Evidence map›Paper›PMID 32073956›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial.

Richard T Penson, Ricardo Villalobos Valencia, David Cibula, Nicoletta Colombo, Charles A Leath, Mariusz Bidziński, Jae-Weon Kim, Joo Hyun Nam, Radoslaw Madry, Carlos Hernández and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00628251 (A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy), which is not on this map. Cited by 159 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
159citing papers in PubMed, 19 pooled it
17.8field-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.

NCT00628251 phase2completednot on this map

A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy

TypeinterventionalSponsorAstraZenecaRan2008 to 2018Enrolled97ConditionsOvarian NeoplasmsArmsAZD2281, Liposomal Doxorubicin
3 · Its place in the literature

Who cites it

159 citing papers in PubMed, 19 syntheses or guidelines pooled it, 289 citations in OpenAlex.

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  19. PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Guideline
  20. Trial

99 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 12 institutions in 7 countries.

Richard T PensonHarvard Medical School and Massachusetts General Hospital, Boston, MA.
Ricardo Villalobos ValenciaCentro Medico Dalinde, Mexico City, Mexico.
David CibulaFirst Faculty of Medicine, Charles University and General University, Prague, Czech Republic.
Nicoletta ColomboUniversity of Milan-Bicocca and IEO European Institute of Oncology IRCCS, Milan, Italy.
Charles A LeathUniversity of Alabama, Birmingham, AL.
Mariusz BidzińskiFaculty of Medicine and Health Sciences, Jan Kochanowski University, Kielce, Poland.
Jae-Weon KimSeoul National University Hospital, Seoul, South Korea.
Joo Hyun NamAsan Medical Center, Seoul, South Korea.
Radoslaw MadryMedical University K. Marcinkowski and Clinical Hospital of the Transfiguration, Poznań, Poland.
Carlos HernándezOaxaca Site Management Organization, Oaxaca de Juarez, Mexico.
Paulo A R MoraInstituto COI de Educação e Pesquisa, Rio de Janeiro, Brazil.
Sang Young RyuKorea Institute of Radiological and Medical Sciences, Seoul, South Korea.
Tsveta MilenkovaAstraZeneca, Cambridge, United Kingdom.
Elizabeth S LoweAstraZeneca, Gaithersburg, MD.
Laura BarkerAstraZeneca, Cambridge, United Kingdom.
Giovanni ScambiaUniversità Cattolica del Sacro Cuore-Fondazione Policlinico A. Gemelli, IRCCS, Rome, Italy.
AstraZeneca (United Kingdom) · GBAsan Medical Center · KRAstraZeneca (Japan) · JPCharles University · CZEuropean Institute of Oncology · ITHarvard University · USIstituti di Ricovero e Cura a Carattere Scientifico · ITJan Kochanowski University · PLKorea Institute of Radiological and Medical Sciences · KRSeoul National University Hospital · KRUniversity Hospital of Lord’s Transfiguration · PLUniversity of Alabama at Birmingham · US

Funding

XRAY CRYSTALLOGRAPHYP30CA013148 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Robert S Welner · 1985 to 2026
$165.9M
NCI NIH HHS P30 CA013148
6 · The paper itself

Abstract

purposeA phase II study (ClinicalTrials.gov identifier: NCT00628251) showed activity of olaparib capsules versus pegylated liposomal doxorubicin in patients with germline BRCA-mutated platinum-resistant or partially platinum-sensitive relapsed ovarian cancer. We conducted a phase III trial (SOLO3) of olaparib tablets versus nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy. PATIENTS AND

methodsIn this randomized, open-label trial, patients were randomly assigned 2:1 to olaparib 300 mg twice a day or physician's choice single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan). The primary end point was objective response rate (ORR) in the measurable disease analysis set assessed by blinded independent central review (BICR). The key secondary end point was progression-free survival (PFS) assessed by BICR in the intent-to-treat population.

resultsOf 266 randomly assigned patients, 178 were assigned to olaparib and 88 to chemotherapy. In patients with measurable disease (olaparib, n = 151; chemotherapy, n = 72), the BICR-assessed ORR was significantly higher with olaparib than with chemotherapy (72.2%

conclusionOlaparib resulted in statistically significant and clinically relevant improvements in ORR and PFS compared with nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.

Indexed as

Genes, BRCA1Genes, BRCA2Germ-Line MutationAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPhthalazinesPiperazinesPlatinum CompoundsolaparibPhthalazinesPiperazinesPlatinum Compounds

Identifiers

PMID32073956
PMCPMC7145583
OpenAlexW3006801800

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.