> Detailanzeige

Colombo, N.; Gadducci, A.; Sehouli, J.; Rulli, E.; Mäenpää, J.; Sessa, C.; Montes, A.; Ottevanger, N. B.; Berger, R.; Vergote, I.; D’Incalci, M.; Churruca Galaz, C.; Chekerov, R.; Nyvang, G. B.; Riniker, S.; Herbertson, R.; Fossati, R.; Barretina-Ginesta, M. P.; Deryal, M.; Mirza, M. R.; Biagioli, E.; Iglesias, M.; Funari, G.; Romeo, M.; [...]

INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

Literatur-
verwaltung

Zur
Merkliste

Lösche von
Merkliste

Per Whatsapp teilen

Schließen

Merkliste



Sie können Bookmarks mittels Listen verwalten, loggen Sie sich dafür bitte in Ihr SLUB Benutzerkonto ein.
  • Medientyp: E-Artikel
  • Titel: INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line
  • Beteiligte: Colombo, N.; Gadducci, A.; Sehouli, J.; Rulli, E.; Mäenpää, J.; Sessa, C.; Montes, A.; Ottevanger, N. B.; Berger, R.; Vergote, I.; D’Incalci, M.; Churruca Galaz, C.; Chekerov, R.; Nyvang, G. B.; Riniker, S.; Herbertson, R.; Fossati, R.; Barretina-Ginesta, M. P.; Deryal, M.; Mirza, M. R.; Biagioli, E.; Iglesias, M.; Funari, G.; Romeo, M.; [...]
  • Erschienen: Springer Science and Business Media LLC, 2023
  • Erschienen in: British Journal of Cancer
  • Sprache: Englisch
  • DOI: 10.1038/s41416-022-02108-7
  • ISSN: 0007-0920; 1532-1827
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC).</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>Patients with OC (up to two previous platinum-based lines), with a TFIp of 6–12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75).</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94–1.35; <jats:italic>p</jats:italic> = 0.197). Grade 3–5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP).</jats:p> </jats:sec><jats:sec> <jats:title>Conclusions</jats:title> <jats:p>This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6–12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities.</jats:p> </jats:sec><jats:sec> <jats:title>Clinical trial registration</jats:title> <jats:p>ClinicalTrials.gov, number NCT01379989.</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang