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Systemic Anti-Cancer Therapy Regimen Library

Home > LYM NHL NK/T-cell Extra Nodal - DDGP [dexamethasone, cISplatin, gemcitabine and pegaspargase]

LYM NHL NK/T-cell Extra Nodal - DDGP [dexamethasone, cISplatin, gemcitabine and pegaspargase]

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

Cycle length:
21

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.
  • Consider TDM for serum asparaginase activity (SAA) when using premedications to prevent hypersensitivity reactions, since premedication may “mask” the systemic allergic reactions that can indicate the development of neutralising antibodies.

Cycle details

Cycles 1 to 6 - 21 days

Medication Dose Route Days Max Duration
dexamethasone * 15 mg/m² Once daily oral administration 1 to 5
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 * 800 mg/m² intravenous 1, 8 30 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 1 to 4 60 minutes
cISplatin * 20 mg/m² Once daily intravenous 1 to 4 60 minutes
sodium chloride 0.9 % intravenous 1 to 4 60 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.
  • Consider TDM for serum asparaginase activity (SAA) when using premedications to prevent hypersensitivity reactions, since premedication may “mask” the systemic allergic reactions that can indicate the development of neutralising antibodies.

Full details

Cycles 1 to 6 - 21 days

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 15 mg/m² Once daily oral administration
Instructions:

30 to 60 minutes prior to pegaspargase with food.
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
gemcitabine * 800 mg/m² intravenous 30 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin * 20 mg/m² Once daily intravenous 60 minutes
Instructions:
  • In 500 - 1000 mL of sodium chloride 0.9%, depending on stability.
  • Ensure patient has passed urine as per institutional policy.
  • Hypersensitivity risk increases with number of cycles of cISplatin.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:

After cISplatin infusion.

If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 15 mg/m² Once daily oral administration
Instructions:

Take in the morning with food.
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin * 20 mg/m² Once daily intravenous 60 minutes
Instructions:
  • In 500 - 1000 mL of sodium chloride 0.9%, depending on stability.
  • Ensure patient has passed urine as per institutional policy.
  • Hypersensitivity risk increases with number of cycles of cISplatin.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:

After cISplatin infusion.

If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 15 mg/m² Once daily oral administration
Instructions:

Take in the morning with food.
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin * 20 mg/m² Once daily intravenous 60 minutes
Instructions:
  • In 500 - 1000 mL of sodium chloride 0.9%, depending on stability.
  • Ensure patient has passed urine as per institutional policy.
  • Hypersensitivity risk increases with number of cycles of cISplatin.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:

After cISplatin infusion.

If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid.

Day: 4

Medication Dose Route Max duration Details
dexamethasone * 15 mg/m² Once daily oral administration
Instructions:

Take in the morning with food.
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin * 20 mg/m² Once daily intravenous 60 minutes
Instructions:
  • In 500 - 1000 mL of sodium chloride 0.9%, depending on stability.
  • Ensure patient has passed urine as per institutional policy.
  • Hypersensitivity risk increases with number of cycles of cISplatin.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:

After cISplatin infusion.

If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid.

Day: 5

Medication Dose Route Max duration Details
dexamethasone * 15 mg/m² Once daily oral administration
Instructions:

Take in the morning with food.

Day: 8

Medication Dose Route Max duration Details
gemcitabine * 800 mg/m² intravenous 30 minutes

Day: 9

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Give ONCE daily from Day 9 until neutrophil recovery past the nadir.

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Supportive Care Factors

Factor Value
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis may be considered
Emetogenicity: Variable
Gastroprotection: Gastroprotection may be considered
Growth factor support: Recommended for primary prophylaxis
Hydration: Routine hydration recommended
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: HIGH days 1 to 4; LOW day 8.


Tumour lysis syndrome prophylaxis: Recommended for cycle 1 and consider for subsequent cycles.

References

Zhang, L., S. Li, S. Jia, et al. 2016. "The DDGP (cisplatin, dexamethasone, gemcitabine, and pegaspargase) regimen for treatment of extranodal natural killer (NK)/T-cell lymphoma, nasal type." Oncotarget 7(36):58396-58404., PMID: 27517317

Li, X., Y. Cui, Z. Sun, et al. 2016. "DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China." Clin Cancer Res 22(21):5223-5228., PMID: 27060152

Wang, X., L. Zhang, X. Liu, et al. 2019. "Efficacy and survival in newly diagnosed advanced extranodal natural killer/T-cell lymphoma: a randomized, controlled, multicenter and open-labeled study with DDGP regimen versus SMILE regimen. Abstract #463. Presented at the 2019 ASH annual meeting, December 8, 2019; Orlando, FL.

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142., PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

Boulanger J, Boursiquot JN, Cournoyer G, et al. Management of hypersensitivity to platinum- and taxane-based chemotherapy: cepo review and clinical recommendations. Curr Oncol. 2014;21(4):e630-e641., PMID: 25089112

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.