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  • Mirza, Mansoor RazaNordic Soc Gynaecol Oncol, Denmark; Copenhagen Univ Hosp, Denmark (författare)

Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial

  • Artikel/kapitelEngelska2019

Förlag, utgivningsår, omfång ...

  • ELSEVIER SCIENCE INC,2019
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:liu-160982
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-160982URI
  • https://doi.org/10.1016/S1470-2045(19)30515-7DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding Agencies|Nordic Society of Gynaecological Oncology; Tesaro
  • Background Platinum-based chemotherapy is the foundation of treatment for platinum-sensitive recurrent ovarian cancer, but has substantial toxicity. Bevacizumab and maintenance poly(ADP-ribose) polymerase (PARP) inhibitors both significantly improve efficacy versus standard therapy, primarily in terms of progression-free survival, and offer the potential for chemotherapy-free treatment. AVANOVA2 compared niraparib and bevacizumab versus niraparib alone as definitive treatment for platinum-sensitive recurrent ovarian cancer. Methods This open-label, randomised, phase 2, superiority trial in 15 university hospitals in Denmark, Sweden, Finland, Norway, and the USA enrolled women aged 18 years or older with measurable or evaluable high-grade serous or endometrioid platinum-sensitive recurrent ovarian cancer. Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2, and had to have previously received platinum-containing therapy for primary disease but amp;lt;= 1 prior non-platinum-containing regimen for recurrent disease. Previous treatment with bevacizumab or first-line maintenance PARP inhibitors was permitted. Eligible patients were randomly assigned 1:1 (by random permuted blocks with block sizes of two and four, no masking), stratified by homologous recombination deficiency status and chemotherapy-free interval, to receive once-daily oral niraparib 300 mg alone or with intravenous bevacizumab 15 mg/kg once every 3 weeks until disease progression. The primary endpoint was progression-free survival, assessed by the investigators in the intention-to-treat population after events in at least 62 patients. Safety was analysed in all patients who received at least one dose of study drug. This ongoing trial is registered with ClinicalTrials.gov , number NCT02354131. Findings Between May 23,2016, and March 6,2017,97 patients were enrolled and randomly assigned: 48 to niraparib plus bevacizumab and 49 to single-agent niraparib. Median follow-up was 16.9 months (IQR 15.4-20.9). Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11.9 months [95% CI 8.5-16.7] vs 5.5 months [3.8-6.3], respectively; adjusted hazard ratio [HR] 0.35 [95% CI 0.21-0.57], pamp;lt;0.0001). Grade 3 or worse adverse events occurred in 31 (65%) of 48 patients who received niraparib plus bevacizumab and 22 (45%) of 49 who received single-agent niraparib. The most common grade 3 or worse adverse events in both groups were anaemia (7 [15%] of 48 vs 9 [18%] of 49) and thrombocytopenia (5 [10%] vs 6 [12%]), and hypertension in the combination group (10 [21%] vs 0). Niraparib plus bevacizumab was associated with increased incidences of any-grade proteinuria (10 [21%] of 48 patients vs 0) and hypertension (27[56%] of 48 vs 11 [22%] of 49) compared with niraparib alone. No treatment-related deaths occurred. Interpretation The efficacy observed with this chemotherapy-free combination of approved agents in women with platinum-sensitive recurrent ovarian cancer warrants further evaluation. A randomised phase 3 trial investigating niraparib plus bevacizumab versus chemotherapy plus bevacizumab in platinum-sensitive recurrent ovarian cancer is planned. Copyright (C) 2019 Elsevier Ltd. All rights reserved.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Åvall Lundqvist, ElisabethLinköpings universitet,Avdelningen för Kirurgi, Ortopedi och Onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US,Nordic Soc Gynaecol Oncol, Denmark(Swepub:liu)eliav51 (författare)
  • Birrer, MichaelUniv Alabama Birmingham, AL USA (författare)
  • Christensen, Rene DePontNordic Soc Gynaecol Oncol, Denmark; Univ Southern Denmark, Denmark (författare)
  • Nyvang, Gitte-BettinaNordic Soc Gynaecol Oncol, Denmark; Odense Univ Hosp, Denmark (författare)
  • Malander, SusanneNordic Soc Gynaecol Oncol, Denmark; Lund Univ Hosp, Sweden (författare)
  • Anttila, MaaritNordic Soc Gynaecol Oncol, Denmark; Kuopio Univ Hosp, Finland (författare)
  • Werner, Theresa L.Univ Utah, UT USA (författare)
  • Lund, BenteNordic Soc Gynaecol Oncol, Denmark; Aalborg Univ Hosp, Denmark (författare)
  • Lindahl, GabrielLinköpings universitet,Avdelningen för Kirurgi, Ortopedi och Onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US,Nordic Soc Gynaecol Oncol, Denmark(Swepub:liu)gabli45 (författare)
  • Hietanen, SakariNordic Soc Gynaecol Oncol, Denmark; Turku Univ Hosp, Finland (författare)
  • Peen, UllaNordic Soc Gynaecol Oncol, Denmark; Hedev Univ Hosp, Denmark (författare)
  • Dimoula, MariaNordic Soc Gynaecol Oncol, Denmark; Sahlgrens Univ Hosp, Sweden (författare)
  • Roed, HenrikNordic Soc Gynaecol Oncol, Denmark; Copenhagen Univ Hosp, Denmark (författare)
  • Knudsen, Anja OrNordic Soc Gynaecol Oncol, Denmark; Odense Univ Hosp, Denmark (författare)
  • Staff, SynnoveNordic Soc Gynaecol Oncol, Denmark; Tampere Univ, Finland; Tampere Univ, Finland; Univ Hosp, Finland (författare)
  • Vistisen, Anders KrogAalborg Univ Hosp, Denmark (författare)
  • Bjorge, LineNordic Soc Gynaecol Oncol, Denmark; Haukeland Hosp, Norway; Univ Bergen, Norway (författare)
  • Maenpaa, Johanna U.Nordic Soc Gynaecol Oncol, Denmark; Tampere Univ, Finland; Tampere Univ, Finland; Univ Hosp, Finland (författare)
  • Nordic Soc Gynaecol Oncol, Denmark; Copenhagen Univ Hosp, DenmarkAvdelningen för Kirurgi, Ortopedi och Onkologi (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:The Lancet Oncology: ELSEVIER SCIENCE INC20:10, s. 1409-14191470-20451474-5488

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