Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
NCT Number: NCT06572735
Acronym: PARIB-OLD-PRO²
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Cancer
Interventions: OTHER: QoL surveys|OTHER: Geriatric assessment (G-CODE)|BIOLOGICAL: Blood sampling
Sponsor: Hospices Civils de Lyon
Sex: FEMALE
Age: OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2026-05-01
Locations: Centre Hospitalier Universitaire d'Amiens Picardie Site Sud, Amiens, 80054, France|Centre de lutte contre le cancer Jean Perrin, Clermont-Ferrand, 63011, France|Groupe Hospitalier Public Sud de l'Oise, Creil, 60100, France|Centre Georges François Leclerc, Dijon, 21079, France|Polyclinique de Blois, La Chaussée-Saint-Victor, 41260, France|Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse, Lyon, 69004, France|Service de Gériatrie, Hôpital Dr Frédéric Dugoujon, Lyon, 69317, France|Service Oncologie Médicale, Hôpital Lyon Sud, Pierre-Bénite, 69495, France|Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne, Saint-Priest-en-Jarez, 42271, France

Summary:
Poly(ADP-ribose) polymerase (PARP) inhibitors are anti-cancer treatments that induce preferential tumor cell death. Their efficacy has been demonstrated in many tumor models, primarily in advanced ovarian cancer. PARP inhibitors also exhibit a particular toxicity, damaging the hematopoietic tissue. With age, pharmacokinetic changes or a reduction in medullary cavity may increase these toxicities and may lead to dose reductions/postponements or premature discontinuation of PARP inhibitors, which may impact the efficacy of treatment. Close biological monitoring must be carried out to limit these toxicities, in most cases anemia, thrombocytopenia and neutropenia. Until now, the geriatric factors impacting the tolerance and uptake of PARP inhibitors in the elderly patient population with advanced ovarian cancer are not clearly established. It is therefore necessary to have prospective real-life data in order to support patients in a decision-making process on whether or not to continue such treatments.

PARIB-OLD-PRO² will evaluate the association between various clinical, biological, and geriatric factors and the relative dose intensity (RDI) of therapy by PARP inhibitors. This is a prospective, multicenter longitudinal and non-interventional study and will involve a population of 50 patients, aged 70 years and elder, with advanced ovarian cancer who are scheduled to start a therapy with PARP inhibitors for the first time. The aim of the study is to better understand the effects of PARP inhibitors on a elderly population, knowledge of the genetic and clinical determinants of PARP inhibitors toxicity in this specific population and an optimal management of this therapy related adverse events in order to maintain an RDI.

Primary Outcome Measures: Relative dose intensity of the PARP inhibitors treatment, Ratio of the delivered PARP inhibitors dose intensity to the planned dose intensity at the beginning of the treatment, at 12 months