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Treatment Name: Trabectedin (Yondelis®)

Trabectedin (Yondelis®) is a Chemotherapy Regimen for Sarcoma

How does trabectedin work?
Trabectedin is designed to kill cancer cells and slow growth of cancer cells.

Goals of therapy:
Trabectedin is given to shrink tumors, alleviate symptoms of sarcoma, and prolong life. Trabectedin is not typically given with the goal of cure.

Schedule

  • Trabectedin intravenous (I.V.) infusion over 24 hours on Day 1
  • A medication known as dexamethasone (Decadron) may be given 30 minutes prior to each trabectedin dose to help prevent or minimize side effects

Estimated total infusion time for this treatment:

  • The infusion for each cycle is given over 24 hours; however, only 2 to 4 hours are 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 I.V. fluids, such as hydration, may add more time
  • Trabectedin infusion requires a special I.V. line known as a "central line" and should not be infused using a standard peripheral I.V. It usually takes more time to receive a "central line," however this can be done on a separate day before you receive your first infusion

Trabectedin may be started in the clinic on Day 1 and continued at home through the remainder of the scheduled 24 hours using a small, portable infusion pump. If the patient receives most of the infusion at home, they will then return to the clinic on Day 2 to have the pump disconnected. In some instances, the entire trabectedin infusion may be given in the hospital.

Trabectedin is repeated every 21 days. This is known as one cycle. Each cycle may be repeated until the drug no longer works or until unacceptable side effects occur. Duration of therapy and the total number of cycles prescribed depend upon response and tolerability.

Click here for common starting doses

Side Effects

In clinical studies, the most commonly reported side effects with trabectedin are shown here. Side effects sometimes have percentage ranges [example 73 – 89%] because they differed between clinical studies:

  • Nausea (73 - 89%)
    • Moderate - Severe Nausea (8%)
  • Low white blood cells [neutropenia] (49 - 84%)
  • Fatigue (20 - 67%)
  • Constipation (12 - 58%)
  • Decreased appetite (34 - 58%)
  • Weakness (44%)
  • Vomiting (17 - 44%)
  • Anemia [low red blood cells] (18 - 39%)
  • Increased bleeding risk [low platelets; thrombocytopenia] (15 - 36%)
  • Diarrhea (22 - 34%)
  • Muscle aches (28%)
  • Fever (25%)
  • Shortness of breath (25%)
  • Swelling in arms and legs (14 - 24%)
  • Headache (17 - 23%)
  • Cough (18%)
  • Mouth sores (17%)
  • Altered taste (14%)
  • Trouble sleeping (14%)
  • Neutropenic fever (14%)
  • Pain at infusion site (11%)

Most side effects were considered mild in nature. Although less likely, moderate or severe side effects seen in clinical studies included: nausea, decreased appetite, diarrhea, fatigue, and febrile neutropenia (also known as neutropenic fever).

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

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingFatigue Fatigue ConstipationConstipationAnemiaAnemiaBleedingBleedingDiarrheaDiarrheaPainPainNeutropenic FeverNeutropenic Fever

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before each treatment and periodically between treatments at your physician’s discretion. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), creatine phosphokinase (CPK), plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment and every 6 to 9 weeks (every 2 or 3 cycles) during treatment. Imaging may include: computerized tomography (CT) scans or positron emission tomography (PET) scans. An echocardiogram may be obtained before treatment, then every 8 to 12 weeks to assess your heart's left ventricular ejection fraction (LVEF).

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

ChemoExperts Tips

  • Premedication with dexamethasone, a corticosteroid, is given 30 minutes before every infusion to reduce the risk of experiencing side effects from trabectedin
  • Trabectedin can possibly leak into tissue surrounding the infusion site causing extravasation. If you have a port, this could be due to the needle being dislodged (being in wrong location). Avoid any strenuous movements or activity during infusion of trabectedin to try and prevent the port needle from moving
  • 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 Trabectedin (Yondelis®), 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 Trabectedin (Yondelis®). Depending upon your income, they may be able to help cover the cost of:

  • Trabectedin

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 Trabectedin (Yondelis®) 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 Trabectedin (Yondelis®)

Individual Drug Label Information

Trabectedin (Yondelis®)

  • Trabectedin is an intravenous infusion
  • If you experience pain or redness around the infusion site, contact your doctor immediately
  • Muscle damage, which can possibly cause serious kidney injury. Let your doctor know if you are experiencing significant unexplained muscle pain
  • May decrease the heart’s ability to pump blood effectively. Your heart function will likely be checked periodically during treatment to assess its function
  • Dosage adjustments may be required for liver toxicity, muscle injury, decreased heart function, or low platelets, red blood cells, or white blood cells
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions
  • May interact with grapefruit and grapefruit juice and increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment
  • Avoid therapy with St. Johns Wort as could decrease the effectiveness of trabectedin
  • May cause fetal harm. Females should use effective contraception during therapy and for 2 months following completion of therapy. Males should use effective contraception during therapy and for 5 months following completion of therapy
General Trabectedin (Yondelis) Side Effects
  • May cause low red blood cells, white blood cells, and platelets
  • Nausea/vomiting can be common
  • Significant fatigue
  • Weakness
  • Constipation or diarrhea can occur
  • Altered taste or decreased appetite may occur
  • Can cause cough and shortness of breath
  • Headache
  • Mouth sores
  • Swelling in arms and legs
  • Click on the trabectedin (Yondelis) package insert below for reported side effects and possible drug interactions

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

See DailyMed package insert.

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References

1) Demetri GD, von Mehren M, Jones RL, et al. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016;34:786-793.

2) Kawai A, Araki N, Sugiura H, et al. Trabectedin monotherapy after standard chemotherapy versus best supportive care in patients with advanced, translocation-related sarcoma: a randomised, open-label, phase 2 study. Lancet Oncol. 2015;16:406–416.

3) Samuels BL, Chawla S, Patel S, et al. Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study. Ann Oncol. 2013;24:1703–1709.

Created: August 8, 2016 Updated: November 15, 2017

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.

Common Starting Doses

  • Trabectedin 1.5 mg/m2 intravenous infusion (I.V.) over 24 hours on Day 1 of each 21-day Cycle
  • Dexamethasone 20 mg I.V. given 30 minutes prior to each dose of trabectedin
    • dexamethasone (decadron) may be infused over 15 - 30 minutes

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

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1) Demetri GD, von Mehren M, Jones RL, et al. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016;34:786-793.

2) Kawai A, Araki N, Sugiura H, et al. Trabectedin monotherapy after standard chemotherapy versus best supportive care in patients with advanced, translocation-related sarcoma: a randomised, open-label, phase 2 study. Lancet Oncol. 2015;16:406–416.

3) Samuels BL, Chawla S, Patel S, et al. Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study. Ann Oncol. 2013;24:1703–1709.

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 Creatine Phosphokinase?

Creatine phosphokinase is a muscle breakdown product and can increase in the blood if the either muscle is rapidly breaking down, the kidneys are not working well, or both. An elevation well above the normal range, may suggest muscle damage

What is LVEF - Left Ventricular Ejection Fraction?

The amount of blood pumped by the left ventrical (chamber) of the heart into the body with each heartbeat. Certain drugs can decrease heart function and result in less blood being pumped by each heartbeat than normal.

What does "Extravasation" mean?

Extravasation is when significant tissue damage occurs after certain chemotherapy agents leak out into the tissues surrounding the blood vessel where chemotherapy is infusing. Chemotherapy agents that cause the most tissue damage when extravasated are known as vesicants. Chemotherapy agents that may still cause damage, but not as severe as vesicants, are known as irritants.

When extravasation occurs, the infusion is immediately stopped and a warm or cold compress is applied to the affected area, depending upon which drug was infusing. In some instances, various medications can be injected around the affected area to help minimize possible tissue damage.