Evidence map›Paper›PMID 36082969›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial.

Paul DiSilvestro, Susana Banerjee, Nicoletta Colombo, Giovanni Scambia, Byoung-Gie Kim, Ana Oaknin, Michael Friedlander, Alla Lisyanskaya, Anne Floquet, Alexandra Leary and 13 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01844986 (A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced), which is not on this map. Cited by 299 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
299citing papers in PubMed, 10 pooled it
42.9field-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.

NCT01844986 phase3active not recruitingnot on this map

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

TypeinterventionalSponsorAstraZenecaRan2013 to 2028Enrolled450ConditionsNewly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV, BRCA MutationArmsOlaparib 300mg tablets
3 · Its place in the literature

Who cites it

299 citing papers in PubMed, 10 syntheses or guidelines pooled it, 447 citations in OpenAlex.

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  9. SEOM-GEICO clinical guideline on epithelial ovarian cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
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  19. Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2024
    Trial
  20. Review

239 more citing papers are in PubMed but not listed here.

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

23 authors at 20 institutions in 10 countries.

Paul DiSilvestroProgram in Women's Oncology, Women & Infants Hospital, Providence, RI.ORCID 0000-0003-2711-6663
Susana BanerjeeThe Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom.ORCID 0000-0002-8840-7934
Nicoletta ColomboUniversity of Milan-Bicocca and Istituto Europeo di Oncologia IRCCS, Milan, Italy.ORCID 0000-0003-2225-715X
Giovanni ScambiaFondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-9503-9041
Byoung-Gie KimSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Ana OakninGynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID 0000-0002-3592-7194
Michael FriedlanderUniversity of New South Wales Clinical School, Prince of Wales Hospital, Randwick, New South Wales, Australia.ORCID 0000-0003-3090-795X
Alla LisyanskayaSt Petersburg City Oncology Dispensary, St Petersburg, Russia.
Anne FloquetInstitut Bergonié, Comprehensive Cancer Center, Bordeaux, France.
Alexandra LearyGroupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Paris, France.ORCID 0000-0002-2043-2244
Gabe S SonkeThe Netherlands Cancer Institute, Amsterdam, the Netherlands.ORCID 0000-0001-8088-9628
Charlie GourleyCancer Research UK Scotland Center, University of Edinburgh, Edinburgh, United Kingdom.ORCID 0000-0002-2377-7221
Amit OzaPrincess Margaret Cancer Center, Toronto, ON, Canada.ORCID 0000-0002-9510-8641
Antonio González-MartínClínica Universidad de Navarra, Madrid, Spain.ORCID 0000-0001-8376-9576
Carol AghajanianMemorial Sloan Kettering Cancer Center, New York, NY.
William BradleyFroedtert and the Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0002-6949-5262
Cara MathewsProgram in Women's Oncology, Women & Infants Hospital, Providence, RI.ORCID 0000-0001-8461-4568
Joyce LiuDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0003-3888-3972
John McNamaraBiostatistics, Oncology Biometrics, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Elizabeth S LoweGlobal Medicines Development, Oncology, AstraZeneca, Gaithersburg, MD.
Mei-Lin Ah-SeeOncology R&D, Late-stage Development, AstraZeneca, Cambridge, United Kingdom.
Kathleen N MooreStephenson Oklahoma Cancer Center, Oklahoma City, OK.ORCID 0000-0002-5803-0718
SOLO1 Investigators
AstraZeneca (United Kingdom) · GBProvidence College · USAgostino Gemelli University Polyclinic · ITAstraZeneca (United States) · USCity Clinical Oncology Center · RUClinica Universidad de Navarra · ESDana-Farber Cancer Institute · USEdinburgh Cancer Research · GBFroedtert Hospital · USInstitut Bergonié · FRInstitut Gustave Roussy · FRMemorial Sloan Kettering Cancer Center · USOklahoma State University Oklahoma City · USPrincess Margaret Cancer Centre · CARoyal Marsden NHS Foundation Trust · GBSamsung Medical Center · KRThe Netherlands Cancer Institute · NLUniversity of Milan · ITUNSW Sydney · AUVall d'Hebron Hospital Universitari · ES

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeIn SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a

methodsThis double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up.

resultsThe median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76;

conclusionResults indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up.

Indexed as

Antineoplastic AgentsOvarian NeoplasmsFemaleFollow-Up StudiesHumansMaintenance ChemotherapyMutationNeoplasm Recurrence, LocalPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsAntineoplastic AgentsolaparibPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase Inhibitors

Identifiers

PMID36082969
PMCPMC9870219
OpenAlexW4295078726

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.