Treatment Name: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) is a Chemotherapy Regimen for Colon Cancer
How does FOLFOX chemotherapy work?
Each chemotherapy drug in FOLFOX is designed to kill colon cancer cells.
FOL – folinic acid (leucovorin)
F - fluorouracil (5-FU)
OX – Oxaliplatin (Eloxatin®)
Goals of therapy:
FOLFOX chemo is given to shrink tumors and help decrease symptoms for a colon cancer patient. If the disease is not metastatic, it is commonly given with the goal of cure. If the disease is advanced colorectal cancer, or metastatic, FOLFOX is not commonly given with the goal of cure but rather to prolong survival.
- Folinic acid (Leucovorin) intravenous infusion (I.V.), given over two hours before fluorouracil on Day 1
- Oxaliplatin I.V. given over two hours on Day 1. This is commonly given at the same time as folinic acid (Leucovorin)
- Fluorouracil (5-FU) I.V. push, usually given over 3 to 5 minutes on Day 1, after the end of the leucovorin infusion
- Fluorouracil (5-FU) continuous I.V. infusion (via home-infusion pump) over 44 - 46 hours, beginning on Day 1
Estimated total infusion time for FOLFOX:
- For Day 1 of each cycle, up to 4 hours is spent at the infusion center
- Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time
FOLFOX chemo is usually given in an outpatient health care infusion center, allowing the cancer patient to go home afterwards where they will continue to receive their continuous 5-FU infusion via ambulatory (home) infusion pump. FOLFOX may be given in the hospital if someone is too sick or if an ambulatory pump is not available or its use is not desired.
FOLFOX is repeated every 14 days. Each 14-day period is known as one Cycle. If the disease is not metastatic, treatment is given for a total of 12 cycles (6 months). If the disease is metastatic, each cycle may be repeated until the treatment no longer works or until unacceptable side effects occur. Duration of FOLFOX chemotherapy depends upon response, tolerability, and number of cycles prescribed.
Click here for common FOLFOX starting doses.
In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most common side effects reported for FOLFOX are shown here. Side effects sometimes have percentage ranges [example: 37 – 92%] because they differed between clinical studies:
- Tingling or burning feeling in arms and legs, mostly mild, (37 - 92%)
- Low white blood cells [neutropenia], (58 - 79%)
- Increased bleeding risk [low platelets; thrombocytopenia], (23 - 77%)
- Anemia [low red blood cells], (76%)
- Nausea*, (64 - 74%)
- Diarrhea, (56 - 61%)
- Vomiting*, (39 - 47%)
- Fatigue, (45%)
- Mouth sores, (37 - 42%)
- Loss of appetite, (30%)
- Hair loss**, (28%)
- Constipation, (28%)
- Fever, (26%)
- Abdominal pain, (26%)
- Weakness, (20%)
- Blisters on palms of hands and soles of feet, (10%)
- Allergic reaction, (10%)
- Blood clots, (6%)
- Neutropenic fever, (2%)
On average, up to 25% of colon cancer patients discontinue treatment at some point due to unacceptable side effects if FOLFOX is being given for metastatic disease. If the disease is not metastatic, most patients are able to complete all planned courses of treatment.
*The actual incidence of nausea or vomiting may be lower today than reported in clinical trials as newer medications used to treat nausea and vomiting are now available
** Hair loss from FOLFOX is almost always mild, not obvious from a distance, and seen only on close inspection. A different hair style can help cover some hair loss, and a wig or hair piece is usually not required.
NOTE: Twelve months after treatment, the incidence of moderate to severe tingling, pain, burning, or numbness in hands or feet from FOLFOX is about 1%, and less than 1% four years after treatment. Many patients experience improvement from these effects within 28 days after treatment is stopped, however mild symptoms may persist beyond 1 year.
How often is monitoring needed?
Labs (blood tests) may be checked before each treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order. CEA (carcinoembryonic antigen) may be checked every six weeks to monitor tumor response to FOLFOX.
How often is imaging needed?
Imaging, such as computerized tomography (CT) scan and/or magnetic resonance imaging (MRI), is checked before treatment and may be checked every 6 weeks during treatment or at the discretion of your doctor.
How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue FOLFOX as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy. The dose of oxaliplatin may be reduced if persistent (lasting more than 14 days) tingling, pain, numbness, or burning are experienced. Fluorouracil or oxaliplatin doses may be reduced for avoiding infection if the white blood cells, known as neutrophils, drop too low. Doses may also be lowered if the platelet count drops too low, or for severe side effects such as severe mouth sores or diarrhea. Other dose reductions may be recommended by your doctor.
- Patients will have an infusion pump connected to their body for 2 days to allow fluorouracil (5-FU) to continuously infuse into a vein. To do this, the I.V. line for continuous infusion 5FU is connected by a nurse after chemotherapy is given in clinic on Day 1. When the home infusion of fluorouracil is finished, the patient will go back to the infusion center or hospital to have it disconnected unless a home health nurse comes to the patient’s home to do this
- Oxaliplatin can make you very sensitive to cold things such as cold drinks or cold weather for a few days after receiving treatment. It is best to wear warm clothes in cold weather and to not drink cold liquids, especially beverages with ice, or hold cold objects in your hands for up to 2 days after each oxaliplatin infusion
- Fluorouracil may cause “Hand-Foot Syndrome.” Ways to help reduce the risk of experiencing hand-foot syndrome include using a non-alcoholic moisturizer daily on your hands and feet, avoid wearing gloves, avoid prolonged exposure to hot water, and avoid activities that put pressure or friction on your hands and feet such as golf or tennis while receiving fluorouracil
- If your white blood cells drop too low, you may need to receive a white blood cell growth factor shot such as filgrastim (Neupogen®) after chemotherapy to stimulate production of white blood cells and avoid periods of neutropenia. This is only typically done if the disease is not metastatic. If the disease is metastatic, these medications are not routinely given, but rather FOLFOX treatment is delayed until the white blood cells recover
- Clinical trials may exist for colon cancer treatment and cancer research. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin), we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin). Depending upon your income, they may be able to help cover the cost of:
- Folinic acid
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
What is Colon Cancer?
A disease of the cells from the large intestine. Colon cancer is the third most common cancer among both men and women. Known causes include: family history, poor diet, sedentary lifestyle, obestity, diabetes, history of colon polyps, smoking, heavy alcohol use, prior radiation treatment to abdomen for other cancers, and old age. The stage can vary at diagnosis and throughout treatment. Stages of colon cancer use Tumor, Node, Metastasis (TNM) staging as well as Stage Grouping using Stages I, II, III, or IV. The effectiveness of the treatment may depend upon the stage at diagnosis.
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.
What does "Cure" mean?
The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.
Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.
What is Leucovorin?
Leucovorin is not a chemotherapy agent. It is a special form of folic acid (vitamin B9) that helps increase the effectiveness of fluorouracil. Folic acid should NOT be confused with leucovorin (foliNic acid) as it does not work the same way.
What is an I.V. Push?
An intravenous medication that is usually prepared in a syringe and infused by vein over a short period of time, such as 15 minutes or less
Common FOLFOX starting doses
- Folinic acid (Leucovorin) 400 mg/m2 intravenous infusion (I.V.) over 2 hours on Day 1
- Oxaliplatin 85 mg/m2 I.V. given over two hours on Day 1
- Fluorouracil 400 mg/m2 I.V. push over 3 to 5 minutes on Day 1, after the end of the leucovorin infusion
- Fluorouracil 1200 mg/m2 continuous I.V. infusion over 44 - 46 hours beginning Day 1, ending Day 3
Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.
If you are interested in reading the clinical trials results, please click on reference below:
1) Cassidy J, Clarke S, Díaz-Rubio E, et al. Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol. 2008; 26:2006-2012.
2) André T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350:2343-2351.
3) André T, Boni T, Navarro M, et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009;27:3109-3116.
What is a CBC?
A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.
2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.
3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.
What is a CMP?
A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status, 2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.
Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein
13) Serum glucose
14) Serum calcium
What is "Hand-Foot Syndrome"?
Hand-foot syndrome is a side effect of fluorouracil that can cause painful redness, blistering, and peeling skin reaction on the palms of your hands and on the soles of your feet. It is sometimes referred to as “palmar-plantar erythrodysesthesia”, or PPE.
What does metastatic mean?Metastatic disease is when cancer cells have spread from their primary (original) location to other parts of the body and started more tumor(s).