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Systemic Anti-Cancer Therapy Regimen Library

LYM NHL B-cell - R-GemOX [RITUximab, 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.

Cycle 1 - 14 days

Cycle length:
14

RITUximab, first dose:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.

Cycles 2 to 8 - 14 days

Cycle length:
14

RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.

Cycle details

Cycle 1 - 14 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
dexamethasone * 12 mg flat dosing intravenous 1 15 minutes
RITUximab * 375 mg/m² intravenous 1 6 hours
gemcitabine * 1000 mg/m² intravenous 1 100 minutes Min: 100 minutes
oxaliplatin * 100 mg/m² intravenous 1 120 minutes

RITUximab, first dose:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.

Cycles 2 to 8 - 14 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
RITUximab * 375 mg/m² intravenous 1 6 hours
gemcitabine * 1000 mg/m² intravenous 1 100 minutes Min: 100 minutes
oxaliplatin * 100 mg/m² intravenous 1 120 minutes

RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.

Full details

Cycle 1 - 14 days

Day: 1

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:

30 to 60 minutes prior to RITUximab.

loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to RITUximab.

dexamethasone * 12 mg flat dosing intravenous 15 minutes
Instructions:

30 to 60 minutes prior to RITUximab, or as per institutional practice.

RITUximab * 375 mg/m² intravenous 6 hours
Instructions:
  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.
  • Start infusion at 50 mg/hour. If tolerated, rate can be increased by 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.
gemcitabine * 1000 mg/m² intravenous 100 minutes Min: 100 minutes
Instructions:

Administer at a rate of 10 mg/m2/minute.

oxaliplatin * 100 mg/m² intravenous 120 minutes
Instructions:

Usual infusion time of two hours may be extended to up to 6 hours if needed to reduce likelihood and/or severity of adverse reactions.

Hypersensitivity risk increases when patients are re-challenged with oxaliplatin.

Cycles 2 to 8 - 14 days

Day: 1

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:

30 to 60 minutes prior to RITUximab.

loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to RITUximab.

RITUximab * 375 mg/m² intravenous 6 hours
Instructions:

Start infusion at 100 mg/hour. If tolerated, rate can be increased by 100 mg/hour every 30 minutes to a maximum rate of 400 mg/hour or as per institutional practice.

Consider administering corticosteroid premedication if previous doses not well tolerated or if clinically indicated, as per institutional practice.

gemcitabine * 1000 mg/m² intravenous 100 minutes Min: 100 minutes
Instructions:

Administer at a rate of 10 mg/m2/minute.

oxaliplatin * 100 mg/m² intravenous 120 minutes
Instructions:

Usual infusion time of two hours may be extended to up to 6 hours if needed to reduce likelihood and/or severity of adverse reactions.

Hypersensitivity risk increases when patients are re-challenged with oxaliplatin.

Supportive Care Factors

Factor Value
Antiviral prophylaxis for hepatitis B virus: Required for anti–HBc positive patients at risk of reactivation
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis may be considered
Emetogenicity: Medium
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

References

El Gnaoui, T., J. Dupuis, K. Belhadj, et al. 2007. "Rituximab, gemcitabine and oxaliplatin: an effective salvage regimen for patients with relapsed or refractory B-cell lymphoma not candidates for high-dose therapy." Ann Oncol 18(8):1363-1368. , PMID: 17496309

Mounier, N., T. El Gnaoui, H. Tilly, et al. 2013. "Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II Lymphoma Study Association trial." Haematologica 98(11):1726-1731., PMID: 23753028

Lopez, A., A. Gutierrez, A. Palacios, et al. 2008. "GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study." Eur J Haematol 80(2):127-132., PMID: 18005385

Rodriguez, J., A. Gutierrez, A. Palacios, et al. 2007. "Rituximab, gemcitabine and oxaliplatin: an effective regimen in patients with refractory and relapsing mantle cell lymphoma." Leuk Lymphoma 48(11):2172-2178., PMID: 17990179

Dhanapal, V., M. Gunasekara, C. Lianwea, et al. 2017. "Outcome for patients with relapsed/refractory aggressive lymphoma treated with gemcitabine and oxaliplatin with or without Rituximab; a retrospective, multicentre study." Leuk Lymphoma 58(9):1-9., PMID: 28093003

Franch-Sarto, M., M. Sorigue, L. Lopez, et al. 2018. "Overall survival in patients with relapsed/refractory high grade B-cell lymphomas treated with gemcitabine, oxaliplatin with or without Rituximab." Leuk Lymphoma:1-3. , PMID: 30322316

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).

Laudati C, Clark C, Knezevic A, Zhang Z, Barton-Burke M. Hypersensitivity Reactions: Priming Practice Change to Reduce Incidence in First-Dose Rituximab Treatment. Clin J Oncol Nurs. 2018 Aug 1;22(4):407-414. doi: 10.1188/18.CJON.407-414. , PMID: 30035788

Doyle J, Raggatt M, Slavin M, McLachlan SA, Strasser SI, Sasadeusz JJ, Howell J, Hajkowicz K, Nandurkar H, Johnston A, Bak N, Thompson AJ. Hepatitis B management during immunosuppression for haematological and solid organ malignancies: an Australian consensus statement. Med J Aust. 2019 Jun;210(10):462-468. doi: 10.5694/mja2.50160. Epub 2019 May 19., PMID: 31104328

Medicines and Hepatitis B Reactivation Prescriber Update 38(1): 2-3 March 2017 https://medsafe.govt.nz/profs/PUArticles/March2017/MedicinesAndHepatitisB.htm

Rituximab and Hepatitis B Reactivation Prescriber Update 34(3):27 September 2013 . https://www.medsafe.govt.nz/profs/PUArticles/Sept2013RituximabHepB.htm

* 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.