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Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial.
Lorusso, Domenica; Mouret-Reynier, Marie-Ange; Harter, Philipp; Cropet, Claire; Caballero, Cristina; Wolfrum-Ristau, Pia; Satoh, Toyomi; Vergote, Ignace; Parma, Gabriella; Nøttrup, Trine J; Lebreton, Coriolan; Fasching, Peter A; Pisano, Carmela; Manso, Luis; Bourgeois, Hugues; Runnebaum, Ingo; Zamagni, Claudio; Hardy-Bessard, Anne-Claire; Schnelzer, Andreas; Fabbro, Michel; Schmalfeldt, Barbara; Berton, Dominique; Belau, Antje; Lotz, Jean-Pierre; Gropp-Meier, Martina; Gladieff, Laurence; Lück, Hans-Joachim; Abadie-Lacourtoisie, Sophie; Pujade-Lauraine, Eric; Ray-Coquard, Isabelle.
Afiliação
  • Lorusso D; Istituto Tumori Milano + Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy kettalorusso@libero.it.
  • Mouret-Reynier MA; Catholic University of Sacred Heart, Milan, Italy.
  • Harter P; Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies, (MITO), Italy.
  • Cropet C; Department of Medical Oncology, Centre Jean Perrin, Clermont Ferrand, France.
  • Caballero C; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, (GINECO), France.
  • Wolfrum-Ristau P; Department of Gynaecology & Gynaecologic Oncology, Ev. Kliniken Essen-Mitte, Essen, Germany.
  • Satoh T; Arbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe, (AGO), Germany.
  • Vergote I; Department of Biostatistics, Centre Léon Bérard, Lyon, France.
  • Parma G; Servicio de Oncología Médica, Hospital General Universitario de Valencia, Valencia, Spain.
  • Nøttrup TJ; Grupo Español de Investigación en Cáncer de Ovario, (GEICO), Spain.
  • Lebreton C; Department of Obstetrics and Gynecology, Paracelsus Medical University Salzburg, Salzburg, Austria.
  • Fasching PA; Arbeitsgemeinschaft Gynaekologische Onkologie Study Group, (AGO-Austria), Austria.
  • Pisano C; Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
  • Manso L; Gynecologic Oncology Trial and Investigation Consortium, (GOTIC), Japan.
  • Bourgeois H; Department of Obstetrics and Gynaecology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium, European Union.
  • Runnebaum I; Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Belgium, European Union.
  • Zamagni C; Gynecologic Oncology Program, European Institute of Oncology IRCCS, Milan, Italy.
  • Hardy-Bessard AC; Mario Negri Gynecologic Oncology Group, (MANGO), Italy.
  • Schnelzer A; Department of Oncology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
  • Fabbro M; Nordic Society of Gynecologic Oncology, (NSGO), Denmark.
  • Schmalfeldt B; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, (GINECO), France.
  • Berton D; Department of Medical Oncology, Institut Bergonié, Bordeaux, France.
  • Belau A; Arbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe, (AGO), Germany.
  • Lotz JP; Gynecology and Obstetrics Translational Medicine, Universitätsfrauenklinik Erlangen, Erlangen, Germany.
  • Gropp-Meier M; Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies, (MITO), Italy.
  • Gladieff L; Department of Urology and Gynecology, Istituto Nazionale Tumori, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)-Fondazione G. Pascale Napoli, Naples, Italy.
  • Lück HJ; Grupo Español de Investigación en Cáncer de Ovario, (GEICO), Spain.
  • Abadie-Lacourtoisie S; Department of Medical Oncology, Hospital 12 de Octubre, Madrid, Spain.
  • Pujade-Lauraine E; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, (GINECO), France.
  • Ray-Coquard I; Medical Oncology Department, Centre Jean Bernard - Clinique Victor Hugo, Le Mans, France.
Int J Gynecol Cancer ; 34(4): 550-558, 2024 Apr 01.
Article em En | MEDLINE | ID: mdl-38129136
ABSTRACT

OBJECTIVE:

In the PAOLA-1/ENGOT-ov25 trial (NCT02477644), adding maintenance olaparib to bevacizumab provided a substantial progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and homologous recombination deficiency (HRD)-positive tumors, irrespective of clinical risk. Subsequently, a clinically meaningful improvement in overall survival was reported with olaparib plus bevacizumab in the HRD-positive subgroup. We report updated progression-free survival and overall survival by clinical risk and HRD status.

METHODS:

Patients in clinical response after first-line platinum-based chemotherapy plus bevacizumab received maintenance olaparib (up to 24 months) plus bevacizumab (up to 15 months in total) or placebo plus bevacizumab. This post hoc analysis evaluated 5-year progression-free survival and mature overall survival in patients classified by clinical risk and HRD status.

RESULTS:

Of 806 randomized patients, 74% were higher-risk and 26% were lower-risk. In higher-risk HRD-positive patients, the hazard ratio (HR) for progression-free survival was 0.46 (95% confidence interval (95% CI) 0.34 to 0.61), with 5-year progression-free survival of 35% with olaparib plus bevacizumab versus 15% with bevacizumab alone; and the HR for overall survival was 0.70 (95% CI 0.50 to 1.00), with 5-year overall survival of 55% versus 42%, respectively. In lower-risk HRD-positive patients, the HR for progression-free survival was 0.26 (95% CI 0.15 to 0.45), with 5-year progression-free survival of 72% with olaparib plus bevacizumab versus 28% with bevacizumab alone; and the HR for overall survival was 0.31 (95% CI 0.14 to 0.66), with 5-year overall survival of 88% versus 61%, respectively. No benefit was seen in HRD-negative patients regardless of clinical risk.

CONCLUSION:

This post hoc analysis indicates that in patients with newly diagnosed advanced HRD-positive ovarian cancer, maintenance olaparib plus bevacizumab should not be limited to those considered at higher risk of disease progression. Five-year progression-free survival rates support long-term remission and suggest an increased potential for cure with particular benefit suggested in lower-risk HRD-positive patients.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Piperazinas Limite: Female / Humans Idioma: En Revista: Int J Gynecol Cancer Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Piperazinas Limite: Female / Humans Idioma: En Revista: Int J Gynecol Cancer Ano de publicação: 2024 Tipo de documento: Article