Trabectedin: Safety and Efficacy in the Treatment of Advanced Sarcoma

Gajdos, Csaba; Elias, A.

doi:10.4137/cmo.s4907

Cited by 16 publications

(9 citation statements)

References 31 publications

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“…The results were comparable to previous reports (13,14,16,19,20). Notably, although patients with L-sarcoma tended to have better PFS than non-L-sarcoma patients, neither L-sarcoma nor TRS significantly affected the efficacy of trabectedin in terms of prognosis.…”

Section: Discussionsupporting

confidence: 87%

“…Trabectedin is a marine-derived, semisynthetic DNAbinding protein that exerts an antineoplastic effect by binding to the minor groove of DNA and bending the DNA towards the main groove (12). This agent has been approved for clinical use in Europe since 2007 and has been used to treat patients with unresectable advanced or recurrent STS (13,14). Following a clinical trial targeting translocation-related sarcoma (TRS), trabectedin was finally approved in Japan in 2015.…”

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confidence: 99%

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Retrospective Analysis of Trabectedin Therapy for Soft Tissue Sarcoma

Kawaguchi

Nakano

Urasaki

et al. 2019

In Vivo

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Background/Aim: Trabectedin is a synthetic antineoplastic agent approved for advanced soft tissue sarcoma (STS) in Japan. The aim of this study was to evaluate the efficacy and safety of the Japan-approved dose of trabectedin for advanced STS. Patients and Methods: We retrospectively reviewed 38 patients with advanced STS who received salvage chemotherapy with trabectedin. Results: The overall response and disease control rates were 16% (5 patients) and 67% (20 patients), respectively. The median progression-free and overall survival were 7.3 and 17.8 months, respectively. There were no significant differences between patients with liposarcoma or leiomyosarcoma and those without, or between patients with TRS and those without. The most common grade 3-4 AEs were elevated transaminases and neutropenia. Conclusion: Trabectedin 1.2 mg/m 2 , as the approved dose in Japan, showed similar efficacy to the dose of 1.5 mg/m 2 used in Western countries. Trabectedin could be an option for advanced STS in Japan, regardless of histological subtype.

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Section: Discussionsupporting

confidence: 87%

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confidence: 99%

Retrospective Analysis of Trabectedin Therapy for Soft Tissue Sarcoma

Kawaguchi

Nakano

Urasaki

et al. 2019

In Vivo

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“… 99 , 100 Adverse effects of trabectedin include neutropenia, transaminase elevation, fatigue and emesis. 101 The success of trabectedin in early clinical trials led to its approval by the European Union for advanced soft tissue sarcoma in 2007 and subsequently the drug has been approved in over 70 countries, especially for patients who have failed to respond to standard therapies. 102 – 104 A recent phase III clinical trial confirmed that advanced liposarcoma and leiomyosarcoma refractory to doxorubicin and ifosfamide showed a 45% reduction in the risk of disease progression or death when treated with trabectedin in comparison with darcarbazine, which prompted the approval of trabectedin by the US Food and Drug Administration (FDA).…”

Section: Systemic Control In Sarcomamentioning

confidence: 99%

Managing sarcoma: where have we come from and where are we going?

et al. 2017

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Sarcomas are a heterogeneous group of neoplasms of mesenchymal origin. Approximately 80% arise from soft tissue and 20% originate from bone. To date more than 100 sarcoma subtypes have been identified and they vary in molecular characteristics, pathology, clinical presentation and response to treatment. While sarcomas represent <1% of adult cancers, they account for approximately 21% of paediatric malignancies and thus pose some of the greatest risks of mortality and morbidity in children and young adults. Metastases occur in one-third of all patients and approximately 10–20% of sarcomas recur locally. Surgery in combination with preoperative and postoperative therapies is the primary treatment for localized sarcoma tumours and is the most promising curative possibility. Metastasized sarcomas, on the other hand, are treated primarily with single-agent or combination chemotherapy, but this rarely leads to a complete and robust response and often becomes a palliative form of treatment. The heterogeneity of sarcomas results in variable responses to current generalized treatment strategies. In light of this and the lack of curative strategies for metastatic and unresectable sarcomas, there is a need for novel subtype-specific treatment strategies. With the more recent understanding of the molecular mechanisms underlying the pathogenesis of some of these tumours, the treatment of sarcoma subtypes with targeted therapies is a rapidly evolving field. This review discusses the current management of sarcomas as well as promising new therapies that are currently underway in clinical trials.

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“…Trabectedin binds to the minor groove of DNA with preference for GC-rich triplets and subsequently forms covalent adducts with the N2-position through its carbinolamine moiety [ 158 , 159 , 160 ]. ET-743, under the trade name Yondelis, was approved for the treatment of refractory soft-tissue sarcomas by the European Commission in July 2007; the currently ongoing Phase III trials along with the already existing clinical evidence may provide enough data for the Food and Drug Administration for an approval in the US [ 161 ]. Based on the preclinical results, trabectedin is also being developed for ovarian, prostate, lung, breast and pediatric cancers [ 149 , 162 , 163 ].…”

Section: Tyrosine- and Phenylalanine-derived Alkaloidsmentioning

confidence: 99%