Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.
ACAL+OBIN
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.
This 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). 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.
For treatment-naive, symptomatic chronic lymphocytic leukemia (CLL)
Cycle 1:
| acalabrutinib | 100 mg | PO | BID (Continuous) |
| (This drug is not currently publicly funded for this regimen and intent) | |||
|
Cycle 2: |
|||
| acalabrutinib | 100 mg | PO | BID (Continuous) |
| (This drug is not currently publicly funded for this regimen and intent) | |||
| oBINutuzumab | 1000* mg | IV | Days 1, 8 and 15 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
|
*Cycle 2 first dose of obinutuzumab may be split over 2 days (100 mg IV day 1 and 900 mg IV day 2). THEN, Cycles 3 to 7: |
|||
| acalabrutinib | 100 mg | PO | BID (Continuous) |
| (This drug is not currently publicly funded for this regimen and intent) | |||
| oBINutuzumab | 1000 mg | IV | Day 1 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
REPEAT EVERY 28 DAYS
Start with acalabrutinib for one cycle, then give up to a usual total of 6 cycles of ACAL+OBIN (cycles 2 to 7) unless disease progression or unacceptable toxicity occurs; acalabrutinib monotherapy continues (see ACAL(MNT))
Minimal
Obinutuzumab:
Hepatitis B screening should be performed prior to treatment for all patients.
Patients at risk for tumour lysis syndrome should receive adequate hydration and uricostatics or alternative starting 12 to 24 hours prior to infusion.
Consider withholding antihypertensives (if applicable) 12 hours prior to infusion, during infusion and for the first hour after drug administration, and withholding concomitant medications that increase bleeding risk, especially in the first cycle.
Premedication recommendations:
|
Treatment cycle, day |
Patients |
Premedication |
|
Cycle 1, Day 1 |
All |
IV corticosteroid* completed at least 1 hr prior to infusion & PO analgesic/antipyretic** & antihistamine*** at least 30 min prior to infusion
|
|
Subsequent infusions |
Patients with no prior IR during previous infusion |
PO analgesic/antipyretic** at least 30 min prior to infusion
|
|
|
Patients with grade 1 or 2 IR with previous infusion |
PO analgesic/antipyretic** & antihistamine*** at least 30 min prior to infusion
|
|
|
Patients with grade 3 IR with previous infusion OR patients with lymphocyte counts > 25 x 109/L prior to next treatment |
IV corticosteroid* completed at least 1 hr prior to infusion & PO analgesic/antipyretic** & antihistamine*** at least 30 min prior to infusion |
*e.g. 100 mg prednisone or 20 mg dexamethasone. Hydrocortisone should not be used as it has not been effective in reducing IR rates.
**e.g. 1000 mg acetaminophen
***e.g. 50 mg diphenhydramine
Acalabrutinib and obinutuzumab drug monographs, Cancer Care Ontario.
Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet 2020;395:1278-91.
October 2020 New ST-QBP regimen
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.