Evidence map›Paper›PMID 30753272›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

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.

J F Liu, W T Barry, M Birrer, J-M Lee, R J Buckanovich, G F Fleming, B J Rimel, M K Buss, S R Nattam, J Hurteau and 6 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 106 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 16 pooled it
12.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06255392 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2024 to 2031Enrolled200ConditionsFludzoparib&#34, and Anti-angiogenic, HRD-positive/HER2-negative Advanced Breast CancerArmsFluzoparib, Apatinib Mesylate, Capecitabine tablets, Vinorelbine Tartrate Oral, Eribulin mesylate injection
NCT07371910 phase3active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Randomized, Open-label, Controlled, Multicenter Phase III Study of Fluorizoparib in Combination With Apatinib Versus Investigator's Choice Chemotherapy in Patients With HRD-positive, HER2-negative Advanced Breast Cancer

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2024 to 2031Enrolled200ConditionsMetastatic Breast Cancer, HRD-Positive/HER2-Negative Advanced Breast CancerArmsChemotherapy/ADC Regimen, Fluorizoparib, Apatinib, Physician's Choice Chemotherapy/ADC Regimen
3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 16 syntheses or guidelines pooled it, 187 citations in OpenAlex.

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  11. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
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46 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 11 institutions in 2 countries.

J F LiuDivision of Gynecologic Oncology, Department of Medical Oncology. Electronic address: joyce_liu@dfci.harvard.edu.
W T BarryDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston.
M BirrerDepartment of Medical Oncology, Massachusetts General Hospital, Boston.
J-M LeeWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda.
R J BuckanovichDepartment of Internal Medicine, University of Pittsburgh Hillman Cancer Center, Pittsburgh.
G F FlemingSection of Hematology/Oncology, University of Chicago, Chicago.
B J RimelDepartment of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles.
M K BussDivision of Hematology/Oncology, Beth-Israel Deaconess Medical Center, Boston.
S R NattamDepartment of Oncology, Fort Wayne Medical Oncology and Hematology, Fort Wayne.
J HurteauDivision of Gynecologic Oncology, NorthShore University HealthSystem, Evanston Hospital, Evanston.
W LuoDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston.
J CurtisDivision of Gynecologic Oncology, Department of Medical Oncology.
C WhalenDivision of Gynecologic Oncology, Department of Medical Oncology.
E C KohnWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda; Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, USA.
S P IvyCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, USA.
U A MatulonisDivision of Gynecologic Oncology, Department of Medical Oncology.
Gynecologic Oncology Group · USDana-Farber Cancer Institute · USNational Cancer Institute · USCedars-Sinai Medical Center · USCenter for Cancer Research · USFort Wayne Medical Institute · USHadassah Medical Center · ILMassachusetts General Hospital · USNorthShore University HealthSystem · USUniversity of Chicago · USUPMC Hillman Cancer Center · US

Funding

Targeting DNA damage repair and related pathways in HRD-womens cancersZIABC011525 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI LEE, JUNG-MIN · 2013 to 2025
$14.8M
ARRA NIH HHS
6 · The paper itself

Abstract

backgroundOlaparib is a poly(ADP-ribose) polymerase inhibitor and cediranib is an oral anti-angiogenic. In the primary analysis of this phase II study, combination cediranib/olaparib improved progression-free survival (PFS) compared with olaparib alone in relapsed platinum-sensitive ovarian cancer. This updated analysis was conducted to characterize overall survival (OS) and update PFS outcomes. PATIENTS AND

methodsNinety patients were enrolled to this randomized, open-label, phase II study between October 2011 and June 2013 across nine United States-based academic centers. Data cut-off was 21 December 2016, with a median follow-up of 46 months. Participants had relapsed platinum-sensitive ovarian cancer of high-grade serous or endometrioid histology or had a deleterious germline BRCA1/2 mutation (gBRCAm). Participants were randomized to receive olaparib capsules 400 mg twice daily or cediranib 30 mg daily and olaparib capsules 200 mg twice daily until disease progression.

resultsIn 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). Subset analyses within stratum defined by BRCA status demonstrated statistically significant improvement in PFS (23.7 versus 5.7 months, P = 0.002) and OS (37.8 versus 23.0 months, P = 0.047) in gBRCA wild-type/unknown patients, although OS was not statistically different in the overall study population (44.2 versus 33.3 months, hazard ratio 0.64; P = 0.11). PFS and OS appeared similar between the two arms in gBRCAm patients. The most common CTCAE grade 3/4 adverse events with cediranib/olaparib remained fatigue, diarrhea, and hypertension.

conclusionsCombination cediranib/olaparib significantly extends PFS compared with olaparib alone in relapsed platinum-sensitive ovarian cancer. Subset analyses suggest this margin of benefit is driven by PFS prolongation in patients without gBRCAm. OS was also significantly increased by the cediranib/olaparib combination in this subset of patients. Additional studies of this combination are ongoing and should incorporate analyses based upon BRCA status.

trial registrationClinicaltrials.gov Identifier NCT0111648.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBRCA1 ProteinBRCA2 ProteinDiarrheaDrug Administration ScheduleDrug Resistance, NeoplasmFatigueFemaleFollow-Up StudiesGerm-Line MutationHumansHypertensionIndolesKaplan-Meier EstimateNeoplasm Recurrence, LocalOvarian NeoplasmsBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humancediranibIndolesolaparibPhthalazinesPiperazinesPlatinum CompoundsQuinazolinesantiangiogenic therapiescombination targeted therapiesovarian cancerPARP inhibitors

Identifiers

PMID30753272
PMCPMC6503628
OpenAlexW2913578326

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.