1. Home
  2. Medical oncology
  3. Upper gastrointestinal
  4. Pancreas and biliary

Pancreas metastatic gemcitabine and nab-PACLitaxel

Check for clinical trials in this patient group. Link to Australian Clinical Trials opens in a new tab or window website

On this page
Expand all Collapse all Back to top

Cycle 1 and further cycles

Drug Dose Route Day
nab-PACLitaxel 125 mg/m2 IV infusion 1, 8, 15
Gemcitabine 1,000 mg/m2 IV infusion 1, 8, 15
Frequency:
28 days 
Cycles:

Continuous until disease progression or unacceptable toxicity

Notes:

This is potentially a toxic regimen and should be used in patients with normal albumin, bilirubin and a good ECOG performance status. Strategies to minimise toxicity include G-CSF support, dose attenuation (e.g. reducing nab-paclitaxel to 100 mg/m2), thorough patient education and vigilant monitoring for any potential septic episodes (link to Patient information - Infection during cancer treatment).

Drug status:

Gemcitabine is on the PBS general schedule  opens in a new tab or window

Nab-paclitaxel  is PBS authority opens in a new tab or window 

Cost:
~ $2,490 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). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

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.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

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, growth factor support 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, 8, 15
Dexamethasone 8 mg (PO) 60 minutes before chemotherapy with or after food
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
nab-PACLitaxel 125 mg/m2 (IV infusion) over 30 minutes
Gemcitabine 1,000 mg/m2 (IV infusion) in 100 mL to 500 mL sodium chloride 0.9% over 30 minutes
Frequency:
28 days 
Cycles:

Continuous until disease progression or unacceptable toxicity

Cycle 1 and further cycles

Drug Dose Route Day
nab-PACLitaxel 125 mg/m2 IV infusion 1, 8, 15
Gemcitabine 1,000 mg/m2 IV infusion 1, 8, 15
Frequency:
28 days 
Cycles:

Continuous until disease progression or unacceptable toxicity

Notes:

This is potentially a toxic regimen and should be used in patients with normal albumin, bilirubin and a good ECOG performance status. Strategies to minimise toxicity include G-CSF support, dose attenuation (e.g. reducing nab-paclitaxel to 100 mg/m2), thorough patient education and vigilant monitoring for any potential septic episodes (link to Patient information - Infection during cancer treatment).

Drug status:

Gemcitabine is on the PBS general schedule  opens in a new tab or window

Nab-paclitaxel  is PBS authority opens in a new tab or window 

Cost:
~ $2,490 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). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

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.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

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, growth factor support 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, 8, 15
Dexamethasone 8 mg (PO) 60 minutes before chemotherapy with or after food
Palonosetron 0.25 mg (IV bolus) 30 minutes before chemotherapy
nab-PACLitaxel 125 mg/m2 (IV infusion) over 30 minutes
Gemcitabine 1,000 mg/m2 (IV infusion) in 100 mL to 500 mL sodium chloride 0.9% over 30 minutes
Frequency:
28 days 
Cycles:

Continuous until disease progression or unacceptable toxicity

Indications:

  • First-line metastatic adenocarcinoma of the pancreas.

Cautions / exclusions:

  • patients with biliary stents or elevated bilirubin
  • patients older than 75 years of age.
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

Low risk with nab-paclitaxel. Not to be used in patients who have had a prior hypersensitivity reaction to albumin.

Read more about Hypersensitivity reaction
Emetogenicity MODERATE

While nab-paclitaxel and gemcitabine each has low emetogenicity, in clinical practice, there may be a need for a moderately emetogenic regimen to manage nausea and vomiting when used in combination.

To address this, a suggested default antiemetic has been included in the treatment schedule and may be substituted to reflect institutional policy.

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
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 anti-cancer drugs.
Peripheral neuropathy

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

Read more about peripheral neuropathy

Link to Anti-cancer drug induced peripheral neuropathy screening tool
Biliary stents

Caution should be exercised in patients with biliary stents in situ as they are at increased risk of biliary sepsis whilst on chemotherapy.
Blood tests

FBC, EUC, eGFR, and LFTs at baseline. Repeat FBC, EUC, and eGFR prior to each treatment, and LFTs monthly or as clinically indicated.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is NOT usually recommended for patients receiving this treatment.

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. Possible suboptimal response to inactivated vaccines.

For more information about vaccinations in people with cancer refer to the Australian Immunisation Handbook opens in a new tab or window.
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 fetal 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 impact of cancer treatment on fertility opens in a new tab or window
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) opens in a new tab or window 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.
  • An alternate schedule showing reduced toxicity whilst preserving efficacy may be explored.r
  • Recommended haematological dose modifications align with the product information; however, more conservative dose modifications should be considered in patients at greater risk of sepsis, e.g. patients aged over 65, with biliary stents, or with concomitant Grade 2 or worse diarrhoea.
Haematological toxicity
Day 1
ANC x 109/L (pre-treatment blood test)
less than 1.5 Delay treatment until recovery
Platelets x 109/L (pre-treatment blood test)
less than 100 Delay treatment until recovery
Day 8
ANC x 109/L (pre-treatment blood test)
0.5 to less than 1.0 Reduce nab-paclitaxel and gemcitabine by 20%* and proceed with treatment
less than 0.5 Omit dose and proceed with the next treatment on the scheduled date if recovered
Febrile neutropenia Delay treatment until recovery and reduce nab-paclitaxel and gemcitabine by 20% for next treatment and subsequent cycles
Platelets x 109/L (pre-treatment blood test)
50 to less than 75 Reduce nab-paclitaxel and gemcitabine by 20%* and proceed with treatment
less than 50 Omit dose and proceed with the next treatment on the scheduled date if recovered

* On Day 15, if ANC greater than 1.0 and platelets greater than 75 x 109/L, return to previous dose and proceed with treatment
Day 15
ANC x 109/L (pre-treatment blood test)
0.5 to less than 1.0 If Day 8 doses were given without modification, reduce nab-paclitaxel and gemcitabine by 20% and proceed with treatment.
If Day 8 doses were given with modification, reduce nab-paclitaxel and gemcitabine by 40% and proceed with treatment.
If Day 8 doses were omitted, reduce nab-paclitaxel and gemcitabine by 40% and proceed with treatment.
less than 0.5 Omit dose for this cycle
Febrile neutropenia Delay treatment until recovery and reduce nab-paclitaxel and gemcitabine by 20% for subsequent cycles
Platelets x 109/L (pre-treatment blood test)
50 to less than 75 If Day 8 doses were given without modification, reduce nab-paclitaxel and gemcitabine by 20% and proceed with treatment.
If Day 8 doses were given with modification, reduce nab-paclitaxel and gemcitabine by 40% and proceed with treatment.
If Day 8 doses were omitted, reduce nab-paclitaxel and gemcitabine by 40% and proceed with treatment.
less than 50 Omit dose for this cycle
Kidney dosing recommendations 
  • Suggested dose modifications are based on the International Consensus Guideline on Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD).
  • Where one or more drugs in a protocol is recommended to be avoided, consider using a clinically appropriate alternative treatment protocol instead.
  • Before dose adjusting or omitting a drug, consider treatment intent.
  • In kidney replacement therapy consult a multidisciplinary team consisting of oncology/haematology with nephrology and/or clinical pharmacology for the management of dosing. 
  • For complete information on individual drug recommendations please review the individual drug monograph in the ADDIKD guideline.
eGFR
(mL/min/1.73m2)		 Gemcitabine Nab-paclitaxel
≥ 60

Full dose

Full dose
45 - 59

Full dose

Potential for increased risk of adverse events

Full dose 
30 - 44

Full dose

Potential for increased risk of adverse events

Full dose 
15 - 29

Full dose

Potential for increased risk of adverse events

Full dose

Potential for increased risk of adverse events
< 15
(without kidney replacement therapy)

Consult a multidisciplinary team consisting of oncology/haematology with nephrology and/or clinical pharmacology for the management of dosing.

Consult a multidisciplinary team consisting of oncology/haematology with nephrology and/or clinical pharmacology for the management of dosing.
Hepatic impairment
Patients with hepatic impairment may be at increased risk of toxicity, particularly myelosuppression; monitor patients for the development of profound myelosuppression.
Hepatic Dysfunction
Mild No dose modifications necessary
Moderate Reduce gemcitabine and nab-paclitaxel by 20%
Severe No data available; withhold treatment
Peripheral neuropathy
Grade 2 No dose modifications necessary
Grade 3 Delay treatment with nab-paclitaxel until toxicity has resolved to Grade 1 or less and reduce the dose of nab-paclitaxel by 20% for subsequent cycles; if persistent, cease nab-paclitaxel.
Grade 4 Cease nab-paclitaxel
Mucositis and stomatitis
Grade 2 No dose modifications necessary
Grade 3 Delay treatment until toxicity has resolved to Grade 1 or less and reduce doses for subsequent cycles as follows:
1st occurrence: Reduce nab-paclitaxel and gemcitabine by 20%
2nd occurrence: Reduce nab-paclitaxel and gemcitabine by 40%
3rd occurrence: Cease treatment
Grade 4 Cease treatment
Diarrhoea
Grade 2 No dose modifications necessary
Grade 3 Delay treatment until toxicity has resolved to Grade 1 or less and reduce doses for subsequent cycles as follows:
1st occurrence: Reduce nab-paclitaxel and gemcitabine by 20%
2nd occurrence: Reduce nab-paclitaxel and gemcitabine by 40%
3rd occurrence: Cease treatment
Grade 4 Cease treatment
Rash maculo-papular
Grade 2 or Grade 3 Delay treatment until toxicity has resolved to Grade 1 or less and reduce doses for subsequent cycles as follows:
1st occurrence: Reduce nab-paclitaxel and gemcitabine by 20%
2nd occurrence: Reduce nab-paclitaxel and gemcitabine by 40%
3rd occurrence: Cease treatment
Cease gemcitabine if any of the following develop:
  • pulmonary toxicity
  • haemolytic uraemic syndrome (HUS)
  • severe cutaneous adverse reactions (SCARs) e.g. Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP)

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: 

For more information see References & Disclaimer.

Gemcitabine
  Interaction Clinical management
Nephrotoxic drugs (e.g. aminoglycosides, amphotericin, contrast dye, frusemide, NSAIDs) Additive nephrotoxicity Avoid combination or monitor kidney function closely

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
Cytidine deaminase (CDA) inhibitors (e.g. cedazuridine) Increased effect/toxicity of gemcitabine possible due to reduced clearance Avoid combination or monitor for increased gemcitabine  effect/toxicity
Nab-paclitaxel
  Interaction Clinical management
CYP3A4 inhibitors (e.g. aprepitant, azole antifungals, clarithromycin, erythromycin, grapefruit juice, ritonavir etc.) Increased toxicity of nab-paclitaxel possible due to reduced clearance Monitor for nab-paclitaxel toxicity
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John's wort etc.) Reduced efficacy of nab-paclitaxel possible due to increased clearance Monitor for decreased clinical response to nab-paclitaxel
CYP2C8 inhibitors (e.g. pazopanib, lapatinib, gemfibrozil, montelukast, ethinyloestradiol, tretinoin, testosterone etc.) Increased toxicity of nab-paclitaxel possible due to reduced clearance Monitor for nab-paclitaxel toxicity
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 opens in a new tab or window and P‑gp opens in a new tab or window inhibitors. If treating VTE, avoid use with strong CYP3A4 opens in a new tab or window and P‑gp opens in a new tab or window inducers. 

Rivaroxaban: avoid concurrent use with strong CYP3A4 opens in a new tab or window and P‑gp opens in a new tab or window  inhibitors.

Dabigatran: avoid combination with strong P‑gp opens in a new tab or window 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 opens in a new tab or window

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 or address chemical compatibilities related to IV drug preparation and administration. 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 opens in a new tab or window and Australian Injectable Drugs Handbook opens in a new tab or window websites for further information.

eviQ is currently updating the way information is presented in the administration section, if you notice any discrepancies please let us know, via feedback@eviq.org.au.

Day 1, 8 and 15

Approximate treatment time: 2 hours

Pre treatment assessment

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

Anti-cancer drug patient assessment tool prior to each day of treatment.

Prior to administration

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

Pre treatment medication

Verify premedication/antiemetics have been taken as prescribed, see treatment schedule detail for suggested medications.

Nab-paclitaxel 

Note: nab-paclitaxel can be administered using a standard PVC IV line and should not be administered through a filter.

Administer nab-paclitaxel (irritant with vesicant properties):
  • via IV infusion over 30 minutes
  • flush with ~100 mL of sodium chloride 0.9%.

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.

Post administration

Remove IV cannula and/or deaccess TIVAD or CVAD. 

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

Discharge information

Discharge medications

Antiemetics - as/if prescribed.

Patient information

Ensure patient receives protocol 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)
Flu-like symptoms
Nausea and vomiting

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

Read more about taste and smell changes

Early (onset days to weeks)
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 and stomatitis

Erythematous and ulcerative lesions of the gastrointestinal tract (GIT). It commonly develops following anti-cancer treatment, 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 and stomatitis
Anorexia

Loss of appetite accompanied by decreased food intake.

Read more about anorexia
Diarrhoea

Read more about treatment induced diarrhoea
Ocular changes

Symptoms may include eye pain, blurred vision, blepharitis, uveitis, optic neuritis, tear duct stenosis, conjunctivitis, hyperlacrimation, watery or dry eyes and photophobia. 
Arthralgia and myalgia

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

Read more about arthralgia and myalgia
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
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
Fluid retention and oedema

An excess amount of fluid around the cells, tissues or serous cavities of the body, leading to swelling.
Severe cutaneous adverse reactions (SCARs)

Severe cutaneous adverse reactions (SCARs) have been reported with this treatment. SCARs are serious drug reactions involving the skin which may be life-threatening, or even fatal, and include conditions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP).

If SCARs occur, discontinue treatment immediately and seek specialist opinion to determine differential diagnosis so that appropriate supportive treatment can be administered.

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 and scalp cooling
Nail changes

Hyperpigmentation, paronychia, onycholysis, splinter haemorrhage, pyogenic granuloma formation, subungual haematoma and subungual hyperkeratosis are some of the nail changes associated with anti-cancer drugs.   

Read more about nail toxicities
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
Haemolytic uraemic syndrome (HUS)

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

Read more about haemolytic uraemic syndrome (HUS)

eviQ is currently updating the way information is presented in the evidence section to improve usability, consistency and facilitate easier update and maintenance. An updated evidence template is being implemented in a staged approach, first across new protocols, then existing protocols as they are reviewed. Find out more

The evidence supporting this protocol is provide by a phase III multicentre international randomised trial (MPACT trial) involving 861 patients comparing nab-paclitaxel 125 mg/m2 followed by gemcitabine 1000 mg/m2 on days 1, 8 and 15 every 4 weeks with gemcitabine 1000 mg/m2 weekly for 7 weeks (cycle 1) then days 1, 8, and 15 every 4 weeks (subsequent cycles) in patients with metastatic pancreatic cancer.r

The primary end point was overall survival and secondary end points were progression-free survival and overall response rate.

In the nab-paclitaxel/gemcitabine group, 41% and 47% of the patients had dose reductions in nab-paclitaxel and gemcitabine respectively. In the gemcitabine group, 33% of patients had dose reductions.r

Kim conducted a systematic review of the role of nab-paclitaxel in pancreatic cancer.r At the time of publication of the review, they had found ten studies reporting median OS for first line gemcitabine and nab-paclitaxel ranging from 8.7 to 13.5 months and 1 year survival ranging from 35 to 62%.  Most of these studies were single arm trials.

MPACTr and these further studies showed that older patients receiving gemcitabine and nab-paclitaxel where not at an increased risk of toxicity.

In conclusion, multiple studies have shown that first line gemcitabine and nab-paclitaxel improves survival in patients with metastatic pancreatic cancer with an OS similar to or better than that observed in MPACT.  The OS benefit holds regardless of age group or performance status. 

The systematic review by Kimr shows that multiple studies have confirmed the efficacy of gemcitabine and nab-paclitaxel in the first line setting in metastatic pancreatic adenocarcinoma.

Efficacy

The median overall survival in the intention to treat population was 8.5 months in the nab-paclitaxel/gemcitabine group compared with 6.7 months in the gemcitabine alone group (HR for death, 0.72; 95% CI, 0.62 to 0.83; p<0.001). The 1 year survival rate in the gemcitabine plus nab-paclitaxel group was 35% compared with 22% in the gemcitabine alone group (p<0.001). The 2 year survival rate in the gemcitabine plus nab-paclitaxel group was 9% compared with 4% in the gemcitabine alone group (p=0.02).r An updated analysis of OS presented at ASCO GI 2014 showed that the survival benefit was further extended in the nab-paclitaxel/gemcitabine group, with a 2.1 month median OS improvement compared to gemcitabine alone (8.7 months vs 6.6 months; HR=0.72; p<0.0001).r

The median progression-free survival was 5.5 months in the nab-paclitaxel/gemcitabine group, as compared with 3.7 months in the gemcitabine group (HR for disease progression or death, 0.69; 95% CI, 0.58 to 0.82; p<0.001) and the response rate was 23% vs 7% in the two groups (p<0.001).r

Kaplan-Meier curve for Overall Survival (intention-to-treat population)r

© New England Journal of Medicine 2013

Toxicity

The most common adverse events of grade 3 or higher in the nab-paclitaxel/gemcitabine group were neutropenia, fatigue, and peripheral neuropathy. Febrile neutropenia occurred in 3% vs 1 % of patients in the nab-paclitaxel/gemcitabine and the gemcitabine groups respectively with 26% vs 15% of patients receiving growth factor support in the two groups.r

Patients over the age of 65 years may be at increased risk of adverse events including diarrhoea, decreased appetite, dehydration and epistaxis.r

Adverse Eventsr
(grade > 3)		 nab-Paclitaxel plus Gemcitabine
n=421 (%)		 Gemcitabine alone
n=402 (%)
Neutropenia 38 27
Leukopenia 31 16
Thrombocytopenia 13 9
Anaemia 13 12
Febrile neutropenia 3 1
Fatigue 17 7
Peripheral neuropathy 17 1
Diarrhoea 6 1
[%id%]
[%title%] [%url%]

Flinders Filters has partnered with eviQ to build reliable, robust search filters to retrieve core high level evidence on topics of significance to eviQ. The project goal is the provision of a sustainable model for evidence retrieval to ensure ongoing currency of content.

These search filters have been developed to retrieve the most up to date evidence from PubMed, in real time, using specifically designed search filters built to meet our needs.

Searches can be used when a protocol is scheduled for review or at any time you choose. Please click on the Specific, Balanced and Sensitive tabs below to access the Pubmed searches.

Specific opens in a new tab or window Balanced opens in a new tab or window Sensitive opens in a new tab or window
restricted to retrieving randomised control trials and systematic reviews.

is the middle ground between sensitive and specific searches.

retrieves all clinically relevant evidence - generally a broader search on a given topic.

Access Flinders Filters opens in a new tab or window, a division of the Flinders Digital Health Research Centre at Flinders University to read more about research solutions to searching problems.

Troubleshooting

Occasionally the searches may not display correctly or take too long to load (and will eventually timeout). This may be caused by Internet Explorer being unable to handle long URL's. You can rectify this by using Firefox, Safari or Google chrome. It is always a good idea to clear the cache regularly to ensure you are getting the most up to date search.

Feedback

If you identify any new articles that you believe should be included in the content, please use the feedback button below to inform us of the name of the article(s). 

Version 5

Date Summary of changes
04/09/2024

Severe cutaneous adverse reactions (SCARs) added to side effects and dose modification section updated with dermatological reactions as per gemcitabine product information. Version increased to V.5.

Version 4

Date Summary of changes
07/09/2023

Protocol updated with ADDIKD guideline recommendations. New kidney dosing recommendation table added to dose modification section.

PDF of previous protocol.

Version number changed to V.4.

Version 3

Date Summary of changes
13/09/2013 New protocol taken to Medical Oncology Reference Committee meeting.
20/03/2014 Approved and published on eviQ.
11/04/2014 Indications, antiemetics and dose modifications updated (changed to v.2).
27/03/2015

Protocol reviewed at Medical Oncology Reference Committee meeting.
Dose modifications: Note about alternate schedule added.
Antiemetics: Dexamethasone removed for day 2, 3, 9, 10, 16 and 17.
10/11/2016 The following change made post Medical Oncology Reference Committee meeting held on 21 October 2016: link to AGITG and ANZCTR added.
31/05/2017

Transferred to new eviQ website. Version number changed to V.3.

Hepatitis B screening changed to NOT recommended.
16/02/2018 Protocol reviewed at Medical Oncology Reference Committee Meeting, evidence updated. Review in 2 years.
 25/09/2020 Protocol reviewed electronically by the Medical Oncology Reference committee. Nil changes. Next review in 2 years.
20/10/2022

Protocol reviewed electronically by Medical Oncology Reference Committee. No changes. Next review 4 years.

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

Send feedback for this page

First approved:
Last reviewed:
Review due:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/1375

23 Jun 2025