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Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study.
O'Cearbhaill, Roisin E; Pérez-Fidalgo, Jose-Alejandro; Monk, Bradley J; Tusquets, Ignacio; McCormick, Colleen; Fuentes, Jose; Moore, Richard G; Vulsteke, Christof; Shahin, Mark S; Forget, Frédéric; Bradley, William H; Hietanen, Sakari; O'Malley, David M; Dørum, Anne; Slomovitz, Brian M; Baumann, Klaus; Selle, Frédéric; Calvert, Paula M; Artioli, Grazia; Levy, Tally; Kumar, Aalok; Malinowska, Izabela A; Li, Yong; Gupta, Divya; González-Martín, Antonio.
Afiliación
  • O'Cearbhaill RE; GOG Foundation and the Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: ocearbhr@mskcc.org.
  • Pérez-Fidalgo JA; Department of Medical Oncology, INCLIVA University Hospital of Valencia, CIBERONC, Valencia, Spain.
  • Monk BJ; Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA.
  • Tusquets I; Medical Oncology Department, Hospital del Mar, Barcelona, Spain.
  • McCormick C; GOG and Legacy Medical Group Gynecologic Oncology, Portland, OR, USA.
  • Fuentes J; Servicio de Oncologia, Hospital de Valme, Sevilla, Spain.
  • Moore RG; Division of Gynecologic Oncology, Wilmot Cancer Institute, Department of Obstetrics and Gynecology, University of Rochester, Rochester, NY, USA.
  • Vulsteke C; BGOG and the Department of Medical Oncology and Hematology, AZ Maria Middelares, Ghent, Belgium, and the Department of Molecular Imaging, Pathology, Radiotherapy, and Oncology, Center for Oncological Research, Antwerp University, Antwerp, Belgium.
  • Shahin MS; Abington Hospital-Jefferson Health, Sidney Kimmel Cancer Center of Thomas Jefferson University, Willow Grove, PA, USA.
  • Forget F; Department of Medical Oncology, Libramont Hospital, Libramont, Belgium.
  • Bradley WH; GOG and the Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI, USA.
  • Hietanen S; Department of Obstetrics and Gynecology, Turku University Hospital and FICAN West, Turku, Finland.
  • O'Malley DM; Ohio State University, James Comprehensive Cancer Center, Columbus, OH, USA.
  • Dørum A; Gynecologic Oncology, Oslo University Hospital, The Norwegian Radiumhospital, Oslo, Norway.
  • Slomovitz BM; Broward Health, Mount Sinai Medical Center, Florida International University Wertheim College of Medicine, Miami Beach, FL, USA.
  • Baumann K; Arbeitsgemeinschaft Gynäkologische Onkologie and the Department of Gynecology and Obstetrics, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany.
  • Selle F; GINECO and Groupe Hospitalier Diaconesses-Croix Saint Simon, Paris, France.
  • Calvert PM; Cancer Trials Ireland, Dublin, Ireland.
  • Artioli G; Ulss2 Oncologia Medica Marca Trevigiana, Treviso, Italy.
  • Levy T; Department of Obstetrics and Gynecology, Wolfson Medical Center, Sackler School of Medicine, Tel Aviv University, Holon, Israel.
  • Kumar A; Department of Medical Oncology, BC Cancer, Fraser Valley Cancer Centre, Surrey, BC, Canada.
  • Malinowska IA; GlaxoSmithKline, Waltham, MA, USA.
  • Li Y; GlaxoSmithKline, Waltham, MA, USA.
  • Gupta D; GlaxoSmithKline, Waltham, MA, USA.
  • González-Martín A; Grupo Español de Investigación en Cáncer de Ovario (GEICO), the Medical Oncology Department, Clínica Universidad de Navarra, and Program in Solid Tumors, Center for Applied Medical Research (CIMA), Madrid, Spain.
Gynecol Oncol ; 166(1): 36-43, 2022 07.
Article en En | MEDLINE | ID: mdl-35550709
OBJECTIVE: To evaluate the association between surgical timing and postoperative residual disease status on the efficacy of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer at high risk of recurrence. METHODS: Post hoc analysis of the phase 3 PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) study of niraparib in patients with newly diagnosed primary advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete/partial response to first-line platinum-based chemotherapy. Progression-free survival (PFS) was assessed by surgical status (primary debulking surgery [PDS] vs neoadjuvant chemotherapy/interval debulking surgery [NACT/IDS]) and postoperative residual disease status (no visible residual disease [NVRD] vs visible residual disease [VRD]) in the intent-to-treat population. RESULTS: In PRIMA (N = 733), 236 (32.2%) patients underwent PDS, and 481 (65.6%) received NACT/IDS before enrollment. Median PFS (niraparib vs placebo) and hazard ratios (95% CI) for progression were similar in PDS (13.7 vs 8.2 months; HR, 0.67 [0.47-0.96]) and NACT/IDS (14.2 vs 8.2 months; HR, 0.57 [0.44-0.73]) subgroups. In patients who received NACT/IDS and had NVRD (n = 304), the hazard ratio (95% CI) for progression was 0.65 (0.46-0.91). In patients with VRD following PDS (n = 183) or NACT/IDS (n = 149), the hazard ratios (95% CI) for progression were 0.58 (0.39-0.86) and 0.41 (0.27-0.62), respectively. PFS was not evaluable for patients with PDS and NVRD because of sample size (n = 37). CONCLUSIONS: In this post hoc analysis, niraparib efficacy was similar across PDS and NACT/IDS subgroups. Patients who had NACT/IDS and VRD had the highest reduction in the risk of progression with niraparib maintenance.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas Tipo de estudio: Clinical_trials Límite: Female / Humans Idioma: En Revista: Gynecol Oncol Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas Tipo de estudio: Clinical_trials Límite: Female / Humans Idioma: En Revista: Gynecol Oncol Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos