Trial reportGynecologic oncology2012
A phase II evaluation of trabectedin in the treatment of advanced, persistent, or recurrent uterine leiomyosarcoma: a gynecologic oncology group study.
Trial report in Gynecologic oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00379145 (A Phase II Evaluation of Trabectedin), which is not on this map. Cited by 36 papers, 1 of them a synthesis 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 Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas
Who cites it
36 citing papers in PubMed, 1 synthesis or guideline pooled it, 92 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
- Trial
- 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.Gynecologic oncology · 2017Trial
- Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG Oncology/Gynecologic Oncology Group study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Trial
- Uterine sarcoma: A 10-year retrospective analysis of clinicopathological and prognostic factors of surgically treated cases.Ecancermedicalscience · 2026Article
- Doxorubicin and trabectedin in leiomyosarcoma: pioneering a new era of smart combinations in soft tissue sarcomas.Future oncology (London, England) · 2025Article
- Doxorubicin and trabectedin for recurrent leiomyosarcoma - A case report.Gynecologic oncology reports · 2024Article
- Pegylated liposomal doxorubicin combined with trabectedin as a treatment option in uterine sarcomas: a single-institution retrospective analysis.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2024Article
- Interrogating the Genomic Landscape of Uterine Leiomyosarcoma: A Potential for Patient Benefit.Cancers · 2022Review
- Trabectedin in Advanced Sarcomas-Experience at a Tertiary Care Center and Review of Literature.South Asian journal of cancer · 2021Article
- Trabectedin-Related Heart Failure: Case Report and a Systematic Review of the Literature.Frontiers in oncology · 2021Review
- Efficacy and safety of trabectedin in metastatic uterine leiomyosarcoma: A retrospective multicenter study of the Spanish ovarian cancer research group (GEICO).Gynecologic oncology reports · 2020Article
- Enriching cancer pharmacology with drugs of marine origin.British journal of pharmacology · 2020Review
- Marine-Derived Anticancer Agents: Clinical Benefits, Innovative Mechanisms, and New Targets.Marine drugs · 2019Review
- Longer survival in patients with metastatic uterine leiomyosarcoma treated with trabectedin: A case report.Molecular and clinical oncology · 2019Article
- Systemic Treatment of Metastatic/Recurrent Uterine Leiomyosarcoma: A Changing Paradigm.The oncologist · 2018Article
- Starvation tactics using natural compounds for advanced cancers: pharmacodynamics, clinical efficacy, and predictive biomarkers.Cancer medicine · 2018Review
- Clinical trials in gynecologic oncology: Past, present, and future.Gynecologic oncology · 2018Review
- Soft Tissue and Uterine Leiomyosarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018Review
- Clinical Benefit in Response to Palbociclib Treatment in Refractory Uterine Leiomyosarcomas with a CommonThe oncologist · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
Abstract
objectiveTo estimate activity and safety of trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (1 cycle) in uterine leiomyosarcoma.
methodsPatients with chemotherapy naive, advanced, persistent or recurrent uterine leiomyosarcoma, acceptable organ function and PS≤2 were eligible. A two-stage design was utilized. Three responses were required in the first stage to initiate the second stage; the target sample size was 40 for the combined stages. If the true response rate was 10%, the study design provided a 95% chance of correctly classifying the treatment as "inactive." Conversely, if the true response rate was 30%, then the average probability of correctly classifying the treatment as active would be 90%.
resultsTwenty patients were eligible and evaluable. The median number of cycles was 10 (123 total cycles, range 2-29). The number of patients with partial responses was 2 (10%; 95% confidence interval of 1.2%-31.7%). Response durations were 3.3 and 5.7 months. Ten patients had stable disease (50%). The median progression-free survival (PFS) and overall survival were 5.8 months and greater than 26.1 months (median not reached), respectively. Observed grade 3/4 toxicity included: neutropenia 16/20 (1 infection); thrombocytopenia 3/20; metabolic 3/20; anemia, gastrointestinal and vascular 1/20 each. There were no treatment related deaths nor cases of liver failure.
conclusionsAlthough a second stage of accrual was not indicated based on the overall response rate, the drug was well tolerated.
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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.