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Association details:
| Biomarker: | BRCA2 mutation |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | Lynparza (olaparib) (PARP inhibitor) + Recentin (cediranib) (VEGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in recurrent platinum-sensitive ovarian cancer.
Published date:
05/13/2020
Excerpt:
In gBRCA pts, HR for PFS was 0.55 (95% CI 0.73-1.30) for C+O vs SOC, and 0.63 (95% CI 0.37-1.07) for O vs SOC. In non-gBRCA pts, HR for these comparisons was 0.97 (95% CI 0.73-1.30) and 1.41 (1.07-1.86). No OS differences between arms were observed at 44% events.
Secondary therapy:
carboplatin + gemcitabine; carboplatin + pegylated liposomal doxorubicin; carboplatin + bisphosphonate bound paclitaxel
DOI:
10.1200/JCO.2020.38.15_suppl.6003
Trial ID:
Source:
Title:
Clinical study, involving Italian clinical sites, comparing the activity of Paclitaxel (weekly administration) to the activity of Cediranib-Olaparib with continuous administration or to Cediranib-Olaparib with intermittent administration, in patients with advanced ovarian cancer, resistant to previous platinum treatment. Studio Barocco: Studio clinico che coinvolge più centri clinici italiani volto a comparare l’attività di paclitaxel somministrato settimanalmente con quella di cediranib e olaparib somministrati in modo continuo o cediranib e olaparib somministrati in modo intermittente, nelle pazienti con tumore dell’ovaio avanzato, resistente a trattamenti a base di platino.
Excerpt:
...10.Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.11.At least one lesion (measurable as defined by RECIST 1.1) that can be accurately assessed by CT scan or MRI with Chest X-ray at baseline and follow up visits.12.BRCA1-2 mutation status known13.Provision of informed consent prior to any study specific procedures. ...
Trial ID:
Source:
Title:
Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer
Excerpt:
...- Due to the long acceptance of BRCA testing through Myriad, Myriad testing will be accepted as documentation of a deleterious mutation; if testing for BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results show a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangements is required to document the presence of a deleterious mutation...
Trial ID:
More C2 evidence
Source:
Title:
Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib
Excerpt:
...BRCA1-2 mutation status known....
Trial ID:
Source:
Title:
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Excerpt:
...- Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with other (clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma) high-risk histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory;...
Trial ID:
Source:
Title:
Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer
Excerpt:
...- Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings; both endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers; patients with clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory -...
Trial ID:
Less C2 evidence
Source:
Title:
Cediranib in combination with olaparib in patients without a germline BRCA1/2 mutation with recurrent platinum-resistant ovarian cancer: Phase IIb CONCERTO trial.
Published date:
05/13/2020
Excerpt:
7% of pts had tumor BRCA2 (confirmed somatic) mutations, 80% of pts had no tumor BRCA mutation (non-tBRCAm) and 13% of pts were not evaluable for tBRCAm. Cedi + ola showed evidence of antitumor activity in heavily pretreated non-gBRCAm pts with recurrent platinum-resistant OC.
DOI:
10.1200/JCO.2020.38.15_suppl.6056
Source:
Title:
Overall survival and updated progression-free survival outcomes in a randomized phase II study of combination cediranib and olaparib versus olaparib in relapsed platinum-sensitive ovarian cancer
Published date:
02/13/2019
Excerpt:
In this updated analysis, median PFS remained significantly longer with cediranib/olaparib compared with olaparib alone (16.5 versus 8.2 months, hazard ratio 0.50; P = 0.007)…PFS and OS appeared similar between the two arms in gBRCAm patients….Subset analyses suggest this margin of benefit is driven by PFS prolongation in patients without gBRCAm.
DOI:
10.1093/annonc/mdz018
