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.
CAPECISP+ZOLB; CAPE+ZOLB(MNT)
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.
Treatment of CLDN18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
capecitabine
ODB - General Benefit
(capecitabine)
(ODB Formulary
)
Cycles 1 to 6:
|
zolbetuximab 1 | 800 mg /m² | IV loading dose | Day 1 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
| CISplatin | 80 mg /m² | IV | Day 1 |
| capecitabine | 1000 mg /m² | PO | BID*, on Days 1-14 |
|
*Total dose 2000 mg/m2/day |
|||
|
zolbetuximab 1 | 600 mg /m² | IV maintenance dose | Day 1 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
|
CISplatin 2 | 80 mg /m² | IV | Day 1 |
|
capecitabine 2 | 1000 mg /m² | PO | BID*, on Days 1-14 |
|
*Total dose 2000 mg/m2/day
|
|||
| zolbetuximab | 600 mg /m² | IV maintenance dose | Day 1 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
| CISplatin | 80 mg /m² | IV | Day 1 |
| capecitabine | 1000 mg /m² | PO | BID*, on Days 1-14 |
|
*Total dose 2000 mg/m2/day |
|||
1Give zolbetuximab before chemotherapy when given on the same day.
2After treatment initiation, if chemotherapy is discontinued due to intolerance, zolbetuximab may be continued as single agent - ZOLB(MNT).
REPEAT EVERY 21 DAYS
For 6 cycles of CAPECISP+ZOLB, followed by CAPE+ZOLB(MNT) until disease progression or unacceptable toxicity.
After treatment initiation, if chemotherapy is discontinued due to intolerance, zolbetuximab may be continued as single agent, until disease progression or unacceptable toxicity. (Refer to ZOLB(MNT).)
High (Day 1)
No routine prophylaxis for capecitabine
- Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Other Supportive Care:
- Standard regimens for Cisplatin premedication and hydration should be followed. Refer to local guidelines.
- Topical emollients (e.g. hand creams, udder balm) therapy may ameliorate the manifestations of hand-foot syndrome in patients receiving capecitabine.
- Supportive care should be provided, including loperamide for diarrhea.
Capecitabine drug monograph. Ontario Health (Cancer Care Ontario).
Cisplatin drug monograph. Ontario Health (Cancer Care Ontario).
Kang YK, Kang WK, Shin D, et al. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol 2009;20(4):666-73.
Product monograph: Zolbetuximab. Astellas Pharma Canada, Inc. December 14, 2024.
Reimbursement recommendation (draft): Zolbetuximab. Canada' Drug Agency. Meeting Date: December 2024.
Shah MA, Shitara K, Ajani JA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023 Aug;29(8):2133-41.
Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-68.
March 2025 new ST-QBP regimen
DPD Deficiency Testing and Guidance
Patients should be tested for DPD deficiency before starting treatment with capecitabine. Refer to the DPD Deficiency Guidance for Clinicians for more information.
In patients with unrecognized DPD deficiency, acute, life-threatening toxicity may occur; if acute grade 2-4 toxicity develops, treatment should be stopped immediately and permanent discontinuation considered based on clinical assessment of the toxicities.
Antidote for Capecitabine Overdose:
Uridine triacetate is a prodrug of uridine and is a specific antidote for treating capecitabine overdose or severe early onset toxicities. If available, consider administering as soon as possible (i.e. within 96 hours) for suspected overdose. If not available, treatment is symptomatic and supportive.
For usage approval and supply, contact Health Canada’s Special Access Program (SAP) (Phone: 613-941-2108. On-call service is available for emergencies).
The recommended dosing and administration for uridine triacetate in patients ≥18 years is:
- 10 grams (1 packet of coated granules) orally every 6 hours for 20 doses in total, without regards to meals.
- Granules should not be chewed. They should be mixed with 3 to 4 ounces of soft foods such as applesauce, pudding or yogurt.
- The dose should be ingested within 30 minutes of preparation, followed by at least 4 ounces of water.
- Refer to the prescribing information on dose preparation for NG-tube or G-tube use.
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.