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 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant, have received at least one prior systemic therapy and have an ECOG performance status of 0 to 2 (see NDFP for detailed funding criteria).
|romidepsin||14 mg /m²||IV over 4 hours||Days 1, 8, 15|
Other Supportive Care:
- Consider prophylaxis for tumour lysis syndrome in patients with high bulk disease.
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.
Plasma potassium and magnesium levels should be within normal range before each romidepsin administration; do not treat if QTc > 480 ms.
|Dose level||Dose (On days 1, 8, 15)|
Dosage with toxicity
Worst Counts (x109/L) / Toxicity
Grade 2 or 3 non-hematological/ organ
Hold*, restart at same dose level
If grade 3 recurs, hold* then ↓ 1 dose level.
If grade 3 recurs after dose reduction, discontinue.
Grade 4 non-hematological/ organ
Hold*, restart by ↓ 1 dose level
If grade 3 or 4 recurs after dose reduction, discontinue.
Grade 3 or 4 ANC or platelets
Hold*, restart at same dose level
|Grade 4 febrile neutropenia or thrombocytopenia requiring platelet transfusion||Hold*, restart by ↓ 1 dose level|
Not formally studied. Population pharmacokinetic analysis suggested the following:
|≤ ULN||and||> ULN||No change (no significant pharmacokinetic differences)|
|1 to 1.5 x ULN||and||any||No change (no significant pharmacokinetic differences)|
|>1.5 to 3||and||any||Caution (no data)|
|> 3 x ULN||and||any||Caution (no data)|
Not formally studied. Population pharmacokinetic analysis suggested that renal impairment was not expected to affect drug exposure significantly:
|Mild (> 50-80)||No change|
|Moderate (30-50)||No change|
|Severe (< 30)||No change|
|ESRD||Caution (no data)|
Dosage in the elderly:
No overall safety and efficacy differences were observed between elderly and younger patients; however, elderly patients may require dose modifications due to increased risk of toxicity.
Refer to romidepsin drug monograph(s) for additional details of adverse effects
|Most Common Side Effects||
Less Common Side Effects, but may be
Refer to romidepsin drug monograph(s) for additional details
- Avoid use with strong CYP3A4 inhibitors (e.g. ketoconzole, macrolide antibiotics, Grapefruit juice)
- Avoid use with strong CYP3A4 inducers (e.g. rifampin, phenytoin. St. John's wort)
- Caution and monitor INR closely with warfarin
- Caution and monitor closely with drugs that may prolong the QT interval (e.g. amiodarone, ondansetron, domperidone)
- Avoid or monitor closely with drugs that may disrupt electrolyte levels (e.g. diuretics)
Refer to romidepsin drug monograph(s) for additional details
- Reconstitute romidepsin using the supplied diluent. Refer to the product monograph for instructions.
- Add the required dose into 500 mL 0.9% Sodium Chloride (NS) and infuse IV over 4 hours.
- Missed doses should be administered as soon as possible, unless it is within 5 days of the next scheduled dose
- Diluted solution is compatible with PVC, ethylene vinyl acetate (EVA) polyethylene (PE) infusion bags as well as glass bottles
- Store unopened vial and diluent together at room temperature (15 to 30oC)
- The manufacturer recommends that the reconstituted drug is stable for at least 8 hours when stored at room temperature. After dilution with 0.9% sodium chloride solution (NS), it is stable up to 24 hours at room temperature
- Patients with baseline QT prolongation > 480 ms or those with congenital long QT syndrome
- Patients with abnormal plasma magnesium or potassium levels
- Patients with a significant cardiac history were excluded from clinical trials; exercise extreme caution in these patients
- Use with caution in patients who are at risk of experiencing torsade de points or QT prolongation, including female patients, age ≥ 65 years, cardiac disease, history of arrhythmias, electrolyte disturbances, bradycardia, acute neurological events, diabetes, on concomitant antiarrhythmics or drugs that prolong QT, or autonomic neuropathy
- Use with caution in patients with bulky disease due to the risk of tumour lysis syndrome
- Use with caution in patients with compromised bone marrow (disease, or heavily pretreated) due to the risk of infection
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
- ECG; baseline; baseline and periodic for patients at risk of QT prolongation; baseline and as clinically indicated
- Electrolytes, including potassium and magnesium; baseline, before each cycle and as clinically indicated
- CBC; baseline and before each treatment (at minimum)
- INR and PT for patients taking warfarin or its derivatives; baseline and regular
- Clinical toxicity assessment for infection, bleeding, thromboembolism, fatigue, GI effects, hypersensitivity, tumour lysis syndrome; at each visit
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Coiffier B, Pro B, Prince HM, et al. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol 2012 Feb 20;30(6):631-6.
Romidepsin drug monograph, Cancer Care Ontario.
November 2017 added reference to product monograph under administration section
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.
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