A TIME WITHOUT SYMPTOMS OR TOXICITY ANALYSIS OF NIRAPARIB COMPARED WITH ROUTINE SURVEILLANCE IN THE MAINTENANCE TREATMENT OF PATIENTS WITH RECURRENT OVARIAN CANCER

Author(s)

Mirza MR1, Walder L2, Monk BJ3, Tinker AV4, Mahner S5, Gil-Martin M6, Kalbacher E7, Waters J8, Wenham RM9, Malander S10, Gilbert L11, Sehouli J12, Casado Herraez A13, Hardy-Bessard A14, Williams SJ15, Rimel BJ16, Lund B17, Levy T18, Guy H2, Matulonis UA19
1NSGO and Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, 2FIECON Ltd, St Albans, UK, 3Arizona Oncology, Phoenix, AZ, USA, 4British Columbia Cancer Agency (BCCA) - Vancouver Centre, Vancouver, BC, Canada, 5AGO and University of Munich, Munich, Germany, 6GEICO and Institut Català d'Oncologia-IDIBELL, Barcelona, Spain, 7GINECO and University Hospital Besançon, Besançon, France, 8NCRI and Maidstone & Tunbridge Wells NHS Trust, Maidstone, UK, 9H. Lee Moffitt Cancer Center, Tampa, FL, USA, 10NSGO and Lund University, Lund, Sweden, 11McGill University Health Centre, Montreal, QC, Canada, 12AGO and Charité - Universitätsmedizin Berlin, Berlin, Germany, 13GEICO and Hospital Universitario San Carlos, Madrid, Spain, 14GINECO and Centre CARIO-HPCA, Plérin, France, 15NCRI and Queen Elizabeth Hospital Birmingham, Birmingham, UK, 16Cedars-Sinai Medical Center, Los Angeles, CA, USA, 17NSGO and Aalborg University Hospital, Aalborg, Denmark, 18ISGO and Edith Wolfson Medical Center, Holon, Israel, 19Dana-Farber Cancer Institute, Boston, MA, USA

Presentation Documents

OBJECTIVES: To estimate the time without symptoms and toxicity (TWiST) of niraparib, a poly (ADP-ribose) polymerase inhibitor, compared with routine surveillance (RS) in the maintenance treatment of patients with recurrent ovarian cancer. METHODS: Mean progression-free survival (PFS) was estimated for niraparib and RS using parametric survival curves based on 553 patients enrolled in the ENGOT-OV16/NOVA Phase 3 trial. A restricted mean time with toxicity (TOX) was estimated based on Kaplan-Meier curves for adverse events (AEs) using patient level data. Symptomatic AEs included were grade ≥2 fatigue, nausea, and vomiting. TOX time was calculated as the number of days a patient experienced an AE after randomisation and prior to disease progression. TWiST was then estimated as the difference between mean PFS and mean TOX between niraparib and RS. RESULTS: Treatment with niraparib resulted in a mean PFS benefit of 3.23 years and a greater mean TOX of 0.28 years compared with RS in the gBRCAmut cohort. Treatment with niraparib resulted in a mean PFS benefit of 1.44 years and a greater mean TOX of 0.10 years compared with RS in the non-gBRCAmut cohort. Hence, treatment with niraparib resulted in a mean TWiST benefit of 2.95 and 1.34 years compared with RS in the gBRCAmut and non-gBRCAmut cohorts, respectively. CONCLUSIONS: These results indicate that patients treated with niraparib experienced increased mean TWiST compared with RS. Thus, patients treated with niraparib in the ENGOT-OV16/NOVA trial experienced more time without symptoms or toxicities compared to control.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PCN7

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy, Relating Intermediate to Long-term Outcomes, Safety & Pharmacoepidemiology

Disease

Oncology

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