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GDP+OBIN

Cancer Type: Hematologic, Lymphoma - Non-Hodgkin's Low Grade  Intent: Palliative
Regimen Category: Evidence-informed
Funding:
New Drug Funding Program
    Obinutuzumab - In Combination with Chemotherapy for Refractory Follicular Lymphoma
ODB - General Benefit
    dexamethasone
A - Regimen Name

GDP+OBIN Regimen
Gemcitabine-Dexamethasone-CISplatin-oBINutuzumab


Disease Site
Hematologic - Lymphoma - Non-Hodgkin's Low Grade

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.

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.


Rationale and Uses

For use in selected patients with relapsed/refractory indolent NHL (refer to NDFP form for specific criteria for obinutuzumab eligibility)
 


Supplementary Public Funding

oBINutuzumab
New Drug Funding Program (Obinutuzumab - In Combination with Chemotherapy for Refractory Follicular Lymphoma)

dexamethasone
ODB - General Benefit (dexamethasone)

 
B - Drug Regimen


Cycle 1:

oBINutuzumab

 

 

1000 mg IV Days 1, 8 and 15

 

Cycles 2+:

oBINutuzumab
1000 mg IV Day 1

 

Plus GDP (all cycles):

gemcitabine
1000 mg /m² IV Days 1 and 8
CISplatin
75 mg /m² IV Day 1
dexamethasone
40 mg PO Once daily on days 1 to 4
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C - Cycle Frequency

REPEAT EVERY 21 DAYS for up to 6 cycles unless disease progression or unacceptable toxicity (see NDFP form)

Refer to OBIN(MNT) if patients are continuing on obinutuzumab maintenance treatment.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High (Day 1)
Low (Day 8)

Other Supportive Care:

Premedications (prophylaxis for infusion reactions) for obinutuzumab:

Table 1:

Treatment cycle, day

Patients

Premedication

Cycle 1, day 1

All

  • IV corticosteroid*^ at least 1 hr prior to infusion
  • PO antipyretic**  at least 30 min prior to infusion
  • antihistamine*** at least 30 min prior to infusion

 

Subsequent infusions

Patients with no IR during previous infusion

  • PO antipyretic** at least 30 min prior to infusion

 

Patients with grade 1 or 2 IR with previous infusion

  • PO antipyretic** at least 30 min prior to infusion
  • 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**^ at least 1 hr prior to infusion
  • PO antipyretic** at least 30 min prior to infusion
  • antihistamine*** at least 30 min prior to infusion

e.g. 80 mg methylprednisolone or 20 mg dexamethasone. Hydrocortisone is not recommended as it has not been effective in reducing IR rates.
** e.g. 1000 mg acetaminophen
*** e.g. 50 mg diphenhydramine
^ If a corticosteroid-containing chemotherapy regimen is given on the same day as obinutuzumab, the corticosteroid can be given as PO if given at least 1 hour prior to obinutuzumab, in which case additional IV corticosteroid as premedication is not required

Other Supportive Care:

  • 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 alternatives starting 12 to 24 hours prior to infusion. Consider splitting the first treatment over two days for patients with high tumour burden.
  • 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.
  • Patients with neutropenia should receive antimicrobial prophylaxis; consider G-CSF, antiviral and antifungal prophylaxis.

Also refer to CCO Antiemetic Recommendations.

The day 1 dexamethasone dose can be given IV before chemotherapy to prevent emesis, with the oral treatment dose reduced accordingly.

  • Consider use of filgrastim to maintain dose intensity for patients with febrile neutropenia or prolonged neutropenia.

  • Standard regimens for Cisplatin premedication and hydration should be followed. Refer to local guidelines.

 

 

 
J - Administrative Information

Outpatient prescription for home administration (dexamethasone)


Approximate Patient Visit
Day 1: Up to 8 hours; Day 8: 4 hours (first cycle), 0.75 hours (subsequent cycles); Day 15: 3 hours (first cycle only)
Pharmacy Workload (average time per visit)
41.897 minutes
Nursing Workload (average time per visit)
86.667 minutes
 
K - References

Cheson BD, Chua N, Mayer J, et al.  Overall survival benefit in patients with rituximab-refractory indolent non-Hodgkin lymphoma who received obinutuzumab plus bendamustine induction and obinutuzumab maintenance in the GADOLIN study.  J Clin Oncol. 2018 Aug 1;36(22):2259-66.

Radford J, Davies A, Cartron G, et al.  Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000).  Blood. 2013 Aug 15;122(7):1137-43.

Schouten HC, Qian W, Kvaloy S, et al. High-dose therapy improves progression-free survival and survivial in relapsed follicular non-hodgkin's lymphoma: results from the randomized European CUP trial. J Clin Oncol 2003;21:3918-27.

Yazdy S, Cheson BD. Impact of obinutuzumab alone and in combination for follicular lymphoma. Blood Lymphat Cancer 2017;7:73-83.

March 2020 New ST-QBP regimen


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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.