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Non-Hodgkin lymphoma O-CHOP21 (oBINUTUZumab CYCLOPHOSPHamide DOXOrubicin vinCRISTine prednisolone)

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

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
Prednisolone 100 mg ONCE a day PO 1 to 5
oBINUTUZumab 1,000 mg IV infusion 1
DOXOrubicin 50 mg/m2 IV 1
vinCRISTine 1.4 mg/m2 (Cap dose at 2 mg) IV infusion 1
CYCLOPHOSPHamide 750 mg/m2 IV infusion 1
oBINUTUZumab 1,000 mg IV infusion 8 and 15

Cycle 2 to 6

Drug Dose Route Day
Prednisolone 100 mg ONCE a day PO 1 to 5
oBINUTUZumab 1,000 mg IV infusion 1
DOXOrubicin 50 mg/m2 IV 1
vinCRISTine 1.4 mg/m2 (Cap dose at 2 mg) IV infusion 1
CYCLOPHOSPHamide 750 mg/m2 IV infusion 1
Frequency:
21 days 
Cycles:
6 , followed by 2 additional cycles of obinutuzumab alone.
Drug status:

Obinutuzumab: (PBS authority)

All other drugs in this protocol are on the PBS general schedule

Cost:
~ $20,770 per cycle "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au), MIMS Online and other sources. These costs are reviewed and updated on eviQ at 6 monthly intervals.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

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
Prednisolone 100 mg (PO) ONCE a day on days 1 to 5.* Take in the morning with food.
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment
oBINUTUZumab 1,000 mg (IV infusion) in 250 mL sodium chloride 0.9%. Start at 50 mg/hr. Rate can be increased by 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
DOXOrubicin 50 mg/m2 (IV) over 5 to 15 minutes
vinCRISTine 1.4 mg/m2 (IV infusion) (Cap dose at 2 mg) in 50 mL sodium chloride 0.9% over 5 to 10 minutes

via minibag
CYCLOPHOSPHamide 750 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes
Day 2 to 5
Prednisolone 100 mg (PO) ONCE a day on days 1 to 5.* Take in the morning with food.
Day 8 and 15
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment.**May be omitted - please see below for criteria.
Dexamethasone 20 mg (IV) 60 minutes before treatment. ** May be omitted - please see below for criteria.
oBINUTUZumab 1,000 mg (IV infusion) in 250 mL sodium chloride 0.9%. Start at 100 mg/hr. Rate can be increased by 100 mg/hr every 30 minutes, to a maximum of 400 mg/hr. ***

Cycle 2 to 6

Day 1
Prednisolone 100 mg (PO) ONCE a day on days 1 to 5.* Take in the morning with food.
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment. ** May be omitted - please see below for criteria.
oBINUTUZumab 1,000 mg (IV infusion) in 250 mL sodium chloride 0.9%. Start at 100 mg/hr. Rate can be increased by 100 mg/hr every 30 minutes, to a maximum of 400 mg/hr. ***
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
DOXOrubicin 50 mg/m2 (IV) over 5 to 15 minutes
vinCRISTine 1.4 mg/m2 (IV infusion) (Cap dose at 2 mg) in 50 mL sodium chloride 0.9% over 5 to 10 minutes

via minibag
CYCLOPHOSPHamide 750 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes
Day 2 to 5
Prednisolone 100 mg (PO) ONCE a day on days 1 to 5.* Take in the morning with food.

* Dose for day 1 should be taken 60 minutes before obinutuzumab infusion.

** For subsequent obinutuzumab infusions (cycle 1, day 8 onwards):

  • Antihistamine premedication may be omitted for subsequent infusions if no infusion related reactions (IRR) occurred with the previous infusion.
  • Intravenous corticosteroid premedication may be omitted for subsequent infusions if no grade 1 or 2 IRR occurred with the previous infusion. If a grade 3 IRR occurred OR lymphocyte count > 25 x109/L prior to next treatment, intravenous corticosteroid premedication should be continued.

*** If the patient experienced a grade 2 or higher infusion related reaction during the previous administration, commence at 50 mg/hr. The rate of infusion should be titrated up at 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.

Frequency:
21 days 
Cycles:
6 , followed by 2 additional cycles of obinutuzumab alone.

Cycle 1

Drug Dose Route Day
Prednisolone 100 mg ONCE a day PO 1 to 5
oBINUTUZumab 1,000 mg IV infusion 1
DOXOrubicin 50 mg/m2 IV 1
vinCRISTine 1.4 mg/m2 (Cap dose at 2 mg) IV infusion 1
CYCLOPHOSPHamide 750 mg/m2 IV infusion 1
oBINUTUZumab 1,000 mg IV infusion 8 and 15

Cycle 2 to 6

Drug Dose Route Day
Prednisolone 100 mg ONCE a day PO 1 to 5
oBINUTUZumab 1,000 mg IV infusion 1
DOXOrubicin 50 mg/m2 IV 1
vinCRISTine 1.4 mg/m2 (Cap dose at 2 mg) IV infusion 1
CYCLOPHOSPHamide 750 mg/m2 IV infusion 1
Frequency:
21 days 
Cycles:
6 , followed by 2 additional cycles of obinutuzumab alone.
Drug status:

Obinutuzumab: (PBS authority)

All other drugs in this protocol are on the PBS general schedule

Cost:
~ $20,770 per cycle "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au), MIMS Online and other sources. These costs are reviewed and updated on eviQ at 6 monthly intervals.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

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
Prednisolone 100 mg (PO) ONCE a day on days 1 to 5.* Take in the morning with food.
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment
oBINUTUZumab 1,000 mg (IV infusion) in 250 mL sodium chloride 0.9%. Start at 50 mg/hr. Rate can be increased by 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
DOXOrubicin 50 mg/m2 (IV) over 5 to 15 minutes
vinCRISTine 1.4 mg/m2 (IV infusion) (Cap dose at 2 mg) in 50 mL sodium chloride 0.9% over 5 to 10 minutes

via minibag
CYCLOPHOSPHamide 750 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes
Day 2 to 5
Prednisolone 100 mg (PO) ONCE a day on days 1 to 5.* Take in the morning with food.
Day 8 and 15
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment.**May be omitted - please see below for criteria.
Dexamethasone 20 mg (IV) 60 minutes before treatment. ** May be omitted - please see below for criteria.
oBINUTUZumab 1,000 mg (IV infusion) in 250 mL sodium chloride 0.9%. Start at 100 mg/hr. Rate can be increased by 100 mg/hr every 30 minutes, to a maximum of 400 mg/hr. ***

Cycle 2 to 6

Day 1
Prednisolone 100 mg (PO) ONCE a day on days 1 to 5.* Take in the morning with food.
Paracetamol 1,000 mg (PO) 60 minutes before treatment
Loratadine 10 mg (PO) 60 minutes before treatment. ** May be omitted - please see below for criteria.
oBINUTUZumab 1,000 mg (IV infusion) in 250 mL sodium chloride 0.9%. Start at 100 mg/hr. Rate can be increased by 100 mg/hr every 30 minutes, to a maximum of 400 mg/hr. ***
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
DOXOrubicin 50 mg/m2 (IV) over 5 to 15 minutes
vinCRISTine 1.4 mg/m2 (IV infusion) (Cap dose at 2 mg) in 50 mL sodium chloride 0.9% over 5 to 10 minutes

via minibag
CYCLOPHOSPHamide 750 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 30 to 60 minutes
Day 2 to 5
Prednisolone 100 mg (PO) ONCE a day on days 1 to 5.* Take in the morning with food.

* Dose for day 1 should be taken 60 minutes before obinutuzumab infusion.

** For subsequent obinutuzumab infusions (cycle 1, day 8 onwards):

  • Antihistamine premedication may be omitted for subsequent infusions if no infusion related reactions (IRR) occurred with the previous infusion.
  • Intravenous corticosteroid premedication may be omitted for subsequent infusions if no grade 1 or 2 IRR occurred with the previous infusion. If a grade 3 IRR occurred OR lymphocyte count > 25 x109/L prior to next treatment, intravenous corticosteroid premedication should be continued.

*** If the patient experienced a grade 2 or higher infusion related reaction during the previous administration, commence at 50 mg/hr. The rate of infusion should be titrated up at 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.

Frequency:
21 days 
Cycles:
6 , followed by 2 additional cycles of obinutuzumab alone.
  • Previously untreated CD20-positive follicular lymphoma
Safety alert vincristine administration

For safe administration of vincristine refer to the safety alert issued by the Australian Commission on Safety and Quality in Health Care
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 obinutuzumab.
Premedication

The product information states that the premedication for obinutuzumab should consist of an analgesic/antipyretic, an antihistamine and an intravenous corticosteroid for the first initial dose.

For subsequent infusions:

  • Antihistamine premedication may be omitted for subsequent infusions if no infusion related reactions (IRR) occurred with the previous infusion.
  • Intravenous corticosteroid* premedication may be omitted for subsequent infusions if no grade 1 or 2 infusion related reactions (IRR) occurred with the previous infusion. If a grade 3 IRR occurred OR lymphocyte counts > 25 x109/L prior to next treatment, intravenous corticosteroid premedication should be continued.
  • Analgesic/antipyretic premedication is given before all infusions.

A suggested default premedication has been added to the treatment schedule, and may be substituted to reflect institutional policy.

Note: hydrocortisone is not recommended as it has not been effective in reducing the rate of infusion reactions.

* IV corticosteroid (may be substituted by oral corticosteroids if contained within the chemotherapy regimen)
Emetogenicity MODERATE

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

As a steroid has been included as part of this protocol, additional antiemetic steroids are not required.

For patients with a prior episode of chemotherapy induced nausea or vomiting, a NK1 receptor antagonist may be available on the PBS in combination with a 5HT3 antagonist and steroid.

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
Cumulative lifetime dose of anthracyclines

Cumulative doses should take into account all previous anthracyclines received during a patient’s lifetime (i.e. daunorubicin, doxorubicin, epirubicin, idarubicin and mitoxantrone). 

Criteria for reducing the total anthracycline cumulative lifetime dose include:

  • patient is elderly
  • prior mediastinal radiation
  • hypertensive cardiomegaly
  • concurrent therapy with high dose cyclophosphamide and some other cytotoxic drugs (e.g. bleomycin, dacarbazine, dactinomycin, etoposide, melphalan, mitomycin and vincristine).

Baseline clinical assessments include echocardiogram (ECHO) or gated heart pool scan (GHPS) and electrocardiogram (ECG) evaluation.

Patients with normal baseline cardiac function (left ventricular ejection fraction (LVEF) > 50%) and low risk patients require LVEF monitoring when greater than 70% of the anthracycline threshold is reached or if the patient displays symptoms of cardiac impairment. Post-treatment cardiac monitoring is recommended for patients who have received high levels of total cumulative doses of anthracyclines at the clinician's discretion.

Read more about cardiac toxicity associated with anthracyclines
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.
Obinutuzumab short duration infusion (SDI)

Administration of obinutuzumab by short duration infusion is not in line with the product monograph, however published literature indicates that it can be completed safely in patients who meet the appropriate criteria.

Read more about obinutuzumab short duration infusion
Peripheral neuropathy

Assess prior to each treatment. Based on clinical findings, temporary omission, dose reduction or cessation of the vinca alkaloid may be indicated; review by medical officer before commencing treatment.

Read more about peripheral neuropathy

Link to chemotherapy-induced peripheral neuropathy screening tool
Constipation

Prescribe prophylactic laxatives to prevent constipation related to the use of vinca alkaloids.
Corticosteroids

Diabetic patients should monitor their blood glucose levels closely. To minimise gastric irritation, advise patient to take immediately after food. Consider the use of a H2 antagonist or proton pump inhibitor if appropriate.

Read more about acute short term effects from corticosteroids
Thrombocytopenia

Severe and life-threatening thrombocytopenia, including acute thrombocytopenia (occurring within 24 hours after the infusion), has been observed during treatment with obinutuzumab. Fatal haemorrhagic events have also been reported in cycle one of treatment.

Patients should be closely monitored for thrombocytopenia throughout treatment, especially during the first cycle.
Correlating the timing of thrombocytopenia after obinutuzumab can assist in differentiating from other causes.
In clinical trials, thrombocytopenia was reported in 10.4% of patients treated with obinutuzumab.
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
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
Blood tests

FBC, EUC, LFTs, LDH and BSL at baseline, prior to each treatment, 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, Platelets x 109/L (pre-treatment blood test) 
ANC less than 1.0 and/or platelets less than 75 Dose modification is not generally indicated. Consider treatment delay and/or add G-CSF
Renal impairment
Creatinine clearance (mL/min)
10 to 50 No reduction
less than 10 Reduce cyclophosphamide by 25%
Hepatic impairment
Bilirubin (micromol/L)
20 to 50 Reduce doxorubicin by 50%
51 to 85 Reduce doxorubicin by 75%
greater than 85 Omit doxorubicin

Note: Consider reducing vincristine dose for hepatic impairment.

Peripheral neuropathy
Grade 2 Consider omitting vincristine

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:  

Cyclophosphamide
  Interaction Clinical management
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Increased toxicity of cyclophosphamide possible due to increased conversion to active (and inactive) metabolites Avoid combination or monitor for cyclophosphamide toxicity
CYP3A4 inhibitors (e.g. aprepitant, azole antifungals, clarithromycin, erythromycin, grapefruit juice, ritonavir etc.) Reduced efficacy of cyclophosphamide possible due to decreased conversion to active (and inactive) metabolites Avoid combination or monitor for decreased clinical response to cyclophosphamide
Amiodarone Possible additive pulmonary toxicity with high-dose cyclophosphamide (i.e. doses used prior to stem cell transplant; 60 mg/kg daily or 120 to 270 mg/kg over a few days) Avoid combination or monitor closely for pulmonary toxicity
Allopurinol, hydrochlorothiazide, indapamide Delayed effect. Increased risk of bone marrow depression; probably due to reduced clearance of active metabolites of cyclophosphamide Avoid combination, consider alternative antihypertensive therapy or monitor for myelosuppression
Ciclosporin Reduced efficacy of ciclosporin due to reduced serum concentration Monitor ciclosporin levels; adjust dosage as appropriate; monitor response to ciclosporin
Suxamethonium Prolonged apnoea due to marked and persistent inhibition of cholinesterase by cyclophosphamide Alert the anaesthetist if a patient has been treated with cyclophosphamide within ten days of planned general anaesthesia
Doxorubicin
  Interaction Clinical management
Cardiotoxic drugs (eg. bevacizumab, calcium channel blockers, propranolol, trastuzumab) Increased risk of doxorubicin-induced cardiotoxicity Avoid combination or monitor closely for cardiotoxicity
Cyclophosphamide Sensitises the heart to the cardiotoxic effects of doxorubicin; also, doxorubicin may exacerbate cyclophosphamide induced cystitis Monitor closely for cardiotoxicity and ensure adequate prophylaxis for haemorrhagic cystitis when combination is used
Glucosamine Reduced efficacy of doxorubicin (due to induction of glucose-regulated stress proteins resulting in decreased expression of topoisomerase II in vitro) The clinical effect of glucosamine taken orally is unknown. Avoid combination or monitor for decreased clinical response to doxorubicin
CYP2D6 inhibitors (e.g. SSRIs (esp. paroxetine), perhexiline, cinacalcet, doxepin, flecainide, quinine, terbinafine) Increased toxicity of doxorubicin possible due to reduced clearance Monitor for doxorubicin toxicity
CYP3A4 inhibitors (e.g. aprepitant, azole antifungals, clarithromycin, erythromycin, grapefruit juice, ritonavir etc.) Increased toxicity of doxorubicin possible due to reduced clearance Monitor for doxorubicin toxicity
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John's wort etc.) Reduced efficacy of doxorubicin possible due to increased clearance Monitor for decreased clinical response to doxorubicin
Prednisolone
  Interaction Clinical management
Antidiabetic agents (e.g. insulin, glibenclamide, glicazide, metformin, pioglitazone, etc) The efficacy of antidiabetic agents may be decreased Use with caution and monitor blood glucose
Azole antifungals (e.g. fluconazole, itraconazole, ketoconazole, posaconazole) Increased toxicity of prednisolone possible due to reduced clearance Avoid combination or monitor for prednisolone toxicity
Oestrogens (e.g. oral contraceptives) Increased toxicity of prednisolone possible due to reduced clearance Avoid combination or monitor for prednisolone toxicity. Dose reduction of prednisolone may be required
Ritonavir Increased toxicity of prednisolone possible due to reduced clearance Avoid combination or monitor for prednisolone toxicity
Obinutuzumab
  Interaction Clinical management
Antihypertensives Additive hypotensive effect Consider withholding antihypertensive medications 12 hours prior to, throughout and 1 hour after the obinutuzumab infusion
Vincristine
  Interaction Clinical management
CYP3A4 and P-gp inhibitors (e.g. amiodarone, aprepitant, azole-antifungals, ritonavir, lapatinib, nilotinib, sorafenib, macrolides, ciclosporin, grapefruit juice etc.) Increased toxicity of vincristine possible due to reduced clearance Monitor for vincristine toxicity (esp. neurotoxicity, paralytic ileus)
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Reduced efficacy of vincristine possible due to increased clearance Monitor for decreased clinical response to vincristine
Mitomycin Acute shortness of breath and severe bronchospasm has occurred following use of vincristine in patients who had received mitomycin simultaneously or within 2 weeks Use combination with caution
Ototoxic drugs (e.g. cisplatin, aminoglycosides, frusemide, NSAIDs) Additive ototoxicity Avoid combination or perform regular audiometric testing
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: 8 hours (initial); 4 to 6 hours (subsequent) 

General patient assessment prior to each day of treatment.

Peripheral neuropathy assessment tool

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

Prime IV line(s) with sodium chloride 0.9%.

Insert IV cannula or access TIVAD or CVAD.

  • baseline weight

Hydration if prescribed

Prednisolone

  • administer orally ONCE a day on days 1 to 5
  • to be taken in the morning with or immediately after food

Note: if a dose is forgotten or vomited, contact treating team.

Obinutuzumab 

Prior to administration:
  • check baseline observations
  • check for previous adverse events with drug infusions
  • verify premedication has been taken. If not, administer 60 minutes prior to obinutuzumab administration:
    • paracetamol 1000 mg orally AND
    • loratadine 10 mg orally (or similar antihistamine)
    • IV corticosteroid (may be substituted by oral corticosteroids if contained within the chemotherapy regimen)
Initial infusion:
  • commence obinutuzumab infusion at 50 mg/hr for 30 minutes
  • repeat observations prior to each rate increase
  • increase rate by 50 mg/hr every 30 minutes to a maximum of 400 mg/hr if observations are stable
  • flush with ~ 100 mL of sodium chloride 0.9%

Hypotension may occur during obinutuzumab intravenous infusion. Consider withholding antihypertensive medication for 12 hours before and throughout each infusion.

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 3 (severe)

  • temporarily interrupt infusion and treat symptoms
  • upon resolution of symptoms, restart the infusion at no more than half the previous rate (the rate being used at the time that the IRR occurred)
  • if patient dose not experience any further IRR symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment dose.
  • stop infusion and permanently discontinue therapy if patients experience a second occurrence of a grade 3 IRR

Grade 1-2 (mild to moderate)

  • reduce infusion rate and treat symptoms
  • upon resolution of symptoms, continue infusion
  • if patient dose not experience any IRR symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment dose.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Doxorubicin

Administer doxorubicin (vesicant):
  • over 5 to 15 minutes
    • via a minibag OR
    • by IV bolus via a side port of a freely flowing IV infusion
  • ensure vein is patent and monitor for signs of extravasation throughout administration
  • flush with ~150 mL of sodium chloride 0.9%
  • potential for flare reaction during administration of doxorubicin (facial flushing and red streaking along the vein) stop infusion and exclude extravasation before continuing at a slower rate of infusion.

Although rare, cardiac arrhythmias may occur during or immediately after doxorubicin administration. If sudden onset of dyspnoea, palpitations or irregular pulse occurs, stop administration immediately and obtain urgent medical officer review.

Vincristine

Administer vincristine (vesicant)
  • via a minibag over 5 to 10 minutes
  • ensure vein is patent and monitor for signs of extravasation throughout administration
  • flush with ~150 mL of sodium chloride 0.9%.

Cyclophosphamide

Administer cyclophosphamide:
  • via IV infusion over 30 to 60 minutes
  • flush with ~ 50 mL of sodium chloride 0.9%
  • rapid infusion can cause dizziness, rhinitis, nausea and perioral numbness. If symptoms develop, slow infusion rate.

Remove IV cannula and/or deaccess TIVAD or CVAD. 

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

Days 8, 15

General patient assessment prior to each day of treatment.

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

Prime IV line(s) with sodium chloride 0.9%.

Insert IV cannula or access TIVAD or CVAD.

  • weigh patient before each treatment 

Obinutuzumab

Prior to administration:
  • check baseline observations
  • check for previous adverse events with drug infusions
  • verify premedication has been taken. If not, administer 60 minutes prior to obinutuzumab administration:
  • paracetamol 1000 mg orally AND
  • loratadine 10 mg orally (or similar antihistamine premedication may be omitted for subsequent infusions if no infusion related reactions (IRR) occurred with the previous infusion)
  • IV corticosteroid if a grade 3 IRR occurred with the previous infusion OR lymphocyte counts > 25 x 109 /L prior to next treatment. 
Subsequent infusions: 

If no IRR or a Grade 1 IRR occurred with the previous infusion:

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

If a Grade 2 IRR or higher occurred with the previous infusion: 

  • commence obinutuzumab infusion at 50 mg/hr 
  • repeat observations prior to each rate increase 
  • increase rate by 50 mg/hr every 30 minutes to a maximum of 400 mg/hr if observations are stable
  • flush with ~100 mL of sodium chloride 0.9%

Hypotension may occur during obinutuzumab intravenous infusion. Consider withholding antihypertensive medication for 12 hours before and throughout each infusion. 

Remove IV cannula and/or deaccess TIVAD or CVAD. 

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

Discharge information

Prednisolone tablets
  • Prednisolone tablets with written instructions on how to take them.
Antiemetics
  • Antiemetics as prescribed.
Laxatives
  • Ensure patient has prophylactic laxatives.
Growth factor support
  • Arrangements for administration if 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: 8 hours (initial); 4 to 6 hours (subsequent) 

General patient assessment prior to each day of treatment.

Peripheral neuropathy assessment tool

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

Prime IV line(s) with sodium chloride 0.9%.

Insert IV cannula or access TIVAD or CVAD.

  • weigh patient on each visit 

Prednisolone

  • administer orally ONCE a day on days 1 to 5
  • to be taken in the morning with or immediately after food

Note: if a dose is forgotten or vomited, contact treating team.

Obinutuzumab

Prior to administration:
  • check baseline observations
  • check for previous adverse events with drug infusions
  • verify premedication has been taken. If not, administer 60 minutes prior to obinutuzumab administration:
  • paracetamol 1000 mg orally AND
  • loratadine 10 mg orally (or similar antihistamine premedication may be omitted for subsequent infusions if no infusion related reactions (IRR) occurred with the previous infusion)
  • IV corticosteroid if a grade 3 IRR occurred with the previous infusion OR lymphocyte counts > 25 x 109 /L prior to next treatment. 
Subsequent infusions: 

If no IRR or a Grade 1 IRR occurred with the previous infusion:

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

If a Grade 2 IRR or higher occurred with the previous infusion: 

  • commence obinutuzumab infusion at 50 mg/hr 
  • repeat observations prior to each rate increase 
  • increase rate by 50 mg/hr every 30 minutes to a maximum of 400 mg/hr if observations are stable
  • flush with ~100 mL of sodium chloride 0.9%

Hypotension may occur during obinutuzumab intravenous infusion. Consider withholding antihypertensive medication for 12 hours before and throughout each infusion. 

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Doxorubicin

Administer doxorubicin (vesicant):
  • over 5 to 15 minutes
    • via a minibag OR
    • by IV bolus via a side port of a freely flowing IV infusion
  • ensure vein is patent and monitor for signs of extravasation throughout administration
  • flush with ~150 mL of sodium chloride 0.9%
  • potential for flare reaction during administration of doxorubicin (facial flushing and red streaking along the vein) stop infusion and exclude extravasation before continuing at a slower rate of infusion.

Although rare, cardiac arrhythmias may occur during or immediately after doxorubicin administration. If sudden onset of dyspnoea, palpitations or irregular pulse occurs, stop administration immediately and obtain urgent medical officer review.

Vincristine

Administer vincristine (vesicant)
  • via a minibag over 5 to 10 minutes
  • ensure vein is patent and monitor for signs of extravasation throughout administration
  • flush with ~150 mL of sodium chloride 0.9%.

Cyclophosphamide

Administer cyclophosphamide:
  • via IV infusion over 30 to 60 minutes
  • flush with ~ 50 mL of sodium chloride 0.9%
  • rapid infusion can cause dizziness, rhinitis, nausea and perioral numbness. If symptoms develop, slow infusion rate.

Remove IV cannula and/or deaccess TIVAD or CVAD. 

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

Discharge information

Prednisolone tablets
  • Prednisolone tablets with written instructions on how to take them.
Antiemetics
  • Antiemetics as prescribed.
Laxatives
  • Ensure patient has prophylactic laxatives.
Growth factor support
  • Arrangements for administration if 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 
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
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
Flare reaction

Anthracycline flare reaction is caused by a localised allergic reaction. It is characterised by erythematous vein streaking, urticaria and pruritus which may occur during drug administration and is often associated with too rapid an infusion. Extravasation must be ruled out if flare occurs.
Flu-like symptoms
Hypotension

Low blood pressure can occur with this treatment.
Red-orange discolouration of urine

Pink/red/orange discolouration of the urine. This can last for up to 48 hours after some anthracycline drugs.
Taste and smell alteration

Read more about taste and smell changes

Early (onset days to weeks)
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
Constipation
Fatigue

Read more about fatigue
Haemorrhagic cystitis

An inflammatory process, characterised by diffuse mucosal inflammation with haemorrhage involving the entire bladder. Patients are at risk following treatment with cyclophosphamide, ifosfamide and radiation therapy. 

Read more about haemorrhagic cystitis
Oral mucositis

Erythematous and ulcerative lesions of the gastrointestinal tract (GIT). It commonly develops following chemotherapy, radiation therapy to the head, neck or oesophagus, and high dose chemotherapy followed by a blood and marrow transplant (BMT).

Read more about oral mucositis
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
Side effects of corticosteroids

Insomnia, oedema, increased risk of infection e.g. oral thrush, gastric irritation, worsening of peptic ulcer disease, increased blood sugar levels, loss of diabetic control, mood and behavioural changes - including anxiety, euphoria, depression, mood swings, increased appetite and weight gain, osteoporosis and fractures (long term use), bruising and skin fragility are associated with corticosteroid use.

Late (onset weeks to months)
Alopecia

Hair loss may occur from all parts of the body. Patients can also experience mild to moderate discomfort of the hair follicles, and rarely pain as the hair is falling out.

Read more about alopecia
Anaemia

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

Read more about anaemia
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)

Delayed (onset months to years)
Cardiotoxicity

Anthracyclines are the most frequently implicated anti-cancer drugs associated with cardiotoxicity, which typically manifests as a reduction in left ventricular ejection fraction (LVEF), cardiomyopathy, or symptomatic CHF. Anthracycline induced cardiotoxicity has been categorised into acute, early-onset chronic progressive and late-onset chronic progressive and is usually not reversible. The risk of clinical cardiotoxicity increases with a number of risk factors including higher total cumulative doses. 

Read more about cardiac toxicity associated with anthracyclines
Pulmonary toxicity

Pulmonary toxicity may include damage to the lungs, airways, pleura and pulmonary circulation. 

Read more about pulmonary toxicity associated with anti-cancer drugs

The evidence of Obinutuzumab-CHOP is predominantly derived from the multicentre phase 3, open labelled GALLIUM study, which compared the combination of obinutuzumab-chemotherapy (G-chemo) versus rituximab-chemotherapy (R-chemo) in previously untreated advanced stage follicular lymphoma. It has limitations when it comes to comparing the different chemotherapy backbones as patients were not randomly assigned to each chemotherapy backbone. 

1202 patients were randomised 1:1 to receive either G-chemo or R-chemo. The choice of chemotherapy regimen was left to investigators discretion between cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP); cyclophosphamide, vincristine, and prednisone (CVP); or bendamustine. Responding patients (complete or partial response at the end of induction) continued on to receive maintenance treatment with the same antibody treatment every 2 months for 2 years, until disease progression or withdrawal from the trial. r

Primary end point was progression free survival (PFS) and secondary end points included overall response (OR) rate at the end of induction therapy, event-free survival, disease-free survival, duration of response, overall survival (OS), time to new anti-lymphoma treatment (TTNAT), and safety.r

Baseline data of each chemotherapy backbone showed some notable differences between groups. More patients receiving CHOP were in the FLIPI high-risk group (47% compared to 40% in bendamustine and 35% in CVP). Patients in the bendamustine arm had more comorbidities (24% with Charlson comorbid index score ≥1 v 17% [CHOP] and 19% [CVP]). There was a higher population patient’s ≥ 80 years in the bendamustine and CVP group (3% in both groups) compared to CHOP (1%).r

A secondary analysis of the GALLIUM study was conducted to evaluate the prognostic value of PET-CT responses after first-line immunochemotherapy in the GALLIUM study. As per protocol, during the trial, PET scans (mandatory in the first 170 patients enrolled at sites with available PET facilities, and optional thereafter), acquired at baseline and end of induction, were assessed prospectively by investigators and an independent review committee (IRC). Pet scans were done in 669 (65%) of 1029 patients enrolled after July 26, 2011, at 103 of the 177 recruiting centres. Results from the investigators and IRC found that PET is a better imaging modality with better predictive ability than contrast-enhanced CT for response assessment.r

Efficacy

After a median follow up of 41.1 months, there was a significant increase in PFS in patients treated with G-chemo compared to R-chemo (HR, 0.68; 95% CI, 0.54 to 0.87; P =0.0016). There was no overall survival benefit seen between these 2 groups. TTNAT was slightly better in the G-chemo group with 14% needing the next line of treatment compared to 20% in the R-chemo group (HR 0.68, 95% CI 0.52-0.90, p=0.007).r Complete response or partial response rate was not significantly different between the two groups regardless of whether CT imaging or CT plus PET was used.rr

The benefit of obinutuzumab over rituximab was seen with all three chemotherapy backbones with Hazard ratios for investigator-assessed PFS of 0.63 (95% CI, 0.46 to 0.88) for bendamustine, 0.72 (0.48 to 1.10) for CHOP, and 0.79 (0.42 to 1.47) for CVP.r  

© Journal of Clinical Oncology 2018

In the previously untreated DLBCL setting, the safety and efficacy of G-CHOP vs. R-CHOP was compared in the randomised phase 3 GOYA study. 1418 patients were randomised 1:1. Both Investigator (INV) and Independent Review Committee (IRC) found no clinically significant difference in 3 year PFS between G-CHOP and R-CHOP (69% vs. 66% INV; 72% vs. 71% IRC).r

Toxicity

Patients on G-CHOP experienced higher numbers of grade 3-5 adverse events compared to G-CVP / G-Bendamustine. However, these were mainly driven by cytopenias. Infection rates appear to be higher in the bendamustine group.r

© Journal of Clinical Oncology 2018

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Version 2

Date Summary of changes
16/05/2022 "Obinutuzumab short duration infusion" block added to clinical information. Version number changed to v.2
11/11/2022 Protocol reviewed electronically by the Haematology Reference Committee, nil changes. Review in 2 years

Version 1

Date Summary of changes
11/03/2019

New protocol developed out of session, discussed by Haematology reference committee electronically via email.
29/03/2019 Protocol approved and published on eviQ v.1. Review in 1 year. 
10/10/2019 Clinical information updated with PBS expanded indications for G-CSF. 
15/04/2020 Evidence updated. Protocol for review in 2 years. 
21/01/2022 Note added to dose modifications.
24/01/2022 Pulmonary toxicity added to side effects.

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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https://www.eviq.org.au/p/3573

31 Mar 2023