Objective: This open-label phase II clinical trial evaluated the antitumor activity and safety of trabectedin in patients with advanced ovarian (OC) or uterine carcinosarcomas (UC).
Methods: Eligible patients were adults (≥18 years) with histologically proven recurrent OC/UC not amenable to surgery or radiotherapy who received up to two prior chemotherapy lines. Trabectedin 1.3 mg/m was administered as a 3-h infusion every three weeks. The primary endpoint was objective response rate (ORR) as per RECIST v.1.1. If at least 8 of 43 patients (18.6%) achieve an objective response, trabectedin would be declared worthy for further investigations.
Results: Forty-five patients with either OC (n = 32) or UC (n = 13) from seven MITO centers across Italy were enrolled. The ORR was 11.9% (90% CI: 6-23) and included two patients with a complete response and three with a partial response. Eight patients (19.0%) had disease stabilization for a disease control rate of 31.0% (90% CI: 20-44). Median progression-free survival was 2.01 months (95% CI: 1.78-2.30) and median overall survival was 4.64 months (95% CI: 3.19-8.29). Neutrophil count decreases (n = 8, 18.2%) and transaminase increases (n = 6, 13.6%) were the most common grade 3-5 adverse events related with trabectedin. Two patients died due to trabectedin-related grade 5 hematological toxicity.
Conclusion: Although trabectedin did not meet the prespecified activity criteria, it confers modest but clinically meaningful benefit to patients with advanced OC/UC as being as effective as any other available treatment for this indication. The toxicity profile appears in line with that previously reported for the drug.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.ygyno.2022.09.023 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Trabectedin for L-Type Sarcoma: A Retrospective Multicenter Study.
Curr Oncol
November 2024
Department of Medical Oncology, Ege University Tilay Aktaş Oncology Hospital, 35100 Izmir, Türkiye.
(1) Background: Metastatic L-type sarcomas (liposarcoma and leiomyosarcoma) are rare and have a poor prognosis. Trabectedin is an effective agent that can be used after anthracyclines. This study was designed to evaluate the real-life effectiveness and safety of trabectedin.
View Article and Find Full Text PDFFour Cases with FUS/CHOP Fusion Gene Products Positive Myxoid Liposarcoma Responding Effectively to Trabectedin Monotherapy.
Onco Targets Ther
November 2024
Department of General Internal Medicine 4, Kawasaki Medical School, Okayama, Japan.
Background: Myxoid liposarcoma, a rare type of tumor, accounts for approximately 30% of all liposarcomas. Myxoid liposarcomas harboring the FUS/CHOP fusion gene have shown promising results with trabectedin in basic research and some clinical experiments. However, the efficacy and safety of trabectedin in chemotherapy-naive soft tissue sarcomas or FUS/CHOP fusion gene-positive myxoid liposarcomas have not yet been established.
View Article and Find Full Text PDFEvaluation of a novel central venous access port for direct catheter insertion without a peel-away sheath.
Jpn J Radiol
September 2024
Department of Radiology, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-Cho Kita-Ku, Okayama, 700-8558, Japan.
Article Synopsis
- The study investigated the safety and effectiveness of a new central venous access port (CV-port) designed for catheter insertion without a peel-away sheath, aiming to reduce risks associated with traditional methods.
- A total of 523 procedures were carried out successfully, with a mean duration of 33.2 minutes, and only a few minor complications were recorded during and shortly after the procedures.
- The findings suggest that this new CV-port device is just as successful and safe as conventional options, with minimal complications and no major risk factors for infection identified in patients during the early postprocedural period.
Trabectedin may be a valuable treatment option for elderly patients with metastatic soft tissue sarcomas.
Front Oncol
July 2024
Immunopathology and Cancer Biomarkers Unit, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano, Italy.
Article Synopsis
- Anthracyclines are effective for treating metastatic soft tissue sarcoma (mSTS), but they can be too toxic for frail elderly patients, making trabectedin a potentially safer alternative.
- This study focused on 11 elderly patients (age ≥70) with mSTS receiving trabectedin as their first treatment, monitoring their dosage and outcomes closely.
- Results showed a median progression-free survival of 77 days and overall survival of 397 days, with a 43% rate of severe toxicity, emphasizing trabectedin's role in providing a treatment option with manageable side effects for elderly patients.
Retrospective multicenter study of elderly patients with platinum-sensitive relapsed ovarian cancer treated with trabectedin and pegylated liposomal doxorubicin (pld) in a real-world setting: a geico study.
BMC Cancer
July 2024
Oncology Department, Clínica Universidad de Navarra, Pamplona, Spain.
Article Synopsis
- A study looked at how well a medicine called trabectedin, combined with another medicine called PLD, works for older patients with ovarian cancer that came back after treatment.
- The study involved 43 patients who were at least 70 years old, and it found that some responded well to the treatment, with 9.3% having a complete response and 32.6% showing partial improvement.
- The results suggest that this treatment is both effective and safe for older patients, which is important for helping them feel better during their care.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!