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regimen-monograph
FOLFOX6
A - Regimen Name
FOLFOX6 Regimen
Folinic Acid (Leucovorin)-Fluorouracil-Oxaliplatin
Disease Site
Gastrointestinal - Colorectal
Intent
Adjuvant
Regimen Category
Local : A regimen not widely used by Regional Cancer Centres in this disease site.
Rationale and Uses
Adjuvant treatment of completely resected stage III or *high risk stage II colorectal cancer where oxaliplatin is given in combination with 5-fluorouracil and leucovorin in the regimens known as FOLFOX or FLOX.
*high risk stage 2 colon cancer is defined as one of the following: Obstruction, perforation, poorly differentiated adenocarcinoma, inadequate lymph node sampling or T4 tumour.
B - Drug Regimen
| oxaliplatin | 100 mg /m² | IV in 500mL D5W over 120 minutes | Day 1 |
| leucovorin | 400 mg /m² | IV diluted in D5W over 120 minute (concurrently with oxaliplatin) | Day 1 |
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(continued on next page)
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| fluorouracil | 400 mg /m² | IV bolus, after leucovorin | Day 1 |
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THEN,
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| fluorouracil | 2400 mg /m² | IV continuous infusion over 46 hours (single dose) | Start on Day 1 |
C - Cycle Frequency
REPEAT EVERY 14 DAYS
For a maximum total of 12 Cycles, unless disease progression or unacceptable toxicity occurs
E - Dose Modifications
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.
Dosage with toxicity
See appendix 6 for general recommendations for hematologic toxicity.
Do not retreat until the ANC is ≥ 1.5 x 109/L and the platelet count is ≥ 100 x 109/L. Consider dose reduction in subsequent cycles after recovery from Grade 3 or 4 hematological toxicities.
|
Grade
|
Dose Modification |
Persistent* Grade 2 Neurotoxicity |
↓ oxaliplatin from 100 → 75 mg/m2
|
Transient* Grade 3 Neurotoxicity |
↓ oxaliplatin to 75mg/m2
|
Persistent ≥ Grade 3 Neurotoxicity |
Discontinue oxaliplatin
|
≥ Grade 3 GI toxicity (after prophylaxis) OR Grade 3 or 4 Platelets OR Grade 3 or 4 Neutropenia |
↓ oxaliplatin from 100 → 75 mg/m2
Reduce 5FU by 20%
|
Other ≥ grade 3 toxicity** |
Consider dose ↓
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Pharyngolaryngeal
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Hold oxaliplatin, then increase duration of infusion to 6 hours
|
|
Pneumonitis
|
Hold, investigate; discontinue permanently if confirmed. |
* transient = 7days-<1 cycle; persistent = ≥ 1 cycle; ** for skin toxicity, reduce 5FU dose only
Note: Pharyngo-laryngeal dysesthesia results in a sensation of apnea without evidence of respiratory distress and may be exacerbated by exposure to cold air. If this occurs during infusion, stop infusion immediately and observe patient. If oxygen saturation is normal, an anxiolytic agent may be given. Subsequent infusions should be administered over 6 hours.
Hepatic Impairment
Omit fluorouracil if bilirubin > 4 x ULN.
Renal Impairment
Oxaliplatin should be used with caution in patients with moderate renal impairment as the clearance of ultrafilterable platinum is decreased in these patients. Oxaliplatin should not be used in patients with severe renal impairment (creatinine clearance <30mL/min).
F - Adverse Effects
Refer to oxaliplatin, leucovorin, fluorouracil drug monograph(s) for additional details of adverse effects
| Most Common Side Effects | Less Common Side Effects, but may be |
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I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- Clinical toxicity assessment (including neurotoxicity, diarrhea, stomatitis, nausea and vomiting).
- Baseline and regular CBC
- Baseline and regular liver & renal function tests.
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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K - References
André T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer. N Eng J Med 350:2343-2351, 2004.
BCCA Cancer Agency. BCCA Protocol Summary for ADJUVANT Combination Chemotherapy for Stage III Colon Cancer Using Oxaliplatin, 5-Fluorouracil and Folinic Acid (Leucovorin)
July 2012: Modified regimen category
PEBC Advice Documents or Guidelines
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.
Last Updated: July 27, 2026
