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

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Gaillard, S; Oaknin, A; Ray-Coquard, I; Vergote, I; Scambia, G; Colombo, N; Fernandez, C; Alfaro, V; Kahatt, C; Nieto, A; Zeaiter, A; Vidal, L ...
Published in: Gynecologic oncology
November 2021

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.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, NCT02421588.442 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.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.

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Published In

Gynecologic oncology

DOI

EISSN

1095-6859

ISSN

0090-8258

Publication Date

November 2021

Volume

163

Issue

2

Start / End Page

237 / 245

Related Subject Headings

  • Topotecan
  • Progression-Free Survival
  • Polyethylene Glycols
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
  • Infusions, Intravenous
  • Humans
  • Heterocyclic Compounds, 4 or More Rings
  • Female
 

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Gaillard, S., Oaknin, A., Ray-Coquard, I., Vergote, I., Scambia, G., Colombo, N., … Lorusso, D. (2021). Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecologic Oncology, 163(2), 237–245. https://doi.org/10.1016/j.ygyno.2021.08.032
Gaillard, Stephanie, Ana Oaknin, Isabelle Ray-Coquard, Ignace Vergote, Giovanni Scambia, Nicoletta Colombo, Cristian Fernandez, et al. “Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL).Gynecologic Oncology 163, no. 2 (November 2021): 237–45. https://doi.org/10.1016/j.ygyno.2021.08.032.
Gaillard, Stephanie, et al. “Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL).Gynecologic Oncology, vol. 163, no. 2, Nov. 2021, pp. 237–45. Epmc, doi:10.1016/j.ygyno.2021.08.032.
Gaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O’Malley DM, Benjamin I, Pautier P, Lorusso D. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecologic oncology. 2021 Nov;163(2):237–245.
Journal cover image

Published In

Gynecologic oncology

DOI

EISSN

1095-6859

ISSN

0090-8258

Publication Date

November 2021

Volume

163

Issue

2

Start / End Page

237 / 245

Related Subject Headings

  • Topotecan
  • Progression-Free Survival
  • Polyethylene Glycols
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
  • Infusions, Intravenous
  • Humans
  • Heterocyclic Compounds, 4 or More Rings
  • Female