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 Overview
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Brief Summary
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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.

Official Title
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Multicenter and Retrospective Observational Study to Analyze the Efficacy and Safety of the Combination With Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to Data Sheet

Conditions
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Ovarian Epithelial Cancer Recurrent

Intervention / Treatment
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* Drug: Trabectedin and Pegylated Liposomal Doxorubicin


Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trabectedin+ PLD<br>Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC. | Drug: Trabectedin and Pegylated Liposomal Doxorubicin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 ) . | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate to previous and post-treatment (Percentage of responses (CR+PR) | Percentage of responses (CR+PR) at pretreatment and post-treatment | Up to 12 months | 
| Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR) | Percentage of responses ( CR + PR ) to trabectedin - DLP | 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) | 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 | Up to 12 months | 
| Toxicity (adverse events) | type , incidence , severity, frequency, severity and relationship to the treatment of adverse events reported in patients reports | Up to 12 months | 
| Comparison between PFS and PFS2 | Comparison of the PFS of prior platinum combination TRB + DLP and subsequent platinum PFS. | Up to 12 months | 
| Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies) | Number and Management of hypersensitivity reactions or allergies. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platinum-sensitive Recurrent Ovarian Cancer