^
Evidence Level:
Sensitive: A1 - Approval

[HRD-Prostate Cancer-olaparib]

Source:
Published date:
11/05/2020
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.
Evidence Level:
Sensitive: A1 - Approval

[BRCA2 mutation-Peritoneal Cancer-olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval

[BRCA1 mutation-Peritoneal Cancer-olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval

[BRCA1 mutation-Ovarian Cancer-niraparib]

Source:
Excerpt:
ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval

[BRCA2 mutation-Ovarian Cancer-niraparib]

Source:
Excerpt:
ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation
Evidence Level:
Sensitive: A1 - Approval

[BRCA2 mutation-Fallopian Tube Cancer-olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval

[BRCA2 mutation-Ovarian Cancer-bevacizumab + olaparib]

Source:
Excerpt:
Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.
Evidence Level:
Sensitive: A1 - Approval

[BRCA1 mutation-Fallopian Tube Cancer-bevacizumab + olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either....a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval

[HRD-Ovarian Cancer-niraparib]

Source:
Excerpt:
ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated:...for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:...a deleterious or suspected deleterious BRCA mutation, or...genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval

[BRCA1 mutation-Fallopian Tube Cancer-olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval

[HRD-Peritoneal Cancer-bevacizumab + olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status...
Evidence Level:
Sensitive: A1 - Approval

[HRD-Fallopian Tube Cancer-bevacizumab + olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status...
Evidence Level:
Sensitive: A1 - Approval

[BRCA2 mutation-Peritoneal Cancer-bevacizumab + olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either....a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval

[BRCA1 mutation-Peritoneal Cancer-bevacizumab + olaparib]

Source:
Excerpt:
"Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either....a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval

[BRCA2 mutation-Fallopian Tube Cancer-bevacizumab + olaparib]

Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either....a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval

[BRCA1 mutation-Ovarian Cancer-bevacizumab + olaparib]

Source:
Excerpt:
Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.
Evidence Level:
Sensitive: B - Late Trials

[HRD-Ovarian Cancer-bevacizumab + olaparib]

Title:
Progression-free survival (PFS) and second PFS (PFS2) by disease stage in patients (pts) with homologous recombination deficiency (HRD)-positive newly diagnosed advanced ovarian cancer receiving bevacizumab (bev) with olaparib/placebo maintenance in the phase III PAOLA-1/ENGOT-ov25 trial.
Published date:
05/28/2021
Excerpt:
Median follow-up for PFS and PFS2 was respectively 24.8 and 37.2 mo in HRD+ stage III pts and 24.0 and 37.0 mo in HRD+ stage IV pts…. In the PAOLA-1 study, maintenance olaparib + bev provided a PFS and PFS2 benefit over pbo + bev in HRD+ pts…
DOI:
10.1200/JCO.2021.39.15_suppl.5514
Trial ID:
Evidence Level:
Sensitive: B - Late Trials

[BRCA2 mutation-Ovarian Cancer-bevacizumab + olaparib]

Source:
Title:
Progression-free survival (PFS) and second PFS (PFS2) by disease stage in patients (pts) with homologous recombination deficiency (HRD)-positive newly diagnosed advanced ovarian cancer receiving bevacizumab (bev) with olaparib/placebo maintenance in the phase III PAOLA-1/ENGOT-ov25 trial.
Published date:
05/19/2021
Excerpt:
...Among HRD+ stage III pts, 36-mo PFS2 (olaparib + bev vs pbo + bev) was 74% vs 60%; among HRD+ stage IV pts, 53% vs 30%. Among HRD+ stage III pts with no residual disease after upfront surgery, HR (95% CI) for PFS was 0.15 (0.07–0.30) and for PFS2 was 0.22 (0.06–0.67). Among HRD+ stage III pts with residual disease after upfront surgery or who received neoadjuvant chemotherapy, or HRD+ stage IV pts, HR (95% CI) for PFS was 0.38 (0.27–0.53) and PFS2 was 0.68 (0.46–1.03).In the PAOLA-1 study, maintenance olaparib + bev provided a PFS and PFS2 benefit over pbo + bev in HRD+ pts, irrespective of
Trial ID:
Evidence Level:
Sensitive: B - Late Trials

[BRCA1 mutation-Ovarian Cancer-bevacizumab + olaparib]

Source:
Title:
Progression-free survival (PFS) and second PFS (PFS2) by disease stage in patients (pts) with homologous recombination deficiency (HRD)-positive newly diagnosed advanced ovarian cancer receiving bevacizumab (bev) with olaparib/placebo maintenance in the phase III PAOLA-1/ENGOT-ov25 trial.
Published date:
05/19/2021
Excerpt:
...Among HRD+ stage III pts, 36-mo PFS2 (olaparib + bev vs pbo + bev) was 74% vs 60%; among HRD+ stage IV pts, 53% vs 30%. Among HRD+ stage III pts with no residual disease after upfront surgery, HR (95% CI) for PFS was 0.15 (0.07–0.30) and for PFS2 was 0.22 (0.06–0.67). Among HRD+ stage III pts with residual disease after upfront surgery or who received neoadjuvant chemotherapy, or HRD+ stage IV pts, HR (95% CI) for PFS was 0.38 (0.27–0.53) and PFS2 was 0.68 (0.46–1.03).In the PAOLA-1 study, maintenance olaparib + bev provided a PFS and PFS2 benefit over pbo + bev in HRD+ pts, irrespective of
Trial ID:
Evidence Level:
Sensitive: B - Late Trials

[BRCA2 mutation-Peritoneal Cancer-bevacizumab + olaparib]

Title:
Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer
Excerpt:
Eligible patients...high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer....median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001)....In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenance olaparib provided a significant progression-free survival benefit, which was substantial in patients with HRD-positive tumors, including those without a BRCA mutation.
DOI:
10.1056/NEJMoa1911361
Trial ID:
Evidence Level:
Sensitive: B - Late Trials

[BRCA2 mutation-Fallopian Tube Cancer-bevacizumab + olaparib]

Title:
Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer
Excerpt:
Eligible patients...high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer....median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001)....In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenance olaparib provided a significant progression-free survival benefit, which was substantial in patients with HRD-positive tumors, including those without a BRCA mutation.
DOI:
10.1056/NEJMoa1911361
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials

[BRCA2 mutation-Ovarian Cancer-olaparib]

Source:
Title:
Maintenance olaparib in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by somatic (s) or germline (g) BRCA and other homologous recombination repair (HRR) gene mutation status: Overall survival (OS) results from the ORZORA study.
Published date:
05/26/2022
Excerpt:
At DCO (June 25, 2021), median OS follow-up in censored pts was 42.6 mo in BRCAm and 39.3 mo in non-BRCA HRRm pts. OS and PFS2 are reported in the Table. PBC was received as a subsequent therapy by 33.1% BRCAm, 32.7% sBRCAm, 33.3% gBRCAm, and 45.5% non-BRCA HRRm pts...In final OS analyses, maintenance olaparib capsules showed consistent clinical activity in BRCAm and sBRCAm PSROC pts...
DOI:
10.1200/JCO.2022.40.16_suppl.5519
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials

[BRCA1 mutation-Ovarian Cancer-olaparib]

Source:
Title:
Maintenance olaparib in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by somatic (s) or germline (g) BRCA and other homologous recombination repair (HRR) gene mutation status: Overall survival (OS) results from the ORZORA study
Published date:
05/26/2022
Excerpt:
At DCO (June 25, 2021), median OS follow-up in censored pts was 42.6 mo in BRCAm and 39.3 mo in non-BRCA HRRm pts. OS and PFS2 are reported in the Table. PBC was received as a subsequent therapy by 33.1% BRCAm, 32.7% sBRCAm, 33.3% gBRCAm, and 45.5% non-BRCA HRRm pts...In final OS analyses, maintenance olaparib capsules showed consistent clinical activity in BRCAm and sBRCAm PSROC pts...
DOI:
10.1200/JCO.2022.40.16_suppl.5519
Trial ID: