Evidence map›Paper›PMID 39361946›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Cediranib and Olaparib Combination Compared With Cediranib or Olaparib Alone, or Chemotherapy in Platinum-Resistant or Primary Platinum-Refractory Ovarian Cancer: NRG-GY005.

Jung-Min Lee, Mark F Brady, Austin Miller, Richard G Moore, Helen MacKay, Leah McNally, Jayanthi Lea, Daron Street, Stephanie Lheureux, Megan E McDonald and 14 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Jung-Min LeeWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD.ORCID 0000-0003-1280-5909
Mark F BradyNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Elm & Carlton Streets, Buffalo, NY.ORCID 0000-0001-6700-2981
Austin MillerNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Elm & Carlton Streets, Buffalo, NY.ORCID 0000-0001-9739-8462
Richard G MooreObstetrics and Gynecology, University of Rochester, Rochester, NY.ORCID 0000-0001-5598-5263
Helen MacKayMedical Oncology & Hematology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.ORCID 0000-0001-6220-1789
Leah McNallyGynecologic Oncology, Duke University Medical Center, Duke Cancer Institute, Durham, NC.ORCID 0000-0001-7567-0162
Jayanthi LeaUniversity of Texas Southwestern Medical Center, Dallas, TX.
Daron StreetOklahoma Cancer Specialists and Research Institute, Tulsa, OK.
Stephanie LheureuxPrincess Margaret Cancer Centre, Cancer Clinical Research Unit, Toronto, Ontario, Canada.ORCID 0000-0003-4405-5890
Megan E McDonaldObstetrics and Gynecology, University of Iowa Hospitals and Clinics, Iowa City, IA.
Linda R DuskaUniversity of Virginia Cancer Center, Charlottesville, VA.ORCID 0000-0002-8878-4123
Guilherme CantuariaUniversity Gynecologic Oncology, Northside Hospital, Cumming, GA.ORCID 0000-0003-2458-6950
Juraj KavecanskyKaiser Permanente NCI Community Oncology Research Program, Antioch, CA.
Charles A LeathUniversity of Alabama at Birmingham/Deep South Research Consortium, Birmingham, AL.ORCID 0000-0002-4034-6845
Matthew PowellWashington University-Siteman Cancer, St Louis, MO.ORCID 0000-0002-1968-2772
Mark G CadungogChristiana Care Gynecologic, Newark, DE.
Peter G RoseCleveland Clinic Gynecologic Oncology, Cleveland, OH.ORCID 0000-0003-2676-0166
Yong-Man KimUniversity of Ulsan College of Medicine, ASAN Medical Center, Seoul, South Korea.ORCID 0000-0003-3225-5748
Helen Q HuangNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Elm & Carlton Streets, Buffalo, NY.
Michèle ProvencherCCTG Study Chair, Division of Gynecologic Oncology, Université de Montréal, Montreal, Quebec, Canada.ORCID 0000-0003-1902-3256
Lari B WenzelUniversity of California, Irvine, Irvine, CA.ORCID 0000-0002-3393-0349
Michael A BookmanKaiser Permanente Northern California, San Francisco, CA.ORCID 0000-0002-4255-7814
Elise C KohnGynecologic Cancer Therapeutics, National Cancer Institute, Rockville, MD.
Angeles Alvarez SecordGynecologic Oncology, Duke University Medical Center, Duke Cancer Institute, Durham, NC.ORCID 0000-0003-0946-7662

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
XRAY CRYSTALLOGRAPHYP30CA013148 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Robert S Welner · 1985 to 2026
$165.9M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
University of Buffalo Clinical and Translational Science Institute - Supplement SchulyerUL1TR001412 · NCATS · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI MURPHY, TIMOTHY F · 2015 to 2024
$33.8M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
NCATS NIH HHS UL1 TR001412NCI NIH HHS P30 CA013148NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA233339
6 · The paper itself

Abstract

purposeWe assessed the efficacy of cediranib, olaparib, and cediranib/olaparib compared with standard-of-care chemotherapy (SOC) in platinum-resistant or platinum-refractory epithelial ovarian cancer (PROC). PATIENTS AND

methodsNRG-GY005 is an open-label, four-arm, phase II/III superiority trial enrolling patients with high-grade serous/endometrioid PROC and one to three previous therapies. Key exclusion criteria included previous receipt of poly(ADP-ribose) polymerase inhibitor or receipt of antiangiogenic therapy in the recurrent setting. Treatment arms (SOC [once weekly paclitaxel, topotecan, or pegylated liposomal doxorubicin], cediranib, olaparib, or cediranib/olaparib) were equally randomized. A preplanned interim futility analysis on the basis of progression-free survival (PFS) selected treatment arms to advance to phase III. PFS and overall survival (OS) were phase III coprimary end points, with hierarchical testing of PFS followed by OS to preserve type 1 error control, designed to have 90% power for a 0.625 PFS hazard ratio (HR). OS was tested after PFS in the multiple hierarchical testing procedure. Secondary end points included objective response rate (ORR) and patient-reported outcomes.

resultsFive hundred sixty-two eligible patients were enrolled for phase II/III. Three arms met PFS criteria to carry forward to phase III (SOC, cediranib/olaparib, and cediranib). Median PFS was 3.4, 5.2, and 4 months with SOC, cediranib/olaparib, and cediranib, respectively, with a median follow-up duration of 42.2 months. PFS HR estimates for cediranib/olaparib and cediranib (

conclusionThe cediranib-containing arms demonstrated clinical activity on the basis of PFS but were not superior compared with SOC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialDrug Resistance, NeoplasmOvarian NeoplasmsPhthalazinesPiperazinesQuinazolinesAdultAgedAged, 80 and overFemaleHumansIndolesMiddle AgedPoly(ADP-ribose) Polymerase InhibitorsProgression-Free SurvivalcediranibIndolesolaparibPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsQuinazolines

Identifiers

PMID39361946
PMCPMC11652233

What OpenQuestion holds

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Registered trials

None linked

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.