Yondelis . Resultados Fase II en Pacientes BRCA mutados Y / O BRCAness fenotipo RECURRENTES del cáncer ovárico . La Actividad del Yondelis parece Comparable a la que se podría obtener utilizando compuestos de Platino ... por lo que Yondelis puede representar una Valiosa Opción Alternativa en Pacientes que presentan Contraindicaciones para recibir Platinos.

Gynecological tumors .

• D. Lorusso, 
• G. Scambia, 
• S. Pignata, 
• R. Sorio, 
• G. Amadio, 
• S. Lepori, 
• A. Mosconi,
• C. Pisano, 
• G. Mangili, 
• G. Maltese, 
• R. Sabbatini, 
• G. Artioli, 
• T. Gamucci, 
• M. Di Napoli, 
• E. Capoluongo, 
• V. Ludovini, 
• F. Raspagliesi, 
• and G. Ferrandina

Ann Oncol first published online December 17, 2015

PROSPECTIVE PHASE II TRIAL OF TRABECTEDIN IN BRCA MUTATED AND/OR BRCAness PHENOTYPE RECURRENT OVARIAN CANCER PATIENTS: THE MITO 15 TRIAL .

• Abstract
 

BACKGROUND:

Current evidence suggest that Trabectedin is particularly effective in cells lacking functional HR repair mechanisms. A prospective phase II trial was designed to evaluate the activity of Trabectedin in the treatment of recurrent ovarian cancer patients presenting BRCA mutation and/or BRCAness phenotype.

PATIENTS AND METHODS:

100 patients with recurrent BRCA mutated ovarian cancer and/or BRCAness phenotype (> 2 previous responses to platinum) were treated with Trabectedin 1.3 mg/mq i.v. q 3 weeks. Activity of the drug with respect to BRCA mutational status and to a series of polymorphisms (SNPs) involved in DNA gene repair was analyzed.

RESULTS:

94 were evaluable for response; in the whole population 4 complete and 33 partial responses were registered for an overall response rate (ORR) of 39.4. In the platinum resistant (PR) and sensitive (PS) population an ORR of 31.2% and 47.8%, and an overall clinical benefit of 54.2% and 73.9% respectively, were registered. In the whole series, median PFS was 18 weeks and median OS was 72 weeks; PS patients showed a more favourable PFS and OS compared to PR patients. BRCA gene mutational status was available in 69 patients. There was no difference in ORR, PFS and OS according to BRCA 1-2 status nor any association between SNPs of genes involved in DNA repair and NER machinery and response toTrabectedin was reported.

CONCLUSIONS:

Our data prospectively confirmed that the signature of "repeated platinum sensitivity" identifies patients highly responsive toTrabectedin. In this setting, the activity of Trabectedin seems comparable to what could be obtained using platinum compounds and the drug may represent a valuable alternative option in patients who present contraindication to receive platinum.

© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.