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Hodgkin lymphoma ChlVPP (chlorambucil vinBLASTine procarbazine 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 to 6

Drug Dose Route Day
Prednisolone 40 mg/m2 ONCE a day (Cap dose at 60 mg) PO 1 to 14
vinBLASTine 6 mg/m2 (Cap dose at 10 mg) IV 1 and 8
Procarbazine 100 mg/m2 ONCE a day (Cap dose at 150 mg) PO 1 to 14
Chlorambucil 6 mg/m2 ONCE a day (Cap dose at 10 mg) PO 1 to 14
Frequency:
28 days 
Cycles:
6 to 8 cycles (complete remission + 2 cycles)
Notes:

Consider commencing with procarbazine 50 mg and increasing gradually by 50 mg increments after 5 to 6 days until full dose is reached as per procarbazine product information.

Drug status:

Chlorambucil, vinblastine and prednisolone are on the PBS general schedule

Procarbazine: TGA registered for this indication but not PBS reimbursed

Chlorambucil is available as 2 mg tablets
Procarbazine is available as 50 mg capsules
Prednisolone is available as 25 mg, 5 mg and 1 mg tablets

Cost:
~ $790 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 to 6

Day 1
Granisetron 2 mg (PO) 60 minutes before chemotherapy. A dose reduction and/or omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment.
Prednisolone 40 mg/m2 (PO) (Cap dose at 60 mg) ONCE a day on days 1 to 14. Take in the morning with food.
vinBLASTine 6 mg/m2 (IV) (Cap dose at 10 mg) in 50 mL sodium chloride 0.9% over 5 to 10 minutes
Procarbazine 100 mg/m2 (PO) (Cap dose at 150 mg) ONCE a day on days 1 to 14.
Chlorambucil 6 mg/m2 (PO) (Cap dose at 10 mg) ONCE a day on days 1 to 14.
Day 2 to 7
Granisetron 2 mg (PO) 60 minutes before chemotherapy. A dose reduction and/or omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment.
Prednisolone 40 mg/m2 (PO) (Cap dose at 60 mg) ONCE a day on days 1 to 14. Take in the morning with food.
Procarbazine 100 mg/m2 (PO) (Cap dose at 150 mg) ONCE a day on days 1 to 14.
Chlorambucil 6 mg/m2 (PO) (Cap dose at 10 mg) ONCE a day on days 1 to 14.
Day 8
Granisetron 2 mg (PO) 60 minutes before chemotherapy. A dose reduction and/or omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment.
Prednisolone 40 mg/m2 (PO) (Cap dose at 60 mg) ONCE a day on days 1 to 14. Take in the morning with food.
vinBLASTine 6 mg/m2 (IV) (Cap dose at 10 mg) in 50 mL sodium chloride 0.9% over 5 to 10 minutes
Procarbazine 100 mg/m2 (PO) (Cap dose at 150 mg) ONCE a day on days 1 to 14.
Chlorambucil 6 mg/m2 (PO) (Cap dose at 10 mg) ONCE a day on days 1 to 14.
Day 9 to 14
Granisetron 2 mg (PO) 60 minutes before chemotherapy. A dose reduction and/or omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment.
Prednisolone 40 mg/m2 (PO) (Cap dose at 60 mg) ONCE a day on days 1 to 14. Take in the morning with food.
Procarbazine 100 mg/m2 (PO) (Cap dose at 150 mg) ONCE a day on days 1 to 14.
Chlorambucil 6 mg/m2 (PO) (Cap dose at 10 mg) ONCE a day on days 1 to 14.
Frequency:
28 days 
Cycles:
6 to 8 cycles (complete remission + 2 cycles)

Cycle 1 to 6

Drug Dose Route Day
Prednisolone 40 mg/m2 ONCE a day (Cap dose at 60 mg) PO 1 to 14
vinBLASTine 6 mg/m2 (Cap dose at 10 mg) IV 1 and 8
Procarbazine 100 mg/m2 ONCE a day (Cap dose at 150 mg) PO 1 to 14
Chlorambucil 6 mg/m2 ONCE a day (Cap dose at 10 mg) PO 1 to 14
Frequency:
28 days 
Cycles:
6 to 8 cycles (complete remission + 2 cycles)
Notes:

Consider commencing with procarbazine 50 mg and increasing gradually by 50 mg increments after 5 to 6 days until full dose is reached as per procarbazine product information.

Drug status:

Chlorambucil, vinblastine and prednisolone are on the PBS general schedule

Procarbazine: TGA registered for this indication but not PBS reimbursed

Chlorambucil is available as 2 mg tablets
Procarbazine is available as 50 mg capsules
Prednisolone is available as 25 mg, 5 mg and 1 mg tablets

Cost:
~ $790 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 to 6

Day 1
Granisetron 2 mg (PO) 60 minutes before chemotherapy. A dose reduction and/or omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment.
Prednisolone 40 mg/m2 (PO) (Cap dose at 60 mg) ONCE a day on days 1 to 14. Take in the morning with food.
vinBLASTine 6 mg/m2 (IV) (Cap dose at 10 mg) in 50 mL sodium chloride 0.9% over 5 to 10 minutes
Procarbazine 100 mg/m2 (PO) (Cap dose at 150 mg) ONCE a day on days 1 to 14.
Chlorambucil 6 mg/m2 (PO) (Cap dose at 10 mg) ONCE a day on days 1 to 14.
Day 2 to 7
Granisetron 2 mg (PO) 60 minutes before chemotherapy. A dose reduction and/or omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment.
Prednisolone 40 mg/m2 (PO) (Cap dose at 60 mg) ONCE a day on days 1 to 14. Take in the morning with food.
Procarbazine 100 mg/m2 (PO) (Cap dose at 150 mg) ONCE a day on days 1 to 14.
Chlorambucil 6 mg/m2 (PO) (Cap dose at 10 mg) ONCE a day on days 1 to 14.
Day 8
Granisetron 2 mg (PO) 60 minutes before chemotherapy. A dose reduction and/or omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment.
Prednisolone 40 mg/m2 (PO) (Cap dose at 60 mg) ONCE a day on days 1 to 14. Take in the morning with food.
vinBLASTine 6 mg/m2 (IV) (Cap dose at 10 mg) in 50 mL sodium chloride 0.9% over 5 to 10 minutes
Procarbazine 100 mg/m2 (PO) (Cap dose at 150 mg) ONCE a day on days 1 to 14.
Chlorambucil 6 mg/m2 (PO) (Cap dose at 10 mg) ONCE a day on days 1 to 14.
Day 9 to 14
Granisetron 2 mg (PO) 60 minutes before chemotherapy. A dose reduction and/or omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment.
Prednisolone 40 mg/m2 (PO) (Cap dose at 60 mg) ONCE a day on days 1 to 14. Take in the morning with food.
Procarbazine 100 mg/m2 (PO) (Cap dose at 150 mg) ONCE a day on days 1 to 14.
Chlorambucil 6 mg/m2 (PO) (Cap dose at 10 mg) ONCE a day on days 1 to 14.
Frequency:
28 days 
Cycles:
6 to 8 cycles (complete remission + 2 cycles)
Caution with oral anti-cancer drugs

Select links for information on the safe prescribing, dispensing and administration of orally administered anti-cancer drugs. 

Read more about the COSA guidelines and oral anti-cancer therapy
Procarbazine oral administration

Procarbazine is a weak monoamine oxidase inhibitor (MAOI) and has the potential to interact with certain medications, alcohol and food. For further information see Interactions section of the protocol.
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
Antiemetics for multi-day protocols

Antiemetic therapy should be administered throughout the duration of the chemotherapy protocol and to cover delayed nausea. The acute and delayed emetic risk of multi-day chemotherapy protocols will overlap depending on the individual drugs and their sequence of administration. More or less antiemetic cover may be required. 

MASCC Guidelines 2016 classify procarbazine as HIGHLY emetogenic, but in clinical practice a moderate antiemetic regimen may be sufficient to control nausea and/or vomiting. Omission of 5HT3 antagonist for subsequent doses of procarbazine may be considered depending on the patient's emetogenic response to the treatment

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.

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
Seizure risk

Chlorambucil is epileptogenic. Patients with a history of seizures or head trauma, or on other epileptogenic medications may be at increased risk of seizures with chlorambucil.

Read more about drugs that may cause seizures
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
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
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
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 and Platelets x 109/L (pre-treatment blood test)
ANC less than or equal to 1.5 and/or platelets less than or equal to 100 Delay treatment until recovery
Renal impairment
Creatinine clearance (mL/min)
Patients with impaired renal function should be closely monitored as they are susceptible to myelosuppression from chlorambucil
less than 30 Reduce chlorambucil by 50%. Consider dose reduction of procarbazine.
Hepatic impairment
Hepatic dysfunction
Mild Reduce vinblastine by 25%
Moderate Reduce vinblastine by 50%
Severe Omit vinblastine. Consider dose reduction of chlorambucil.
Peripheral neuropathy
Grade 2 which is present at the start of the next cycle Dose reduce or omit vinblastine

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:  

Chlorambucil
No specific clinically significant drug-drug interactions
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
Procarbazine
  Interaction Clinical management
CNS depressants (including opiates, opioids, phenothiazines) Additive CNS depressant effects (e.g. drowsiness, ataxia) Avoid combination or monitor for excessive CNS depression
Alcohol Disulfiram-like reaction (can include copious vomiting, dyspnoea, syncope) and increased sedation Patients should abstain from alcohol during and for one week after completing treatment with procarbazine
Anti-depressants (including SSRIs, tricyclics, monoamine oxidase inhibitors (MAO-Is)), other MAO-Is (e.g. linezolid, selegiline), serotonergic agents (e.g. 'triptans', tramadol, pethidine, St John's wort) Serotonin syndrome (hypertension, hyperthermia, agitation, hallucinations, rigidity, hyperreflexia, diaphoresis, tremor etc.) may be precipitated due to weak monoamine oxidase inhibition by procarbazine Avoid combination
Sympathomimetic agents (e.g. pseudoephedrine and other cold and flu medications, stimulants such as guarana, some appetite suppressants) Hypertensive crisis (headache, hyperpyrexia, hypertension) may be precipitated due to weak monoamine oxidase inhibition by procarbazine Avoid combination
Tyramine-rich foods (e.g. aged cheeses, yoghurt, cured meats, liver, pickled herrings, over-ripe bananas, avocados and yeast extracts such as Vegemite® and Marmite®) Hypertensive crisis (headache, hyperpyrexia, hypertension) may be precipitated due to weak monoamine oxidase inhibition by procarbazine Patients should be advised to avoid excessive consumption of tyramine-rich foods while taking procarbazine; total abstinence is not considered necessary
Oral hypoglycaemics Hypoglycaemia

(MAO-Is can stimulate insulin secretion; procarbazine is a weak MAO-I)		 Monitor blood glucose levels. Adjustment of the dose of antidiabetic medication may be required
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Increased risk of hypersensitivity reactions due to increased production of the reactive metabolite of procarbazine thought to be responsible Avoid combination; select alternative antiepileptic (e.g. clonazepam, diazepam, lorazepam) or monitor for hypersensitivity reaction
Vinblastine
  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 vinblastine possible due to reduced clearance Monitor for vinblastine toxicity (esp. neurotoxicity, adynamic ileus)
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Reduced efficacy of vinblastine possible due to increased clearance Monitor for decreased clinical response to vinblastine
Drugs undergoing P-gp-mediated elimination (e.g. dabigatran, loperamide, phenytoin etc.) Reduced efficacy of these drugs possible due to induction of P-gp by vinblastine resulting in increased clearance Avoid combination or monitor for decreased clinical response to interacting drugs
Mitomycin Increased risk of pulmonary toxicity when vinblastine administered following or concomitantly with mitomycin Avoid combination or monitor closely for pulmonary toxicity (i.e. interstitial infiltrates, pleural effusion resulting in respiratory distress and cough)
Ototoxic drugs (e.g. cisplatin, aminoglycosides, frusemide, NSAIDs) Additive ototoxicity (as reported with other vinca alkaloids) 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 to 14 (PO)

This is an oral treatment

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.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Prednisolone

  • administer orally ONCE a day on days 1 to 14
  • to be taken in the morning with or after food

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

Chlorambucil

  • administer orally ONCE a day on days 1 to 14
  • to be swallowed whole with a glass of water; do not break, crush or chew
  • to be taken on an empty stomach, one hour before or three hours after food
  • may be given in divided doses if nausea is a problem
  • chlorambucil tablets should be stored in the fridge (2 to 8 degrees C).

Note: missed doses should not be replaced; if a dose is forgotten or vomited, normal dosing should be resumed at the next scheduled dose.

Procarbazine

  • administer orally ONCE a day on days 1 to 14
  • to be swallowed whole with a glass of water; do not break, crush or chew
  • can be taken with food or on an empty stomach.

Note: missed doses should not be replaced; if a capsule is forgotten or vomited, consult treating team. If treating team unavailable, advise patient that normal dosing should be resumed at the next scheduled dose.

Patients should be advised to avoid alcohol and large amounts of tyramine-rich foods  (e.g. aged cheeses, cured meats, yeast extracts such as Vegemite® etc) while taking procarbazine.

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

Day 1 and 8 (IV)

Approximate treatment time: 30 minutes

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).

Insert IV cannula or access TIVAD or CVAD.

  • weigh patient on each visit
  • urinalysis each visit

Hydration if prescribed.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Vinblastine

Administer vinblastine (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%.

Remove IV cannula and/or deaccess TIVAD or CVAD. 

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

Discharge information

Procarbazine capsules, prednisolone and chlorambucil tablets 
  • Procarbazine capsules, prednisolone and chlorambucil 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, 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)
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
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Flu-like symptoms
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
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
Constipation
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.
Fatigue

Read more about fatigue
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)
Anaemia

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

Read more about anaemia
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
Cognitive changes (chemo fog)

Changes in cognition characterised by memory loss, forgetfulness and feeling vague. This is also referred to as 'chemo brain' or 'chemo fog'.

Read more about cognitive changes (chemo fog) 

Delayed (onset months to years)
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

A retrospective analysis of 960 patients from four research groupsr demonstrated comparable results in younger patients when compared to published results for MOPP. ChlVPP was better tolerated, but it should be noted that many patients also received radiation therapy. In a randomised trial of 100 patients with advanced Hodgkin's lymphomar ChlVPP had comparable efficacy to ChlVPP alternating with ABOD (doxorubicin, bleomycin, vincristine and dacarbazine).

Efficacy

The results of the 3 largest studies are tabulated below, but appear comparably efficacious. It was noted that patients over the age of 50 did less well than those under 50 years of age and another regimen should be considered.

Selby et alr No prior treatment (%) Prior radiation therapy (%)
complete remission (CR) 85 91
10 year probability of survival 65 64
10 year probability of CR 71 68
Holte et alr ChlVPP (%) ChlVPP/ABOD (%)
complete remission 80 80
5 year overall survival 87 74
5 year relapse free survival 76 73
Stager Complete remission (%) 5 year failure free survival (%) 5 year overall survival (%)
IA 84 78 82
IIA 89 73 85
IB/IIA 77 62 69
IIIA 89 67 78
IIIA less than 50 years 94 76 88
IIIA greater than or equal to 50 years 75 39 44
IIIB/IV 72 51 63
IVA less than 50 years 84 72 82
IVB less than 50 years 77 58 71
IVA greater than or equal to 50 years 67 45 47
IVB greater than or equal to 50 years 55 26 36

International ChlVPP groupr

Toxicity

The International ChlVPP Treatment Groupr found that there were decreased acute toxicities (in particular nausea/vomiting, alopecia and peripheral neuropathy) associated with ChlVPP compared to MOPP. With a median follow up of 92 months, Selby et alr encountered 2 cases of acute myeloid leukaemia that were seen at 7.5 and 8.7 years. The actuarial risk of secondary leukaemia was 2.7% at 10 years. Twelve other second cancers were noted: one malignant melanoma, one stomach cancer, two carcinoma of the bronchus, one non-Hodgkin's lymphoma, one breast, one pancreas and five basal cell carcinomas. The actuarial risk of any second malignancy is 8.3% at 10 years. Toxicities from Selby et alr are tabulated below.

Toxicityr Grade 1 to 2 (%) Grade 3 to 4 (%)
Anaemia 29 0
Leucopenia 41 9
Thrombocytopenia 18 4.5
Nausea and vomiting 31 2
Alopecia 6.5 0.5
Neuropathy 14 0
Infection 17 3
Diarrhoea 3 0
Stomatitis 2.5 0
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Bibliography

Swerdlow, A. J., J. A. Barber, A. Horwich, et al. 1997. "Second malignancy in patients with Hodgkin's disease treated at the Royal Marsden Hospital." Br.J.Cancer. 75(1):116-123.

Risk of second primary malignancy was assessed in follow-up to June 1991 of 1039 patients first treated for Hodgkin's disease at the Royal Marsden Hospital during 1963-91. A total of 77 second malignancies occurred. There were significantly raised risks of stomach [standardized incidence ratio (SIR)=4.0], lung (SIR=3.8), bone (SIR=26.5), soft tissue (SIR=16.9) and non-melanoma skin (SIR=3.9) cancers, non-Hodgkin's lymphoma (SIR=4.6), and acute and non-lymphocytic leukaemia (SIR=31.3), with a relative risk of 3.3 for all second cancers other than non-melanoma skin cancer. Solid cancer risk was raised to a similar extent in patients treated only with radiotherapy (SIR=2.6, P <0.001), only with chemotherapy (SIR=2.1, P=0.08) and with both (SIR=3.1, P <0.001). Leukaemia risk was raised only in those receiving chemotherapy, whether alone or with radiotherapy. The relative risk for solid cancers was much greater in patients who were younger at first treatment (trend P <0.001), whereas leukaemia risk was greatest for those first treated at ages 25-44. For solid cancers (P <0.001) but not leukaemia (P=0.05) there was a strong gradient of greater relative risks at younger attained ages. The relative risk of second cancers overall was 27.5 at ages under 25 and 2.0 at ages 55 and above. Leukaemia and solid cancer risks in patients treated with chlorambucil, vinblastine, procarbazine and prednisone (ChlVPP) were not significantly greater than those in patients treated with mustine, vincristine, procarbazine and prednisone (MOPP). Number of cycles of chemotherapy was significantly related to risk of leukaemia (P <0.001), and there was a trend in the same direction for solid cancers (P=0.07). The study adds to evidence that alkylating chemotherapy may increase the risk of solid cancers, and that ChlVPP does not provide a less carcinogenic alternative to MOPP chemotherapy. The very large relative risks found for solid cancers at young attained ages and in patients treated when young may have important implications as, in the long term, the majority of second malignancies after Hodgkin's disease are solid cancers. The risks of solid malignancies need clarification by larger collaborative epidemiological studies

Vose, J. M., P. J. Bierman, J. R. Anderson, et al. 1991. "CHLVPP chemotherapy with involved-field irradiation for Hodgkin's disease: favorable results with acceptable toxicity." J.Clin Oncol. 9(8):1421-1425.

Patients with Hodgkin's disease who were previously untreated with chemotherapy received the chlorambucil, vinblastine, procarbazine, and prednisone (CHLVPP) regimen plus limited involved-field radiation therapy for treatment of Hodgkin's disease through the Nebraska Lymphoma Study Group. One hundred patients, 87 with newly diagnosed Hodgkin's disease and 13 who relapsed after receiving previous radiation therapy, were treated with this regimen between 1982 and 1989. Complete remissions (CRs) were obtained in 88 of 100 patients (88%), and there have been a total of eight relapses. The overall 3-year failure-free survival was 76%, with good-prognosis patients (i.e., Karnofsky performance status greater than or equal to 80) having a 3-year failure-free survival of 87%. Toxicity with this regimen was minimal, with neutropenic fevers reported in 13% of the patient population, moderate alopecia in 5%, and mild to moderate nausea and vomiting in 11% of the patients. As primary induction therapy for Hodgkin's disease, CHLVPP is an effective regimen with a high patient acceptance profile.

Weekes, C. D., J. M. Vose, J. C. Lynch, et al. 2002. "Hodgkin's disease in the elderly: improved treatment outcome with a doxorubicin-containing regimen." J.Clin Oncol. 20(4):1087-1093.

PURPOSE: Hodgkin's disease (HD) is a malignancy that displays a bimodal age distribution. Previous reports of treatment in patients greater-than-or-equal 60 years have found a poor outcome, particularly in patients with advanced disease. Because of an improved side-effect profile, the regimen of chlorambucil, vinblastine, procarbazine, and prednisone (ChlVPP) has been proposed for use in elderly patients. PATIENTS AND METHODS: From September 1982 to May 1998, 262 patients with previously untreated HD received either ChlVPP (n = 176) or ChlVPP plus doxorubicin/bleomycin/vincristine (ChlVPP/ABV hybrid; n = 86). Fifty-six patients were greater-than-or-equal 60 years old, and 206 were younger than 60 years. RESULTS: The 5-year overall survival (OS; 87% v 39%) and the 5-year event-free survival (EFS; 75% v 31%) favoured patients younger than 60 years of age. Prognostic factors analysed in patients greater-than-or-equal 60 years of age, other than type of therapy, included sex, stage, Karnofsky performance score, lactic dehydrogenase, number of extra nodal sites, B symptoms, size of largest mass, and histologic subtype. In patients older than 60 years, none of the clinical features was a statistically significant predictor of EFS; however, ChlVPP/ABV hybrid was associated with a decreased risk of an event (relative risk, 0.40; 95% confidence interval, 0.19 to 0.83; P =.014) compared with ChlVPP. The 5-year OS for patients greater-than-or-equal 60 years who received ChlVPP was 30%, compared with 67% for those patients receiving the ChlVPP/ABV regimen (P =.0086) CONCLUSION: Patients greater-than-or-equal 60 years with HD who require chemotherapy are better treated with ChlVPP/ABV hybrid than with ChlVPP alone.

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Version 4

Date Summary of changes
09/10/2007 Minor reformatting
22/05/2008 Clarification of drug doses and addition of extra information
02/06/2008 Review and addition of extra information, including missing side effects and special clinical instructions (hepatitis B screening), to increase the comprehensiveness of the protocol
26/06/2008 Rewording of administration of vesicants to the standardised format
29/03/2010 Review of protocol; review of dose modifications; transferred to eviQ
16/03/2011 New format to allow for export of protocol information
Protocol version number changed to V.2
Antiemetics and premedications added to the treatment schedule
Additional Clinical Information, Key Prescribing table and Key Administration table combined into new section titled Clinical Considerations
Drug specific information placed behind the drug name link
19/01/2012 PHC format created
04/06/2012 Palonosetron added as default 5HT3 antagonist antiemetic in treatment schedule
11/10/2013 Reviewed at categorisation meeting, not for review, review in 2 years. PHC view removed.
11/09/2015 Reviewed at RCM, no changes, review in 2 years, updated drug costs
19/09/2016

Updated the volume of vinblastine in 50 mL in the treatment schedule.
31/05/2017

Transferred to new eviQ website. Version number change to V.4.
25/05/2018 Reviewed by Haematology Reference Committee with no significant changes, review in 2 years
10/10/2019 Clinical information updated with PBS expanded indications for G-CSF. 
27/03/2020 Reviewed by Haematology Reference Committee with no changes, review in 2 years
11/11/2022 Protocol electronically reviewed by the Haematology Reference Committee, nil changes.Review in 2 years.

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31 Mar 2023