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Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO)

Primary Purpose

Germline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the Pancreas

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olaparib
Olaparib
Placebo
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Germline BRCA1/2 Mutations and focused on measuring BRCA, metastatic adenocarcinoma pancreas, maintenance olaparib monotherapy, first line platinum chemotherapy, pancreatic cancer, PARP inhibitor

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria

  • Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment
  • Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in this study.
  • Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious
  • Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16 weeks of continuous platinum treatment and have no evidence of progression based on investigator's opinion.
  • Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and initiation of the platinum-based chemotherapy for metastatic pancreas cancer.

Major Exclusion Criteria:

  • gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg, "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favour polymorphism" or "benign polymorphism" etc.)
  • Progression of tumour between start of first line platinum based chemotherapy for metastatic pancreas cancer and randomisation.

  • Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle

    1 Day 1 is not permitted.

  • Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
  • Any previous treatment with a PARP inhibitor, including Olaparib

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olaparib

Placebo

Arm Description

Olaparib tablets po. 300 mg twice daily

Placebo tablets twice daily

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.

Secondary Outcome Measures

Overall Survival (OS)
To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.
Time From Randomisation to Second Progression (PFS2)
To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.
Time From Randomisation to Second Subsequent Therapy or Death (TSST)
To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.
Time From Randomisation to First Subsequent Therapy or Death (TFST)
To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.
Time From Randomisation to Study Treatment Discontinuation or Death (TDT)
To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.
Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1
To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.
Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1
Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.
Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100. A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful. bd twice daily.
Number of Participants With Adverse Events (AEs)
To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events

Full Information

First Posted
June 6, 2014
Last Updated
August 18, 2023
Sponsor
AstraZeneca
Collaborators
Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02184195
Brief Title
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Acronym
POLO
Official Title
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2014 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
Detailed Description
Approximately 145 patients will be randomised using an Interactive Voice Response System /Interactive Web Response System (IVR/IWR system) in a 3:2 ratio (Olaparib:placebo) to the treatments as specified below: Olaparib tablets p.o. 300 mg twice daily Matching placebo tablets p.o. twice daily Eligible patients will be those patients with pancreas cancer previously treated for metastatic disease who have not progressed following completion of at least 16 weeks (can be more) of first line platinum-based chemotherapy. All patients must have a known deleterious or suspected deleterious germline BRCA mutation to be randomised; this may have been determined prior to enrolment into the study or may be assessed as part of the enrolment procedure for the study (via centrally provided MyriadIntegrated BRAC. Patients will be randomised within 6 weeks after their last dose of chemotherapy (last dose is the day of the last infusion) and treatment started as soon as possible but no less than 4 and no more than 8 weeks of the last chemotherapy dose. At the time of starting protocol treatment, all previous chemotherapy treatment should be discontinued. Following randomisation, patients will attend clinic visits weekly for the first 4 weeks of treatment (Days 8, 15, 22 and 29). Patients will then attend clinic visits every 4 weeks whilst on study treatment. Patients should continue to receive study treatment until objective radiological disease progression as per RECIST as assessed by the investigator and as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria. Once a patient has progressed the patient will be followed for second progression (PFS2) every 8 weeks and then survival until the final analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Germline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the Pancreas
Keywords
BRCA, metastatic adenocarcinoma pancreas, maintenance olaparib monotherapy, first line platinum chemotherapy, pancreatic cancer, PARP inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olaparib
Arm Type
Experimental
Arm Description
Olaparib tablets po. 300 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets twice daily
Intervention Type
Drug
Intervention Name(s)
Olaparib
Intervention Description
Tablet -100mg
Intervention Type
Drug
Intervention Name(s)
Olaparib
Intervention Description
Tablet-150mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Match Olaparib 100mg placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Match Olaparib 150mg placebo
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
Description
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.
Time Frame
Upto 4 years
Title
Time From Randomisation to Second Progression (PFS2)
Description
To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.
Time Frame
Up to 4 years
Title
Time From Randomisation to Second Subsequent Therapy or Death (TSST)
Description
To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.
Time Frame
Up to 4 years
Title
Time From Randomisation to First Subsequent Therapy or Death (TFST)
Description
To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.
Time Frame
Up to 4 years
Title
Time From Randomisation to Study Treatment Discontinuation or Death (TDT)
Description
To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.
Time Frame
Up to 4 years
Title
Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1
Description
To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.
Time Frame
Up to 4 years
Title
Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1
Description
Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.
Time Frame
At 16 weeks
Title
Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
Description
To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100. A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful. bd twice daily.
Time Frame
From baseline up to 6 months
Title
Number of Participants With Adverse Events (AEs)
Description
To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in this study. Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16 weeks of continuous platinum treatment and have no evidence of progression based on investigator's opinion. Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and initiation of the platinum-based chemotherapy for metastatic pancreas cancer. Major Exclusion Criteria: gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg, "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favour polymorphism" or "benign polymorphism" etc.) Progression of tumour between start of first line platinum based chemotherapy for metastatic pancreas cancer and randomisation. Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation Any previous treatment with a PARP inhibitor, including Olaparib
Facility Information:
Facility Name
Research Site
City
Gilbert
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Arizona
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85234
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United States
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Orange
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California
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92868
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United States
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Stanford
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California
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94305-5720
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United States
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Aurora
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Colorado
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80045
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United States
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New Haven
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Connecticut
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06510
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United States
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Boca Raton
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Florida
ZIP/Postal Code
33486
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United States
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Miami
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Florida
ZIP/Postal Code
33136
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United States
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Chicago
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Illinois
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60637
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United States
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Baltimore
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Maryland
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21287
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United States
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Boston
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Massachusetts
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02215
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United States
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Saint Louis
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Missouri
ZIP/Postal Code
63110
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United States
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Commack
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New York
ZIP/Postal Code
11725
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United States
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Research Site
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New York
State/Province
New York
ZIP/Postal Code
10016
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United States
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New York
State/Province
New York
ZIP/Postal Code
10022
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United States
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Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
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United States
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Research Site
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New York
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New York
ZIP/Postal Code
10065
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United States
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Columbus
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Ohio
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43210
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United States
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Philadelphia
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Pennsylvania
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19111
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United States
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Houston
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Texas
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77030
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United States
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Seattle
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Washington
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98104
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United States
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Campbelltown
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2560
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Australia
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Randwick
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2031
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Australia
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St Leonards
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2065
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Australia
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Antwerpen
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2020
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Belgium
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Brussel
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1070
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Belgium
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Leuven
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3000
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Belgium
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London
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Ontario
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N6A 4L6
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Canada
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Montreal
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Quebec
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H3T 1E2
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Canada
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Sherbrooke
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Quebec
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J1G 2E8
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Canada
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Toronto
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M5G 2M9
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Canada
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Amiens
ZIP/Postal Code
80054
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France
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City
Besançon
ZIP/Postal Code
25000
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France
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Bordeaux
ZIP/Postal Code
33075
Country
France
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Brest Cedex
ZIP/Postal Code
29609
Country
France
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Research Site
City
Clichy Cedex
ZIP/Postal Code
92118
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France
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La Roche sur Yon
ZIP/Postal Code
85925
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France
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Lille
ZIP/Postal Code
59020
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France
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Lyon Cedex 03
ZIP/Postal Code
69437
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France
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Nice
ZIP/Postal Code
06189
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France
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Paris CEDEX 14
ZIP/Postal Code
75674
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France
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Paris
ZIP/Postal Code
75014
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France
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Research Site
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Poitiers
ZIP/Postal Code
86021
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France
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STRASBOURG Cedex
ZIP/Postal Code
67065
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France
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Toulouse
ZIP/Postal Code
31059
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France
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Research Site
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Villejuif
ZIP/Postal Code
94800
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France
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Berlin
ZIP/Postal Code
10967
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Germany
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Berlin
ZIP/Postal Code
D-13353
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Germany
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Research Site
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Bochum
ZIP/Postal Code
44791
Country
Germany
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Research Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
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Research Site
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Dresden
ZIP/Postal Code
01307
Country
Germany
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Research Site
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Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
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Research Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
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Leipzig
ZIP/Postal Code
04103
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Germany
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Research Site
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München
ZIP/Postal Code
81675
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Germany
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Research Site
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Schweinfurt
ZIP/Postal Code
97422
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Germany
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Ulm
ZIP/Postal Code
89081
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Germany
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Beer Sheva
ZIP/Postal Code
84101
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Israel
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Haifa
ZIP/Postal Code
3109601
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Israel
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Holon
ZIP/Postal Code
58100
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Israel
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Nahariya
ZIP/Postal Code
22100
Country
Israel
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Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
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Research Site
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
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City
Rehovot
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76100
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Israel
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Research Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
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Research Site
City
Zefir
ZIP/Postal Code
7030000
Country
Israel
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Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
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Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
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Research Site
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Parma
ZIP/Postal Code
43126
Country
Italy
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Research Site
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Research Site
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
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Research Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
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Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
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Research Site
City
Seoul
ZIP/Postal Code
03080
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Korea, Republic of
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Research Site
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
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Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
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Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
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Research Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
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Research Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
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Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
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Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
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Research Site
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
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City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
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Research Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
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Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
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Research Site
City
Edinburgh
ZIP/Postal Code
EH4 2XR
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L69 3GA
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
WC1E 6AG
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Research Site
City
Surrey
ZIP/Postal Code
SM1 2DL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
31157963
Citation
Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2.
Results Reference
background
PubMed Identifier
35596182
Citation
Amin S, Joo S, Nolte S, Yoo HK, Patel N, Byrnes HF, Costa-Cabral S, Johnson CD. Health-related quality of life scores of metastatic pancreatic cancer patients responsive to first line chemotherapy compared to newly derived EORTC QLQ-C30 reference values. BMC Cancer. 2022 May 20;22(1):563. doi: 10.1186/s12885-022-09661-7.
Results Reference
derived
PubMed Identifier
33959007
Citation
Li N, Zheng H, Huang Y, Zheng B, Cai H, Liu M. Cost-Effectiveness Analysis of Olaparib Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer. Front Pharmacol. 2021 Apr 20;12:632818. doi: 10.3389/fphar.2021.632818. eCollection 2021.
Results Reference
derived
PubMed Identifier
33364840
Citation
Zhan M, Zheng H, Yang Y, He Z, Xu T, Li Q. Cost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/2 Mutation Based on the POLO Trial. Cancer Manag Res. 2020 Dec 16;12:12919-12926. doi: 10.2147/CMAR.S283169. eCollection 2020.
Results Reference
derived
PubMed Identifier
32073954
Citation
Golan T, Kindler HL, Park JO, Reni M, Macarulla T, Hammel P, Van Cutsem E, Arnold D, Hochhauser D, McGuinness D, Locker GY, Goranova T, Schatz P, Liu YZ, Hall MJ. Geographic and Ethnic Heterogeneity of Germline BRCA1 or BRCA2 Mutation Prevalence Among Patients With Metastatic Pancreatic Cancer Screened for Entry Into the POLO Trial. J Clin Oncol. 2020 May 1;38(13):1442-1454. doi: 10.1200/JCO.19.01890. Epub 2020 Feb 19.
Results Reference
derived
PubMed Identifier
31562758
Citation
Hammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Joo S, Yoo HK, Patel N, Golan T; POLO Investigators. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959-1968. doi: 10.1093/annonc/mdz406.
Results Reference
derived
PubMed Identifier
29223478
Citation
Lowery MA, Kelsen DP, Capanu M, Smith SC, Lee JW, Stadler ZK, Moore MJ, Kindler HL, Golan T, Segal A, Maynard H, Hollywood E, Moynahan M, Salo-Mullen EE, Do RKG, Chen AP, Yu KH, Tang LH, O'Reilly EM. Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma. Eur J Cancer. 2018 Jan;89:19-26. doi: 10.1016/j.ejca.2017.11.004. Epub 2017 Dec 8.
Results Reference
derived
Links:
URL
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Description
Related Info
URL
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Redacted_SAP
URL
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Description
Related Info

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Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

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