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Non-Hodgkin lymphoma bendamustine polatuzumab vedotin and rituximab

Patients with lymphoma should be considered for inclusion into clinical trials. Link to ALLG website, ANZCTR website and Lymphoma Australia website.

This protocol is based on limited evidence; refer to the evidence section of this protocol for more information.

The anticancer drug(s) in this protocol may have been included in the ADDIKD guideline. Dose recommendations in kidney dysfunction have yet to be updated to align with the ADDIKD guideline. Recommendations will be updated once the individual protocol has been evaluated by the reference committee. For further information refer to the ADDIKD guideline. To assist with calculations, use the eviQ Estimated Glomerular Filtration Rate (eGFR) calculator.

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Cycle 1

Drug Dose Route Day
Rituximab 375 mg/m2 IV infusion 1
Polatuzumab vedotin 1.8 mg/kg IV infusion 2
Bendamustine * 90 mg/m2 IV infusion 2 and 3

Cycle 2 to 6

Drug Dose Route Day
Rituximab 375 mg/m2 IV infusion ** 1
Polatuzumab vedotin 1.8 mg/kg IV infusion 1
Bendamustine * 90 mg/m2 IV infusion 1 and 2

*Bendamustine doses in this protocol are expressed as bendamustine hydrochloride

** From dose 2 onwards, rituximab may be administered subcutaneously as a flat dose of 1,400 mg. For more information see the Non-Hodgkin lymphoma subcutaneous rituximab document.

Frequency:
21 days 
Cycles:
6 (up to 6 cycles can be given; treatment is often used as a bridge to transplant or CAR T-cell therapy).
Drug status:

Polatuzumab vedotin: is TGA registered but not PBS listed

Bendamustine: is TGA registered but not PBS listed for this indication 

Rituximab: is on the PBS general schedule

Rituximab SC: TGA registered but not PBS listed.

The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1

Day 1
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment
Hydrocortisone 100 mg (IV) 30 minutes before treatment
Rituximab 375 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% as per graded administration rate
Day 2
Dexamethasone 8 mg (PO) ONCE a day with or after food (or in divided doses).
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment
Polatuzumab vedotin 1.8 mg/kg (IV infusion) in 50 mL to 100 mL sodium chloride 0.9% over 90 minutes

, subsequent doses may be administered over 30 minutes if prior infusion well tolerated.
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
Bendamustine 90 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes *
Day 3
Dexamethasone 8 mg (PO) ONCE a day with or after food (or in divided doses).
Bendamustine 90 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes *
Day 4 and 5
Dexamethasone 8 mg (PO) with or after food (or in divided doses). Note: dexamethasone doses on days 4 and 5 may not be required and may be reduced or omitted at the clinician's discretion. ***

Cycle 2 to 6

Day 1
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment
Hydrocortisone 100 mg (IV) 30 minutes before treatment
Rituximab 375 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% as per graded administration rate**
Polatuzumab vedotin 1.8 mg/kg (IV infusion) in 50 mL to 100 mL sodium chloride 0.9% over 90 minutes

, subsequent doses may be administered over 30 minutes if prior infusion well tolerated.
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
Bendamustine 90 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes *
Day 2
Dexamethasone 8 mg (PO) with or after food (or in divided doses).
Bendamustine 90 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes *
Day 3 and 4
Dexamethasone 8 mg (PO) with or after food (or in divided doses). Note: dexamethasone doses on days 3 and 4 may not be required and may be reduced or omitted at the clinician's discretion. ***

*Bendamustine doses in this protocol are expressed as bendamustine hydrochloride

** From dose 2 onwards, rituximab may be administered subcutaneously as a flat dose of 1,400 mg. For more information see the Non-Hodgkin lymphoma subcutaneous rituximab document. 

*** Link to ID 7 Prevention of chemotherapy induced nausea and vomiting

Frequency:
21 days 
Cycles:
6 (up to 6 cycles can be given; treatment is often used as a bridge to transplant or CAR T-cell therapy).

Cycle 1

Drug Dose Route Day
Rituximab 375 mg/m2 IV infusion 1
Polatuzumab vedotin 1.8 mg/kg IV infusion 2
Bendamustine * 90 mg/m2 IV infusion 2 and 3

Cycle 2 to 6

Drug Dose Route Day
Rituximab 375 mg/m2 IV infusion ** 1
Polatuzumab vedotin 1.8 mg/kg IV infusion 1
Bendamustine * 90 mg/m2 IV infusion 1 and 2

*Bendamustine doses in this protocol are expressed as bendamustine hydrochloride

** From dose 2 onwards, rituximab may be administered subcutaneously as a flat dose of 1,400 mg. For more information see the Non-Hodgkin lymphoma subcutaneous rituximab document.

Frequency:
21 days 
Cycles:
6 (up to 6 cycles can be given; treatment is often used as a bridge to transplant or CAR T-cell therapy).
Drug status:

Polatuzumab vedotin: is TGA registered but not PBS listed

Bendamustine: is TGA registered but not PBS listed for this indication 

Rituximab: is on the PBS general schedule

Rituximab SC: TGA registered but not PBS listed.

The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1

Day 1
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment
Hydrocortisone 100 mg (IV) 30 minutes before treatment
Rituximab 375 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% as per graded administration rate
Day 2
Dexamethasone 8 mg (PO) ONCE a day with or after food (or in divided doses).
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment
Polatuzumab vedotin 1.8 mg/kg (IV infusion) in 50 mL to 100 mL sodium chloride 0.9% over 90 minutes

, subsequent doses may be administered over 30 minutes if prior infusion well tolerated.
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
Bendamustine 90 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes *
Day 3
Dexamethasone 8 mg (PO) ONCE a day with or after food (or in divided doses).
Bendamustine 90 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes *
Day 4 and 5
Dexamethasone 8 mg (PO) with or after food (or in divided doses). Note: dexamethasone doses on days 4 and 5 may not be required and may be reduced or omitted at the clinician's discretion. ***

Cycle 2 to 6

Day 1
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment
Hydrocortisone 100 mg (IV) 30 minutes before treatment
Rituximab 375 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% as per graded administration rate**
Polatuzumab vedotin 1.8 mg/kg (IV infusion) in 50 mL to 100 mL sodium chloride 0.9% over 90 minutes

, subsequent doses may be administered over 30 minutes if prior infusion well tolerated.
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
Bendamustine 90 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes *
Day 2
Dexamethasone 8 mg (PO) with or after food (or in divided doses).
Bendamustine 90 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes *
Day 3 and 4
Dexamethasone 8 mg (PO) with or after food (or in divided doses). Note: dexamethasone doses on days 3 and 4 may not be required and may be reduced or omitted at the clinician's discretion. ***

*Bendamustine doses in this protocol are expressed as bendamustine hydrochloride

** From dose 2 onwards, rituximab may be administered subcutaneously as a flat dose of 1,400 mg. For more information see the Non-Hodgkin lymphoma subcutaneous rituximab document. 

*** Link to ID 7 Prevention of chemotherapy induced nausea and vomiting

Frequency:
21 days 
Cycles:
6 (up to 6 cycles can be given; treatment is often used as a bridge to transplant or CAR T-cell therapy).
  • Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients who are transplant ineligible. 
Venous access required

IV cannula (IVC) or central venous access device (CVAD) is required to administer this treatment.

Read more about central venous access device line selection
Hypersensitivity/infusion related reaction

High risk with polatuzumab vedotin, bendamustine and rituximab 
Premedication

The product information states that premedication is required for this treatment.

Please refer to the treatment schedule for suggested premedication regimen. This may be substituted to reflect institutional policy.
Emetogenicity MODERATE

Suggested default antiemetics have been added to the treatment schedule, and may be substituted to reflect institutional policy.

A steroid has been included both as an antiemetic and premedication for hypersensitivity in this protocol.

Ensure that patients also have sufficient antiemetics for breakthrough emesis:

Metoclopramide 10 mg three times a day when necessary (maximum of 30 mg/24 hours, up to 5 days) OR

Prochlorperazine 10 mg PO every 6 hours when necessary.

Read more about preventing anti-cancer therapy induced nausea and vomiting
Myelosuppression

Serious and severe neutropenia and febrile neutropenia have been reported in patients treated with polatuzumab vedotin as early as the first cycle of treatment. Prophylactic G-CSF administration should be considered. 
Cardiac toxicity

In patients with cardiac disorders the concentration of potassium in the blood must be closely monitored and ECG measurement must be performed during treatment with bendamustine. Potassium supplementation must be given when K+ < 3.5 mEq/L.

Read more about cardiac toxicity associated with anti-cancer drugs
Hepatotoxicity

Serious cases of hepatic toxicity have occurred in patients treated with polatuzumab vedotin. Liver enzymes and bilirubin level should be monitored.
Peripheral neuropathy

Assess prior to each treatment. If a patient experiences grade 2 or greater peripheral neuropathy, a dose reduction, delay, or omission of treatment may be required; review by medical officer before commencing treatment.

Read more about peripheral neuropathy

Link to chemotherapy-induced peripheral neuropathy screening tool
Subcutaneous rituximab

Please note that subcutaneous rituximab is no longer subsidised by the Pharmaceutical Benefit Scheme and is currently unavailable in Australia.

All patients must always receive their first dose of rituximab by intravenous administration. Subcutaneous (SC) rituximab must only be given at the second or subsequent doses. From dose 2 onwards, rituximab may be administered subcutaneously as a flat dose of 1,400 mg. If patient was not able to receive one full rituximab intravenous infusion dose, they should continue the subsequent dose with intravenous rituximab until a full IV dose is successfully administered.

Premedication consisting of an analgesic/antipyretic and an antihistamine should always be administered before each dose of rituximab SC. Premedication with glucocorticoids should also be considered, particularly if rituximab SC is not given in combination with steroid-containing chemotherapy.

 Read more about Non-Hodgkin lymphoma subcutaneous rituximab 
Rituximab rapid infusion

This regimen is not in line with the product monograph, however published literature indicates that it can be completed safely.

Read more about the rapid infusion of rituximab
Progressive multifocal leukoencephalopathy

Use of monoclonal antibodies may be associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal opportunistic viral infection of the brain. Patients must be monitored for any new or worsening neurological symptoms.

Read more about progressive multifocal leukoencephalopathy and the Therapeutic Goods Administration Medicines Safety update on progressive multifocal leukoencephalopathy from the Australian Government, Department of Health.
Central nervous system (CNS) prophylaxis

Consider CNS relapse assessment in patients with high grade lymphoma. 

Read more about CNS prophylaxis in diffuse large cell lymphoma
Tumour lysis risk

Assess patient for risk of developing tumour lysis syndrome.

Read more about prevention and management of tumour lysis syndrome.
Pneumocystis jirovecii pneumonia (PJP) prophylaxis

­

Read more about prophylaxis of pneumocystis jiroveci (carinii) in cancer patients
Antiviral prophylaxis

­

Read more about antiviral prophylaxis drugs and doses
Antifungal prophylaxis ­

Read more about antifungal prophylaxis drugs and doses.
Growth factor support

G-CSF (short or long-acting) is available on the PBS for chemotherapy induced neutropenia depending on clinical indication and/or febrile neutropenia risk.  

Access the PBS website
Irradiated blood components

The use of irradiated of blood components is recommended for patients receiving this treatment.

Read more about the indications for the use of irradiated blood components
Biosimilar drug

Read more about biosimilar drugs on the Biosimilar Awareness Initiative page
Blood tests

FBC, EUC, LFTs and LDH at baseline, and prior to each cycle and as clinically indicated.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is recommended prior to initiation of treatment. Prophylaxis should be determined according to individual institutional policy.

Read more about hepatitis B screening and prophylaxis in cancer patients requiring cytotoxic and/or immunosuppressive therapy
Vaccinations

Live vaccines are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease.

Refer to the recommended schedule of vaccination for immunocompromised patients, as outlined in the Australian Immunisation Handbook.

Read more about COVID-19 vaccines and cancer.
Fertility, pregnancy and lactation

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive potential prior to commencing treatment. There is a risk of foetal harm in pregnant women. A pregnancy test should be considered prior to initiating treatment in females of reproductive potential if sexually active. It is important that all patients of reproductive potential use effective contraception whilst on therapy and after treatment finishes. Effective contraception methods and adequate contraception timeframe should be discussed with all patients of reproductive potential. Possibility of infant risk should be discussed with breastfeeding patients.

Read more about the effect of cancer treatment on fertility
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the anti-cancer regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences.Suggested dose modifications are based on clinical trial findings, product information, published guidelines and reference committee consensus . The dose reduction applies to each individual dose and not to the total number of days or duration of treatment cycle unless stated otherwise. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.
The dose recommendations in kidney dysfunction (i.e.renal impairment) displayed may not reflect those in the ADDIKD guideline and have been included for historical reference only. Recommendations will be updated once the individual protocol has been evaluated by the reference committee, with this version of the protocol then being archived. Clinicians are expected to refer to the ADDIKD guideline prior to prescribing in kidney dysfunction.
International Consensus Guideline for Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD).

Note: All dose reductions are calculated as a percentage of the starting dose

Haematological toxicity
ANC x 109/L (pre-treatment blood test)
less than 1.0

Hold all treatment until ANC recover to >1 x 109/L.

  • If ANC recovers to >1 x 109/L on or before day 7, resume all treatment without any additional dose reductions.
  • If ANC recovers to >1 x 109/L after day 7, restart all treatment, with a dose reduction of bendamustine from 90 mg/m2 to 70 mg/m2 or 70 mg/m2 to 50 mg/m2.
  • If a bendamustine dose reduction to 50 mg/m2 has already occurred, discontinue all treatment. 
Platelets x 109/L (pre-treatment blood test)
less than 75

Hold all treatment until platelets recover to >75 x 109/L.

  • If platelets recover to >75 x 109/L on or before day 7, resume all treatment without any additional dose reductions.
  • If platelets recover to >75 x 109/L after day 7 restart all treatment, with a dose reduction of bendamustine from 90 mg/m2 to 70 mg/m2 or 70 mg/m2 to 50 mg/m2.
  • If a bendamustine dose reduction to 50 mg/m2 has already occurred, discontinue all treatment. 
Renal impairment
Creatinine clearance (mL/min)
greater than 30 No dose reduction

There is limited data available in patients with severe renal impairment

Hepatic impairment
Hepatic dysfunction
AST or ALT up to 2.5 x ULN or Bilirubin up to 1.5 x ULN No dose reduction polatuzumab vedotin
Bilirubin less than 1.2 mg/dL No dose reduction for bendamustine
Bilirubin 1.2 to 3.0 mg/dL Consider reducing bendamustine dose by 30% 

No data is available in patients with severe hepatic impairment

Non-haematological toxicity  
Grade 3

Delay treatment until recovery consider reducing bendamustine dose by 50%

If the toxicity resolves and the previous dose is tolerated the reduced dose may be increased again

Note: this does not include grade 3 infusion-related reactions (IRR). Please see the administration section for more information on this. 
Grade 4 Withhold chemotherapy
Peripheral neuropathy                                                                                                                             
Grade 2 - 3

Hold polatuzumab vedotin until improvement to ≤ Grade 1.

  • If recovered to Grade ≤ 1 on or before day 14, restart at a permanently reduced dose of 1.4mg/kg.
  • If a prior dose reduction to 1.4mg/kg has occurred, discontinue polatuzumab vedotin.
  • If not recovered to Grade ≤ 1 on or before day 14, discontinue polatuzumab vedotin
Grade 4 Discontinue polatuzumab vedotin

Drug interactions in eviQ protocols are under review and being updated to align with current literature. Further site-wide updates and changes will occur in due course. References & Disclaimer

The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources:  

Bendamustine
No specific clinically significant drug-drug interactions. No formal clinical drug interaction studies with bendamustine have been conducted however there is potential for CYP1A2 inhibitors (e.g. aciclovir, ciprofloxacin and fluvoxamine).
Polatuzumab vedotin
No formal clinical drug interaction studies with polatuzumab vedotin have been conducted; however there is potential for interaction with strong CYP3A inhibitors and inducers.
  Interaction Clinical management
CYP3A4 inhibitors (e.g. azole-antifungals, ritonavir, macrolides etc.) Increased toxicity of polatuzumab vedotin possible due to reduced clearance Avoid combination or monitor for polatuzumab vedotin toxicity
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Reduced efficacy of polatuzumab vedotin possible due to increased clearance Avoid combination or monitor for decreased clinical response to polatuzumab vedotin
Rituximab
  Interaction Clinical management
Antihypertensives Additive hypotensive effect Consider withholding antihypertensive medications 12 hours prior to the rituximab infusion
General
  Interaction Clinical management
Warfarin Anti-cancer drugs may alter the anticoagulant effect of warfarin. Monitor INR regularly and adjust warfarin dosage as appropriate; consider alternative anticoagulant.
Direct oral anticoagulants (DOACs) e.g. apixaban, rivaroxaban, dabigatran

Interaction with both CYP3A4 and P-gp inhibitors /inducers.

DOAC and anti-cancer drug levels may both be altered, possibly leading to loss of efficacy or toxicity (i.e. increased bleeding).

Apixaban: avoid concurrent use with strong CYP3A4 and P‑gp inhibitors. If treating VTE, avoid use with strong CYP3A4 and P‑gp inducers. 

Rivaroxaban: avoid concurrent use with strong CYP3A4 and P‑gp  inhibitors.

Dabigatran: avoid combination with strong P‑gp inducers and inhibitors.

If concurrent use is unavoidable, monitor closely for efficacy/toxicity of both drugs.
Digoxin Anti-cancer drugs can damage the lining of the intestine; affecting the absorption of digoxin. Monitor digoxin serum levels; adjust digoxin dosage as appropriate.
Antiepileptics Both altered antiepileptic and anti-cancer drug levels may occur, possibly leading to loss of efficacy or toxicity. Where concurrent use of an enzyme-inducing antiepileptic cannot be avoided, monitor antiepileptic serum levels for toxicity, as well as seizure frequency for efficacy; adjust dosage as appropriate.
Also monitor closely for efficacy of the anti-cancer therapy.
Antiplatelet agents and NSAIDs Increased risk of bleeding due to treatment related thrombocytopenia. Avoid or minimise combination.
If combination deemed essential, (e.g. low dose aspirin for ischaemic heart disease) monitor for signs of bleeding.
Serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs e.g. paroxetine) and serotonin noradrenaline reuptake inhibitors (SNRIs e.g. venlafaxine) Increased risk of serotonin syndrome with concurrent use of 5-HT3 receptor antagonists (e.g. palonosetron, ondansetron, granisetron, tropisetron, dolasetron, etc.) Avoid combination.
If combination is clinically warranted, monitor for signs and symptoms of serotonin syndrome (e.g. confusion, agitation, tachycardia, hyperreflexia).
For more information link to TGA Medicines Safety Update
Vaccines Diminished response to vaccines and increased risk of infection with live vaccines. Live vaccines (e.g. BCG, MMR, zoster and varicella) are contraindicated in patients on immunosuppressive therapy. Use with caution in patients on non-immunosuppressive therapy.
For more information; refer to the recommended schedule of vaccination for cancer patients, as outlined in the Australian Immunisation Handbook

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA website for further information.

Day 1

Approximate treatment time: 4 to 5 hours

General patient assessment prior to each day of treatment.

Any toxicity grade 2 or greater may require delay of treatment and review by medical officer before commencing treatment.

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

  • baseline weight

Rituximab

Prior to administration:
  • check baseline observations
  • check for previous adverse events during previous infusions
  • verify premedication has been taken. If not, administer 30 to 60 minutes prior to rituximab administration:
    • paracetamol 1000 mg orally AND
    • loratadine 10 mg orally (or similar antihistamine)
    • a steroid may also be included as a premed according to local guidelines
Initial infusion:
  • commence rituximab infusion at 50 mg/hr for 30 minutes
  • repeat observations prior to each rate increase
  • increase rate by 50 mg/hr every 30 minutes, up to a maximum of 400 mg/hr if observations are stable
  • flush with ~ 100 mL of sodium chloride 0.9%

If an infusion reaction occurs, temporarily discontinue the infusion and notify medical officer

  • when symptoms have completely resolved, recommence the infusion at half the rate prior to the reaction
  • for severe reactions stop infusion and manage as per emergency

Transient hypotension may occur. Consider withholding antihypertensive medication for 12 hours before and during infusion.

Subsequent infusions:

If an adverse event was experienced with initial infusion recommence infusion at the same rate as initial infusion

  • commence rituximab infusion at 100 mg/hr
  • repeat observations prior to each rate increase
  • increase rate by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr if observations are stable
  • flush with ~ 100 mL of sodium chloride 0.9%

If an infusion reaction occurs, temporarily discontinue the infusion and notify medical officer

  • when symptoms have resolved, recommence the infusion at half the rate prior to the reaction
  • for severe reactions stop infusion and manage as per emergency

Read more about rapid infusion rituximab

Read more about subcutaneous rituximab

Remove IV cannula and/or deaccess TIVAD or CVAD. 

Continue safe handling precautions (reproductive risk only) for 7 days after completion of drug(s).

Day 2

Approximate treatment time: 3 to 4 hours 

General patient assessment prior to each day of treatment.

Any toxicity grade 2 or greater may require delay of treatment and review by medical officer before commencing treatment.

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

  • continue daily weigh 

Hydration if prescribed.

Polatuzumab vedotin

Prior to administration:
  • check baseline observations
  • verify premedication has been taken. If not, administer 30 to 60 minutes prior to polatuzumab vedotin administration:
    • paracetamol 1000 mg orally AND
    • loratadine 10 mg orally (or similar antihistamine)
Initial infusion (irritant):
  • via IV infusion over 90 minutes
  • use a dedicated infusion line with a sterile, non-pyrogenic, low-protein binding 0.2 or 0.22 micron in-line or add-on filter
  • flush with ~ 50 mL of sodium chloride 0.9%
  • monitor patient for infusion related reactions during the infusion and for at least 90 minutes following completion of the initial dose.

If a patient experiences any grade infusion related reaction (IRR) during infusion, adjust the infusion as outlined below:

Grade 4 (life threatening)

  • stop infusion and permanently discontinue therapy

Grade 1- 3

  • temporarily interrupt infusion and treat symptoms
  • for the first instance of Grade 3 wheezing, bronchospasm, or generalised urticaria, permanently discontinue therapy
  • for recurrent Grade 2 wheezing or urticaria, or for recurrence of any Grade 3 symptoms, permanently discontinue therapy.
  • Otherwise, upon resolution of symptoms, restart the infusion at half the previous rate (the rate being used at the time that the IRR occurred).
  • In the absence of IRR, the rate of infusion may be escalated in increments of 50 mg/hour every 30 minutes.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Bendamustine

Prior to administration check:
  • blood pressure (hypertensive crisis has been reported with bendamustine, hypertension should be well controlled prior to treatment with bendamustine)
  • baseline ECG, then regularly throughout treatment for patients with cardiac disorders
  • monitor potassium levels throughout treatment, potassium supplements must be given when K+ < 3.5 mEq/L.
Administer bendamustine (irritant with vesicant properties):
  • via IV infusion over 30 to 60 minutes
  • flush with ~ 100 mL of sodium chloride 0.9%

Stop infusion at first sign of reaction:

  • if symptoms are mild and resolve when infusion is stopped, consider recommencing infusion after review by medical officer at a slower rate.
  • for severe reactions seek medical assistance immediately and do not restart infusion
  • hypersensitivity are more common after the first cycle

Remove IV cannula and/or deaccess TIVAD or CVAD. 

Continue safe handling precautions until 7 days after completion of drug(s)

Day 3

Approximate treatment time: 1.5 to 2 hours

General patient assessment prior to each day of treatment.

Any toxicity grade 2 or greater may require delay of treatment and review by medical officer before commencing treatment.

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

  • continue daily weigh 

Hydration if prescribed.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Bendamustine

Prior to administration check:
  • blood pressure (hypertensive crisis has been reported with bendamustine, hypertension should be well controlled prior to treatment with bendamustine)
  • baseline ECG, then regularly throughout treatment for patients with cardiac disorders
  • monitor potassium levels throughout treatment, potassium supplements must be given when K+ < 3.5 mEq/L.
Administer bendamustine (irritant with vesicant properties):
  • via IV infusion over 30 to 60 minutes
  • flush with ~ 100 mL of sodium chloride 0.9%

Stop infusion at first sign of reaction:

  • if symptoms are mild and resolve when infusion is stopped, consider recommencing infusion after review by medical officer at a slower rate.
  • for severe reactions seek medical assistance immediately and do not restart infusion
  • hypersensitivity are more common after the first cycle

Remove IV cannula and/or deaccess TIVAD or CVAD. 

Continue safe handling precautions until 7 days after completion of drug(s)

Discharge information

Antiemetics
  • Antiemetics as prescribed.
Prophylaxis medications
  • Prophylaxis medications (if prescribed) i.e. tumour lysis prophylaxis, PJP prophylaxis, antifungals, antivirals.
Patient information
  • Ensure patient receives patient information sheet.

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA website for further information.

Day 1

Approximate treatment time: 4 to 5 hours

General patient assessment prior to each day of treatment.

Any toxicity grade 2 or greater may require delay of treatment and review by medical officer before commencing treatment.

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

  • baseline weight

Rituximab

Prior to administration:
  • check baseline observations
  • check for previous adverse events during previous infusions
  • verify premedication has been taken. If not, administer 30 to 60 minutes prior to rituximab administration:
    • paracetamol 1000 mg orally AND
    • loratadine 10 mg orally (or similar antihistamine)
    • a steroid may also be included as a premed according to local guidelines
Initial infusion:
  • commence rituximab infusion at 50 mg/hr for 30 minutes
  • repeat observations prior to each rate increase
  • increase rate by 50 mg/hr every 30 minutes, up to a maximum of 400 mg/hr if observations are stable
  • flush with ~ 100 mL of sodium chloride 0.9%

If an infusion reaction occurs, temporarily discontinue the infusion and notify medical officer

  • when symptoms have completely resolved, recommence the infusion at half the rate prior to the reaction
  • for severe reactions stop infusion and manage as per emergency

Transient hypotension may occur. Consider withholding antihypertensive medication for 12 hours before and during infusion.

Subsequent infusions:

If an adverse event was experienced with initial infusion recommence infusion at the same rate as initial infusion

  • commence rituximab infusion at 100 mg/hr
  • repeat observations prior to each rate increase
  • increase rate by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr if observations are stable
  • flush with ~ 100 mL of sodium chloride 0.9%

If an infusion reaction occurs, temporarily discontinue the infusion and notify medical officer

  • when symptoms have resolved, recommence the infusion at half the rate prior to the reaction
  • for severe reactions stop infusion and manage as per emergency

Read more about rapid infusion rituximab

Read more about subcutaneous rituximab

Polatuzumab vedotin

Prior to administration:
  • check baseline observations
  • check for previous adverse events during previous infusions
  • verify premedication has been taken. If not, administer 30 to 60 minutes prior to polatuzumab vedotin administration:
    • paracetamol 1000 mg orally AND
    • loratadine 10 mg orally (or similar antihistamine) 
Subsequent infusions (irritant): 

If no infusion related reactions (IRR) occurred with the previous infusion:

  • via IV infusion over 30 minutes
  • use a dedicated infusion line with a sterile, non-pyrogenic, low-protein binding 0.2 or 0.22 micron in-line or add-on filter
  • flush with ~ 50 mL of sodium chloride 0.9%
  • monitor patient for infusion related reactions  during the infusion and for at least 30 minutes following completion.

If a Grade 1 IRR or higher occurred with the previous infusion administer therapy as per initial infusion instructions.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Bendamustine

Prior to administration check:
  • blood pressure (hypertensive crisis has been reported with bendamustine, hypertension should be well controlled prior to treatment with bendamustine)
  • baseline ECG, then regularly throughout treatment for patients with cardiac disorders
  • monitor potassium levels throughout treatment, potassium supplements must be given when K+ < 3.5 mEq/L.
Administer bendamustine (irritant with vesicant properties):
  • via IV infusion over 30 to 60 minutes
  • flush with ~ 100 mL of sodium chloride 0.9%

Stop infusion at first sign of reaction:

  • if symptoms are mild and resolve when infusion is stopped, consider recommencing infusion after review by medical officer at a slower rate.
  • for severe reactions seek medical assistance immediately and do not restart infusion
  • hypersensitivity are more common after the first cycle

Remove IV cannula and/or deaccess TIVAD or CVAD. 

Continue safe handling precautions until 7 days after completion of drug(s)

Day 2

Approximate treatment time: 60 minutes

General patient assessment prior to each day of treatment.

Any toxicity grade 2 or greater may require delay of treatment and review by medical officer before commencing treatment.

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

  • continue daily weigh 

Hydration if prescribed.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Bendamustine

Prior to administration check:
  • blood pressure (hypertensive crisis has been reported with bendamustine, hypertension should be well controlled prior to treatment with bendamustine)
  • baseline ECG, then regularly throughout treatment for patients with cardiac disorders
  • monitor potassium levels throughout treatment, potassium supplements must be given when K+ < 3.5 mEq/L.
Administer bendamustine (irritant with vesicant properties):
  • via IV infusion over 30 to 60 minutes
  • flush with ~ 100 mL of sodium chloride 0.9%

Stop infusion at first sign of reaction:

  • if symptoms are mild and resolve when infusion is stopped, consider recommencing infusion after review by medical officer at a slower rate.
  • for severe reactions seek medical assistance immediately and do not restart infusion
  • hypersensitivity are more common after the first cycle

Remove IV cannula and/or deaccess TIVAD or CVAD. 

Continue safe handling precautions until 7 days after completion of drug(s)

Discharge information

Antiemetics
  • Antiemetics as prescribed.
Prophylaxis medications
  • Prophylaxis medications (if prescribed) i.e. tumour lysis prophylaxis, PJP prophylaxis, antifungals, antivirals.
Patient information
  • Ensure patient receives patient information sheet.

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

Immediate (onset hours to days)
Hypersensitivity reaction

Anaphylaxis and infusion related reactions can occur with this treatment.

Read more about hypersensitivity reaction 
Extravasation, tissue or vein injury

The unintentional instillation or leakage of a drug or substance out of a blood vessel into surrounding tissue. This has the potential to cause damage to affected tissue.

Read more about extravasation management
Flu-like symptoms
Headache
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Taste and smell alteration

Read more about taste and smell changes

Early (onset days to weeks)
Anaemia

Abnormally low levels of red blood cells (RBCs) or haemoglobin in the blood. 

Read more about anaemia
Neutropenia

Abnormally low levels of neutrophils in the blood. This increases the risk of infection. Any fever or suspicion of infection should be investigated immediately and managed aggressively. 

Read more about immediate management of neutropenic fever
Thrombocytopenia

A reduction in the normal levels of functional platelets, increasing the risk of abnormal bleeding.  

Read more about thrombocytopenia
Abdominal pain

Dull ache, cramping or sharp pains are common with some anti-cancer drugs. These are caused by either increased or decreased gastrointestinal motility and can be associated with diarrhoea or constipation.
Anorexia

Loss of appetite accompanied by decreased food intake.

Read more about anorexia
Arthralgia and myalgia

Generalised joint pain or and/or stiffness and muscle aches, often worse upon waking or after long periods of inactivity. Can improve with movement. May be mild or severe, intermittent or constant and accompanied by inflammation. 

Read more about arthralgia and myalgia
Constipation
Diarrhoea

Read more about treatment induced diarrhoea
Fatigue

Read more about fatigue
Fluid retention and oedema

An excess amount of fluid around the cells, tissues or serous cavities of the body, leading to swelling.
Injection-site reaction

Inflammation of or damage to the tissue surrounding the area where a drug was injected.
Peripheral neuropathy

Typically symmetrical sensory neuropathy, affecting the fingers and toes, sometimes progressing to the hands and feet.  It is associated with several classes of anti-cancer drugs. These include taxanes, platinum-based compounds, vinca alkaloids and some drugs used to treat multiple myeloma.

Read more about peripheral neuropathy
Skin rash

Anti-cancer drugs can cause a number of changes in the skin with maculo-papular rash the most common type of drug-induced skin reaction. 

Read more about skin rash

Late (onset weeks to months)
Progressive multifocal leukoencephalopathy (PML)

A rare opportunistic viral infection of the brain, usually leading to death or severe disability, can occur with monoclonal antibodies (e.g. rituximab, obinutuzumab, ofatumumab, brentuximab vedotin) and other targeted therapies (e.g. ibrutinib, ruxolitinib, idelalisib). Onset may occur up to months after the final dose.  

Read more about progressive multifocal leukoencephalopathy (PML)

The evidence supporting this protocol is provided by a phase II multicentre, randomised international trial (NCT01287741, hereafter known as GO29365). This trial was conducted in patients with transplant-ineligible, relapsed or refractory DLBCL, including patients who experienced treatment failure with prior ASCT.r Trial design included a randomly assigned cohort of 80 patients (40 per treatment arm) in which polatuzumab vedotin, bendamustine and rituximab (Pola-BR) was compared with bendamustine and rituximab (BR) alone.

Between October 15, 2014, and June 10, 2016, 40 patients were randomised to receive Pola-BR (bendamustine 90 mg/m2 intravenously (IV) on days 2 and 3 of cycle 1 and then on days 1 and 2 of subsequent cycles, rituximab IV 375 mg/m2 on day 1 of each cycle and polatuzumab vedotin 1.8 mg/kg IV on day 2 of cycle 1 and day 1 of subsequent cycles) for up to six 21-day cycles and 40 patients were randomised to receive BR (bendamustine 90 mg/m2 IV on days 2 and 3 of cycle 1 and then on days 1 and 2 of subsequent cycles and rituximab IV 375 mg/m2 on day 1 of each cycle) for up to six 21-day cycles.

The median age of patients was 67 years in the Pola-BR arm and 71 years in the BR arm. The median number of prior lines of therapy was 2, with most patients refractory to the last treatment (75% Pola-BR; 85% BR). The primary endpoint was the complete response rate (CRR) of Pola-BR versus BR, as measured by PET-CT using modified Lugano Response Criteria at the end of treatment (EOT). EOT was 6-8 weeks after cycle 6 day 1 or last dose of study treatment and secondary endpoints included overall response rate at end of treatment, best overall response, duration of response, and progression free survival (PFS). Improved outcomes were observed in patients receiving Pola-BR compared with BR in the activated B-cell–like (ABC) and germinal center B-cell–like (GCB) subgroups of patients and in double expressor and non-double expressor patients.

The same group later reported on an extension single-arm cohort of 106 additional patients, compared with the same original control arm, allowing analysis of the largest cohort to date of 151 patients. The baseline characteristics in the extension cohort were similar to the randomised Pola-BR cohort, with some exceptions. Although the median age was similar between the two groups, the proportion of patients aged 65 years or older was 73% in the extension cohort compared to 58% in the randomised Pola-BR cohort. While the majority of patients in the randomised arm and extension cohort had lymphoma that was refractory to the last treatment, the extension cohort included more patients with primary refractory lymphomas (69%) compared to the Pola-BR randomised group (53%).r

In another multicenter, open-label, single arm, phase 2 study by Terui et alr (hereafter known as P-DRIVE), the BR arm of GO29365 was used as the historical control and included 35 patients with relapsed or refractory DLBCL who were ineligible for autologous stem cell transplant (ASCT). Reasons for ineligibility for ASCT were age (n = 23), insufficient response to salvage therapy (n = 7), patient refused transplant (n = 5), and failure of prior autologous haematopoietic transplant (n = 3).

Between October 19, 2018 and July 23, 2019, 35 patients (median age 71 [range 46-86] years), were enrolled, and received up to six 21-day cycles of Pola-BR (bendamustine 90 mg/m2 IV on days 2 and 3 of cycle 1 and then on days 1 and 2 of subsequent cycles; rituximab 375 mg/m2 IV on day 1 of each cycle; polatuzumab vedotin1.8 mg/kg IV on day 2 of cycle 1 and on day 1 of subsequent cycles). All patients received prophylactic granulocyte colony-stimulating factor (G-CSF or peg G-CSF); dose and form were at the discretion of the investigator. The number of patients who were refractory to the last prior anti-lymphoma therapy was 23 (66%). The median number of prior lines of therapy was 2 (range 1-7), and 23 (66%) patients had received more than two prior lines of therapy. The primary endpoint was the CRR to Pola-BR, as measured by [18F] fluorodeoxyglucose PET-CT using modified Lugano Response Criteria at EOT (6-8 weeks after the last dose of study treatment).

In a retrospective analysis by Liebers et alr, polatuzumab vedotin was investigated as a salvage and bridging treatment in relapsed or refractory large B-cell lymphomas. In this study, 105 patients received polatuzumab vedotin alongside chemoimmunotherapy, 54 patients received salvage treatment with a polatuzumab- containing regimen and 51 patients were treated with a polatuzumab- containing regimen with the intention of bridging to a cellular immunotherapy such as allogeneic stem cell transplant (n=10) or CAR T-cell therapy (n=41). Patients in the bridging cohort were significantly younger (median age 61 years) than patients in the salvage cohort (median age 73.5 years), had more often undergone a prior autologous stem cell transplantation, and tended to have a shorter interval between diagnosis and study entry. In both cohorts, patients were heavily pre-treated with a median of 3 prior treatment lines (range, 2-8) and the majority of patients were refractory to their last treatment line (bridging cohort: 84.3%; salvage cohort: 87%).

Source Study & Year Published Supports Use Is the dose and regimen consistent with the protocol? Comments
Phase II trials

Sehn et al. 2019r

Sehn at al. 2021r

Terui et al. 2021r

 Yes  Yes  -
Case series Liebers et al. 2021r Yes Yes - 
Observational studies N/A  N/A  N/A  -
Guidelines Date published/revised  Supports Use Is the dose and regimen consistent with the protocol? Comments
NCCN v.5.2019  Yes Yes  -
BCCA N/A  N/A  N/A  -
CCO Yes  Yes  Yes  -

Efficacy

In GO29365, primary analysis showed significantly higher independent review committee (IRC) assessed complete response rates (CRR) at end of treatment with Pola-BR versus BR (40.0% v 17.5%; P = 0.026). After a median follow up of 27 months, overall survival (OS) was significantly improved in the Pola-BR arm, with risk of death reduced by 58% (HR: 0.42; 95% CI, 0.24 to 0.75; P = 0.002) and a longer median OS with Pola-BR (12.4 months; 95% CI, 9.0 to not evaluable) compared with BR alone (4.7 months; 95% CI, 3.7 to 8.3 months).r

Longer term follow up was recently published and the benefit of Pola-BR versus BR persisted in the randomised arms (median PFS: 9.2 vs 3.7 months, HR: 0.42; 95% CI, 0.25 to 0.71; median OS: 12.4 vs 4.7 months, HR: 0.42; 95% CI, 0.24 to 0.72). Including the later extension cohort (total of 151 patients inclusive), the IRC-assessed objective response rate was 41.5% and CR rate was 38.7%; the median IRC-assessed PFS and OS were 6.6 months and 12.5 months, respectively.r

Summary of Efficacy Outcomes

(A) Progression-free survival by independent review committee. (B) Progression-free survival by investigator. (C) Overall survival of polatuzumab vedotin combined with bendamustine-obinutuzumab (pola-BR) compared with bendamustine-rituximab (BR). (D) Forest plot of overall survival according to clinical and biologic characteristics. 

© JCO 2019

However, upon submission to the Pharmaceutical Benefits Advisory Committee for PBS listing, concerns over the validity of the GO29365 study results arose. These were due to differences between the control arm and the intervention arm, where age (71 vs. 67), rate of IPI >3 (42.5% vs. 22.5%), and disease bulk (37.5% vs. 25%) appeared to consign the control arm to perform poorly. The CRR for the control arm was closer to the lower end of historical CRR for BR used in the relapsed setting, ranging from 15.3% (Vacirca et al)r to 37.3% (Ohmachi et al)r. As a result, PBS listing for polatuzumab vedotin was not granted, thereby limiting its use in the Australian context.

In the P-DRIVE study, the overall response rate at end-of-treatment (EOT) by modified Lugano response criteria based on PET-CT was 42.9% (95% CI, 26.3 to 60.7), with a CR achieved in 34.3% (95% CI, 19.1 to 52.2). At a median follow-up of 5.4 months, median duration of response (DOR), progression free survival (PFS), and event-free survival (EFS) were 6.6 months, 5.2 months, and 5.1 months, respectively.r The lower limit of the 95% CI for P-DRIVE (19.1%) was higher than that of the BR arm of GO29365 (17.5%), and as such the trial met its primary objective.

Progression-free survival and overall survival (ITT population)

(A) Progression-free survival by investigator based on PET-CT or CT.. (B) Overall survival. ITT, intention-to-treat; OS, overall survival; PET-CT, positron emission tomography–computed tomography; pola + BR, polatuzumab vedotin + bendamustine + rituximab; PFS, progression-free survival.

© Cancer Sci 2021

In the retrospective analysis of polatuzumab vedotin as a salvage and bridging treatment in relapsed or refractory large B-cell lymphomas, Liebers et alr demonstrated a best overall response rate of 48.1%. The 6-month progression-free survival and overall survival (OS) rates were 27.7% and 49.6%, respectively. In the bridging cohort, 51.2% of patients could be successfully bridged with polatuzumab vedotin to the intended CAR T-cell therapy. The combination of polatuzumab vedotin bridging and successful CAR T-cell therapy resulted in an impressive 6-month OS of 77.9%.

Outcome of patients in the bridging cohort

(A) Actual treatment of patients intended for CAR T-cell therapy and (B) overall survival of patients who received the intended CAR T-cell therapy after polatuzumab vedotin (pola) bridging. (C-D) Intent-to-treat-analysis with progression-free survival and overall survival of complete bridging cohort intended for CAR T-cell therapy. Survival times were calculated from the initiation of pola treatment. For the estimation of progression-free survival, data were only assessed in the efficacy-evaluable population. Three patients had no response evaluation and were excluded from the progression-free survival estimation.

© Blood Advances 2021

Toxicity

Although rates of grade 3-4 anaemia and thrombocytopenia were higher with Pola-BR, transfusion rates were similar between treatment arms. Rates of grade 3-4 anaemia was similar between studies (37% in P-DRIVE, 28.2% in the Pola-BR arm in GO29365), though thrombocytopenia was lower in P-DRIVE compared to the Pola-BR arm in GO29365 (20% vs. 41% respectively).

In an updated report of the GO29365 study on a total of 151 patients (original and extension cohorts combined), 80 patients (53.0%) discontinued treatment with polatuzumab vedotin early. The most common reason for treatment discontinuation was progressive disease (PD) (n = 40; 26.5%). Bendamustine was discontinued in 54.3% of patients, and rituximab was discontinued in 53.0% of patients in the pooled Pola-BR cohort. PD was also the most common reason for bendamustine (26.5%) and rituximab (26.5%) treatment discontinuation.r

The overall incidence of peripheral neuropathy (PN) in GO29365 was higher in the Pola-BR patients 43.6% (grade 2, n = 6 and grade 1, n = 11) versus 7.7%. In the Pola-BR group resolution of PN was seen in 10 patients and improvement in 1 patient. In this study, PN was the only reason for polatuzumab vedotin dose reduction, which occurred in 2 patients (5.1%; both grade 2 PN), and in both cases, the PN resolved. In P-DRIVE, neuropathy occurred at a rate of 22.9%, (grade 2, n = 2 and grade 1, n = 3). One patient discontinued the drug due to neuropathy alongside fatigue.

The proportions of patients with ECOG PS 2 and IPI scores of ≥3 at enrolment were 20.0% and 72.5% in the BR arm of GO29365 and 8.6% and 51.4% in the current study, respectively. The percentages of patients with a duration of response to last treatment ≤12 months were 82.5% in the BR arm of GO29365 and 74.3% in P-DRIVE. The median number of lines of prior therapies was two in the BR arm of both the GO29365 and the P-DRIVE study. The percentages of refractory patients were 85.0% in the BR arm of GO29365 and 65.7% in the P-DRIVE study. Yet, the percentages of patients completing six cycles of all treatments were 23.1% in the BR arm of GO29365 and 40% in the P-DRIVE study.

In GO29365, fatal outcomes occurred in 9 Pola-BR patients and 11 BR patients, with infection being the most common cause (4 Pola-BR; 4 BR). There were no deaths attributed to adverse reactions in P-DRIVE. 

Table 1: GO29365 study: Adverse events in patients treated with Pola-BR compared with BR

© JCO 2019

Tbale 2: P-DRIVE study: Adverse events by highest NCI CTCAE grade (safety-evaluable population)

© Cancer Sci 2021

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Version 3

Date Summary of changes
22/10/2021

Evidence updated & protocol reviewed at the Haematology Reference Committee meeting. Title amended to comply with eviQ naming convention. Number of cycles clarified for "up to 6". Version number changed to v.3. Review in 2 years.
31/08/2022 Polatuzumab vedotin extravasation category updated to align with extravasation clinical resources update.

Version 2

Date Summary of changes
15/07/2020

Updated premedication for day 1 of cycle 2 to 6. For review in 1 year. 
14/08/2020 Irradiated blood components added to clinical information. 
01/10/2021 Drug status updated: rituximab SC is TGA registered but no longer PBS listed.

Version 1

Date Summary of changes
17/04/2020

New protocol presented at the Haematology reference committee meeting and approved for publication. For review in 1 year. 

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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31 Mar 2023