Evidence map›Paper›PMID 34030643›Full record

Trial reportBMC cancer2021

Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS).

P Grivas, Y Loriot, R Morales-Barrera, M Y Teo, Y Zakharia, S Feyerabend, N J Vogelzang, E Grande, N Adra, A Alva and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03397394 (A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
10.0field-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.

NCT03397394 phase2terminatednot on this map

A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

TypeinterventionalSponsorpharmaand GmbHRan2018 to 2020Enrolled97ConditionsBladder Cancer, Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Renal Pelvis CarcinomaArmsRucaparib
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Treatment Efficacy and Molecular Dynamics of Neoadjuvant Durvalumab and Olaparib in Resectable Urothelial Bladder Cancer: The NEODURVARIB Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. PARP Inhibitors in Genitourinary Cancer: A New Paradigm Beyond Prostate Cancer.International journal of urology : official journal of the Japanese Urological Association · 2025
    Review
  11. Article
  12. Review
  13. Article
  14. Similar genetic profile in early and late stage urothelial tract cancer.Journal of cancer research and clinical oncology · 2024
    Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Landscape of targeted therapies for advanced urothelial carcinoma.Exploration of targeted anti-tumor therapy · 2024
    Review
  20. Review
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

22 authors at 15 institutions in 6 countries.

P GrivasDepartment of Medicine, Division of Medical Oncology, University of Washington, Seattle, WA, 98109, USA. pgivas@uw.edu.ORCID https://orcid.org/0000-0003-3965-3394
Y LoriotDepartment of Medicine, Gustave Roussy Cancer Campus, INSERM U981, Université Paris-Saclay, 39 Rue Camille Desmoulins, 94800, Villejuif, France.
R Morales-BarreraPasseig Vall d'Hebron 119-129, 08035, Barcelona, Spain.
M Y TeoDepartment of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Y ZakhariaDivision of Hematology, Oncology, and Blood and Marrow Transplant, University of Iowa and Holden Comprehensive Cancer Center, 200 Hawkins Drive, Iowa City, IA, 52242, USA.
S FeyerabendStudienpraxis Urologie, Steinengrabenstraße 17, 72622, Nürtingen, Germany.
N J VogelzangDivision of Hematology/Oncology, Comprehensive Cancer Centers of Nevada, 3730 S Eastern Avenue, Las Vegas, NV, 89169, USA.
E GrandeDepartment of Medical Oncology, MD Anderson Cancer Center, Calle de Arturo Soria, 270 28033, Madrid, Spain.
N AdraDepartment of Medicine, Indiana University Simon Cancer Center, 535 Barnhill Drive, Indianapolis, IN, 46202, USA.
A AlvaDepartment of Internal Medicine, University of Michigan Comprehensive Cancer Center, 1500 E Medical Center Drive, Ann Arbor, MI, 48109, USA.
A NecchiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Giacomo Venezian, 1, 20133, Milan, Italy.
A Rodriguez-VidaMedical Oncology Department, Hospital del Mar, Passeig Maritim 25-29, 08003, Barcelona, Spain.
S GuptaDivision of Medical Oncology, Huntsman Cancer Institute, University of Utah, 1950 Circle of Hope, Salt Lake City, UT, 84112, USA.
D H JosephsDepartment of Medical Oncology, Guy's and St. Thomas' NHS Foundation Trust, Great Maze Pond, London, SE1 9RT, UK.
S SrinivasDivision of Medical Oncology, Stanford University School of Medicine, 875 Blake Wilbur Drive, Stanford, CA, 94305, USA.
K WrideClovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO, 80301, USA.
D ThomasClovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO, 80301, USA.
A SimmonsClovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO, 80301, USA.
A LoehrClovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO, 80301, USA.
R L DusekClovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO, 80301, USA.
D NepertClovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO, 80301, USA.
S ChowdhuryDepartment of Medical Oncology, Guy's and St. Thomas' NHS Foundation Trust & Sarah Cannon Research Institute, Great Maze Pond, London, SE1 9RT, UK.
Clovis Oncology (United States) · USCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZAComprehensive Cancer Centers of Nevada · USFondazione IRCCS Istituto Nazionale dei Tumori · ITGuy's and St Thomas' NHS Foundation Trust · GBHospital Del Mar · ESIndiana University Health · USInserm · FRMD Anderson Cancer Center Madrid · ESMemorial Sloan Kettering Cancer Center · USSarah Cannon Research Institute · GBStanford University · USUniversity of Iowa · USUniversity of Michigan · USUniversity of Utah · US

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

backgroundATLAS evaluated the efficacy and safety of the PARP inhibitor rucaparib in patients with previously treated locally advanced/unresectable or metastatic urothelial carcinoma (UC).

methodsPatients with UC were enrolled independent of tumor homologous recombination deficiency (HRD) status and received rucaparib 600 mg BID. The primary endpoint was investigator-assessed objective response rate (RECIST v1.1) in the intent-to-treat and HRD-positive (loss of genome-wide heterozygosity ≥10%) populations. Key secondary endpoints were progression-free survival (PFS) and safety. Disease control rate (DCR) was defined post-hoc as the proportion of patients with a confirmed complete or partial response (PR), or stable disease lasting ≥16 weeks.

resultsOf 97 enrolled patients, 20 (20.6%) were HRD-positive, 30 (30.9%) HRD-negative, and 47 (48.5%) HRD-indeterminate. Among 95 evaluable patients, there were no confirmed responses. However, reductions in the sum of target lesions were observed, including 6 (6.3%) patients with unconfirmed PR. DCR was 11.6%; median PFS was 1.8 months (95% CI, 1.6-1.9). No relationship was observed between HRD status and efficacy endpoints. Median treatment duration was 1.8 months (range, 0.1-10.1). Most frequent any-grade treatment-emergent adverse events were asthenia/fatigue (57.7%), nausea (42.3%), and anemia (36.1%). Of 64 patients with data from tumor tissue samples, 10 (15.6%) had a deleterious alteration in a DNA damage repair pathway gene, including four with a deleterious BRCA1 or BRCA2 alteration.

conclusionsRucaparib did not show significant activity in unselected patients with advanced UC regardless of HRD status. The safety profile was consistent with that observed in patients with ovarian or prostate cancer.

trial registrationThis trial was registered in ClinicalTrials.gov (NCT03397394). Date of registration: 12 January 2018. This trial was registered in EudraCT (2017-004166-10).

Indexed as

Administration, OralAgedBRCA1 ProteinBRCA2 ProteinCarcinoma, Transitional CellDNA RepairFemaleFollow-Up StudiesHumansIndolesLoss of HeterozygosityMaleMiddle AgedPoly(ADP-ribose) Polymerase InhibitorsProgression-Free SurvivalResponse Evaluation Criteria in Solid TumorsBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanIndolesPoly(ADP-ribose) Polymerase InhibitorsrucaparibBladder cancerGenomic biomarkersPARP inhibitorRucaparibUrothelial carcinoma

Identifiers

PMID34030643
PMCPMC8147008
OpenAlexW3164048465

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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.