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Lymphoma gemcitabine and vinORELBine

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

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

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

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Cycle 1 to 4

Drug Dose Route Day
vinORELBine 25 mg/m2 IV infusion 1 and 8
Gemcitabine 1,000 mg/m2 IV infusion 1 and 8
Pegfilgrastim 6 mg Subcut 9
Frequency:
21 days 
Cycles:
4 to 6
Notes:

As this protocol is used in the outpatient setting, pegfilgrastim was included as in the Pasricha et al study.r 

Drug status:

Gemcitabine and vinorelbine are on the PBS general schedule

Pegfilgrastim: (PBS authority)

Cost:
~ $380 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 4

Day 1 and 8
Metoclopramide 10 mg (PO)

one tablet when necessary (maximum of 30 mg/24 hours, up to 5 days)
vinORELBine 25 mg/m2 (IV infusion) in 50 mL sodium chloride 0.9% over 6 to 10 minutes
Gemcitabine 1,000 mg/m2 (IV infusion) in 100 mL to 500 mL sodium chloride 0.9% over 30 minutes
Day 9
Pegfilgrastim 6 mg (Subcut) inject subcutaneously on day 9
Frequency:
21 days 
Cycles:
4 to 6

Cycle 1 to 4

Drug Dose Route Day
vinORELBine 25 mg/m2 IV infusion 1 and 8
Gemcitabine 1,000 mg/m2 IV infusion 1 and 8
Pegfilgrastim 6 mg Subcut 9
Frequency:
21 days 
Cycles:
4 to 6
Notes:

As this protocol is used in the outpatient setting, pegfilgrastim was included as in the Pasricha et al study.r 

Drug status:

Gemcitabine and vinorelbine are on the PBS general schedule

Pegfilgrastim: (PBS authority)

Cost:
~ $380 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 4

Day 1 and 8
Metoclopramide 10 mg (PO)

one tablet when necessary (maximum of 30 mg/24 hours, up to 5 days)
vinORELBine 25 mg/m2 (IV infusion) in 50 mL sodium chloride 0.9% over 6 to 10 minutes
Gemcitabine 1,000 mg/m2 (IV infusion) in 100 mL to 500 mL sodium chloride 0.9% over 30 minutes
Day 9
Pegfilgrastim 6 mg (Subcut) inject subcutaneously on day 9
Frequency:
21 days 
Cycles:
4 to 6
  • Relapsed/refractory non-Hodgkin Lymphoma (NHL) and Hodgkin Lymphoma (HL)
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
Emetogenicity LOW

Suggested default antiemetics have been added to 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.

There have been infrequent reports (less than 5% of patients) of pulmonary toxicity associated with vinorelbine.

Read more about pulmonary toxicity associated with anti-cancer drugs.
Constipation

Prescribe prophylactic laxatives to prevent constipation related to the use of vinca alkaloids.
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
Central nervous system (CNS) prophylaxis

Consider CNS relapse assessment in patients with high grade lymphoma. 

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

Assess patient for risk of developing tumour lysis syndrome.

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

­

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

­

Read more about antiviral prophylaxis drugs and doses
Biosimilar drug

Read more about biosimilar drugs on the Biosimilar Awareness Initiative page
Growth factor support

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

Access the PBS website
Blood tests

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

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

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

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

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

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

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

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

Notes:

  • All dose reductions are calculated as a percentage of the starting dose.
  • Dose reduction was permitted on the basis of clinical and laboratory parameters before day 1 treatment, however it was not permitted on the basis of day 8 haematological parameters.r
Haematological toxicity
ANC x 109/L (pre-treatment blood test)
0.5 to less than 1.0 Reduce vinorelbine and gemcitabine by 25% for subsequent cycles
less than 0.5 Delay treatment until recovery
Platelets x 109/L (pre-treatment blood test)
50 to less than 100 Reduce vinorelbine and gemcitabine by 25% for subsequent cycles
less than 50 Delay treatment until recovery
Renal impairment
Creatinine clearance (mL/min)
30 to 50 Reduce gemcitabine by 25%
less than 30 Reduce gemcitabine by 50%
Hepatic impairment
Hepatic dysfunction
Mild Reduce vinorelbine by 25%
Moderate Reduce vinorelbine by 50% and gemcitabine by 25%
Severe Omit vinorelbine, no data for gemcitabine
Peripheral neuropathy
Grade 2 which is present at the start of the next cycle Reduce vinorelbine by 25%,
if persists, reduce vinorelbine by 50%
Grade 3 or Grade 4 Omit vinorelbine
Mucositis and stomatitis
Grade 2 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: No dose reduction
2nd occurrence: Reduce gemcitabine by 25%
3rd occurrence: Reduce gemcitabine by 50%
4th occurrence: Omit gemcitabine
Grade 3 or Grade 4 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: Reduce gemcitabine by 50%
2nd occurrence: Omit gemcitabine
Cease gemcitabine if any one of the following develops:
  • Pulmonary toxicity
  • Thrombotic microangiopathy (TMA)/haemolytic uraemic syndrome (HUS).

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:  

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
Vinorelbine
  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 vinorelbine possible due to reduced clearance Monitor for vinorelbine toxicity (esp. neurotoxicity, myelosuppression)
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John's wort etc.) Reduced efficacy of vinorelbine possible due to increased clearance Monitor for decreased clinical response to vinorelbine
Mitomycin Increased risk of pulmonary toxicity when vinorelbine 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)
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.

Days 1 and 8

Approximate treatment time: 60 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.

Vinorelbine

Administer vinorelbine (vesicant):
  • over 6 to 10 minutes via a minibag
  • ensure vein is patent and monitor for signs of extravasation throughout administration
  • flush with ~250 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.

Remove IV cannula and/or deaccess TIVAD or CVAD. 

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

Day 9

Pegfilgrastim

  •  administer subcutaneously at least 24 hours post chemotherapy.

Discharge information

Antiemetics
  • Antiemetics as prescribed.
Laxatives
  • Ensure patient has prophylactic laxatives.
Growth factor support
  • Arrangements for administration if prescribed.
Prophylaxis medications
  • Prophylaxis medications (if prescribed) i.e. tumour lysis prophylaxis, PJP prophylaxis, antifungals, antivirals.
Patient information
  • Ensure patient receives patient information sheet.

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

Immediate (onset hours to days)
Bone pain

Bone pain, usually in the lower back or pelvis, associated with G-CSF.
Extravasation, tissue or vein injury

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

Read more about extravasation management
Flu-like symptoms
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)
Anorexia

Loss of appetite accompanied by decreased food intake.

Read more about anorexia
Arthralgia and myalgia

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

Read more about arthralgia and myalgia
Constipation
Diarrhoea

Read more about treatment induced diarrhoea
Fatigue

Read more about fatigue
Fluid retention and oedema

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

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

Read more about oral mucositis
Peripheral neuropathy

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

Read more about peripheral neuropathy
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
Thrombocytopenia

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

Read more about thrombocytopenia

Late (onset weeks to months)
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
Anaemia

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

Read more about anaemia
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)
Pulmonary toxicity

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

Read more about pulmonary toxicity associated with anti-cancer drugs

The evidence supporting this protocol is provided by a an open-label, single-arm study conducted by Spencer et al. involving 40 patients with relapsed or refractory lymphoma between February 2001 and April 2002. Patients were given vinorelbine 25 mg/m2 and gemcitabine 1000 mg/m2 on days 1 and 8 of each treatment cycle with filgrastim (VGF) given on days 2 to 7 and either day 9 or 10 until the absolute neutrophil count was >10 x 109/L on one day or >1.0 x 109/L on two consecutive days after the expected chemotherapy-induced nadir. Treatment cycles were repeated every 21 days and four cycles were planned.r

Primary efficacy end-points were the early response rate (ERR) after two cycles of chemotherapy and overall response rate (ORR) after completion of four cycles of treatment. This study has shown VGF can be safely given in an ambulatory care setting and is efficacious against a range of advanced lymphoma subtypes (including NHL and HL).r

More recently, Pasricha et al. conducted a phase II study to evaluate the effectiveness of vinorelbine and gemcitabine based chemotherapy in the ambulatory, salvage setting against lymphoma. 90 patients were enrolled between December 2002 and December 2004 through 10 centres around Australia. Group 1 and 3 risk adjusted patients to receive VGF (vinorelbine 25 mg/m2, gemcitabine 1000 mg/m2, dexamethasone 16 mg/m2 on days 1 and 8, pegfilgrastim on day 9 with 4 cycles planned) and Group 2 patients received FGIV (addition of ifosfamide 3 g/m2 on day 1 to VGF) every 21 days. Four cycles were planned for all groups.r

The results of this study showed vinorelbine and gemcitabine based chemotherapy is effective in the salvage setting against lymphoma and can be administered in an ambulatory setting.r

Furthermore, a multicenter study by Hellenic Cooperative Oncology Group involving 22 patients with relapsed/refractory diffuse large B-cell non-Hodgkin lymphoma (DLBCL). Patients were treated with gemcitabine 1000 mg/m2 and vinorelbine 30 mg/m2 on days 1 and 8 every 3 weeks for a maximum of six cycles. Granulocyte colony stimulating factor (G-CSF) 5 mcg/kg was administered subcutaneously on days 3 to 6 and 10 to 16 of each treatment cycle.r

The primary objective was to evaluate the efficacy as well as toxicity for patients with relapsed of refractory DLBCL. The combination of gemcitabine and vinorelbine was effective and well-tolerated with minimal toxicity, and all patients were treated on an outpatient basis.r

A search of the literature found limited evidence to support the use of gemcitabine and vinorelbine in the treatment of lymphoma. The expert reference panel supported publication of the protocol on the basis of the information summarised below.

Source Study & Year Published Supports Use Is the dose and regimen consistent with the protocol? Comments
Phase II trials Spencer et al. 2007 Yes No Gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 and 8 of each treatment cycle with filgrastim 5 mcg/kg/day (VGF) given on days 2 to 7 and either day 9 or 10 until the ANC was 10 x 109/L, every 21 days for 4 cycles
  Papageorgiou et al. 2005 Yes No Gemcitabine 1000 mg/m2 and vinorelbine 30 mg/m2 on days 1 and 8 every 21 days for a maximum of 6 cycles.
  Pasricha et al. 2008 Yes No Gemcitabine 1000 mg/m2, vinorelbine 25 mg/m2, dexamethasone 16 mg/m2 on days 1 and 8, pegfilgrastim on day 9, every 21 days for 4 cycles
Guidelines Date published/revised Supports Use Is the dose and regimen consistent with the protocol? Comments
NCCN NHL 2016/HL 2015 N/A N/A -
BCCA 2016 N/A N/A -
CCO 2016 N/A N/A -

Efficacy

After a median follow up of 44 months, the median [OS] was 12.9 months (range 4-54 months). Three (14%) patients achieved complete remission and eight (36%) patients achieved partial remission accounting for an overall response rate of 50%.r

© European Journal of Haematology 2005

The ORR on an ITT basis was 53% with a 2-year OS of 50%. VGF appeared to have significant efficacy against heavily pretreated NHL and HL.r

© Internal Medicine Journal 2007

However, only 17 (43%) patients proceeded to a subsequent SCT (13 autologous, 4 allogeneic). Patients proceeding to transplantation received a median of 4 cycles of VGF, whereas those not receiving a transplant received a median of only two cycles of VGF (range 1–4). OS at 2 years for those who did or did not proceed to a subsequent transplant procedure was 71% versus 35%, respectively (P = 0.01) (Fig. 2).r

Toxicity

None of the patients died as a result of treatment toxicity and all the treatment was given in a outpatient facility.r

© European Journal of Haematology 2005

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Bibliography

Muller-Beissenhirtz, H., C. Kasper, H. Nuckel, et al. 2005. "Gemcitabine, vinorelbine and prednisone for refractory or relapsed aggressive lymphoma, results of a phase II single center study." Ann Hematol 84(12):796-801.

The optimum therapy for patients with relapsed or refractory aggressive non-Hodgkin's lymphomas (NHL) not qualifying for platinum-based and/or high-dose chemotherapy is not known. We conducted a prospective phase II study evaluating a regimen consisting of gemcitabine (1 g/m2, days 1 and 8), vinorelbine (30 mg/m2, days 1 and 8) and prednisone (100 mg/day, days 1-8) (GVP) given every 21 days. Fifteen patients with a median age of 68 years and a median of three previous therapies were enrolled. Diagnoses included B lymphoblastic (n=1), diffuse large B cell (n=10), anaplastic large T cell (n=2) and peripheral T-cell NHL (n=2). The median international prognostic index score was 3 (six patients with a score of 4 or 5). Five patients achieved a complete remission and three patients a partial remission. The median overall survival was 13.8 months, and the median time to next treatment was 4.4 months. Haematological toxicities of World Health Organisation grades 3/4 were leucopenia in 58%, thrombocytopenia in 33% and anaemia in 17% of all courses. Three patients had grade 3 infections. There was no treatment-related mortality. GVP shows substantial activity in poor prognosis relapsed or refractory aggressive lymphomas and is generally well tolerated, but haematological toxicity is dose limiting.

Perrotti, A. P., P. Niscola, A. Tendas, et al. 2008. "Vinorelbine and gemcitabine as salvage treatment in advanced and very poor prognosis non-Hodgkin's lymphoma patients." Ann Hematol 87(6):493-494.
Sivam, V., L. Cook, G. Hughes, et al. 2012. "Gemcitabine and vinorelbine chemotherapy for refractory or relapsing aggressive non-Hodgkin lymphoma." Hematol Oncol 30(4):214-215.

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Version 3

Date Summary of changes
22/09/2020 Biosimilar drug added to clinical information. Version number changed to V.3

Version 2

Date Summary of changes
03/05/2016 Approved and published on eviQ.
19/09/2016 In treatment schedule: updated/added volume to vinorelbine (50 mL sodium chloride 0.9%) and changed infusion time from 5-10 mins to 6-10 mins as per literature.

31/05/2017

 Transferred to new eviQ website. Version number change to V.2.
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 significant changes, review in 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

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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/627

31 Mar 2023