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Bladder/Urothelial locally advanced or metastatic cARBOplatin and gemcitabine (modified) (day 8 cARBOplatin) SUPERSEDED

This protocol has been superseded because cisplatin/gemcitabine or MVAC regimens have a greater evidence base. However this regimen could be considered if other regimens are contraindicated.

Check for clinical trials in this patient group. Link to Australian Clinical Trials website

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Cycle 1 and further cycles

Drug Dose Route Day
Gemcitabine 1,000 mg/m2 IV infusion 1 and 8
cARBOplatin 5 AUC * IV infusion 8

*if estimated GFR is greater than 125 mL/min (i.e. 5 AUC dose greater than 750 mg), obtaining direct measurement rather than an estimated renal function and/or dose capping is strongly recommended

Frequency:
21 days 
Cycles:
Continuous until disease progression or unacceptable toxicity; usually 6 cycles
Notes:

In this protocol, carboplatin is given on day 8, not day 1 as in the original study, in order that the second dose of gemcitabine need not be delayed or abandoned as a result of haematological toxicities.

Data in clinical trials indicate that carboplatin and gemcitabine may be an alternative to cisplatin-based regimens for the treatment of advanced urothelial cancer, particularly in patients with poor performance status. However, in the absence of randomised studies, carboplatin should not be substituted for cisplatin as a general rule. Carboplatin and gemcitabine should not be used in the adjuvant setting.

Drug status:

All drugs in this protocol are on the PBS general schedule

Cost:
~ $260 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 antineoplastic drugs only (not antiemetics or other supportive medications), 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 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 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 antineoplastic 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 and further cycles

Day 1
Metoclopramide 10 mg (PO)

one tablet when necessary (maximum of 30 mg/24 hours, up to 5 days)
Gemcitabine 1,000 mg/m2 (IV infusion) in 100 mL to 500 mL sodium chloride 0.9% over 30 minutes
Day 8
Dexamethasone 12 mg (PO) 60 minutes before chemotherapy
Netupitant 300 mg (PO)

60 minutes before chemotherapy (fixed dose preparation with palonosetron) 
Palonosetron 0.5 mg (PO)

60 minutes before chemotherapy (fixed dose preparation with netupitant)
Gemcitabine 1,000 mg/m2 (IV infusion) in 100 mL to 500 mL sodium chloride 0.9% over 30 minutes
cARBOplatin 5 AUC (IV infusion) in 500 mL glucose 5% over 30 to 60 minutes (Note: If estimated GFR is greater than 125 mL/min (i.e. 5 AUC dose greater than 750 mg), obtaining direct measurement rather than an estimated renal function and/or dose capping is strongly recommended)
Day 9 to 11
Dexamethasone 8 mg (PO) ONCE a day (or in divided doses) with or after food.
Frequency:
21 days 
Cycles:
Continuous until disease progression or unacceptable toxicity; usually 6 cycles

Cycle 1 and further cycles

Drug Dose Route Day
Gemcitabine 1,000 mg/m2 IV infusion 1 and 8
cARBOplatin 5 AUC * IV infusion 8

*if estimated GFR is greater than 125 mL/min (i.e. 5 AUC dose greater than 750 mg), obtaining direct measurement rather than an estimated renal function and/or dose capping is strongly recommended

Frequency:
21 days 
Cycles:
Continuous until disease progression or unacceptable toxicity; usually 6 cycles
Notes:

In this protocol, carboplatin is given on day 8, not day 1 as in the original study, in order that the second dose of gemcitabine need not be delayed or abandoned as a result of haematological toxicities.

Data in clinical trials indicate that carboplatin and gemcitabine may be an alternative to cisplatin-based regimens for the treatment of advanced urothelial cancer, particularly in patients with poor performance status. However, in the absence of randomised studies, carboplatin should not be substituted for cisplatin as a general rule. Carboplatin and gemcitabine should not be used in the adjuvant setting.

Drug status:

All drugs in this protocol are on the PBS general schedule

Cost:
~ $260 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 antineoplastic drugs only (not antiemetics or other supportive medications), 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 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 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 antineoplastic 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 and further cycles

Day 1
Metoclopramide 10 mg (PO)

one tablet when necessary (maximum of 30 mg/24 hours, up to 5 days)
Gemcitabine 1,000 mg/m2 (IV infusion) in 100 mL to 500 mL sodium chloride 0.9% over 30 minutes
Day 8
Dexamethasone 12 mg (PO) 60 minutes before chemotherapy
Netupitant 300 mg (PO)

60 minutes before chemotherapy (fixed dose preparation with palonosetron) 
Palonosetron 0.5 mg (PO)

60 minutes before chemotherapy (fixed dose preparation with netupitant)
Gemcitabine 1,000 mg/m2 (IV infusion) in 100 mL to 500 mL sodium chloride 0.9% over 30 minutes
cARBOplatin 5 AUC (IV infusion) in 500 mL glucose 5% over 30 to 60 minutes (Note: If estimated GFR is greater than 125 mL/min (i.e. 5 AUC dose greater than 750 mg), obtaining direct measurement rather than an estimated renal function and/or dose capping is strongly recommended)
Day 9 to 11
Dexamethasone 8 mg (PO) ONCE a day (or in divided doses) with or after food.
Frequency:
21 days 
Cycles:
Continuous until disease progression or unacceptable toxicity; usually 6 cycles
  • Locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium when cisplatin is contraindicated
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 carboplatin. Hypersensitivity risk increases with number of cycles of carboplatin.
Emetogenicity HIGH

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

Carboplatin  AUC > 4 is classified by NCCN Guidelines v2.2017 as having high emetogenicity.

A NK1 receptor antagonist and a 5HT3 receptor antagonist in combination with dexamethasone are available on the PBS for primary prophylaxis of carboplatin induced nausea and vomiting.

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 or 12.5 mg IV every 6 hours when necessary.

Read more about preventing chemotherapy induced nausea and vomiting
Pulmonary toxicity

Dyspnoea developing within hours of the infusion has been reported in about 10% of patients treated with gemcitabine.

Read more about pulmonary toxicity associated with antineoplastic drugs.
Blood tests

FBC, EUC and LFTs at baseline, and prior to each cycle. Recalculate carboplatin dose if significant change in weight and/or creatinine. INR tests if patient is on warfarin 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, including BCG, MMR, zoster and varicella 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.
Effects of cancer treatment on fertility

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive age prior to commencing treatment.

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 antineoplastic 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 and reference committee consensus. 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.

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

Haematological toxicity
ANC x 109/L (pre-treatment blood test) 
1.0 to less than 1.5 Refer to local institutional guidelines; it is the view of the expert clinicians that treatment should continue if patient is clinically well. 
0.5 to less than 1.0 Delay treatment until recovery
less than 0.5 Delay treatment until recovery and reduce carboplatin and gemcitabine by 25% for subsequent cycles
Febrile neutropenia or previous delay for myelosuppression Delay treatment until recovery and reduce carboplatin and gemcitabine by 25% for subsequent cycles
Prolonged recovery greater than two weeks delay or 3rd delay for myelosuppression Delay treatment until recovery and reduce carboplatin and gemcitabine by 50% for subsequent cycles or cease
Platelets x 109/L (pre-treatment blood test) 
75 to less than 100 The general recommendation is to delay, however if the patient is clinically well it may be appropriate to continue treatment; refer to treating team and/or local institutional guidelines.
50 to less than 75 Delay treatment until recovery
less than 50 Delay treatment until recovery and reduce carboplatin and gemcitabine by 25% for subsequent cycles

If treatment cannot be delivered on Day 8, it should be omitted rather than delayed. Treatment for the next cycle should proceed on the date originally scheduled and should incorporate dose modifications as appropriate.

Renal impairment
Creatinine clearance (mL/min)
30 to 50 Reduce gemcitabine by 25% and recalculate carboplatin dose using Calvert formula
less than 30 Reduce gemcitabine by 50% and recalculate carboplatin dose using Calvert formula
Hepatic impairment
Hepatic dysfunction
Moderate Reduce gemcitabine by 25%
Severe No data for gemcitabine
Mucositis and stomatitis
Grade 2 Delay treatment until toxicity has resolved to Grade 1 or less and reduce doses for subsequent cycles as follows:
1st occurrence: No dose reduction
2nd occurrence: Reduce carboplatin and gemcitabine by 25%
3rd occurrence: Reduce carboplatin and gemcitabine by 50%
4th occurrence: Omit carboplatin and gemcitabine
Grade 3 or Grade 4 Delay treatment until toxicity has resolved to Grade 1 or less and reduce doses for subsequent cycles as follows:
1st occurrence: Reduce carboplatin and gemcitabine by 50%
2nd occurrence: Omit carboplatin and gemcitabine
Cease gemcitabine if either of the following develop:
Pulmonary toxicity
Haemolytic uraemic syndrome (HUS)

References & Disclaimer

Carboplatin
  Interaction Clinical management
Nephrotoxic drugs (e.g. aminoglycosides, amphotericin, cisplatin, contrast dye, frusemide, NSAIDs) Additive nephrotoxicity Avoid combination or monitor renal function closely
Ototoxic drugs (e.g. aminoglycosides, frusemide, NSAIDs) Additive ototoxicity Avoid combination or perform regular audiometric testing
Paclitaxel Administration schedule may influence the development of myelosuppression Minimise toxicity by administering paclitaxel first in regimens using the combination
Gemcitabine
  Interaction Clinical management

Warfarin		 Increased anticoagulant effect/increased bleeding risk due to decreased hepatic metabolism of warfarin and decreased synthesis of clotting factors Monitor INR regularly and adjust warfarin dosage as appropriate
Netupitant
  Interaction Clinical management
Dexamethasone Increased effects/toxicity of dexamethasone due to inhibition of its metabolism via CYP3A4

Reduce dose of antiemetic dexamethasone by approximately 50% when adding netupitant. For protocols that already recommend netupitant, the dose reduction of antiemetic dexamethasone has already been taken into account.

If dexamethasone is part of the chemotherapy protocol, dose reduction as per the product information is not routinely recommended in clinical practice and no additional dexamethasone is required for antiemetic cover. 
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Reduced efficacy of netupitant possible due to increased clearance Avoid combination or monitor for decreased antiemetic effect. Consider using an alternative antiemetic regimen
CYP3A4 inhibitors (e.g. azole antifungals, clarithromycin, erythromycin, grapefruit juice, ritonavir etc.) Increased toxicity of netupitant possible due to reduced clearance Avoid combination or monitor for increased adverse effects of netupitant (e.g. headache, hiccups, constipation)
Drugs metabolised by CYP3A4 (e.g. etoposide, imatinib, irinotecan, midazolam, paclitaxel, vinblastine, vincristine etc.) Increased effects/toxicity of these drugs possible due to inhibition of CYP3A4 by netupitant Avoid combination or monitor for increased toxicity especially with orally administered drugs.
General
  Interaction Clinical management
Digoxin Antineoplastic agents 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 antineoplastic 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 antineoplastic 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

Day 1

Approximate treatment time: 60 minutes

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).

Insert IV cannula or access port or CVC.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Gemcitabine 

Administer gemcitabine (irritant):
  • via IV infusion over 30 minutes
    • if pain develops along the vein, verify the drug has not extravasated
    • further dilution (using a second saline line), warmth or temporarily slowing the infusion may help
  • flush with ~ 100 mL of sodium chloride 0.9% 
  • prolonged infusion times have been shown to increase toxicity.

Remove IV cannula and/or deaccess port or CVC.

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

Day 8

Approximate treatment time: 2 hours

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).

Insert IV cannula or access port or CVC.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Verify dexamethasone taken or administer as prescribed.

Gemcitabine 

Administer gemcitabine (irritant):
  • via IV infusion over 30 minutes
    • if pain develops along the vein, verify the drug has not extravasated
    • further dilution (using a second saline line), warmth or temporarily slowing the infusion may help
  • flush with ~ 100 mL of sodium chloride 0.9% 
  • prolonged infusion times have been shown to increase toxicity.

Carboplatin 

Administer carboplatin (irritant):
  • via IV infusion over 30 to 60 minutes
  • observe for hypersensitivity reactions
  • flush with 100 mL of sodium chloride 0.9%
  • hypersensitivity risk increases with number of cycles administered.
Stop infusion at first sign of reaction:
  • if symptoms are mild and resolve when infusion is stopped, consider recommencing infusion after review by medical officer at a slower rate
  • for severe reactions seek medical assistance immediately and do not restart infusion.

Remove IV cannula and/or deaccess port or CVC.

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

Discharge information

Antiemetics
  • Antiemetics as prescribed.
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
Taste and smell alteration

Read more about taste and smell changes
Flu-like symptoms

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 neutropenia
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, radiotherapy to the head, neck or oesophagus, and high dose chemotherapy followed by a blood and marrow transplant (BMT).

Read more about oral mucositis
Diarrhoea

Read more about treatment induced diarrhoea
Fatigue

Read more about fatigue
Skin rash

Antineoplastic agents 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
Fluid retention and oedema

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

Late (onset weeks to months)
Anaemia

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

Read more about anaemia
Alopecia - partial

Hair thinning and/or patchy hair loss. 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
Pulmonary toxicity

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

Read more about pulmonary toxicity associated with antineoplastic drugs
Haemolytic uraemic syndrome (HUS)

A rare but serious acute syndrome characterised by haemolysis of red blood cells and renal failure.

Read more about haemolytic uraemic syndrome (HUS)

Rationale for superseding:

There is no evidence demonstrating equivalent efficacy for day 8 dosing of carboplatin vs the day 1 schedule. Whilst a small phase II study did demonstrate fewer dose adjustments with day 8 carboplatin, no difference in outcomes were notedr, and carboplatin/gemcitabine regimens across several malignancies have continued to administer carboplatin on day 1. For this reason the Medical Oncology Reference Committee has superseded this protocol. 

Cisplatin and gemcitabine or MVAC remain the standard systemic regimen for metastatic or locally advanced TCC of the urothelium. However, this cancer commonly occurs in an elderly population often with multiple co-morbidities and these cisplatin-based regimens may be poorly tolerated, particularly in those with a poor performance status or in the very elderly.  A number of phase 2 studies have examined the substitution of carboplatin for cisplatin, suggesting better tolerability and response rates of 30 to 60%.rrr 

There are no randomised studies of gemcitabine + carboplatin or cisplatin. However, a study of 47 patients of MVAC vs carboplatin based regimen (M-CAVI) showed an overall response rates of 39% for M-CAVI and 52% for M-VAC (P = 0.3). There was a statistically significant difference in median disease-related survival time favouring M-VAC (16 months; range, 6 to 22+) versus M-CAVI (9 months; range, 6 to 14+) (P = 0.03).r

An audit of 381 elderly patients with advanced TCC of the bladder showed the elderly tolerate cisplatin-based therapy and gain as much benefit as their younger counterparts. Survival correlated with performance status and haemoglobin level but not with age.r Additionally, the advent of novel anti-emetics such as aprepitant makes cisplatin easier to use in this population.

These data indicate that carboplatin and gemcitabine may be an alternative to cisplatin-based regimen for the treatment of advanced urothelial cancer, particularly in those with poor performance status.  However, in the absence of randomised studies, carboplatin should not be substituted for cisplatin in these regimens as a general rule. Carboplatin and gemcitabine should not be used in the adjuvant setting.

Efficacy

Overall Survival (n=41) r:

© Cancer 2003

Toxicity

Toxicityr Grade 1 to 2 (%) Grade 3 to 4 (%)
Leucopenia 49 44
Neutropenia 31 63
Thrombocytopenia 24 32
Anaemia 39 63
Vomiting 24  7
Serum Creatinine 47  2
Alopecia 31  0
Oedema 10  7
Peripheral Neuropathy  5  2
Asthenia 54 19
Infection 34  5
Hepatic 36  0

© Cancer 2003

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Review due:

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https://www.eviq.org.au/p/311

16 Dec 2018