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.
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.
First-line treatment, in patients with good performance status, of:
- locally advanced unresectable or metastatic esophageal adenocarcinoma or squamous cell carcinoma
- HER2-negative advanced or metastatic adenocarcinoma of the esophagogastric junction
Pembrolizumab every 6 weeks:
|4 mg /kg||IV (max 400 mg)||Day 1; Every 6 weeks|
|oxaliplatin||85 mg /m²||IV||Day 1|
|leucovorin||400 mg /m²||IV (concurrently with oxaliplatin)||Day 1|
|fluorouracil||400 mg /m²||IV bolus, after leucovorin||Day 1|
|fluorouracil||2400 mg /m²||IV continuous infusion over 46 hours (single dose)||Start on Day 1|
1Dosing based on NDFP funding criteria. Refer to NDFP form for alternative pembrolizumab dosing schedule (2 mg/kg IV q3 weeks).
2Give pembrolizumab before chemotherapy when given on the same day.
MFOLFOX6: Repeat every 2 weeks
Until disease progression or unacceptable toxicity^
PEMBROLIZUMAB: Repeat every 6 weeks (4 mg/kg)†
Until disease progression or unacceptable toxicity, or up to a maximum of 2 years, whichever occurs first
^If chemotherapy is discontinued after at least 1 cycle due to intolerance, pembrolizumab may be continued as single agent (PEMB(MNT)) for up to 2 years, unless disease progression or unacceptable toxicity.
†Alternative pembrolizumab dosing schedule is 2 mg/kg IV every 3 weeks.
Premedications for Oxaliplatin (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 chips as cold temperatures can precipitate or exacerbate acute neurological symptoms of oxaliplatin.
Also refer to CCO Antiemetic Recommendations.
Al-Batran SE, Hartmann JT, Probst S, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol 2008;26(9):1435-42.
pCODR reimbursement review (pembrolizumab: esophageal carcinoma, gastroesophageal junction adenocarcinoma). February 2022.
Sun JM, Shen L, Shah MA, et al. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet 2021;398(10302):759-71. doi: 10.1016/S0140-6736(21)01234-4.
November 2022 Modified Cycle Frequency section
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.
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.