Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL)

Stephanie Gaillard, Ana Oaknin, Isabelle Ray-Coquard, Ignace Vergote, Giovanni Scambia, Nicoletta Colombo, Cristian Fernandez, Vicente Alfaro, Carmen Kahatt, Antonio Nieto, Ali Zeaiter, Miguel Aracil, Laura Vidal, Beatriz Pardo-Burdalo, Zsuzsanna Papai, Rebecca Kristeleit, David M. O'Malley, Ivor Benjamin, Patricia Pautier, Domenica Lorusso

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: The randomized phase 3 CORAIL trial evaluated whether lurbinectedin improved progression-free survival (PFS) compared to pegylated liposomal doxorubicin (PLD) or topotecan in patients with platinum-resistant ovarian cancer. Methods: Patients were randomly assigned (1:1) to lurbinectedin 3.2 mg/m2 1-h i.v. infusion q3wk (experimental arm), versus PLD 50 mg/m2 1-h i.v. infusion q4wk or topotecan 1.50 mg/m2 30-min i.v. infusion Days 1–5 q3wk (control arm). Stratification factors were PS (0 vs. ≥1), prior PFI (1–3 months vs. >3 months), and prior chemotherapy lines (1–2 vs. 3). The primary endpoint was PFS by Independent Review Committee in all randomized patients. This study was registered with ClinicalTrials.gov, NCT02421588. Results: 442 patients were randomized: 221 in lurbinectedin arm and 221 in control arm (127 PLD and 94 topotecan). With a median follow-up of 25.6 months, median PFS was 3.5 months (95% CI, 2.1–3.7) in the lurbinectedin arm and 3.6 months (95% CI, 2.7–3.8) in the control arm (stratified log-rank p = 0.6294; HR = 1.057). Grade ≥ 3 treatment-related adverse events (AEs) were most frequent in the control arm: 64.8% vs. 47.9% (p = 0.0005), mainly due to hematological toxicities. The most common grade ≥ 3 AEs were: fatigue (7.3% of patients) and nausea (5.9%) with lurbinectedin; mucosal inflammation (8.5%) and fatigue (8.0%) in the control arm. Conclusions: The primary endpoint of improvement in PFS was not met. Lurbinectedin showed similar antitumor efficacy and was better tolerated than current standard of care in patients with platinum-resistant ovarian cancer.

Original languageEnglish (US)
Pages (from-to)237-245
Number of pages9
JournalGynecologic oncology
Volume163
Issue number2
DOIs
StatePublished - Nov 2021
Externally publishedYes

Keywords

  • Lurbinectedin
  • Ovarian cancer
  • Phase III study
  • Platinum-resistant

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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