Trabectedin

What this treatment is and how it works

Trabectedin is chemotherapy that attaches to DNA (the genetic instructions inside cells) and disrupts the way cancer cells read and repair their genetic instructions. This can stop cancer cells growing and lead to their death.

When it may be used

It is used for selected adults with advanced soft-tissue sarcoma, particularly leiomyosarcoma and liposarcoma. It is often considered after earlier chemotherapy or when some usual treatments are unsuitable. Exact licensed indications differ between countries.

In selected patients with advanced leiomyosarcoma, specialists may use doxorubicin with trabectedin followed by trabectedin maintenance, based on clinical-trial evidence. This is a distinct combination protocol; it should not be confused with the usual single-drug schedule.

In the European product information, trabectedin with pegylated liposomal doxorubicin (PLD) is also an option for ovarian cancer that has returned and is still considered sensitive to platinum treatment. This ovarian combination is not included in the US Yondelis indication. Your oncologist will explain the locally applicable use and alternatives.

Licences and access differ by country and product. This sheet does not establish Indian regulatory approval or availability. Your oncologist will explain the locally appropriate treatment.

Before treatment

Before starting, tell the team about previous cancer treatment, allergies, infection symptoms, heart, lung, kidney or liver disease, hearing or nerve problems, diabetes and all medicines you take. Discuss pregnancy, contraception and fertility. Ask for a written treatment calendar, supportive-medicine instructions and a 24-hour oncology contact number. Baseline blood tests usually include a full blood count and kidney and liver function; additional tests depend on the medicine and your health. Before chemotherapy that reaches the whole body, the team should check for current or past hepatitis B infection. If a test is positive, extra monitoring or antiviral treatment may be needed to prevent the virus becoming active again. The team will coordinate testing and treatment; do not delay urgent cancer treatment yourself.

How treatment is given and the schedule

An infusion into a vein, usually through a central line such as a peripherally inserted central catheter (PICC line) or an implanted port. This reduces the risk of the medicine leaking into surrounding tissue. It may be given using a portable pump or during a hospital stay.

For the usual single-drug sarcoma schedule, the infusion runs over 24 hours and is repeated about every 3 weeks. In the ovarian combination, trabectedin usually runs over 3 hours after PLD, every 3 weeks. Other specialist combinations have their own timing.

Dexamethasone is given before each infusion to help prevent sickness and reduce liver toxicity. Other anti-sickness medicines may be added. The number of cycles depends on benefit, side effects and your preferences, rather than one fixed number for everyone.

The dose is calculated for your treatment and health. Do not change the dose or treatment dates yourself. The team will provide a revised calendar if treatment needs to be delayed, reduced or stopped.

Tests and monitoring during treatment

• Blood counts, liver tests, kidney function and the muscle enzyme creatine phosphokinase (CPK, also called CK) are checked before treatment. CPK helps identify muscle injury.
• The SmPC recommends blood-count, liver and CPK monitoring weekly during the first 2 cycles, then at least once between later cycles as well as assessment before further treatment. The team may check more often if there are symptoms or abnormal results.
• A heart assessment, usually an echocardiogram to measure pumping strength, is needed before treatment and about every 2 to 3 months during treatment. Previous doxorubicin or other anthracyclines, heart disease and older age can increase risk. Kidney function is assessed throughout treatment; scans assess the cancer’s response.

Tell the team about symptoms since the previous dose, including problems that have already settled. A normal earlier test does not make new symptoms safe to ignore.

Side effects: what to expect

The table groups common or very common problems. Some regulatory data combine single-drug sarcoma treatment with the PLD ovarian combination; they cannot provide one precise risk for every patient. PLD can add hand–foot soreness and other side effects, so read its sheet too.

You are unlikely to have every effect listed, and this is not an exhaustive list. Report new symptoms even if they are not mentioned here.

Common or more frequent side effects

Other reported side effects (frequency varies)

Hair thinning or loss, taste changes, dizziness, tingling or numbness, rash and sleep problems can occur. Acute kidney injury is listed as common in the current EMA SmPC. Muscle breakdown and capillary leak syndrome are uncommon, and liver failure is rare. Their seriousness is why the warning symptoms are separated below.

Important serious side effects, including rare effects

Serious effects can be common, uncommon, rare or have an uncertain frequency. The following advice explains when to seek help; it does not label all serious effects as rare.

Serious infection or bleeding

Low blood counts can lead to sepsis or serious bleeding. Call immediately for fever, chills or feeling suddenly unwell. Uncontrolled bleeding, collapse or severe breathing difficulty needs emergency care.

Muscle breakdown (rhabdomyolysis)

Urgently report severe muscle pain, unusual muscle weakness, dark or cola-coloured urine, or much less urine. Muscle breakdown can damage the kidneys and may occur together with liver and blood-count changes. Do not wait for the next scheduled CPK test.

Liver or kidney injury

Yellow eyes or skin, marked upper-abdominal pain, confusion, reduced urine or new swelling need urgent assessment. Blood-test abnormalities may precede symptoms. Kidney injury may occur with or without obvious muscle symptoms.

Weakened heart function

Report increasing breathlessness, swelling of the legs, palpitations or difficulty breathing when lying flat promptly. Chest pain, collapse or severe breathlessness requires emergency help.

Capillary leak syndrome

Fluid can leak from small blood vessels into tissues. Rapid weight gain, widespread swelling, dizziness or low blood pressure, with or without breathlessness, needs immediate assessment.

Tissue injury or severe allergic reaction

Pain, burning or swelling around the infusion site needs immediate attention, even if it appears later. Wheezing, facial swelling, collapse or breathing difficulty can indicate a severe allergic reaction and requires emergency help.

Practical advice for this treatment

Keep the central-line dressing dry and intact and check the area daily. Ask how to protect a pump during sleep, bathing and travel. If it alarms, leaks, disconnects or empties unexpectedly, call the unit; do not change settings or repair it yourself. Record your temperature and symptoms as instructed. Avoid alcohol during trabectedin treatment because of the risk to the liver.

Medicines, interactions and vaccinations

Give the oncology pharmacist a complete list of prescription medicines, over-the-counter products, vitamins, herbal and Ayurvedic remedies and supplements. Ask before starting anything new. Do not stop prescribed medicines, including anticoagulants or infection-prevention medicines, without a coordinated plan. Live vaccines are generally unsuitable while immunity is suppressed; discuss vaccine type and timing with the team. Non-live vaccines may be offered, although protection can be reduced. Follow any specific stop-and-call instructions for the cancer medicine on this page or in your written treatment plan.

Important interactions include some antifungals, antibiotics such as clarithromycin, HIV medicines, rifampicin, some anti-seizure medicines and St John’s wort. They can change trabectedin levels. Grapefruit products should be avoided. Statins and other medicines that can injure muscle or liver need review. Anti-sickness medicines, including aprepitant, should also be selected by the oncology pharmacist. Do not stop prescribed medicines yourself.

Pregnancy, fertility and breastfeeding

Chemotherapy can harm a developing baby and may affect fertility temporarily or permanently. Discuss sperm, egg or embryo storage before treatment when feasible. Tell the team immediately about a suspected pregnancy. Periods stopping does not guarantee infertility.

The current EMA Yondelis SmPC advises highly effective contraception during treatment and for 8 months afterwards for women who could become pregnant, and for 5 months afterwards for men with partners who could become pregnant. It also advises no breastfeeding during treatment and for 3 months afterwards. Other products or combination drugs may require different or longer precautions; ask for a written end date.

Everyday life

Gentle activity, regular meals and rest can help you cope. Prepare food hygienically and drink according to your individual fluid plan. Avoid smoking; avoid alcohol during trabectedin treatment. Plan work, travel and driving around symptoms and monitoring visits. Do not drive if dizzy, sleepy, weak, visually affected or impaired by neuropathy. You can usually be close to family and friends: chemotherapy does not make you radioactive. Follow the unit’s instructions for handling urine, vomit, laundry and sexual precautions for the period it specifies.

When to contact the oncology team

Contact the oncology team the same day for persistent vomiting or diarrhoea, difficulty drinking, reduced urine, mouth pain affecting eating, new cough, jaundice, a painful or spreading rash, unusual bruising, worsening constipation or new nerve symptoms. Use the more urgent instructions for the particular symptom when given above. If the team cannot be reached and you are unwell, seek urgent medical care.

Write down your hospital’s daytime and out-of-hours numbers before treatment. CTI’s general contact details do not replace the emergency number provided by your treating hospital.

After treatment

Keep the planned blood tests and follow-up appointments after the last dose. Blood counts and immunity may take time to recover, and some effects can start or persist later. Contact the team about symptoms rather than waiting for a routine visit. Keep a treatment summary, including drug names, dates and any serious reactions, for future doctors. Response may be assessed with examination, scans or blood or marrow tests, depending on the cancer.

Words you may hear

Soft-tissue sarcoma

A cancer arising in tissues such as muscle, fat or connective tissue.

CPK or CK

A blood enzyme used to check for muscle injury.

Maintenance

Treatment continued after an initial treatment phase to help keep cancer controlled.

Frequently asked questions

Related treatment guides

• Doxorubicin
• Pegylated liposomal doxorubicin