Trial reportGynecologic oncology2017
Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial.
Trial report in Gynecologic oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01343277 (A Randomized Controlled Study of YONDELIS), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma
Who cites it
31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Evaluation of the efficacy of systemic therapy for advanced uterine leiomyosarcoma: A systematic review, meta-analysis, and meta-regression analysis.Cancer medicine · 2023Pooled it
- Trabectedin and lurbinectedin: Mechanisms of action, clinical impact, and future perspectives in uterine and soft tissue sarcoma, ovarian carcinoma, and endometrial carcinoma.Frontiers in oncology · 2022Pooled it
- Efficacy and Safety of Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy for Recurrent Uterine Leiomyosarcoma: Results of a Phase 2 Study.Annals of surgical oncology · 2026Trial
- A Phase 1/2 Trial Combining Avelumab and Trabectedin for Advanced Liposarcoma and Leiomyosarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Trial
- A phase II randomised (calibrated design) study on the activity of the single-agent trabectedin in metastatic or locally relapsed uterine leiomyosarcoma.British journal of cancer · 2018Trial
- How I treat soft tissue sarcomas.Future oncology (London, England) · 2026Review
- Promising effects of high-intensity focused ultrasound combined with eribulin and sintilimab in a patient with advanced leiomyosarcoma: a case report and literature review.Frontiers in oncology · 2026Article
- Relative Dose Intensity of Trabectedin and Outcome of Advanced L-Sarcomas.Cancer medicine · 2025Article
- Phase Ib Study of Unesbulin (PTC596) Plus Dacarbazine for the Treatment of Locally Recurrent, Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Article
- Phase II Study of Olaparib and Temozolomide for Advanced Uterine Leiomyosarcoma (NCI Protocol 10250).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Article
- Downregulation of miR‑10b‑5p facilitates the proliferation of uterine leiomyosarcoma cells: A microRNA sequencing‑based approach.Oncology reports · 2023Article
- Therapeutic advances in leiomyosarcoma.Frontiers in oncology · 2023Review
- Uterine sarcomas: clinical practice guidelines for diagnosis, treatment, and follow-up, by Spanish group for research on sarcomas (GEIS).Therapeutic advances in medical oncology · 2023Review
- Aberrant Activation of Cell-Cycle-Related Kinases and the Potential Therapeutic Impact of PLK1 or CHEK1 Inhibition in Uterine Leiomyosarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Article
- Role of Homologous Recombination Repair (HRR) Genes in Uterine Leiomyosarcomas: A Retrospective Analysis.Cancers · 2022Article
- What Clinical Trials Are Needed for Treatment of Leiomyosarcoma?Current treatment options in oncology · 2022Review
- Uterine Leiomyosarcoma.Journal of the advanced practitioner in oncology · 2022Article
- New Aspects of Sarcomas of Uterine Corpus-A Brief Narrative Review.Clinics and practice · 2021Review
- Leiomyosarcoma: Does Location of Primary Help to Determine the Best Systemic Therapy Options?Current treatment options in oncology · 2021Review
- Review
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 12 institutions in 1 country.
Funding
Abstract
objectiveTrabectedin demonstrated significantly improved disease control in leiomyosarcoma and liposarcoma patients in a global phase 3 trial (NCT01343277). A post hoc analysis was conducted to assess the efficacy and safety of trabectedin or dacarbazine in women with uterine leiomyosarcoma (uLMS), the largest subgroup of enrolled patients (40%).
methodsOf 577 patients randomized 2:1 to receive trabectedin 1.5mg/m
resultsPFS for trabectedin was 4.0months compared with 1.5months for dacarbazine (hazard ratio [HR]=0.57; 95% CI 0.41-0.81; P=0.0012). OS was similar (trabectedin 13.4months vs. dacarbazine 12.9months, HR=0.89; 95% CI 0.65-1.24; P=0.51) between groups. ORR was 11% with trabectedin vs. 9% with dacarbazine (P=0.82). CBR for trabectedin was 31% vs. 18% with dacarbazine (P=0.05); median DOR was 6.5months for trabectedin vs. 4.1months for dacarbazine (P=0.32). Grade 3/4 treatment-emergent adverse events observed in ≥10% of patients in the trabectedin group included transient aminotransferase (aspartate/alanine) elevations, anemia, leukopenia, and thrombocytopenia.
conclusionsIn this post hoc subset analysis of patients with uLMS who had received prior anthracycline therapy, trabectedin treatment resulted in significantly longer PFS versus dacarbazine, with an acceptable safety profile. There was no difference in OS.
Indexed as
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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.