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Gynaecological cancers

3057 - Quality of Life in Patients with Recurrent Ovarian Cancer (OC) Treated with Niraparib: Results from the ENGOT-OV16/NOVA Trial


08 Sep 2017


Gynaecological cancers


Cytotoxic Therapy;  Supportive and Palliative Care;  Ovarian Cancer


Amit Oza


Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372


A.M. Oza1, U.A. Matulonis2, S. Malander3, J. Sehouli4, J.M. del Campo5, D. Berthon-Rigaud6, S. Banerjee7, G. Scambia8, J.S. Berek9, B. Lund10, A.V. Tinker11, F. Hilpert12, I. Palacio Vázquez13, V. D’hondt14, B. Benigno15, D.M. Provencher16, J. Buscema17, S. Hudgens18, S. Agarwal19, M.R. Mirza20

Author affiliations

  • 1 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, University Health Network, M5G 1Z5 - Toronto/CA
  • 2 Gynecologic Oncology, Dana-Farber Cancer Institute, 2115 - Boston/US
  • 3 Oncology, The Nordic Society of Gynecological Oncology (NSGO) & Lund University Hospital, Lund/SE
  • 4 Gynecologic Oncology, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) & Charité Berlin, 13353 - Berlin/DE
  • 5 Medical Oncology, Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Vall d'Hebrón University Hospital, Barcelona/ES
  • 6 Gynecologic Oncology, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) & ICO Centre René Gauducheau, Saint-Herblain/FR
  • 7 Gynaecology Unit, The National Cancer Research Institute (NCRI) & The Royal Marsden NHS Foundation Trust, SW3 6JJ - London/GB
  • 8 Gynecologic Oncology, Multicenter Italian Trials in Ovarian cancer/Mario Negri Gynecologic Oncology (MITO/MaNGO) & Università Cattolica del Sacro Cuore, Roma/IT
  • 9 Gynecologic Oncology, Stanford Cancer Institute, Palo Alto/US
  • 10 Gynecologic Oncology, The Nordic Society of Gynecological Oncology (NSGO) & Aalborg University Hospital, Aalborg/DK
  • 11 Systemic Therapy, BC Cancer Agency Vancouver, V5Z4E6 - Vancouver/CA
  • 12 Oncology, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) & Krankenhaus Jerusalem Hamburg, Hamburg/DE
  • 13 Oncology, Hospital Central de Asturias, Oviedo/ES
  • 14 Gynecologic Oncology, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) & French Investigator Group for Ovarian and Breast Cancer and Institut Régional du Cancer de Montpellier, Montpellier/FR
  • 15 Gynecologic Oncology, Northside Hospital, Atlanta/US
  • 16 Obstetrics And Gynecology, Centre Hospitalier de L'Universite de Montreal (CHUM), Montreal/CA
  • 17 Gynecologic Oncology, Arizona Oncology Associates, Tuscon/US
  • 18 Quantitative Science, Clinical Outcomes Solutions, Tuscon/US
  • 19 Clinical Science, TESARO, Inc., 2451 - Waltham/US
  • 20 Oncology, Nordic Society of Gynecologic Oncology (NSGO) and Rigshospitalet, Copenhagen University Hospital, Copenhagen/DK


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Abstract 3057


The highly selective poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor niraparib (ZEJULA™) concentrated in the tumor vs plasma in preclinical studies, delivering ≥90% durable PARP inhibition, and showed significantly longer progression-free survival vs placebo in patients (pts) with recurrent OC following complete (CR) or partial response (PR) to platinum-based chemotherapy (PBC) regardless of germline BRCA mutation (gBRCAmut) or homologous recombination deficiency (HRD) status in the phase 3 ENGOT-OV16/NOVA trial. Quality of life (QoL) measures are important to determine the benefit of drug therapy in this population. We evaluated patient-reported outcomes (PROs) associated with QoL and individual patient-reported symptoms using the Functional Assessment of Cancer Therapy-Ovarian Symptoms Index (FOSI) and European Quality of Life Scale 5-Dimensions (EQ-5D-5L) in ENGOT-OV16/NOVA pts treated with niraparib vs placebo.


A mixed-effects growth-curve model adjusted for baseline demographic values and 3 stratification factors was constructed to model the relationship between treatment and PRO score for each measure. The relationship between health status and PROs was evaluated through a cross-sectional analysis of adjusted EQ-5D-5L health utility index (HUI) scores. A disutility analysis of hematologic adverse events was conducted at different time points.


No significant difference in mean PRO scores was observed between niraparib and placebo arms in either cohort. Adjusted HUI scores were similar in both arms at baseline, but average adjusted HUI pre-progression scores trended higher in the niraparib arm (0.812 vs 0.803 in gBRCAmut cohort; 0.845 vs 0.828 in non-gBRCAmut cohort). Hematologic toxicities had no detrimental effect on pts’ overall health utility.


These data suggest pts with recurrent OC treated with niraparib following CR or PR to PBC can continuously maintain their QoL while on treatment.

Clinical trial identification


Legal entity responsible for the study





A.M. Oza: Consulting/Advisory: Amgen, Verastem, Clovis Oncology, Immunovaccine; Travel, Accommodations, Expenses: AstraZeneca; Honoraria: WebRx. U.A. Matulonis: Consulting/Advisory: Merck KGaA, AstraZeneca, Immunogen, Tesaro, Genentech. S. Malander: Honoraria: AstraZeneca, Roche. J. Sehouli: Honoraria: Roche, AstraZeneca, Tesaro, PharmaMar; Consulting/Advisory: Clovis Oncology, Roche, AstraZeneca, Tesaro, Novocure Research; Funding: Amgen, Novartis, Lilly, Bayer. J.M. del Campo: Speakers’ Bureau: Roche, MSD Oncology, PharmaMar, Boehringer Ingelheim. S. Banerjee: Travel, Accommodations, Expenses: AstraZeneca, Clovis Oncology. G. Scambia: Honoraria: Roche, AstraZeneca, PharmaMar Consulting/Advisory: Roche, AstraZeneca, PharmaMar Speakers’ Bureau: Roche, AstraZeneca, PharmaMar; Travel, Accommodations, Expenses: Roche, AstraZeneca, PharmaMar. J.S. Berek: Consulting/Advisory: Atara Biotherapeutics. A.V. Tinker: Consulting/Advisory: AstraZeneca. F. Hilpert: Honoraria: Roche, AstraZeneca, Novartis, Medac, MSD, PharmaMar; Consulting/Advisory: PharmaMar, Roche, AZ, MSD; Travel, Accommodations, Expenses: AZ, Roche, PharmaMar. I. Palacio Vázquez: Research Funding: Novartis, Tesaro; Expert Testimony: AstraZeneca; Travel, Accommodations, Expenses: Roche, PharmaMar. V. D’hondt: Travel, Accommodations, Expenses: Amgen. B. Benigno: Honoraria: AstraZeneca, Insys Therapeutics; Research funding: Tesaro. D.M. Provencher: Consulting or Advisory Role: AstraZeneca; Speakers\' Bureau: AstraZeneca. S. Hudgens: Consulting/Advisory: Tesaro; Research Funding: Tesaro. S. Agarwal: Employment: TESARO, Inc. Stock: TESARO, Inc. M.R. Mirza: Consulting or Advisory Role: Clovis Oncology, AstraZeneca, Tesaro. All other authors have declared no conflicts of interest.

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