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Treatment Name: Pembrolizumab (Keytruda®) + Carboplatin + Pemetrexed (Alimta®)

Pembrolizumab (Keytruda®) + Carboplatin + Pemetrexed (Alimta®) is a Chemotherapy Regimen for Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)

How does pembrolizumab + carboplatin + pemetrexed work?
Pembrolizumab is designed to block the signals that tumor cells use to suppress the immune system and prevent the immune system from attacking lung cancer cells.

Carboplatin and pemetrexed are designed to slow the growth of and kill cancer cells by altering (changing) cancer cell DNA.

Goals of therapy:
Pembrolizumab + carboplatin + pemetrexed are given to shrink lung cancer tumors and decrease symptoms of lung cancer. This combination of drugs is not commonly given with the goal of cure.

Schedule

Cycles 1 through 4

  • Pembrolizumab intravenous (I.V.) infusion over 30 minutes on Day 1
  • Pemetrexed I.V. infusion over ten minutes on Day 1
  • Carboplatin I.V. infusion over 15-60 minutes on Day 1 (most commonly over 30 minutes)

Following Cycle 4

  • Pembrolizumab I.V. infusion over 30 minutes every 21 days for 24 months 

Note: in some cases, your doctor may decide to continue therapy with pemetrexed until it not longer works or until unacceptable side effects occur.

Estimated total infusion time for this treatment:

  • Up to two hours for Day 1 of each cycle when pembrolizumab, carboplatin, and pemetrexted are all given; as short as one hour on Day 1 when only pembrolizumab is given
  • 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

Pembrolizumab + carboplatin + pemetrexed is usually given in an outpatient infusion center, allowing the person to go home afterwards.

Pembrolizumab + carboplatin + pemetrexed is repeated every 21 days. This is known as one Cycle. Each cycle may be repeated up to four times. After four cycles of pembrolizumab + carboplatin + pemetrexed are given, pembrolizumab alone is given for up to two years. Total duration of therapy may last up to 28 months, depending upon response, tolerability, and number of cycles prescribed.

Click here for the  common pembrolizumab + carboplatin + pemetrexed 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 side effects of pembrolizumab + carboplatin + pemetrexed are shown here:

  • Fatigue (64%)
  • Nausea (58%)
  • Low red blood cells [Anemia] (32%)
  • Vomiting (27%)
  • Rash (27%)
  • Diarrhea (20%)
  • Decreased appetite (19%)
  • Constipation (19%)
  • Altered taste (17%)
  • Decreased thyroid function (15%)
  • Hair loss (14%)
  • Fluid retention in arms and legs (12%)
  • Itching (12%)
  • Increased saliva production (12%)
  • Dizziness (10%)
  • Low blood potassium levels (10%)
  • Low white blood cells [neutropenia] (8%)
  • Increased thyroid function (8%)
  • Low platelets (6%)
  • Mouth sores (5%)
  • Lung injury (5%)
  • Low blood calcium (5%)
  • Infusion reaction (4%)
  • Skin infection (4%)
  • Kidney injury (3%)
  • Neutropenic fever (2%)
  • Heart attack (2%)
  • Pneumonia (2%)
  • Severe skin rash (2%)

 On average, 10% of patients discontinue treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
Fatigue Fatigue Nausea and VomitingNausea and VomitingDiarrheaDiarrheaConstipationConstipationHair LossHair LossPainPainNeutropenic FeverNeutropenic Fever

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment then every three weeks. Labs often include: Complete Blood Count (CBC) and Comprehensive Metabolic Panel (CMP), plus any others your doctor may order. Thyroid Function Tests may be checked before the first two treatments, then every 12 weeks thereafter.

How often is imaging needed?
Imaging may be checked before treatment, every six weeks for the first 18 weeks, then every nine weeks for the next 34 weeks, and then every 12 weeks thereafter. 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 pembrolizumab + carboplatin + pemetrexed as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

  • Serious immune reactions may occur. The most common organs affected are the lungs, intestines, liver, thyroid, kidneys, and pituitary gland, but may affect others as well. If immune reactions occur, corticosteroids may be given and pembrolizumab treatment may need to be interrupted or discontinued
  • Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil®, Motrin®) or naproxen (Aleve®) can affect your body’s ability to get rid of (eliminate) pemetrexed. Avoid NSAIDs starting 2 to 5 days prior to each treatment and for at least two days after receiving pemetrexed
  • An intramuscular (I.M.) injection of Vitamin B-12 is recommended beginning one week prior to the first dose of pemetrexed to avoid possible toxicity. Injections are often given every 9 weeks (or 3 cycles) until therapy with pemetrexed is complete
  • Starting one week prior to your first dose of pemetrexed, folic acid should be taken by mouth every day to avoid possible toxicity. Folic acid should be taken daily until 21 days after the last dose of pemetrexed
  • Remember to take the dexamethasone tablets twice daily for three days prior to treatment with pemetrexed. This drug helps prevent skin reactions. If you forget, be sure to alert the doctor, nurse, or pharmacist at the infusion center. An intravenous dose of dexamethasone may be given if you forget a dose(s) at home. On occasion, your doctor may decide to give intravenous dexamethasone at the infusion center instead of oral dexamethasone at home
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for NSCLC. 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 Pembrolizumab (Keytruda®) + Carboplatin + Pemetrexed (Alimta®), 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 Pembrolizumab (Keytruda®) + Carboplatin + Pemetrexed (Alimta®). Depending upon your income, they may be able to help cover the cost of:

  • Pembrolizumab
  • Carboplatin
  • Pemetrexed

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 Pembrolizumab (Keytruda®) + Carboplatin + Pemetrexed (Alimta®) 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 Pembrolizumab (Keytruda®) + Carboplatin + Pemetrexed (Alimta®)

Individual Drug Label Information

Pembrolizumab (Keytruda)

  • Pembrolizumab is an intravenous (I.V.) infusion commonly infused over 30 minutes 
  • Reactions may occur during an infusion. The infusion may need to stop if this occurs 
  • Dose adjustments may need to be made due to kidney or liver problems 
  • Inflammation in the lung can occur. This is known as pneumonitis. Treatment with pembrolizumab may have to be permanently discontinued if pneumonitis is severe 
  • Severe or life-threatening reactions have occurred and may affect the lung, large intestine, liver, skin, nerves, pancreas or certain glands such as the thyroid or pituitary gland. If severe immune-mediated side effects are experienced, pembrolizumab therapy should be stopped and high-dose steroids should be started  
  • A severe reaction in the intestine (colon) known as “colitis”, may present as diarrhea, abdominal cramping, mucus or red blood in the stool, and may cause a fever. Seek a doctor immediately if any of these symptoms occur. The doctor will evaluate whether it could be infection, whether it is severe enough to advise hospitalization, or whether it can be managed at home with either loperamide (Imodium®) or corticosteroids 
  • Inflammation in the liver can occur. This is known as hepatitis. Treatment with pembrolizumab may have to be permanently discontinued if hepatitis is severe. If moderate or severe, high-dose corticosteroids (such as prednisone 1 to 2 mg/kg or equivalent) are recommended until liver enzymes return to normal, at which time the steroid dose may be slowly decreased over time as tolerated  
  • Fatigue, headache, difficulty thinking, uncontrolled bowel movements, low blood pressure, dizziness, swelling, or muscle aches, may suggest pembrolizumab-induced inflammation of the adrenal, thyroid, or pituitary gland  
  • May cause fetal harm, avoid this drug during pregnancy and breastfeeding. Females of child-bearing potential should take a pregnancy test before starting pembrolizumab and use effective contraceptive during therapy and for at least 30 days after the last dose 
General Pembrolizumab (Keytruda) Side Effects  
  • Fatigue 
  • Itching 
  • Rash 
  • Constipation 
  • Diarrhea 
  • Nausea 
  • Decreased Appetite 
  • Shortness of breath 
  • Cough 
  • Click on the pembrolizumab (Keytruda) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

Carboplatin (Paraplatin®)

  • Carboplatin is an intravenous infusion 
  • This medication is dosed based on your kidney function. If your kidney function improves or worsens during therapy, your dose may need to be adjusted
  • This drug should not be used during pregnancy, it may cause fetal harm
General Carboplatin (Paraplatin) Side Effects:  
  • Low red blood cells, low white blood cells, and most commonly, low platelets can be occur
  • Nausea and vomiting is common but can be prevented by taking certain pre-medications
  • Hair loss
  • Constipation and/or diarrhea
  • Pain
  • Allergic reactions to carboplatin can occur. These typically are not seen until after the 6th dose of carboplatin is given 
  • Can cause liver damage at high doses 
  • May cause kidney damage or hearing loss if combined with other medications that also cause these side effects 
  • Click on the carboplatin (Paraplatin) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossBleedingBleedingConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

Pemetrexed (Alimta®)

  • Pemetrexed is an intravenous infusion 
  • Dosage adjustments may be required for severe toxicity 
  • Non-steroidal anti-inflammatory drugs (NSAIDs) should be avoided starting 2 to 5 days prior to therapy and for at least 2 days after receiving pemetrexed 
  • Intramuscular (I.M.) injection of vitamin B12 and oral folic acid are given throughout treatment to decrease the risk of experiencing side effects from pemetrexed. These are started 7 days prior to the first dose of pemetrexed 
  • Skin reactions can be common. Oral dexamethasone should be taken twice daily for 3 days prior to treatment to decrease the severity of skin reactions. As an alternative, intravenous dexamethasone may be given on the day of treatment instead 
  • Avoid during pregnancy. Contact your doctor immediately if you think you may have become pregnant. Females who are of child bearing age should use contraception during treatment 
General Pemetrexed (Alimta) Side Effects 
  • May cause low red blood cells, white bloods cells, and platelets 
  • Severe liver toxicity can occur in patients with decreased liver function 
  • Can cause various gastrointestinal symptoms such as nausea, vomiting, diarrhea, or decreased appetite 
  • Fatigue and weakness 
  • Constipation 
  • Although rare, serious allergic reactions have been reported 
  • May cause mouth sores 
  • Click on the pemetrexed (Alimta) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue ConstipationConstipationAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

Langer CJ, Gadgeel SM, Borghaei H, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol 2016;17(11):1497-1508.

Created: August 9, 2017 Updated: August 9, 2017

What is Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)?

What is Non-Small Cell Lung Cancer?
A disease of the tissue found in the lung.  Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Known causes include smoking and exposure to environmental toxins.  The stage of NSCLC can vary at diagnosis and throughout treatment.  Stages include stage I, II, III, and 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, 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 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

Common Starting Doses

Cycles 1 through 4:

  • Pembrolizumab 200 mg intravenous (I.V.) infusion over 30 minutes on Day 1
  • Pemetrexed 500 mg/m2 I.V. infusion over 10 minutes on Day 1
  • Carboplatin (AUC 5) I.V. infusion over 15-60 minutes on Day 1 (commonly over 30 minutes)

Following Cycle 4:

  • Pembrolizumab 200 mg I.V. infusion over 30 minutes every 21 days for 24 months

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

 

Thyroid Function Tests

Thyroid function tests are a set of labs that can help indicate if there are any changes to thyroid function such as an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Thyroid function tests typically consist of three labs: thyroid stimulating hormone (TSH), thyroxine (T4), and triiodothyronine (T3).