Trabectedin (Yondelis) is an alkylating antineoplastic agent that exerts its antitumor effect by binding to the minor groove of DNA. It is indicated for the treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients who have previously received an anthracycline-containing regimen.

Adverse Reactions of Trabectedin (Yondelis)

Common Systemic Reactions (≥20%)

Gastrointestinal: Nausea (75%), vomiting (46%), constipation (37%), diarrhea (35%).

Systemic symptoms: Fatigue (69%), peripheral edema (28%).

Metabolic and nutritional: Decreased appetite (37%).

Respiratory: Dyspnea (25%).

Neurological: Headache (25%).

Laboratory Abnormalities (≥20%)

Liver function: Increased ALT (90%, with 31% being grade 3-4), increased AST (84%, with 17% being grade 3-4), increased alkaline phosphatase (70%).

Hematology: Anemia (96%, with 19% being grade 3-4), neutropenia (66%, with 43% being grade 3-4), thrombocytopenia (59%, with 21% being grade 3-4).

Others: Hypoalbuminemia (63%), increased creatine phosphokinase (33%, with 6.4% being grade 3-4).

Severe Adverse Reactions of Trabectedin (Yondelis)

Neutropenia with Infection

The incidence of grade 3-4 neutropenia is as high as 43%, of which 5% progresses to febrile neutropenia.

Neutropenic sepsis occurs in 2.6% of patients, with 1.1% resulting in death.

Management requirements: Monitor neutrophil count before each administration; delay dosing if the count is <1500/μL.

Rhabdomyolysis

Increased creatine phosphokinase is observed in 32% of patients, with 6% being grade 3-4.

Fatal rhabdomyolysis occurs in 0.8% of patients, and 1.1% develop complicated renal failure.

Monitoring requirements: Test CPK before each dose; suspend medication if CPK >2.5 times the upper limit of normal (ULN).

Hepatotoxicity

Grade 3-4 liver function abnormalities occur in 35% of patients.

Drug-induced liver injury (meeting Hy's Law criteria) develops in 1.3% of patients.

Cardiomyopathy

Cardiomyopathy occurs in 6% of patients, with 4% being grade 3-4.

High-risk factors: LVEF below the lower limit of normal, cumulative anthracycline dose ≥300mg/m², age ≥65 years, history of cardiovascular disease.

Precautions for the Use of Trabectedin (Yondelis)

Permanent Discontinuation Indications

Adverse reactions that cannot be relieved after delaying administration for more than 3 weeks.

Need for further dose reduction after the dose has been lowered to 1.0mg/m² in patients with normal liver function.

Grade 3-4 cardiac adverse events or persistently low LVEF below the normal range.

Medication Use in Special Populations

Pregnant women: Has embryo-fetal toxicity; effective contraceptive measures must be taken.

Lactating women: Breastfeeding is prohibited during treatment.

Pediatric patients: Efficacy has not been established.