Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer

Nicoletta Colombo, Eleonora Zaccarelli, Alessandra Baldoni, Simona Frezzini, Giovanni Scambia, Eleonora Palluzzi, Germana Tognon, Andrea A Lissoni, Daniela Rubino, Annamaria Ferrero, Gabriella Farina, Emanuele Negri, Angela Pesenti Gritti, Francesca Galli, Elena Biagioli, Eliana Rulli, Davide Poli, Chiara Gerardi, Valter Torri, Roldano FossatiMaurizio D'Incalci

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated.

METHODS: In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6  ≥ 30% as unacceptable.

RESULTS: BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).

CONCLUSIONS: BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity.

CLINICAL TRIAL REGISTRATION: NCT01735071 (Clinicaltrials.gov).

Original languageEnglish
Pages (from-to)744-750
JournalBritish Journal of Cancer
Volume121
DOIs
Publication statusPublished - Sep 20 2019

Fingerprint Dive into the research topics of 'Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer'. Together they form a unique fingerprint.

  • Cite this