Trial reportInvestigational new drugs2012
A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials.
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 27 papers.
What it found
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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
27 citing papers in PubMed.
- Hepatic safety analysis of trabectedin: results of a pharmacokinetic study with trabectedin in patients with hepatic impairment and experience from a phase 3 clinical trial.Investigational new drugs · 2018Trial
- Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016Trial
- Observational
- Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial.Cancers · 2022Article
- Transcription regulators and ultra-rare and other rare translocation-related sarcomas treated with trabectedin: A proof of principle from aFrontiers in oncology · 2022Article
- Article
- Trabectedin-Related Heart Failure: Case Report and a Systematic Review of the Literature.Frontiers in oncology · 2021Review
- Pharmacogenetic Study of Trabectedin-Induced Severe Hepatotoxicity in Patients with Advanced Soft Tissue Sarcoma.Cancers · 2020Article
- Trabectedin plus pegylated liposomal doxorubicin (PLD) for patients with platinum-sensitive recurrent ovarian cancer: a prospective, observational, multicenter study.Journal of cancer research and clinical oncology · 2018Observational
- Central venous access related adverse events after trabectedin infusions in soft tissue sarcoma patients; experience and management in a nationwide multi-center study.Clinical sarcoma research · 2017Article
- Complete response after rechallenge with trabectedin in a patient with previously responding high-grade undifferentiated sarcoma.Anti-cancer drugs · 2016Article
- Article
- Long-term response to first-line trabectedin in an elderly female patient with a metastatic leiomyosarcoma unfit for anthracycline.Anti-cancer drugs · 2016Article
- Drug Monographs: Trabectedin and Trifluridine-Tipiracil.Hospital pharmacy · 2016Article
- Trabectedin for inoperable or recurrent soft tissue sarcoma in adult patients: a retrospective cohort study.BMC cancer · 2016Article
- The value of trabectedin in the treatment of soft tissue sarcoma.Therapeutics and clinical risk management · 2016Review
- Lack of Correlation Between Liver Tests Abnormalities and Trabectedin Efficacy in the Treatment of Soft Tissue Sarcoma: a Retrospective Study.Scientific reports · 2015Article
- Trabectedin in soft tissue sarcomas.Marine drugs · 2015Review
- Ecteinascidins. A review of the chemistry, biology and clinical utility of potent tetrahydroisoquinoline antitumor antibiotics.Natural product reports · 2015Review
- Trabectedin therapy as an emerging treatment strategy for recurrent platinum-sensitive ovarian cancer.Chinese journal of cancer · 2015Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo summarize the safety experience obtained from phase II clinical trials conducted with trabectedin as single-agent therapy in patients with advanced solid tumors.
methodsThis retrospective analysis includes 1,132 patients exposed to trabectedin in 19 phase II trials carried out between February 1999 and April 2008. Trabectedin was administered intravenously as 1 of 3 schedules: 24-hour infusion every 3 weeks (q3wk 24-h; n = 570/2,818 cycles), 3-hour infusion every 3 weeks (q3wk 3-h; n = 258/1,003 cycles), and 3-hour infusion for three consecutive weeks every 4 weeks (qwk 3-h; n = 304/1,198 cycles).
resultsThe majority of patients (90%) had received previous chemotherapy. Patients were given a median of three treatment cycles of trabectedin (range, 1-59). Nausea, fatigue and vomiting were the most common trabectedin-related adverse events, reported in ≥20% of patients. Reversible myelosuppression (mainly neutropenia) and transient reversible transaminase increases were the most common laboratory abnormalities seen with trabectedin, with a very low incidence of relevant clinical consequences. Deaths associated with drug-related adverse events were infrequent, occurring in 19 (1.7%) patients.
conclusionSingle-agent trabectedin treatment was reasonably well tolerated. Trabectedin can be administered for prolonged periods to patients with sustained clinical benefit (induction of disease stability or shrinkage) without cumulative toxicities over time.
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