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Assessment of safety and efficacy of combined trabectedin and low-dose radiotherapy for patients with metastatic soft-tissue sarcomas: A nonrandomized phase 1/2 clinical trial

JAMA Feb 26, 2020

Martin-Broto J, Hindi N, Lopez-Pousa A, et al. - This study was carried out to investigate the combined use of trabectedin and radiotherapy in treating patients with progressing metastatic soft-tissue sarcomas. A nonrandomized phase 1/2 clinical trial was performed in 9 sarcoma referral centers in Spain, France, and Italy between April 13, 2015, and November 20, 2018. Researchers recruited 11 individuals (11 of whom were male) and 27 individuals (14 of whom were female) in phase 1 and phase 2, respectively. In phases 1 and 2, the median ages of those enrolled were 42 (range, 23-74) years and 51 (range, 27-73) years, respectively. The data of this research demonstrated that the recommended dose of trabectedin for use in combination with this irradiation regimen is 1.5 mg/m2. In individuals with metastatic, progressing soft-tissue sarcomas, the trial met its primary endpoint, with a high overall response rate that shows the potential of this combination therapy for achieving substantial tumor shrinkage beyond first-line systemic therapy.
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