Trabectedin

(Yondelis®)

Trabectedin

Drug updated on 11/5/2024

Dosage FormInjection (intravenous; 1 mg)
Drug ClassAlkylating agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Trabectedin demonstrated antineoplastic activity across cancer types by forming DNA adducts that induce DNA strand breaks, leading to cell cycle arrest and apoptosis, and by reducing tumor-associated macrophages and inhibiting cytokine and chemokine secretion in the tumor microenvironment.
  • In specific cancer applications, trabectedin is approved for use in unresectable or metastatic liposome-associated leiomyosarcoma post-anthracycline treatment and is used in combination with pegylated liposomal doxorubicin for platinum-sensitive recurrent ovarian cancer in the EU.
  • For metastatic synovial sarcoma (mSS), a pooled analysis indicated a median overall survival (mOS) of 10.4 months with trabectedin, comparable to pazopanib (mOS of 10.3 months), though pazopanib showed a higher overall response rate (Objective Response Rate (ORR) of 18.9% compared to 12.3% for trabectedin.
  • The incidence of cardiac toxicity in patients treated with trabectedin is approximately 3.4%, with an elevated risk of heart failure observed, particularly in patients with prior or concurrent anthracycline exposure; NT-pro-BNP monitoring may aid in the early detection of trabectedin-induced heart failure.
  • Case reports highlight acute heart failure with preserved ejection fraction following trabectedin administration, underscoring the need for cardiac monitoring in high-risk populations.
  • There is no population type or subgroup information available in the reviewed studies.