Evidence map›Paper›PMID 35803835›Full record

Trial reportGynecologic oncology2022

Olaparib treatment for platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency status: Phase II LIGHT study primary analysis.

Karen Cadoo, Fiona Simpkins, Cara Mathews, Ying L Liu, Diane Provencher, Colleen McCormick, Adam C ElNaggar, Alon D Altman, Lucy Gilbert, Destin Black and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gynecologic oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02983799 (Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–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.

NCT02983799 phase2completednot on this map

Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy

TypeinterventionalSponsorAstraZenecaRan2016 to 2020Enrolled272ConditionsRelapsed Ovarian Cancer, BRCA Mutation, Platinum SensitivityArmsOLAPARIB
3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

  1. Trial
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  14. Cellular Responses to Widespread DNA Replication Stress.International journal of molecular sciences · 2023
    Review
  15. Article
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  17. Review
  18. Shedding Light on PARP Inhibitor Response through Functional Imaging.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  19. Chemotherapy-free treatment of recurrent advanced ovarian cancer: myth or reality?International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
    Review
  20. Article
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

14 authors.

Karen CadooMemorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, New York, NY, USA,. Electronic address: kcadoo@stjames.ie.
Fiona SimpkinsDepartment of Obstetrics and Gynecology, Jordan Center for Gynecologic Oncology at the Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
Cara MathewsProgram in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Brown University, Providence, RI, USA.
Ying L LiuMemorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, New York, NY, USA.
Diane ProvencherCHUM Gynecologie-Oncologie, Montreal, QC, Canada.
Colleen McCormickLegacy Medical Group Gynecologic Oncology, Portland, OR, USA.
Adam C ElNaggarWest Cancer Center and Research Institute, Memphis, TN, USA.
Alon D AltmanCancerCare Manitoba, Research Institute of Oncology and Hematology, University of Manitoba, Winnipeg, Manitoba, Canada.
Lucy GilbertDivision of Gynecologic Oncology, McGill University Health Centre, Montreal, Quebec, Canada.
Destin BlackWillis-Knighton Cancer Center, Shreveport, LA, USA.
Nashwa KabilAstraZeneca, Gaithersburg, MD, USA.
James BennettAstraZeneca, Cambridge, UK.
Jiefen MunleyAstraZeneca, Wilmington, DE, USA.
Carol AghajanianMemorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, New York, NY, USA.

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

objectiveOlaparib treatment resulted in significant improvement in objective response rates (ORRs) and progression-free survival (PFS) over non‑platinum chemotherapy in patients with BRCA1/BRCA2-mutated (BRCAm) platinum-sensitive relapsed ovarian cancer (PSROC) and ≥2 prior lines of platinum-based chemotherapy in the phase III SOLO3 study. LIGHT (NCT02983799) prospectively evaluated olaparib treatment for patients with PSROC and known BRCAm and homologous recombination deficiency (HRD) status.

methodsIn this phase II open-label multicenter study, patients with PSROC and ≥1 prior line of platinum-based chemotherapy were assigned to cohorts by presence of germline BRCAm (gBRCAm), somatic BRCAm (sBRCAm), HRD-positive tumors without BRCAm, or HRD-negative tumors. The primary endpoint was investigator-assessed ORR. Secondary endpoints included disease control rate (DCR) and PFS. Tumors were analyzed using Myriad BRACAnalysis CDx and myChoice HRD assays; HRD-positive tumors were defined using a genomic instability score of ≥42.

resultsOf 272 enrolled patients, 271 received olaparib and 270 were included in efficacy analyses. At data cut-off, ORRs in the gBRCAm, sBRCAm, HRD-positive, and HRD-negative cohorts were 69.3%, 64.0%, 29.4%, and 10.1%, respectively. DCRs were 96.0%, 100.0%, 79.4%, and 75.3% in each cohort, respectively. Median PFS was 11.0, 10.8, 7.2, and 5.4 months, respectively. The most common (≥ 20%) treatment-emergent adverse events included nausea, fatigue/asthenia, vomiting, anemia, constipation, diarrhea, and decreased appetite.

conclusionsOlaparib treatment demonstrated activity across all cohorts. The greatest efficacy was observed in the BRCAm cohorts, regardless of gBRCAm/sBRCAm. For patients without a BRCAm, greater efficacy was observed in the HRD-positive than the HRD-negative cohorts. The safety profile was consistent with that established in previous olaparib studies.

Indexed as

Ovarian NeoplasmsBRCA1 ProteinBRCA2 ProteinCarcinoma, Ovarian EpithelialFemaleHomologous RecombinationHumansMutationNeoplasm Recurrence, LocalPhthalazinesPiperazinesBRCA1 ProteinBRCA2 ProteinolaparibPhthalazinesPiperazinesBRCAHomologous recombination deficiencyOlaparibOvarian cancerTreatment

Identifiers

PMID35803835
PMCPMC9909678

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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.