You are here

  • Home
  • Archive
  • Volume 32, Issue Suppl 3
  • O003/#557 Overall survival results from ARIEL3: a phase 3 randomized, double-blind study of rucaparib vs placebo following response to platinum-based chemotherapy for recurrent ovarian carcinoma

Article Text

Article menu

Download PDFPDF

Oral Abstracts (Regular and Late-Breaking Submission)
Plenary 01: Opening ceremony and oral abstract presentations
O003/#557 Overall survival results from ARIEL3: a phase 3 randomized, double-blind study of rucaparib vs placebo following response to platinum-based chemotherapy for recurrent ovarian carcinoma
Free
  1. Robert L Coleman1,
  2. Amit Oza2,
  3. Domenica Lorusso3,
  4. Carol Aghajanian4,
  5. Ana Oaknin5,
  6. Andrew Dean6,
  7. Nicoletta Colombo7,
  8. Johanne Weberpals8,
  9. Andrew Clamp9,
  10. Giovanni Scambia10,
  11. Alexandra Leary11,
  12. Robert Holloway12,
  13. Margarita Amenedo Gancedo13,
  14. Peter Fong14,
  15. Jeffrey Goh15,
  16. David O’Malley16,
  17. Sandra Goble17,
  18. Lara Maloney18 and
  19. Jonathan Ledermann19
  1. 1The University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology and Reproductive Medicine, Houston, USA
  2. 2Princess Margaret Cancer Centre, University Health Network, Division of Medical Oncology and Hematology, Toronto, Canada
  3. 3MITO and Fondazione IRCCS Istituto Nazionale dei Tumori, Gynecologic Oncology Unit, Milan, Italy
  4. 4Memorial Sloan Kettering Cancer Center, Gynecologic Medical Oncology, New York, USA
  5. 5Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Gynaecologic Cancer Programme, Barcelona, Spain
  6. 6St John of God Subiaco Hospital, Department of Oncology, Subiaco, Australia
  7. 7European Institute of Oncology and University of Milan-Bicocca, Gynecologic Cancer Program, Milan, Italy
  8. 8Ottawa Hospital Research Institute, Division of Gynecologic Oncology, Ottawa, Canada
  9. 9The Christie NHS Foundation Trust and University of Manchester, Department of Medical Oncology, Manchester, UK
  10. 10Fondazione Policlinico Universitario A. Gemelli IRCCS and Scientific Directorate, Ginecologia E Ostetricia, Rome, Italy
  11. 11Gustave Roussy Cancer Center, INSERM U981, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO), Gynecological Unit, Villejuif, France
  12. 12Florida Hospital Cancer Institute, Department of Gynecologic Oncology, Orlando, USA
  13. 13Oncology Center of Galicia, La Coruña, Medical Oncology Department, La Coruña, Spain
  14. 14Auckland City Hospital, Medical Oncology Department, Grafton, Auckland, New Zealand
  15. 15Cancer Care Services, Royal Brisbane and Women’s Hospital, Department of Oncology, Herston, QLD, Australia and University of Queensland, St Lucia, Australia
  16. 16The Ohio State University, James Cancer Center, Clinical Research Gynecologic Oncology, Columbus, USA
  17. 17Clovis Oncology, Inc., Biostatistics, Boulder, USA
  18. 18Clovis Oncology, Inc., Clinical Development, Boulder, USA
  19. 19UCL Cancer Institute, University College London and UCL Hospitals, Department of Oncology, London, UK

Abstract

Objectives In ARIEL3 (NCT01968213), rucaparib maintenance treatment significantly improved progression-free survival (PFS) vs placebo. We present updated PFS2 and preplanned final overall survival (OS) analyses.

Methods Patients were randomized to receive rucaparib 600 mg BID or placebo. Efficacy was analyzed across the 3 protocol-defined nested cohorts (BRCA-mutant, homologous recombination deficient [HRD], and intent-to-treat [ITT]). PFS2 was an exploratory endpoint, defined as time from randomization to second event of investigator-assessed disease progression, or death due to any cause. OS was a secondary endpoint with analysis planned after 70% of death events. The data cutoff was April 4, 2022, for efficacy and December 31, 2019, for safety. Patients were followed after treatment discontinuation for incidence of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); MDS/AML are reported as of April 12, 2022.

Results Median follow-up was 77.0 months as of the efficacy data cutoff. In the ITT population, death events had occurred in 410/564 (72.7%) patients. PFS2 and OS are presented in the table 1. Among placebo-arm patients, ≈45% received a PARP inhibitor as a subsequent treatment. Safety was consistent with prior reports; MDS/AML was reported in 14 (3.8%) rucaparib-arm and 6 (3.2%) placebo-arm patients (P=0.72) (reported post-study drug treatment in 8 cases in the rucaparib arm and 6 in the placebo arm).

View this table:
Abstract O003/#557 Table 1

Conclusions These data support the use of rucaparib as a maintenance treatment for recurrent ovarian carcinoma; although no OS benefit was seen, the PFS benefit for rucaparib was maintained through the subsequent line of therapy.

https://doi.org/10.1136/ijgc-2022-igcs.5

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.