |
Platelets (x 109/L) |
Action |
|
Starting dose 800mg |
< 1 |
< 50 |
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Hepatic Impairment
Imatinib is excreted via the liver and increased exposure is likely in the presence of hepatic impairment. See dosage table.
Renal Impairment
Imatinib is not excreted via the kidney to a significant extent; however, increased exposure and adverse effects are correlated with renal impairment. Exercise caution in patients with mild to moderate renal impairment. See dosage table.
Refer to imatinib drug monograph(s) for additional details of adverse effects
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Most Common Side Effects |
Less Common Side Effects, but may be Severe or Life-Threatening
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|
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Refer to imatinib 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
- Brain imaging for patients suspected of having subdural hemorrhage; as clinically indicated
- CBC; weekly for first month, biweekly for second month, and as indicated thereafter (e.g. every 2 to 3 months)
- Electrolytes and serum creatinine; baseline and regular
- INR for patients taking warfarin, especially when starting treatment and with imatinib dose adjustments; baseline and regular
- Liver function tests; baseline and monthly or as clinically indicated
- LVEF, in patients with known underlying heart disease or in elderly patients; baseline and as clinically indicated
- Platelet counts and prothrombin time when imatinib is used concurrently with anticoagulants, prostacyclins, or other medications that increase bleeding risk; baseline and periodic
- TSH levels in patients with previous thyroidectomy or patients on replacement therapy; baseline and regular
- Serum or urine pregnancy test in women of childbearing potential; within one week before starting treatment
- HBV infection status: Prior to starting treatment; consult infectious disease if positive
- For carriers of HBV: signs and symptoms of active HBV infection; At each visit during treatment and for several months after treatment discontinues
- Clinical assessment of fluid retention, bleeding, infection, cardiac effects, thromboembolism, rhabdomyolysis, tumour lysis syndrome and gastrointestinal effects, pneumonitis, rash; regular
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- EKG and troponin in patients with hypereosinophilia and cardiac involvement
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BCR-ABL Tyrosine Kinase Inhibitors [GLEEVEC (imatinib mesylate), TASIGNA (nilotinib), BOSULIF (bosutinib), SPRYCEL (dasatinib), ICLUSIG (ponatinib hydrochloride)] - Risk of Hepatitis B Reactivation. Health Canada, May 4, 2016. [Accessed May 13, 2016]. Available from: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/58222a-eng.php
Imatinib drug monograph, Cancer Care Ontario
Lebbé C, Kerob D, Porcher R, et al. Imatinib mesylate as a preoperative therapy in dermatofibrosarcoma: Results of a multicentric phase II study on 25 patients. Journal of Clinical Oncology 2007 (ASCO Annual Meeting Proceedings); 25(18S): 10032.
McArthur GA, Demetri GD, van Oosterom A, et al. Molecular and clinical analysis of locally advanced dermatofibrosarcoma protuberans treated with imatinib: imatinib target exploration consortium study B2225. JCO 2005; 23(4); 866-73.
April 2024 Changed imatinib to ODB general benefit
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.
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