Trial reportBritish journal of cancer2007
A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens.
Trial report in British journal of cancer, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 105 citations in OpenAlex.
- 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
- Overcoming platinum resistance in ovarian carcinoma.Expert opinion on investigational drugs · 2010Pooled it
- Growth modulation index as metric of clinical benefit assessment among advanced soft tissue sarcoma patients receiving trabectedin as a salvage therapy.Annals of oncology : official journal of the European Society for Medical Oncology · 2013Trial
- A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials.Investigational new drugs · 2012Trial
- Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2011Trial
- Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval.Annals of oncology : official journal of the European Society for Medical Oncology · 2011Trial
- The Role of Trabectedin in Soft Tissue Sarcoma.Frontiers in pharmacology · 2022Review
- A phase I study of combined trabectedin and pegylated liposomal doxorubicin therapy for advanced relapsed ovarian cancer.International journal of clinical oncology · 2021Article
- Marine Natural Products from Tunicates and Their Associated Microbes.Marine drugs · 2021Review
- The Tumor Microenvironment in SCC: Mechanisms and Therapeutic Opportunities.Frontiers in cell and developmental biology · 2021Review
- Trabectedin-Related Heart Failure: Case Report and a Systematic Review of the Literature.Frontiers in oncology · 2021Review
- Starvation tactics using natural compounds for advanced cancers: pharmacodynamics, clinical efficacy, and predictive biomarkers.Cancer medicine · 2018Review
- Emesis and nausea related to single agent trabectedin in ovarian cancer patients: a sub-study of the MITO15 project.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Article
- Drug Monographs: Trabectedin and Trifluridine-Tipiracil.Hospital pharmacy · 2016Article
- The value of trabectedin in the treatment of soft tissue sarcoma.Therapeutics and clinical risk management · 2016Review
- Phase I study of the safety and pharmacokinetics of trabectedin with docetaxel in patients with advanced malignancies.Cancer chemotherapy and pharmacology · 2015Article
- Trabectedin therapy as an emerging treatment strategy for recurrent platinum-sensitive ovarian cancer.Chinese journal of cancer · 2015Review
- Alkaloids from marine invertebrates as important leads for anticancer drugs discovery and development.Molecules (Basel, Switzerland) · 2014Review
- Clinical utility of trabectedin for the treatment of ovarian cancer: current evidence.OncoTargets and therapy · 2014Review
- Estrogen biosynthesis and action in ovarian cancer.Frontiers in endocrinology · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The objective of this study was to determine the objective response rate in patients with platinum-sensitive and platinum-resistant recurrent ovarian cancer to treatment with trabectedin (Yondelis) administered as a 3-h infusion weekly for 3 weeks of a 4-week cycle. We carried out a multicentre Phase II trial of trabectedin in patients with advanced recurrent ovarian cancer. Trabectedin (0.58 mg m(-2)) was administered via a central line, after premedication with dexamethasone, to 147 patients as a 3-h infusion weekly for 3 weeks followed by 1-week rest. Major eligibility criteria included measurable relapsed advanced ovarian cancer and not more than two prior platinum-containing regimens. Patients were stratified according to the treatment-free interval (TFI) between having either platinum-sensitive (>/=6 months TFI) or platinum-resistant disease (<6 months TFI)/platinum-refractory disease (progression during first line therapy). In the platinum-sensitive cohort, 62 evaluable patients with measurable disease had an overall response rate (ORR) of 29.0% (95% CI: 18.2-41.9%) and median progression-free survival (PFS) was 5.1 months (95% CI: 2.8-6.2). Four patients with measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) criteria had no follow-up scans at the end of treatment. In the platinum-resistant/refractory cohort, 79 patients were evaluable with an ORR of 6.3% (95% CI: 2.1-14.2%). Median PFS was 2.0 months (95% CI: 1.7-3.5 months). Two patients with measurable disease per RECIST criteria had no follow-up scans at the end of treatment. The most frequent (>/=2% of patients) drug-related treatment-emergent grade 3/4 adverse events were reversible liver alanine transferase elevation (10%), neutropaenia (8%), nausea, vomiting, and fatigue (5% each). Trabectedin is an active treatment, with documented responses in patients with platinum sensitive advanced relapsed ovarian cancer, and has a manageable toxicity profile.
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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.