Systemic Anti-Cancer Therapy Regimen Library
LYM NHL NK/T-cell Extra Nodal - P-GemOx [pegaspargase, gemcitabine and oxaliplatin]
Treatment Overview
This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.
Cycles 1 to 6 - 21 days
filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from day 9 until neutrophil recovery past the nadir.
pegaspargase:
- Intramuscular (IM) injection is the preferred route of administration because of the lower incidence of hepatotoxicity, coagulopathy, and gastrointestinal and renal disorders, as compared with the intravenous route. Pegaspargase can be administered intravenously over 120 minutes.
- Pegaspargase (and asparaginase products) should only be administered by centres with appropriate expertise.
- Consideration can be given to reducing dose of pegaspargase to 2000 international units/m2 for certain patients.
- There is limited data available for use of pegaspargase in patients 65 years and older. Strongly consider not using pegaspargase in patients 65 years and older.
- Monitor patients for one hour after administration of pegaspargase in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g. adrenaline, oxygen, intravenous steroids, antihistamines).
- See also Further information - pegaspargase.
Cycle details
Cycles 1 to 6 - 21 days
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| paracetamol * | 1000 mg flat dosing | oral administration | 1 | |
| loratadine * | 10 mg | oral administration | 1 | |
| famotidine * | 20 mg | oral administration | 1 | |
| pegaspargase * | 2500 international unit/m² | intramuscular injection | 1 | |
| gemcitabine * | 1000 mg/m² | intravenous | 1, 8 | 30 minutes |
| oxaliplatin * | 130 mg/m² | intravenous | 1 | 120 minutes |
| filgrastim | 5 microgram/kg Once daily | subcutaneous injection | 9 |
filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from day 9 until neutrophil recovery past the nadir.
pegaspargase:
- Intramuscular (IM) injection is the preferred route of administration because of the lower incidence of hepatotoxicity, coagulopathy, and gastrointestinal and renal disorders, as compared with the intravenous route. Pegaspargase can be administered intravenously over 120 minutes.
- Pegaspargase (and asparaginase products) should only be administered by centres with appropriate expertise.
- Consideration can be given to reducing dose of pegaspargase to 2000 international units/m2 for certain patients.
- There is limited data available for use of pegaspargase in patients 65 years and older. Strongly consider not using pegaspargase in patients 65 years and older.
- Monitor patients for one hour after administration of pegaspargase in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g. adrenaline, oxygen, intravenous steroids, antihistamines).
- See also Further information - pegaspargase.
Full details
Cycles 1 to 6 - 21 days
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
30 minutes prior to pegaspargase. |
|
| loratadine * | 10 mg | oral administration |
Instructions:
30 minutes prior to pegaspargase. |
|
| famotidine * | 20 mg | oral administration |
Instructions:
30 minutes prior to pegaspargase.
|
|
| pegaspargase * | 2500 international unit/m² | intramuscular injection |
Instructions:
|
|
| gemcitabine * | 1000 mg/m² | intravenous | 30 minutes | |
| oxaliplatin * | 130 mg/m² | intravenous | 120 minutes |
Instructions:
|
Day: 8
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| gemcitabine * | 1000 mg/m² | intravenous | 30 minutes |
Day: 9
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| filgrastim | 5 microgram/kg Once daily | subcutaneous injection |
Instructions:
|
Supportive Care Factors
| Factor | Value |
|---|---|
| Antiviral prophylaxis for herpes virus: | Routine antiviral prophylaxis may be considered |
| Emetogenicity: | Variable |
| Growth factor support: | Recommended for primary prophylaxis |
| Hypersensitivity / Infusion related reaction risk: | High - routine premedication recommended |
| Pneumocystis jirovecii pneumonia (PJP) prophylaxis: | Routine antibiotic prophylaxis may be considered |
| Tumour lysis syndrome prophylaxis: | Tumour lysis syndrome prophylaxis is recommended |
Antiviral prophylaxis for hepatitis B virus: Guidance is limited to high-risk anti-cancer medicines. Clinicians will need to assess individual patient risk for other anti-cancer medicines.
Emetogenicity:
- MEDIUM day 1: Women 50 years and under should be considered high risk for oxaliplatin-induced nausea and vomiting, so antiemetic prophylaxis regimen should include an NK1 (e.g. aprepitant 125 mg day 1 and 80 mg days 2 and 3) based on trial evidence.
- LOW day 8.
Tumour lysis syndrome prophylaxis: Recommended for cycle 1 and consider for subsequent cycles.
References
Yan G, Huang H, Wang X, et al. P-Gemox regimen (pegaspargase, gemcitabine, oxaliplatin) for extranodal natural killer cell lymphoma: 10 years' real-world clinical experience from China. Blood. 2018;132(Suppl 1):1659.
Castells, M.C., Matulonis, U.A., and Horton, TM. Infusion reactions to systemic chemotherapy. Savarese DMF and Feldweg AM, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/infusion-reactions-to-systemic-chemotherapy (Accessed 26 March 2021).
* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.
s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.