Trial reportInvestigational new drugs2012
Trabectedin in pre-treated patients with advanced or metastatic soft tissue sarcoma: a phase II study evaluating co-treatment with dexamethasone.
Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 41 citations in OpenAlex.
- Trabectedin is a feasible treatment for soft tissue sarcoma patients regardless of patient age: a retrospective pooled analysis of five phase II trials.British journal of cancer · 2013Trial
- Trabectedin decreases myeloid resistance to improve the efficacy of anti-PD1 immunotherapy and delay glioma malignant progression.Molecular therapy. Oncology · 2026Article
- Relative Dose Intensity of Trabectedin and Outcome of Advanced L-Sarcomas.Cancer medicine · 2025Article
- Trabectedin Enhances the Antitumor Effects of IL-12 in Triple-Negative Breast Cancer.Cancer immunology research · 2025Article
- Trabectedin and Lurbinectedin Modulate the Interplay between Cells in the Tumour Microenvironment-Progresses in Their Use in Combined Cancer Therapy.Molecules (Basel, Switzerland) · 2024Review
- Trabectedin may be a valuable treatment option for elderly patients with metastatic soft tissue sarcomas.Frontiers in oncology · 2024Article
- Article
- Starvation tactics using natural compounds for advanced cancers: pharmacodynamics, clinical efficacy, and predictive biomarkers.Cancer medicine · 2018Review
- Systemic Therapy in Metastatic or Unresectable Well-Differentiated/Dedifferentiated Liposarcoma.Frontiers in oncology · 2017Review
- Update on the role of trabectedin in the treatment of intractable soft tissue sarcomas.OncoTargets and therapy · 2017Review
- Drug Monographs: Trabectedin and Trifluridine-Tipiracil.Hospital pharmacy · 2016Article
- Advanced soft-tissue sarcoma and treatment options: critical appraisal of trabectedin.Cancer management and research · 2016Review
- A Systematic Literature Review of Adverse Events Associated with Systemic Treatments Used in Advanced Soft Tissue Sarcoma.Sarcoma · 2016Review
- Review
- Trabectedin for advanced soft tissue sarcomas: optimizing use.Therapeutics and clinical risk management · 2014Review
- Trabectedin as single agent in relapsed advanced ovarian cancer: results from a retrospective pooled analysis of three phase II trials.Medical oncology (Northwood, London, England) · 2013Article
- A comprehensive safety analysis confirms rhabdomyolysis as an uncommon adverse reaction in patients treated with trabectedin.Cancer chemotherapy and pharmacology · 2012Article
- Review
- Educational paper. The development of new therapies for pediatric oncology.European journal of pediatrics · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study assesses the efficacy, toxicity and pharmacokinetic profile of trabectedin with or without prophylactic dexamethasone co-treatment in patients with recurrent advanced soft tissue sarcoma (STS). PATIENTS AND
methodsPatients were randomized to receive trabectedin as a 3-h infusion every 3 weeks with dexamethasone or placebo in the first cycle, with the alternate in the second cycle and with the patient's choice subsequently. Due to toxicity, the randomized design was modified to open-label to make dexamethasone mandatory and the initial dose (1,650 μg/m(2)) was reduced to 1,500 μg/m(2) and then to 1,300 μg/m(2).
resultsForty-one patients were enrolled and 35 were evaluable for efficacy. One partial response and 18 disease stabilizations were found. The median PFS and OS were 2.1 and 10.2 months, respectively, with the 3- and 6-month PFS rates indicating activity in pretreated STS. Twenty-three and 27 patients developed transient asymptomatic grade 3/4 AST and ALT elevation, respectively, and 21 patients had grade 3/4 neutropenia. Dose reduction from 1,650 μg/m(2) to 1,300 μg/m(2) decreased the incidence of grade 3/4 thrombocytopenia (26% vs. 0%), neutropenia (51% vs. 25%) and AST increase (76% vs. 25% of patients). Four patients died due to drug-related toxicities (3 with placebo). The total body clearance of trabectedin was 28% higher and half-life was 21% lower with dexamethasone compared to placebo, with no differences in volume of distribution.
conclusionsTrabectedin has confirmed activity in patients with pretreated STS. This study shows that co-treatment with dexamethasone improves the safety of trabectedin by reducing drug-induced hepatotoxicity and myelosuppression.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.