Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 1 mg) |
| Drug Class | Alkylating 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.
Latest News
Summary
- 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 European Union (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 (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; N-terminal pro B-type natriuretic peptide (NT-proBNP) 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.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Yondelis (trabectedin) Prescribing Information. | 2020 | Janssen Products, LP., Titusville, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Trabectedin and lurbinectedin: Mechanisms of action, clinical impact, and future perspectives in uterine and soft tissue sarcoma, ovarian carcinoma, and endometrial carcinoma | 2022 | Frontiers in Oncology |
| Meta-analysis of pazopanib and trabectedin effectiveness in previously treated metastatic synovial sarcoma (second-line setting and beyond) | 2022 | Future Oncology (London, England) |
| Trabectedin-Related Heart Failure: Case Report and a Systematic Review of the Literature | 2021 | Frontiers in Oncology |
| Maintenance therapy and drug holiday in sarcoma patients: systematic review | 2020 | Acta Oncologica (Stockholm, Sweden) |