Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC

Grupo Español de Investigación en Cáncer de Ovario90 enrolled

Overview

Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ovarian Epithelial Cancer Recurrent

Interventions

Trabectedin and Pegylated Liposomal DoxorubicinDRUG

Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC from October 28, 2009 to October 31, 2014

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have received at least one dose of trabectedin - doxorubicin pegylated for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin. Exclusion Criteria: * Patients with records unavailable (lost, empty or not recoverable).

Outcomes

Primary Outcomes

Efficacy progression-free survival (PFS)

Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of progression-free survival ( PFS).

Time frame: Up to 12 months

Overall survival (OS)

Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of overall survival (OS ) .

Time frame: Up to 12 months

Secondary Outcomes

Response rate to previous and post-treatment (Percentage of responses (CR+PR)

Percentage of responses (CR+PR) at pretreatment and post-treatment

Time frame: Up to 12 months

Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)

Percentage of responses ( CR + PR ) to trabectedin - DLP

Time frame: Up to 12 months

Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)

Percentage of clinical benefit (CR + PR + SD for at least 4 months)

Time frame: Up to 12 months

Impact of trabectedin - PLD combination in subsequent treatments

Assessment of the impact of treatment with trabectedin - PLD combination at the beginning of subsequent treatments

Time frame: Up to 12 months

Toxicity (adverse events)

type , incidence , severity, frequency, severity and relationship to the treatment of adverse events reported in patients reports

Data from ClinicalTrials.gov

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