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2 Exploratory analysis of postprogression and patient-centered outcomes in ariel3: a phase 3, randomized, placebo-controlled study of rucaparib maintenance treatment in patients with recurrent ovarian carcinoma
  1. R Coleman1,
  2. AM Oza2,
  3. D Lorusso3,
  4. C Aghajanian4,
  5. A Oaknin5,
  6. A Dean6,
  7. N Colombo7,
  8. JI Weberpals8,
  9. AR Clamp9,
  10. G Scambia3,
  11. A Leary10,
  12. RW Holloway11,
  13. M Amenedo Gancedo12,
  14. PC Fong13,
  15. JC Goh14,
  16. DM O’Malley15,
  17. S Goble16,
  18. T Cameron17,
  19. J Bedel18 and
  20. JA Ledermann19
  1. 1The University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology and Reproductive Medicine, Houston- TX, USA
  2. 2Princess Margaret Cancer Centre- University Health Network, Division of Medical Oncology and Hematology, Toronto- ON, Canada
  3. 3Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology Unit, Rome, Italy
  4. 4Memorial Sloan Kettering Cancer Center, Gynecologic Medical Oncology, New York- NY, USA
  5. 5Vall d’Hebron Institute of Oncology VHIO, Medical Oncology Department, Barcelona, Spain
  6. 6St John of God Subiaco Hospital, Department of Oncology, Subiaco- WA, 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- ON, Canada
  9. 9The Christie NHS Foundation Trust and University of Manchester, Department of Medical Oncology, Manchester, UK
  10. 10Gustave Roussy Cancer Center- INSERM U981- and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens GINECO, Gynecological Unit, Villejuif, France
  11. 11Florida Hospital Cancer Institute, Department of Gynecologic Oncology, Orlando- FL, USA
  12. 12Oncology Center of Galicia, Medical Oncology Department, La Coruña, Spain
  13. 13Auckland City Hospital, Medical Oncology Department, Grafton- Auckland, New Zealand
  14. 14Royal Brisbane and Women’s Hospital and University of Queensland, Department of Oncology- Cancer Care Services, Herston and St Lucia- QLD, Australia
  15. 15The Ohio State University- James Cancer Center, Clinical Research Gynecologic Oncology, Columbus- OH, USA
  16. 16Clovis Oncology- Inc., Biostatistics, Boulder- CO, USA
  17. 17Clovis Oncology UK Ltd., Clinical Science, Cambridge, UK
  18. 18Clovis Oncology Switzerland GmBH, Pricing and Market Access – Europe, Zurich, Switzerland
  19. 19UCL Cancer Institute- University College London and UCL Hospitals, Department of Oncology, London, UK


Objectives In ARIEL3, rucaparib maintenance treatment significantly improved progression-free survival (PFS) vs placebo. A prespecified exploratory analysis investigated postprogression outcomes. Additionally, a post hoc exploratory analysis investigated patient-centered outcomes during rucaparib maintenance treatment.

Methods Patients were randomized 2:1 to receive oral rucaparib (600 mg BID) or placebo. Postprogression endpoints included time to start of first subsequent therapy (TFST), time to second investigator-assessed PFS or death (PFS2), and time to start of second subsequent therapy (TSST); overall survival data are not yet mature. Patient-centered outcomes included quality-adjusted investigator-assessed PFS (QA-PFS) and quality-adjusted progression-free time without symptoms or toxicity (Q-TWiST). Analyses are presented for the predefined BRCA-mutant cohort and the intent-to-treat (ITT) population.

Results The visit cutoff dates for efficacy and safety were April 15, 2017, and December 31, 2017, respectively. Postprogression and patient-centered outcome data are given in the table 1. The most common treatment-emergent adverse events (TEAEs) of any grade (rucaparib vs placebo) were nausea (75.8% vs 36.5%), asthenia/fatigue (70.7% vs 44.4%), dysgeusia (39.8% vs 6.9%), and anemia/decreased hemoglobin (39.0% vs 5.3%). Any grade TEAEs of nausea, asthenia/fatigue, and anemia/decreased hemoglobin led to discontinuation in only 2.7%, 1.6%, and 2.7% of rucaparib-treated patients.

Abstract 2 Table 1

Conclusions Rucaparib significantly improved clinically meaningful postprogression outcomes vs placebo in the BRCA-mutant cohort and ITT population. The quality-adjusted analyses, which incorporated patient-centered perspectives during rucaparib maintenance treatment, confirmed the benefit of rucaparib vs placebo. The updated safety profile of rucaparib in ARIEL3 was consistent with prior reports.

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