Yondelis en Pacientes con Cáncer de Ovario Recurrente Fuertemente Pretratados . Un estudio caso-control realizado en China .

International Gynecologic Cancer Society Meeting ( IGCS ) Portugal del 26 al 31 Octubre 2016 .

Abstract:

TRABECTEDIN IN HEAVILY PRETREATED RECURRENT OVARIAN CANCER PATIENTS: A CASE-CONTROL STUDY .

Background and Aims: Trabectedin has been approved for recurrent ovarian cancer (ROC) treatment in combination with pegylated liposomal doxorubicin. Trabectedin was also effective and tolerable as single agent in pretreated ROC patients. The aim of our study was to analyze the safety and efficacy of single agent Trabectedin in heavily pretreated ROC patients. Methods: Patients with ROC treated with single agent Trabectedin 0,6 mg/m2 every 10 days (10dTr) at our Institution were included. Response and toxicity to treatment were evaluated according to RECIST and CTCAE criteria, respectively. We matched results with an historical group of ROC patients submitted to weekly Paclitaxel 80 mg/m2 (wP). Overall survival (OS) was analyzed. Results: From 2010 to 2015 we treated 34 ROC patients with 10dTr. Patients characteristics are presented in table 1. Comparison with 34 patients treated with wP showed no difference in clinical response (Table 2). No different hematological and non-hematological toxicities were found except for grade 3/4 thrombocitopenia and reversible AST/ALT elevation (12% versus 6% and 24% versus 3% of patients in 10dTr and wP group respectively). There were no treatment-related deaths nor cases of liver failure. Median OS of patients who received 10dTr was 11 months, compared with 5 months of wP (p=0.07). Conclusions: 10dTr seems to be a valid option in heavily pretreated ROC patients, with acceptable toxicity profile. Prospective studies investigating efficacy and quality of life are needed.