演題抄録

シンポジウム

開催概要
開催回
第53回・2015年・京都
 

Frontier of Precision Medicine in Oncology: Results of the SHIVA trial

演題番号 : S4-3

[筆頭演者]
Le Tourneau Christophe:1 

1:Clinical Trial Unit, Department of Medical Oncology, Institut Curie, France

 

Unprecedented antitumor activity has been reported with molecularly targeted agents (MTAs) in patients selected on the presence of the matching molecular alteration in some tumor types. As most druggable molecular alterations exist across various tumor types, large-scale genomic testing has largely been endorsed by physicians and patients with the aim to guide therapy. We initiated the proof-of-concept randomized phase II SHIVA trial evaluating the efficacy of selecting MTAs outside of their indications based on the molecular profile of patients' tumors and conventional chemotherapy in patients with any kind of cancer that was refractory to standard of care. The molecular profile of patients' tumors was established on a biopsy of a metastatic site using next generation sequencing for mutations, CGH for gene copy number alterations and immunohistochemistry. Patients for whom a molecular alteration was identified and matched one of the available marketed MTAs according to a pre-specified treatment algorithm, were randomly allocated to matching MTA or treatment at physician's choice (TPC). MTAs were only allowed outside their licensed indications and if not previously given. The primary end point was progression-free survival (PFS). Patients were allowed to cross-over at disease progression. Results of the SHIVA trial will be presented at the meeting.

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