Evidence map›Paper›PMID 32861537›Full record

ArticleGynecologic oncology2020

The effect of age on efficacy, safety and patient-centered outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase 3, randomized, maintenance study in patients with recurrent ovarian carcinoma.

Nicoletta Colombo, Amit M Oza, Domenica Lorusso, Carol Aghajanian, Ana Oaknin, Andrew Dean, Johanne I Weberpals, Andrew R Clamp, Giovanni Scambia, Alexandra Leary and 16 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Gynecologic 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 NCT01968213 (A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.1field-weighted citation impact, top 20% 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.

NCT01968213 phase3completednot on this map

A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )

TypeinterventionalSponsorpharmaand GmbHRan2014 to 2022Enrolled564ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal CancerArmsRucaparib, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Ovarian cancer in the older patient: where are we now? What to do next?Therapeutic advances in medical oncology · 2023
    Review
  7. Review
  8. Efficacy and safety of PARP inhibitors in elderly patients with advanced ovarian cancer: a systematic review and meta-analysis.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2022
    Article
  9. PARP Inhibitors: Clinical Limitations and Recent Attempts to Overcome Them.International journal of molecular sciences · 2022
    Review
  10. Targeted Therapies in Older Adults With Solid Tumors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Review
  11. 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

26 authors at 20 institutions in 8 countries.

Nicoletta ColomboGynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology IRCCS, via Ripamonti 435, 20146 Milan, Italy. Electronic address: nicoletta.colombo@ieo.it.
Amit M OzaDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, 610 University Ave, Toronto, ON, Canada.
Domenica LorussoGynecologic Oncology Unit, Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
Carol AghajanianGynecologic Medical Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA.
Ana OakninMedical Oncology Department, Vall d'Hebron Institute of Oncology, C/Natzaret, 115-117, 08035 Barcelona, Spain.
Andrew DeanDepartment of Medical Oncology, St John of God Hospital Subiaco, 12 Salvado Rd, Subiaco, WA 6008, Australia.
Johanne I WeberpalsDivision of Gynecologic Oncology, Ottawa Hospital Research Institute, 501 Smyth Rd, Ottawa, ON K1H 8L6, Canada.
Andrew R ClampDepartment of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester M20 4BX, UK.
Giovanni ScambiaGynecologic Oncology Unit, Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
Alexandra LearyGynecological Unit, Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), 98405 Villejuif, France.
Robert W HollowayGynecologic Oncology, Advent Health Cancer Institute, 601 East Rollins St, Orlando, FL 32803, USA.
Margarita Amenedo GancedoMedical Oncology Department, Oncology Center of Galicia, Rúa Doctor Camilo Veiras, 1, 15009 La Coruña, Spain.
Peter C FongMedical Oncology Department, Auckland City Hospital, Grafton, 2 Park Road, Grafton, Auckland 1023, New Zealand.
Jeffrey C GohDepartment of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, and University of Queensland, Cnr Butterfield St and Bowen Bridge Rd, Herston, QLD 4029, Australia.
David M O'MalleyGynecologic Oncology, James Cancer Center, The Ohio State University, Starling-Loving Hall, 320 West 10th Ave, Columbus, OH 43210, USA.
Deborah K ArmstrongGynecology and Obstetrics, Johns Hopkins University Medical Center, 601 N Caroline St, Baltimore, MD 21287, USA.
Susana BanerjeeGynaecology Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK.
Jesus García-DonasDivision of Medical Oncology, HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Calle Oña 10, 28050 Sanchinarro, Madrid, Spain.
Elizabeth M SwisherDivision of Gynecologic Oncology, University of Washington, 1959 NE Pacific Street, Box 356460, Seattle, WA 98195, USA.
Juliette MeunierModus Outcomes, 61 Cours de la Liberte, 69003 Lyon, France.
Terri CameronClinical Science, Clovis Oncology UK Ltd., Granta Centre, Granta Park, Great Abington, Cambridge CB21 6GP, UK.
Lara MaloneyClinical Development, Clovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO 80301, USA.
Sandra GobleBiostatistics, Clovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO 80301, USA.
Josh BedelPricing & Market Access - Europe, Clovis Oncology Switzerland GmBH, Seefeldstrasse 69, 8008 Zurich, Switzerland.
Jonathan A LedermannDepartment of Oncology, UCL Cancer Institute, University College London and UCL Hospitals, 72 Huntley St, London WC1E 6DD, UK.
Robert L ColemanDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.
Clovis Oncology (United States) · USAgostino Gemelli University Polyclinic · ITAuckland City Hospital · NZCentro Oncológico de Galicia · ESClovis Oncology (United Kingdom) · GBCRUK Lung Cancer Centre of Excellence · GBEuropean Institute of Oncology · ITFlorida Hospital Cancer Institute · USHospital Universitario HM Sanchinarro · ESInstitut Gustave Roussy · FRIstituti di Ricovero e Cura a Carattere Scientifico · ITJohns Hopkins University · USMemorial Sloan Kettering Cancer Center · USOttawa Hospital · CAPrincess Margaret Cancer Centre · CARoyal Brisbane and Women's Hospital · AURoyal Marsden NHS Foundation Trust · GBSt John of God Subiaco Hospital · AUThe Christie NHS Foundation Trust · GBThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · US

Funding

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

Abstract

backgroundIn the phase 3 trial ARIEL3, maintenance treatment with the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib provided clinical benefit versus placebo for patients with recurrent, platinum-sensitive ovarian cancer. Here, we evaluate the impact of age on the clinical utility of rucaparib in ARIEL3.

methodsPatients with platinum-sensitive, recurrent ovarian carcinoma with ≥2 prior platinum-based chemotherapies who responded to their last platinum-based therapy were enrolled in ARIEL3 and randomized 2:1 to rucaparib 600 mg twice daily or placebo. Exploratory, post hoc analyses of progression-free survival (PFS), patient-centered outcomes (quality-adjusted PFS [QA-PFS] and quality-adjusted time without symptoms or toxicity [Q-TWiST]), and safety were conducted in three age subgroups (<65 years, 65-74 years, and ≥75 years).

resultsInvestigator-assessed PFS was significantly longer with rucaparib than placebo in patients aged <65 years (rucaparib n = 237 vs placebo n = 117; median, 11.1 vs 5.4 months; hazard ratio [HR]: 0.33 [95% confidence interval (95% CI) 0.25-0.43]; P < 0.0001) and 65-74 years (n = 113 vs n = 64; median, 8.3 vs 5.3 months; HR 0.43 [95% CI 0.29-0.63]; P < 0.0001) and numerically longer in patients aged ≥75 years (n = 25 vs n = 8; median, 9.2 vs 5.5 months; HR 0.47 [95% CI 0.16-1.35]; P = 0.1593). QA-PFS and Q-TWiST were significantly longer with rucaparib than placebo across all age subgroups. Safety of rucaparib was generally similar across the age subgroups.

conclusionsEfficacy, patient-centered outcomes, and safety of rucaparib were similar between age subgroups, indicating that all eligible women with recurrent ovarian cancer should be offered this therapeutic option, irrespective of age. https://clinicaltrials.gov/ct2/show/NCT01968213.

Indexed as

Quality-Adjusted Life YearsQuality of LifeAdultAgedAged, 80 and overAge FactorsFemaleHumansIndolesMaintenance ChemotherapyMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPlacebosProgression-Free SurvivalResponse Evaluation Criteria in Solid TumorsIndolesPlacebosrucaparibElderly patientsMaintenanceOvarian cancerPARP inhibitorRucaparib

Identifiers

PMID32861537
PMCPMC8450972
OpenAlexW3080218538

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.