Trabectedin (Yondelis) is an alkylating agent indicated for the treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients who have received prior anthracycline-containing regimens. While demonstrating efficacy in some patients, its administration is associated with a range of adverse reactions.

Adverse Reactions of Trabectedin (Yondelis)

Common Adverse Reactions

Gastrointestinal reactions: Nausea (75%), vomiting (46%), constipation (37%), diarrhoea (35%), decreased appetite (37%).

General systemic reactions: Fatigue (69%), peripheral oedema (28%).

Respiratory system reactions: Dyspnoea (25%).

Abnormal Laboratory Findings

Hepatic function abnormalities: Increased alanine aminotransferase (ALT) (90%), increased aspartate aminotransferase (AST) (84%), increased alkaline phosphatase (70%).

Hematological abnormalities: Anaemia (96%), neutropenia (66%), thrombocytopenia (59%).

Other abnormalities: Increased creatine phosphokinase (33%), hypoalbuminemia (63%), increased creatinine (46%).

Severe Adverse Reactions of Trabectedin (Yondelis)

Neutropenic Infection and Sepsis

It has a relatively high incidence: grade 3–4 neutropenia occurs in up to 43% of patients, and neutropenic sepsis has an incidence of 2.6%, which can be fatal in some cases.

Management measures: Monitor neutrophil count before each administration; withhold the medication if the count is below 1500/μL. Seek immediate medical attention if fever or signs of infection develop.

Rhabdomyolysis

It may cause muscle injury and even renal failure, with an incidence of 0.8%, and some cases can be fatal.

Management measures: Monitor creatine phosphokinase levels before each administration; suspend treatment if the level exceeds 2.5 times the upper limit of the normal range. Report immediately if severe muscle pain or weakness occurs.

Hepatotoxicity

Hepatic function abnormalities are common. The incidence of grade 3–4 liver enzyme elevation is 35%, and drug-induced liver injury has an incidence of 1.3%.

Management measures: Conduct regular monitoring of liver function during treatment. Seek immediate medical care if jaundice, right upper abdominal pain, nausea, vomiting, or altered mental status appears.

Cardiomyopathy

It may lead to heart failure and reduced left ventricular function, with an overall incidence of 6%, among which grade 3–4 cases account for 4%; fatal cases have been reported occasionally.

Management measures: Perform echocardiography or MUGA scan to assess left ventricular ejection fraction before treatment and every 2–3 months thereafter. Report promptly if symptoms such as chest pain, dyspnoea, or lower extremity oedema arise.

Precautions for Trabectedin (Yondelis)

Pre-treatment Assessment

Confirm whether the patient has received prior chemotherapy with anthracycline-containing regimens.

Evaluate hepatic and renal function, complete blood count, electrocardiogram, and cardiac function.

Confirm that the patient is not pregnant or has adopted effective contraceptive measures.

Drug Interactions

Avoid concomitant use with strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, etc.) or inducers (e.g., rifampicin, St. John's wort).

Refrain from consuming grapefruit or grapefruit juice during treatment.