Yondelis ( Trabectedin ) in combination with pegylated liposomal doxorubicin in patients with ovarian tumors . Nuevo Estudio avala que de 11 Pacientes tratados con esta combinación ... 4 Obtuvieron una " Respuesta Completa " .

P.J. : A tener en cuenta que en EEUU este tratamiento aún no está aprobado y que como todos sabéis lo lleva J&J . Ya terminó el reclutamiento de Pacientes en la Fase III y última antes de intentar salir al mercado ... y por tanto está en la cuenta atrás :

Estimated Study Completion Date : December 31, 2018 .


Authors: Alessandro Villanucci Ketty Tavella Laura Vannini Virginia Rossi Stefania Nobili Gianni Amunni Teresita Mazzei Enrico Mini .

Published online on: October 1, 2018

Abstract

The majority of patients with ovarian cancer will experience relapse and thus require second‑line therapy. While platinum-based therapies are the primary treatments for refractory disease other options are required, particularly for those with partially platinum‑sensitive disease as their response rates are lower. Agents that can resensitize relapsed ovarian cancers to platinum, including trabectedin, are therefore of increasing interest.

Trabectedin is a multitarget agent that has a complex, novel mechanism of action and has exhibited promising results in platinum‑sensitive ovarian cancer when in combination with pegylated liposomal doxorubicin (PLD).

The present study conducted retrospective analysis involving 11 cases (median age 60 years; range 45‑75 years) of recurrent ovarian tumors and partial platinum sensitivity undergoing treatment with trabectedin + PLD.

The cohort consisted of 7 serous carcinomas, 1 endometrial carcinoma, 2 undifferentiated carcinomas, and 1 mucinous carcinoma. Of the 11 patients, 4 exhibited a complete response, 3 achieved stable disease, and 4 had progression of disease. 

Mean overall survival was 32.42 months and median progression‑free survival was 5.9 months. Trabectedin in combination with PLD was well tolerated in terms of gastrointestinal and hematological toxicity; Grade 3 cutaneous toxicity and grade 3 neutropenia were each observed in 18.2% of patients. There were no grade 4 events. 

Thus, the present study supports the use of trabectedin + PLD in patients with relapsed ovarian cancer and partial platinum sensitivity, with predictable and manageable toxicity.