Evidence Level:Sensitive: C1 - Off-label
(Approved for Pancreatic Cancer)
New
Title:
Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers
Excerpt:AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers….The three approvals authorise Lynparza for:...maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
ANZ 1103 Study of Olaparib Clinical Effect in Patients with Breast Cancer or Ovarian Cancer
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A study, performed in several centers, to examine the treatment of Olaparib at the time of disease progression in ovarian, peritoneal or fallopian tube cancer before an operation.
Excerpt:...• Biological effects in the primary tumour following a short pre-operative course of treatment with Olaparib in patients with platinum sensitive relapsed ovarian cancer; the biological effects are assess in terms of the degree of PAR or PARP-1 inhibition (in tissue and ctDNA) • Germline HRD mutations and tissue mutation with respect to BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 (in tissue and ctDNA)• Generate initial clinical efficacy data for future studies (RECIST 1.1)...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments
Excerpt:...Patients are eligible to undergo BRCA testing even if they have - Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) - At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
NUVOLA TRIAL Open-label Multicentre Study
Excerpt:...Documented mutation in BRCA1 or BRCA2 germline and/or somatic that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function); 4....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Excerpt:...Difference in levels of PAR or PARP-1 before and after study treatment`Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Excerpt:...- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)....
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
Safety and survival in adult women with platinum sensitive relapsed BRCA mutant ovarian cancer: A study of patients in Olaparib Turkey Early Access Program—LynTurk study.
Excerpt:Patients with BRCA mutated relapsed ovarian cancer who are in complete or partial response following platinum based chemotherapy were eligible for Olaparib maintenance….All patients have high grade serous adenocarcinoma of ovary or primary peritoneal carcinoma....Median progression free survival from the end of last chemotherapy was 19.3 months. One-year PFS rate was 88.4% and 2-y PFS rate was 53.8%. One-year OS rate from the end of chemotherapy was 92.3% and 2-year was 61.5%....The real world data from Turkey managed access program has showed that Olaparib has a safety profile in paralel with clinical trials (SOLO).
DOI:10.1200/JCO.2023.41.16_suppl.e17509
Evidence Level:Sensitive: C3 – Early Trials
Title:
Real-world clinical outcomes of olaparib therapy in Chinese patients with advanced serous ovarian cancer treated in Macau
Excerpt:The median PFS for the overall population was 4.2 months (95% CI 2.7-5.2), while those for patients with wild-type BRCA1/2 and BRCA1/2 mutations were 3.1 months (95% CI 1.3-4.6) and 5.3 months (95% CI 2.8-7.1), respectively. Our findings demonstrate clinical benefit of olaparib to mainland Chinese patients with high-grade SOC, particularly for patients with BRCA mutations and who require maintenance therapy.
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial
Excerpt:An overall survival advantage was seen with maintenance olaparib versus placebo in all patients (hazard ratio [HR] 0·73 [95% CI 0·55-0·96]; nominal p=0·025, which did not meet the required threshold for statistical significance [p<0·0095]; median overall survival was 29·8 months [95% CI 26·9-35·7] for those treated with olaparib vs 27·8 months [24·9-33·7] for those treated with placebo), and in patients with BRCAm (HR 0·62 [95% CI 0·41-0·94] nominal p=0·025; 34·9 months [95% CI 29·2-54·6] vs 30·2 months [23·1-40·7])...
DOI:10.1016/S1470-2045(16)30376-X
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial
Excerpt:Of patients with a BRCA mutation, median PFS was significantly longer in the olaparib group than in the placebo group (11·2 months [95% CI 8·3-not calculable] vs 4·3 months [3·0-5·4]; HR 0·18 [0·10-0·31]; p<0·0001)….that patients with platinum-sensitive recurrent serous ovarian cancer with a BRCA mutation have the greatest likelihood of benefiting from olaparib treatment.
DOI:10.1016/S1470-2045(14)70228-1