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Treatment Name: Olaratumab (Lartruvo®) + Doxorubicin

Olaratumab (Lartruvo®) + Doxorubicin is a Chemotherapy Regimen for Sarcoma

How does olaratumab (Lartruvo®) + doxorubicin work?
Olaratumab is an antibody that is designed to bind to a protein on the surface of cancer cells. When it binds, it blocks the protein from sending signals within the cell that tell the cancer cell to grow and divide. Doxorubicin is a chemotherapy designed to attack and kill rapidly dividing cells and slow the growth of cancer cells.

Goals of therapy:
Olaratumab + doxorubicin is given to shrink tumors and decrease symptoms caused by sarcoma. It is not commonly given with the goal of cure and but is given to prolong life.

Schedule

  • Olaratumab intravenous (I.V.) infusion over 1 hour on Days 1 and 8 of each cycle
  • Doxorubicin I.V. push or a short intravenous infusion on Day 1 of Cycles 1 through 8
  • Pre-medications with diphenhydramine and dexamethasone are recommended before the first dose of olaratumab is given

Estimated total infusion room time for this treatment:

  • Up to 3 hours for Cycle 1, Day 1; as short as two hours for the remaining days of each cycle
  • 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

Olaratumab + doxorubicin is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, it may be given in the hospital if someone is too sick.

Olaratumab + doxorubicin is repeated every 21 days. This is known as one Cycle. Although doxorubicin may be repeated eight times, olaratumab may continue every Day 1 and Day 8 of a 21-day cycle until it no longer works or until unacceptable side effects occur. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.

Click here for the common olaratumab (Lartruvo®) plus doxorubicin 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 olaratumab (Lartruvo®) + doxorubicin side effects are shown here:

Roughly 15% of patients discontinue treatment due to unacceptable side effects.

Infusion reactions, when they occur, usually happen in the first or second cycle, and are rare afterwards.

Hair loss from olaratumab + doxorubicin 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. Hair should begin to grow back after cycle 8, once doxorubicin is no longer given.

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingFatigue Fatigue PainPainBleedingBleedingHair LossHair LossAnemiaAnemiaConstipationConstipationDiarrheaDiarrheaNeutropenic FeverNeutropenic Fever

Monitoring

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

How often is imaging needed?
Imaging may be checked before treatment and up to every 6 weeks if ordered by your doctor during treatment. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans. Echocardiograms (Echo) or multigated acquisition (MUGA) scans to check heart function are typically performed prior to starting treatment and before cycles 5 and 7.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue olaratumab + doxorubicin as planned, delay treatment until white blood cells known as neutrophils return to the normal range, or switch therapy if unacceptable side effects occur or it is no longer working

ChemoExperts Tips

  • Infusion reactions may occur during the infusion of olaratumab and are usually mild. The majority of infusion reactions happen during cycles 1 and 2 and are rare in subsequent cycles. Before your first dose of olaratumab, you will receive I.V. infusions of both diphenhydramine (Benadryl®) and dexamethasone (Decadron®) to help prevent infusion reactions. These medications may also be given before subsequent doses as the discretion of your doctor
  • Signs or symptoms of an infusion reaction may include: flushing, shortness of breath, difficulty breathing, fever, chills, and very rarely low blood pressure or shock
  • Doxorubicin can potentially decrease LVEF. Your heart function will be checked before starting treatment and periodically during treatment with an echocardiogram or multigated acquisition (MUGA) scan
  • Your doctor may also choose to give a medication called dexrazoxane (Zinecard®) during cycles 5 through 8 to protect your heart from doxorubicin-related damage
  • In order for all of the olaratumab to make it in your body and so no medication is left in the bag, it is recommended that a nurse flush the I.V. line with a saline solution, known as 0.9% sodium chloride injection at the end of the olaratumab infusion
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for sarcoma. 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 Olaratumab (Lartruvo®) + Doxorubicin, 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 Olaratumab (Lartruvo®) + Doxorubicin. Depending upon your income, they may be able to help cover the cost of:

  • Olaratu­mab
  • Doxorubicin

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 Olaratumab (Lartruvo®) + Doxorubicin 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 Olaratumab (Lartruvo®) + Doxorubicin

Individual Drug Label Information

Olaratu­mab (Lartruvo®)

  • Olaratumab is an intravenous infusion
  • Dosage adjustments may be required for low white blood cell counts, specifically neutrophils
  • May cause fetal harm if given to pregnant women. Females that are of reproductive potential should use contraception during treatment and for 3 months AFTER the last dose of olaratumab
  • It is not known if olaratumab is excreted into breast milk. Therefore, to be safe, women should not breastfeed during treatment and for 3 months AFTER the last dose of olaratumab
  • Olaratumab may decrease a man’s ability to father a child
General side effects from olaratumab (Lartruvo®)
  • Infusion reactions may occur and most commonly happen during cycles 1 and 2. Medications such as diphenhydramine (Benadryl®) and a corticosteroid such as dexamethasone (Decadron®) are given before the first dose and potentially subsequent doses to help prevent reactions 
  • Low white blood cells, red blood cells, and platelets can be common
  • Nausea and vomiting can be common. Be sure to ask your doctor for anti-nausea medications to have at home to use if these symptoms occur
  • Mouth sores, also called mucositis
  • Gastrointestinal effects such as decreased appetite, and abdominal pain
  • Diarrhea
  • Abdominal pain
  • Fatigue
  • Muscle or bone pain
  • Hair loss
  • Decreased appetite
  • Nerve pain
  • Headache
  • Dry eyes
  • Click on the olaratumab (Lartruvo®) package insert below for all reported side effects and possible drug interactions

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

See DailyMed package insert.

Doxorubicin (Adriamycin®)

  • Doxorubicin is administered as an intravenous infusion and is red in color
  • Can affect heart function. A heart study (echocardiogram) may be required before receiving the first dose
  • Dosage may be reduced in patients with poor liver function
  • Has been linked to the development of other cancers in a small number of people (1.5% chance at 10 years)
General Doxorubicin (Adriamycin) Side Effects
  • Nausea, vomiting, diarrhea, and mouth sores (stomatitis)
  • Leakage into skin or surrounding muscle during infusion may cause severe irritation (extravasation)
  • May temporarily turn urine orange
  • Hair loss, which is usually reversible
  • Increased risk of infection due to decrease white blood cell count (neutropenia)
  • Click on the doxorubicin (Adriamycin) package insert for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossPainPainNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

Tap WD, Jones RL, Van Tine BA, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016;388:488-497.

Created: December 14, 2016 Updated: October 7, 2018

What is Sarcoma?

A name given to a type of cancer based on the body tissue the cancer cells most closely resemble. Examples include liposarcoma resembling fat tissue, osteosarcoma resembling bone tissue, leiomyosarcoma resembling smooth muscle tissue, and chondrosarcoma resembling cartilage tissue. Another way doctors classify sarcomas is by grade: high, low, and intermediate.

Sarcomas are treated with surgery (including amputation), chemotherapy, radiation therapy, or a combination of these. Chemotherapy for sarcomas can last for many months, to more than one year. The stage of sarcoma can vary at diagnosis and throughout treatment. The Tumor, Node, Metastatis (TNM) staging system is used to describe different areas of cancer growth along with Stage Grouping using Stages I, II, III, or IV. 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.

What does I.V. push mean?

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 olaratumab (Lartruvo®) + doxorubicin starting doses

  • Olaratumab 15mg/kg intravenous infusion over 1 hour on days 1 and 8 of each cycle
  • Doxorubicin 75 mg/m2 intravenous push or a short intravenous infusion on Day 1 ONLY of each 21-day cycle
  • Doxorubicin is given during cycles 1, 2, 3, 4, 5, 6, 7, and 8

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

What is an Antibody?

A small protein shaped like a “Y” that can attach to specific things in the blood, such as a cancer cell.

1) Once an antibody binds to something, your immune system may attempt to get rid of it.

2) Antibodies may also work by binding to the cancer cell surface and prevent other things from binding to the cancer cell that help it survive. Without the ability to bind growth factors, cancer cells may be forced to die