ArticleInvestigational new drugs2014
Phase I and pharmacokinetic study of trabectedin, a DNA minor groove binder, administered as a 24-h continuous infusion in Japanese patients with soft tissue sarcoma.
Article in Investigational new drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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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.
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Who cites it
20 citing papers in PubMed, 36 citations in OpenAlex.
- Efficacy of Trabectedin in Patients with Advanced Translocation-Related Sarcomas: Pooled Analysis of Two Phase II Studies.The oncologist · 2017Trial
- Results of sub-analysis of a phase 2 study on trabectedin treatment for extraskeletal myxoid chondrosarcoma and mesenchymal chondrosarcoma.BMC cancer · 2016Trial
- Historical contributions and future horizons of Japanese orthopaedic oncology: from surgical innovation to nationwide collaborations.International orthopaedics · 2026Article
- Relative Dose Intensity of Trabectedin and Outcome of Advanced L-Sarcomas.Cancer medicine · 2025Article
- Trabectedin for L-Type Sarcoma: A Retrospective Multicenter Study.Current oncology (Toronto, Ont.) · 2024Article
- Pharmacometabolomics of trabectedin in metastatic soft tissue sarcoma patients.Frontiers in pharmacology · 2023Article
- Article
- The Role of Trabectedin in Soft Tissue Sarcoma.Frontiers in pharmacology · 2022Review
- Trabectedin-Related Heart Failure: Case Report and a Systematic Review of the Literature.Frontiers in oncology · 2021Review
- Time lapse analysis of tumor response in patients with soft tissue sarcoma treated with trabectedin: A pooled analysis of two phase II clinical trials.Cancer medicine · 2020Article
- Long lasting response with trabectedin monotherapy in relapsed metastatic mesenchymal chondrosarcoma.Clinical sarcoma research · 2020Article
- Article
- Translocation-Related Sarcomas.International journal of molecular sciences · 2018Review
- Starvation tactics using natural compounds for advanced cancers: pharmacodynamics, clinical efficacy, and predictive biomarkers.Cancer medicine · 2018Review
- Systemic Therapy for Soft Tissue Sarcoma: Proposals for the Optimal Use of Pazopanib, Trabectedin, and Eribulin.Advances in 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
- The value of trabectedin in the treatment of soft tissue sarcoma.Therapeutics and clinical risk management · 2016Review
- Mixed up minor groove binders: Convincing A·T specific compounds to recognize a G·C base pair.Bioorganic & medicinal chemistry letters · 2015Article
- Retrospective Analysis of Trabectedin Therapy for Soft Tissue Sarcoma.In vivo (Athens, Greece)Article
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTrabectedin is a novel anticancer agent used to treat soft tissue sarcoma (STS). This phase I study of trabectedin was performed to determine the recommended dose for phase II studies in Japanese patients with STS.
methodsPatients who had STS refractory to, or who could not tolerate, anthracycline-based chemotherapy were enrolled. The starting dose of trabectedin was 0.9 mg/m(2), given as a 24-h continuous infusion every 21 days. The dose was escalated to 1.2 mg/m(2) and then to 1.5 mg/m(2), using a "3 + 3" cohort expansion design. Plasma samples were collected for pharmacokinetic analysis.
resultsFifteen patients received 1 of 3 dose levels of trabectedin. Dose-limiting toxicity occurred in two of three patients at 1.5 mg/m(2): 1 had a grade 3 increase in creatine phosphokinase and grade 3 anorexia, and the other had grade 4 platelet count decreased. Frequent grade 3 or 4 adverse events (AEs) included elevations of alanine aminotransferase and aspartate aminotransferase and decrease in neutrophil count. The frequency and severity of AEs were clearly greater at 1.5 mg/m(2) than at the lower doses. Pharmacokinetic analysis showed that the area under the concentration-time curve at a dose of 1.2 mg/m(2) was adequate to produce antitumor activity. A partial response was obtained in three patients with translocation-related sarcomas (1 each with myxoid liposarcoma, synovial sarcoma, and extraskeletal Ewing sarcoma).
conclusionsThe recommended dose of trabectedin for phase II studies is 1.2 mg/m(2) in Japanese patients with STS. Trabectedin may be especially effective against translocation-related sarcomas.
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