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Treatment Name: Cisplatin + Fluorouracil (5-FU) + Cetuximab (Erbitux)

Cisplatin + Fluorouracil (5-FU) + Cetuximab (Erbitux) is a Chemotherapy Regimen for Head and Neck Cancer

How does cisplatin + fluorouracil (5-FU) + cetuximab work?

  • Cisplatin binds to the DNA in cancer cells and prevents it from replicating. This prevents cancer cells from growing and dividing.
  • Fluorouracil (5-FU) is designed to target rapidly dividing cells and kills or the slows the growth of head & neck cancer cells.
  • Cetuximab binds to receptors, called EGFR (epidermal growth factor receptor), located on the surface of cancer cells. When cetuximab binds to cancer cells, it sends a signal through the cancer cell which tells it to die. Cetuximab is commonly called immunotherapy.

Goals of therapy:
Cisplatin + Fluorouracil + Cetuximab is given to shrink tumors and decrease symptoms from head and neck cancer. It is not commonly given with the goal of cure, but is given to help patients live longer.

Schedule

  • Cisplatin intravenous (I.V.) infusion over one hour on Day 1
  • Fluorouracil continuous I.V. infusion (via home-infusion pump) over 96 hours, beginning Day 1 and ending on Day 5
  • Cetuximab I.V. infusion over two hours on Day 1 of Cycle 1, then over one hour weekly on Days 1, 8, and 15 starting one week after the first dose

Estimated total clinic infusion time for this treatment:

  • Up to six hours for Cycle 1, Day 1 if treatment is well tolerated. If the first treatment is tolerated well, infusion time can be four to five hours for Day 1 of subsequent cycles. Typically, I.V. hydration is given both before and after cisplatin and I.V. magnesium can add up to two hours
  • On days when just cetuximab is given, infusion time can take up to two hours
  • 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

Cisplatin + fluorouracil + cetuximab is usually given in an outpatient infusion center, allowing the person to go home afterwards where they will continue to receive their continuous infusion of fluorouracil via home-infusion pump. On occasion, it may be given in the hospital if someone is too sick.

Cisplatin + fluorouracil + cetuximab is repeated every 21 days. This is known as one Cycle. Each cycle may be repeated up to 6 times, depending upon the stage of the disease. Duration of therapy may last up to five months, depending upon response, tolerability, and number of cycles prescribed.

Click here for the common cisplatin + 5-fluorouracil + cetuximab 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 commonly reported drug side effects of cisplatin + fluorouracil + cetuximab are shown here. These percentages reflect the amount of patients who experienced severe or life threatening side effects only:

  • Low white blood cells (22%)
  • Anemia [low red blood cells] (13%)
  • Increased bleeding risk [low platelets; thrombocytopenia] (11%)
  • Skin reaction (9%)
  • Low blood potassium (7%)
  • Vomiting (5%)
  • Fatigue or weakness (5%)
  • Loss of appetite (5%)
  • Low blood magnesium (5%)
  • Neutropenic fever (5%)
  • Shortness of breath (4%)
  • Pneumonia (4%)
  • Low blood calcium (4%)
  • Severe infection (4%)
  • Heart attack (3%)
  • Heart failure (2%)

Roughly 12% of patients discontinue treatment with cisplatin + fluorouracil + cetuximab due to unacceptable side effects.

Side effect videos Side Effect Videos
AnemiaAnemiaBleedingBleedingNausea and VomitingNausea and VomitingFatigue Fatigue Neutropenic FeverNeutropenic FeverPainPain

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before each treatment and periodically in-between treatments, decided by your doctor. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood magnesium level, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment and every six weeks until the end of treatment. Imaging may include: X-rays, magnetic resonance imaging (MRI) or computerized tomography (CT) scans.

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

ChemoExperts Tips

  • Patients will have an infusion pump strapped to their body for 4 days to allow fluorouracil (5-FU) to continuously infuse into a vein. The I.V. line for this continuous infusion chemo is connected at the end of the clinic chemotherapy session by a nurse. When the 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
  • Fluorouracil may cause painful redness, blistering, and peeling skin reaction on the palms of your hands and on the soles of your feet. This is known as 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
  • The first dose of cetuximab is the dose that is most likely to cause an infusion reaction, which may include: fever, shaking, chills, and shortness of breath; the incidence of this is very low, 2% or less. Even if medications are given beforehand this can happen. Side effects generally go away when the cetuximab is stopped. It may be restarted at a slower rate. Most patients are able to receive the entire dose, although it may take longer than expected
  • Development of a skin rash is common while on cetuximab however, development of skin rashes may be linked with better disease response from cetuximab. Mild skin rashes can be treated with topical or oral antibiotics that are prescribed by your doctor. More severe rashes may be treated with oral medications. Tell your doctor about any skin reactions
  • Avoid excess sun exposure while receiving cetuximab and up to 2 months after the last dose
  • Before each infusion, you may receive an antihistamine such as diphenhydramine (Benadryl®) to help prevent reactions. This can make you sleepy so it is best to have someone drive you to the infusion appointments if possible
  • Cetuximab and cisplatin may decrease your blood levels of potassium and/or magnesium. You may need to receive fluids into the vein containing magnesium and potassium. Oral potassium and magnesium may also be prescribed for you to take at home to minimize the amount of time spent in the the infusion center
  • Cisplatin can possibly damage the kidneys. Be sure to maintain good hydration to lessen the risk of experiencing kidney damage
  • Cetuximab may cause changes to fingernails and toenails such as redness, swelling, oozing, bleeding, cracking, discoloration, or ridges in the nails. This is known as “paronychia”. This can first develop weeks or months after starting therapy with cetuximab and can last for months after therapy is stopped. To help prevent paronychia from developing, avoid wearing tight fitting shoes or gloves and avoid putting unnecessary pressure or friction on fingernails and toenails. If you experience symptoms of paronychia, talk with your doctor as prescription corticosteroid creams or antibiotics may be needed
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for head and neck 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 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 Cisplatin + Fluorouracil (5-FU) + Cetuximab (Erbitux), 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 Cisplatin + Fluorouracil (5-FU) + Cetuximab (Erbitux). Depending upon your income, they may be able to help cover the cost of:

  • Cisplatin
  • Fluorouracil
  • Cetuximab

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 Cisplatin + Fluorouracil (5-FU) + Cetuximab (Erbitux) 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 Cisplatin + Fluorouracil (5-FU) + Cetuximab (Erbitux)

Individual Drug Label Information

Cisplatin (Platinol®)

  • Cisplatin is an intravenous (I.V.) infusion that is typically given over one to two hours
  • Cumulative toxicity to kidneys from cisplatin can be severe 
  • Other toxicities from multiple doses are:  low blood counts, nausea, vomiting, and hearing loss
  • Dosage adjustments may be required for poor kidney function or bone marrow toxicity (low blood counts) 
  • Cisplatin is hazardous to a human fetus; women should avoid pregnancy while on this drug 
  • Women should not breast-feed while on cisplatin; it has been reported to be in human milk 
  • Patients on anticonvulsant drugs may have decreased levels while on cisplatin 
General Cisplatin (Platinol) Side Effects 
  • Kidney problems (nephrotoxicity), especially in elderly patients. 
  • Nausea and vomiting, both acute (within first 24 hours) and delayed (two to five days after infusion) 
  • Diarrhea 
  • Low blood cell counts (myelotoxicity, acute leukemia)
  • Hearing problems- ringing ears.  All patients should have a baseline hearing test done.  All children should have hearing test done before each dose and for several years after therapy is complete 
  • Low blood electrolytes:  magnesium, potassium, calcium, sodium, and phosphate
  • Nerve pain 
  • Vision problems; improvement and/or complete recovery usually occurs after stopping therapy 
  • Liver toxicity; recovery usually occurs after stopping therapy 
  • Click on the cisplatin (Platinol) package insert below for reported side effects and possible drug interactions

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

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.

Cetuximab (Erbitux®)

  • Cetuximab is an intravenous infusion given over one to two hours
  • Severe infusion reactions such as difficulty breathing, low blood pressure, and heart problems can occur. You will receive medications before each dose of cetuximab to lower your risk of experiencing these reactions
  • Heart attack (cardiac arrest) can occur due to blood electrolyte abnormalities.  Your blood electrolytes (potassium, magnesium, and calcium) will usually be checked before each dose of cetuximab
  • Dosage adjustments may be required for serious skin reactions or other toxicities
  • Cetuximab does not have any drug interactions, but it does boost the effect of platinum drugs and radiation therapy
General Cetuximab (Erbitux) Side Effects
  • Skin reactions, acne-like rash and dry skin
  • Mouth sores
  • Difficult swallowing, painful swallowing
  • Dry mouth
  • Throat pain
  • Shortness of breath
  • Weight loss
  • Dehydration
  • Nausea 
  • Infection
  • Weakness and fatigue
  • Decrease in blood magnesium, potassium, or calcium levels
  • Diarrhea
  • Headache
  • Click on the cetuximab (Erbitux) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPain

See DailyMed package insert.

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References

1) Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008;359:1116-1127.

2) Pinto C, Barone CA, Girolomoni G, et al. Management of Skin Toxicity Associated with Cetuximab Treatment in Combination with Chemotherapy or Radiotherapy. Oncologist. 2011;16:228-238.

Created: January 11, 2017 Updated: October 7, 2018

What is Head and Neck Cancer?

A group of diseases of cells found in the mouth, lip, nasal cavity, throat, sinuses, and lymph nodes in the neck. Head and neck cancer is a rare condition. Known causes of head and neck cancer are strongly related with lifestyle and environmental risk factors including: tobacco use, alcohol consumption, UV light (sun exposure), certain strains of viruses (Epstein Barr virus [EBV] and human papilloma virus [HPV]), exposure to certain chemicals in the workplace, and vitamin A deficiency. If detected early it is highly curable. The stage of head and neck cancer can vary at diagnosis and throughout treatment. Stages of head and neck cancer include the Tumor, Node, Metastatis (TNM) staging system to describe a different area of cancer growth. After that is known, Stage Grouping using Stages I, II, III, or IV is assigned. This describes the extent of cancer throughout the body. 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 cisplatin + 5-fluorouracil + cetuximab starting doses

  • Cisplatin 100 mg/m2 intravenous (I.V.) infusion over 1 hour on Days 1
  • Fluorouracil 1000 mg/m2 I.V. infusion over 24 hours (via home-infusion pump) on Days 1, 2, 3, and 4, ending on Day 5
  • Cetuximab 400 mg/m2 I.V. infusion over 2 hours on Day 1 of Cycle 1, then 250 mg/m2 I.V. infusion over 1 hour weekly on days 1, 8, and 15 starting one week after the first dose

Note:

  • In the clinical study, cetuximab ended one hour before the start of chemotherapy
  • Individual doses may vary based upon your Doctor's recommendation, or drug availability

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