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Treatment Name: FOLFIRINOX (Fluorouracil + Leucovorin + Irinotecan + Oxaliplatin)

FOLFIRINOX (Fluorouracil + Leucovorin + Irinotecan + Oxaliplatin) is a Chemotherapy Regimen for Pancreatic Cancer

How does FOLFIRINOX work?
Each of the medications in FOLFIRINOX are designed to kill cancer cells or slow their growth and ability to multiply.

FOL - folinic acid (leucovorin)
F - fluorouracil (5-FU)
IRIN - irinotecan (Camptosar)
OX – oxaliplatin (Eloxatin)

Goals of therapy:
FOLFIRINOX is most commonly given to decrease symptoms and extend life when the disease is advanced pancreatic cancer or, metastatic, which means: spread beyond the pancreas and lymph nodes. FOLFIRINOX chemotherapy is not commonly given with the goal of cure. In rare instances, FOLFIRINOX can be given to shrink tumors early in treatment with the goal of then removing the cancer by surgery leading to better overall survival or a cure.

Schedule

  • Oxaliplatin intravenous (I.V.) infusion is given over 2 hours on Day 1
  • Folinic acid (Leucovorin) I.V. infusion is given over 2 hours on Day 1
  • Irinotecan I.V. infusion is given over 90 minutes on Day 1
  • Fluorouracil (5-FU) I.V. push, is usually given over 3 to 5 minutes on Day 1
  • Fluorouracil (5-FU) continuous I.V. infusion is given via home-infusion pump over 46 hours beginning Day 1

Estimated total infusion time for FOLFIRINOX treatment:

  • Total infusion time usually takes up to 50 hours, but typically only up to 5 hours are spent in the outpatient infusion center and the rest is spent at home receiving chemotherapy via home-infusion pump
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and I.V. fluids, such as hydration, may add more time

FOLFIRINOX cancer treatment is usually given in an outpatient infusion center, allowing the person to go home afterwards.

Each two-day FOLFIRINOX treatment is repeated every 14 days (two weeks). This is known as one Cycle. Each cycle may be repeated up to 12 times. Duration of therapy may last up to six months, depending upon response, tolerability, and number of cycles prescribed.

Click for the common FOLFIRINOX starting doses.

Side Effects

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 drug side effects with FOLFIRINOX are shown here. The percentages represent only the most severe incidences of side effects reported in clinical trials:

Side effect videos Side Effect Videos
Fatigue Fatigue Nausea and VomitingNausea and VomitingDiarrheaDiarrheaBleedingBleedingPainPainAnemiaAnemiaBlood ClotsBlood ClotsNeutropenic FeverNeutropenic Fever

Monitoring

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. The CA19-9 (a tumor marker) is usually checked using a blood test at the beginning of treatment, then about every eight weeks thereafter to determine response rate, which means: are the chemotherapy drugs working?

How often is imaging needed?
Imaging may be checked before treatment and may be checked periodically during treatment and after completion of treatment. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue FOLFIRINOX as planned, or delay or switch therapy.

ChemoExperts Tips

  • The cancer patient will have an infusion pump strapped to their body for 2 days to allow fluorouracil (5-FU) to continuously infuse into a vein. The I.V. line is connected at the end of the Day 1 chemotherapy session by a nurse and the patient is able to go home, if not home already. When the two-day continuous infusion is finished, the patient will have to 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
  • Diarrhea caused by irinotecan is treated with atropine injections in the medical setting, both before and after the irinotecan infusion. Diarrhea at home is commonly treated with loperamide purchased over-the-counter at a pharmacy. You may receive special instructions on how to use loperamide for diarrhea caused specifically by irinotecan. Tell your doctor immidiately of you have severe diarrhea at home or go to an emergency department immediately
  • Oxaliplatin can make you very sensitive to cold things such as cold drinks or cold weather for a few days after receiving oxaliplatin. It is best to wear warm clothes in cold weather and to not drink cold liquids, especially those with ice, or hold cold objects in your hands for up to 2 days after each oxaliplatin infusion
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for pancreatic cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering treatments for pancreatic cancer

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 FOLFIRINOX (Fluorouracil + Leucovorin + Irinotecan + 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 FOLFIRINOX (Fluorouracil + Leucovorin + Irinotecan + Oxaliplatin). Depending upon your income, they may be able to help cover the cost of:

  • Folinic acid
  • Fluorouracil
  • Irino­tecan
  • Oxaliplatin

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 FOLFIRINOX (Fluorouracil + Leucovorin + Irinotecan + 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.

Emotional Wellness

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 FOLFIRINOX (Fluorouracil + Leucovorin + Irinotecan + Oxaliplatin)

Individual Drug Label Information

Folinic acid (Leucovorin)

  • Folinic acid is an intravenous (I.V.) drug that is a derivative of folic acid, also known as vitamin B9
  • Is clear to slightly yellow in color
General Folinic Acid (Leucovorin) Side Effects
  • Seizures and fainting have been rarely reported
  • Click on the Folinic Acid (Leucovorin) package insert for all reported side effects and possible drug interactions
See DailyMed package insert.

Fluorouracil (Adrucil®)

  • Fluorouracil (5-FU) Is an intravenous (I.V.) drug
  • Recommended to be given only under the supervision of a qualified physician well versed in administering chemotherapy
General Fluorouracil (5-FU, Adrucil) Side Effects
  • Low white blood cell count (leucopenia and neutropenia)
  • Mouth and throat sores or ulcers (mucositis)
  • Diarrhea
  • Nausea and vomiting
  • Low red blood cell and platelet counts
  • Allergic reactions, rarely
  • Eye pain, light sensitivity, excess watering, visual changes
  • Headache
  • Skin conditions:  dryness, redness, tingling, light sensitivity, pain, swelling, loss of nails (hand-foot syndrome)
  • Dosage adjustments may be required for severe liver dysfunction
  • Click on the Fluorouracil (5-FU, Adrucil) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPainNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

Irino­tecan (Camp­tosar®)

  • Irinotecan is an intravenous (I.V.) drug
  • Recommended to be given only under the supervision of a qualified physician well versed in administering chemotherapy
  • Can induce two forms of diarrhea: early and late. Late usually occurs 24 hours after finishing an irinotecan infusion.  Late diarrhea can be life threatening and should be quickly reported to your physician or visit an emergency department immediately
  • Severe low white blood count may occur, which can lead to infections
  • Dosage adjustments may be required for patients experiencing severe diarrhea, liver dysfunction, or patients with very low white blood cell counts (neutropenia)
  • Irinotecan can interact with ketoconazole and St. John’s Wort.  Those medications should be stopped 2 weeks before starting irinotecan therapy
  • There are known drug interactions of irinotecan with CYP3A4 inducers:  phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, and atazanavir
General Irinotecan (Camptosar) Side Effects
  • Diarrhea
  • Nausea
  • Vomiting
  • Low white blood cell count (neutropenia)
  • Fevers from low white blood cell count (neutropenic fever)
  • Mouth sores and inflammation (mucositis)
  • Inflammation of the large intestine (colitis)
  • Kidney impairment or kidney failure has rare reports
  • Blockage of blood vessels by a clot (thromboembolism)
  • Lung toxicities, such as shortness of breath or cough
  • Avoid during pregnancy, known to cause fetal harm
  • Click on the irinotecan (Camptosar) package insert link below for a complete list of reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue PainPainNeutropenic FeverNeutropenic FeverBlood ClotsBlood Clots

See DailyMed package insert.

Oxaliplatin (Eloxatin®)

  • Oxaliplatin is an intravenous (I.V.) drug
  • Allergic reactions have been reported and may occur within minutes. Certain drugs can be given to alleviate the symptoms: antihistamines, corticosteroids, or epinephrine
  • Oxaliplatin is usually diluted in a dextrose 5% I.V. bag and infused over 2 hours
  • Dosage adjustments may be required for liver dysfunction
General Oxaliplatin (Eloxatin) Side Effects
  • Nerve pain or tingling in feet and hands, loss of tendon reflexes
  • Oxaliplatin can make you very sensitive to cold things such as cold drinks or cold weather for a few days after receiving oxaliplatin. It is best to wear warm clothes in cold weather and to not drink cold liquids, especially those with ice, or hold cold objects in your hands for up to 2 days after each oxaliplatin infusion
  • Lung toxicity:  avoid with certain lung conditions
  • Low white blood cells, platelets, and red blood cells
  • Constipation
  • Diarrhea
  • Vomiting or nausea
  • Fatigue
  • Mouth sores
  • Change in liver function
  • Avoid during pregnancy, known to cause fetal harm
  • Click on the oxaliplatin (Eloxatin) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPain

See DailyMed package insert.

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References

Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364:1817-1825.

Created: April 5, 2016 Updated: October 3, 2018

What is Pancreatic Cancer?

A disease of the cells of the pancreas organ. There are different types of pancreatic cancer, the most common being pancreatic adenocarcinoma that accounts for about 85% of cases. This type affects the digestive enzymes produced by the pancreas. Risk factors include: smoking tobacco, obesity, diabetes, and some rare genetic conditions. It can spread to neighboring organs such as: liver, duodenum, stomach, colon, spleen, and kidneys.

Pancreatic cancer is treated with surgery, chemotherapy, radiation therapy, a combination of all these, or sometimes supportive care alone. Surgery can be curative, but it can also be used to reduce tumor size and improve quality of life. The stage can vary at diagnosis and throughout treatment. The Tumor, Node, Metastasis (TNM) staging system is used to stage pancreas cancer. Staging systems describe the extent of cancer throughout the body and help doctors determine which treatments to offer. 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.

Common Starting Doses

  • Oxaliplatin 85 mg/m2 intravenous (I.V.) infusion is given over 2 hours on Day 1
  • Folinic acid (Leucovorin) 400 mg/m2 I.V. infusion is given over 2 hours on Day 1
  • Irinotecan 180 mg/m2 I.V. infusion is given over 90 minutes on Day 1
  • Fluorouracil 400 mg/m2 I.V. push, is usually given over 3 to 5 minutes on Day 1
  • Fluorouracil 2400 mg/m2 continuous I.V. infusion is given via home-infusion pump over 46 hours beginning Day 1 and ending on Day 2

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.

Common uses:
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 status2) 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

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium