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FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen.

Author: BaroneAmy, ChenHuanyu, ChiDow-Chung, GoldbergKirsten B, HeKun, HelmsWhitney S, KeeganPatricia, KufrinDubravka, PatelAnuja, PazdurRichard, SubramaniamSriram, TheoretMarc R, ZhaoHong

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

Trabectedin was approved by the FDA for the treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients who have received a prior anthracycline-containing regimen. Trabectedin significantly improved progression-free survival (PFS) compared to dacarbazine. However, it was associated with several adverse reactions, including anaphylaxis, neutropenic sepsis, and cardiomyopathy.
Paper Details　
Original Abstract of the Article :
On October 23, 2015, the FDA approved trabectedin, a new molecular entity for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen. Approval was based on results of a single, randomized, active-controlled, 518-p...See full text at original site
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引用元：
https://doi.org/10.1158/1078-0432.CCR-17-0898

データ提供：米国国立医学図書館（NLM）

Trabectedin: A New Treatment Option for Liposarcoma and Leiomyosarcoma

This research focuses on the treatment of liposarcoma and leiomyosarcoma, rare and aggressive types of soft tissue cancers. The study investigates the efficacy and safety of trabectedin, a new chemotherapy drug, in patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have received prior anthracycline-containing chemotherapy. The researchers conducted a randomized clinical trial comparing trabectedin to dacarbazine, a standard chemotherapy agent, in 518 patients.

Trabectedin: A Promising Treatment for Liposarcoma and Leiomyosarcoma

The study demonstrated that trabectedin significantly improved progression-free survival (PFS) compared to dacarbazine. However, trabectedin was associated with a range of adverse reactions, including nausea, fatigue, and potential serious side effects like anaphylaxis and cardiomyopathy. This study highlights the potential of trabectedin as a new treatment option for patients with liposarcoma and leiomyosarcoma, but emphasizes the need for careful monitoring for potential side effects.

Expanding Treatment Options for Rare Cancers

This research provides hope for patients with liposarcoma and leiomyosarcoma, two rare and challenging cancers. The study's findings highlight the potential of trabectedin as a new treatment option, offering a glimmer of hope for patients facing limited therapeutic options. However, it underscores the importance of carefully weighing the potential benefits against the risks associated with this new drug. This study is a testament to the ongoing efforts to develop innovative treatments for rare cancers.

Dr. Camel's Conclusion

This study provides valuable insights into the potential of trabectedin as a new treatment option for patients with unresectable or metastatic liposarcoma or leiomyosarcoma. While trabectedin demonstrated a significant improvement in progression-free survival, it is important to consider the potential risks and side effects associated with this drug. This research highlights the importance of carefully evaluating the benefits and risks of new therapies in the context of rare cancers.

Date :
  1. Date Completed 2018-08-01
  2. Date Revised 2018-12-02
Further Info :

Pubmed ID

28774898

DOI: Digital Object Identifier

10.1158/1078-0432.CCR-17-0898

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in preparation
Languages

English

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