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Screen for hepatitis B virus in all cancer patients starting systemic treatment. Find out more about hepatitis B virus screening and management.

Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.

OXALRALT

Cancer Type:
Gastrointestinal, 
Colorectal, 
Esophagus, 
Gastric / Stomach, 
Small bowel and appendix
Intent: Adjuvant, Palliative
Regimen Category: Evidence-informed
Funding:
New Drug Funding Program
    Raltitrexed - Metastatic Colorectal Small Bowel or Appendiceal Cancer
New Drug Funding Program
    Raltitrexed - Metastatic Esophageal, Gastroesophageal Junction, or Gastric Cancer
New Drug Funding Program
    Raltitrexed - Adjuvant Colorectal, Small Bowel, or Appendiceal Cancer
New Drug Funding Program
    Raltitrexed - Adjuvant Esophageal, Gastroesophageal Junction, or Gastric Cancer
A - Regimen Name

OXALRALT Regimen
Oxaliplatin-Raltitrexed


Disease Site
Gastrointestinal
Colorectal
Esophagus
Gastric / Stomach
Small bowel and appendix


Intent
Adjuvant
Palliative

Regimen Category
Evidence-informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully  improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.


Rationale and Uses
  • For adjuvant or palliative treatment of colorectal, small bowel, appendiceal, esophageal, gastroesophageal junction, or gastric cancer

  • Funded by NDFP for patients who have complete dihydropyrimidine dehydrogenase (DPD) deficiency, have experienced unacceptable toxicity with 5-FU chemotherapy, live more than 60 km from the treatment centre/hospital, or have special transportation needs


Supplementary Public Funding

raltitrexed
New Drug Funding Program (Raltitrexed - Metastatic Colorectal Small Bowel or Appendiceal Cancer) (NDFP Website )

raltitrexed
New Drug Funding Program (Raltitrexed - Metastatic Esophageal, Gastroesophageal Junction, or Gastric Cancer) (NDFP Website )

raltitrexed
New Drug Funding Program (Raltitrexed - Adjuvant Colorectal, Small Bowel, or Appendiceal Cancer) (NDFP Website )

raltitrexed
New Drug Funding Program (Raltitrexed - Adjuvant Esophageal, Gastroesophageal Junction, or Gastric Cancer ) (NDFP Website )

 
B - Drug Regimen

raltitrexed
3 mg /m² IV Day 1
oxaliplatin
100 to 130 mg /m² IV Day 1
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

Adjuvant: Until disease progression, unacceptable toxicity, or up to a maximum of 8 cycles, whichever comes first

Palliative: Until disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate


Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.


Oxaliplatin premedication (prophylaxis for infusion reactions):

  • There is insufficient evidence that routine prophylaxis with pre-medications reduces IR rates.
  • Consider corticosteroids and H1-receptor antagonists ± H2-receptor antagonists in high-risk patients (i.e. ≥ cycle 6, younger age, female gender, prior platinum exposure, platinum-free interval ≥ 3 years).


Other Supportive Care:

  • Avoid mucositis prophylaxis with ice chip as cold temperatures can precipitate or exacerbate acute neurological symptoms of oxaliplatin.
 
J - Administrative Information

Approximate Patient Visit
3 hours
Pharmacy Workload (average time per visit)
25.24 minutes
Nursing Workload (average time per visit)
49.167 minutes
 
K - References

BCCA Protocol Summary for Adjuvant Combination Chemotherapy for Node Positive Colon Cancer Using Oxaliplatin and Raltitrexed in Patients Intolerant to Fluorouracil or Capecitabine, Feb 1, 2021.

Cascinu S, Graziano F, Ferraù F, et al. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian group for the study of gastrointestinal tract carcinomas (GISCAD). Annals of Oncology 2002;13:716–20.

Feliu J, Castañón C, Salud A, et al.  Phase II randomised trial of raltitrexed-oxaliplatin vs raltitrexed-irinotecan as first-line treatment in advanced colorectal cancer.  Br J Cancer 2005;93(11):1230-5.

Fluoropyrimidine Treatment in Patients with Dihydropyrimidine Dehydrogenase (DPD) Deficiency: Guidance for Clinicians. Ontario Health (Cancer Care Ontario), April 2023.

GI Drug Advisory Committee consensus, Ontario Health (Cancer Care Ontario).

Gravalos C, Salut A, García-Girón C, et al.  A randomized phase II study to compare oxaliplatin plus 5-fluorouracil and leucovorin (FOLFOX4) versus oxaliplatin plus raltitrexed (TOMOX) as first-line chemotherapy for advanced colorectal cancer.  Clin Transl Oncol 2012;14(8):606–12.   

Laudani A, Gebbia V, Leonardi V, et al. Activity and toxicity of oxaliplatin plus raltitrexed in 5-fluorouracil refractory metastatic colorectal adeno-carcinoma. Anticancer Res 2004;24(2C):1139-42.

Popov I , Carrato A, Sobrero A, et al.  Raltitrexed (Tomudex) versus standard leucovorinmodulated bolus 5fluorouracil: Results from the randomised phase III PanEuropean trial in Adjuvant Colon Cancer 01 (PETACC1).  Eur J Cancer 2008;44(15):220411. 

Scheithauer W, Kornek GV, Schuell B, et al.  Second-line treatment with oxaliplatin + raltitrexed in patients with advanced colorectal cancer failing fluoropyrimidine/leucovorin-based chemotherapy.  Ann Oncol 2001;12(5):709-14.

Scheithauer W, Kornek GV, Ulrich-Pur H, et al.  Oxaliplatin plus raltitrexed in patients with advanced colorectal carcinoma. Cancer 2001; 91:1264–71.

Seitz JF, Bennouna J, Paillot B, et al.  Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients.  Ann Oncol 2002;13(7):1072-9.

Wilson KS , Fitzgerald CA, Barnett JB, et al.  Adjuvant therapy with raltitrexed in patients with colorectal cancer intolerant of 5fluorouracil: British Columbia Cancer Agency experience.  Cancer Invest 2007;25(8):7114.  

April 2023 Modified Disease site, Rationale/uses, Supplementary public funding, and Premedications/supportive care sections


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.