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ROMI

Cancer Type: Hematologic, Lymphoma - T-cell  Intent: Palliative
Regimen Category: Evidence-Informed
Funding:
New Drug Funding Program
    Romidepsin - Relapsed or Refractory Peripheral T-Cell Lymphoma
A - Regimen Name

ROMI Regimen
Romidepsin


Disease Site
Hematologic - Lymphoma - T-cell

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 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).


Supplementary Public Funding

romidepsin
New Drug Funding Program (Romidepsin - Relapsed or Refractory Peripheral T-Cell Lymphoma) (NDFP Website)

 
B - Drug Regimen

romidepsin
14 mg /m² IV over 4 hours Days 1, 8, 15
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C - Cycle Frequency

REPEAT EVERY 28 DAYS

Until disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

Other Supportive Care:

  • Consider prophylaxis for tumour lysis syndrome in patients with high bulk disease.
 
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.

Plasma potassium and magnesium levels should be within normal range before each romidepsin administration; do not treat if QTc > 480 ms.

Dose levels:  Do not re-escalate reduced doses.
 
Dose level Dose (On days 1, 8, 15)
0 14 mg/m2
-1 10 mg/m2
-2 Discontinue

Dosage with toxicity

Worst Counts (x109/L) / Toxicity
Action
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
 *Do not retreat until platelets ≥ 75 x 109/L, ANC ≥ 1.5 x 109/L, non-hematological/ organ toxicities recover to ≤ grade 1 or baseline.



Hepatic Impairment

Not formally studied.  Population pharmacokinetic analysis suggested the following:

Bilirubin   AST Dose
≤ 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)

 

 

 


Renal Impairment

Not formally studied. Population pharmacokinetic analysis suggested that renal impairment was not expected to affect drug exposure significantly:

Renal Impairment Dose
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.


 
F - Adverse Effects

Refer to romidepsin drug monograph(s) for additional details of adverse effects


Most Common Side Effects 

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

  • Nausea, vomiting
  • Fatigue
  • Diarrhea
  • Constipation
  • ↑ LFTs
  • Myelosuppression ± infection (including opportunistic), bleeding (may be severe)
  • Anorexia, weight loss
  • Dysgeusia
  • Cough, dyspnea
  • Headache
  • Abdominal pain
  • Abnormal electrolyte(s)
  • Mucositis
  • Edema
  • Tachycardia
  • Venous thromboembolism
  • Tumor lysis syndrome
  • Hypersensitivity
  • QT prolonged
  • Viral reactivation
 
G - Interactions

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)
 
H - Drug Administration and Special Precautions

Refer to romidepsin drug monograph(s) for additional details

 


Administration

  • 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

 

Contraindications

  • Patients with baseline QT prolongation > 480 ms or those with congenital long QT syndrome
  • Patients with abnormal plasma magnesium or potassium levels

Other Warnings/Precautions

  • 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
 
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

  • 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


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J - Administrative Information

Approximate Patient Visit
4.5 hours
Pharmacy Workload (average time per visit)
16.783 minutes
Nursing Workload (average time per visit)
36.667 minutes
 
K - References

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


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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.