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Association details:
| Biomarker: | BRCA2 mutation |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | Yondelis (trabectedin) (Alkylating agent, DNA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
830P - Subanalysis of a randomized phase III study comparing trabectedin and PLD vs PLD alone in patients with recurrent ovarian cancer (ROC)
Published date:
09/14/2020
Excerpt:
Among all patients included in the study, only 57.8% were PS after the last platinum, precluding a reliable estimation of PFS or OS. Despite that, there is a trend toward improved PFS combined with significant improvement in ORR with trabectedin/PLD in this subset of patients. More pronounced benefits were observed in PS patients with a PFI 6-12 months and PS patients with BRCA 1/2 mutations.
Secondary therapy:
pegylated liposomal doxorubicin
Trial ID:
Source:
Title:
Maintenance therapy with Trabectedin after combination therapy Liposomal Doxorubicin plus Trabectedin vs Liposomal Doxorubicin plus Trabectedin in patients affected by relapsed ovarian cancer. Studio di fase II:Terapia di mantenimento con Trabectedina dopo terapia di combinazione con Doxorubicina Liposomiale e Trabectedina in pazienti affetti da carcinoma ovarico.
Excerpt:
...Hepatic function variables:• Total bilirubin = ULN• Total alkaline phosphatase = 2.5 ULN (consider hepatic isoenzymes of 5-nucleotidase or GGT if the elevation could be osseous in origin)• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be = 2.5 x ULN- All randomized patients must be able to receive dexamethasone or its equivalent, - Informed consent of the patient obtained within the 6th chemo-cycle and before any study-specific procedure- Determination of BRCA 1 and BRCA 2 mutation within the screening visit - Conferma citologica e / o istologica di carcinoma epiteliale ovarico, carcinoma epiteliale alla tube di falloppio o carcinoma peritoneale primario- Donna, età = 18 anni- Indicazione per chemioterapia- Non più di 3 precedenti linee di chemioterapia- Aspettativa di vita maggiore di 3 mesi- Presenza di CVC- Completamento di n 6 cicli di terapia combinata di Doxorubicina Liposomiale più Trabectedina- Malattia stabile, risposta parziale, risposta completa confermata da immagini radiologiche, come la risonanza magnetica (MRI), tomografia computerizzata (TC), o PET / TAC, dopo n. 6 cicli di terapia combinata di Doxorubincin liposomiale più Trabectedina- carcinoma ovarico recidivante con un intervallo libero progressione di sei e dodici (6-12) mesi (calcolato a partire dal primo giorno dell'ultimo ciclo dell'ultima chemioterapia a base di platino fino alla data di conferma progressione attraverso l'immagine radiologica). ...
Trial ID:
Source:
Title:
Study With Trabectedin in BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype Ovarian Cancer
Excerpt:
...high-grade serous cancers, great initial sensitivity to platinum drugs and retention of platinum-sensitivity through multiple relapses, long history of disease, long survival, long TFIs between relapses (patients with high personal risk factors will be included after doing the analysis for BRCA 1-2 mutation before knowing the results)....
Trial ID:
More C2 evidence
Source:
Title:
Phase II study aiming at evaluating activity of Yondelis in recurrent ovarian cancer patients with BRCA mutation Studio clinico di fase 2 finalizzato a valutare l'attivita' dello Yondelis nelle pazienti con recidiva di carcinoma dell'ovaio con la mutazione genetica BRCA.
Excerpt:
...Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have previously received at least two platinum based chemotherapy lines, BRCA mutated or with BRCAness phenotype Definition of BRCAness phenotype: high-grade serous cancers, great initial sensitivity to platinum drugs and retention of platinum-sensitivity through multiple relapses, long history of disease, long survival, long TFIs between relapses (patients with high personal risk factors will be included after doing the analysis for BRCA 1-2 mutation before knowing the results). ...
Trial ID:
