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Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study

Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study

Authors :
Colombo, N
Van Gorp, T
Matulonis, U
Oaknin, A
Grisham, R
Fleming, G
Olawaiye, A
Nguyen, D
Greenstein, A
Custodio, J
Pashova, H
Tudor, I
Lorusso, D
Colombo, Nicoletta
Van Gorp, Toon
Matulonis, Ursula A
Oaknin, Ana
Grisham, Rachel N
Fleming, Gini F
Olawaiye, Alexander B
Nguyen, Dorothy D
Greenstein, Andrew E
Custodio, Joseph M
Pashova, Hristina I
Tudor, Iulia C
Lorusso, Domenica
Colombo, N
Van Gorp, T
Matulonis, U
Oaknin, A
Grisham, R
Fleming, G
Olawaiye, A
Nguyen, D
Greenstein, A
Custodio, J
Pashova, H
Tudor, I
Lorusso, D
Colombo, Nicoletta
Van Gorp, Toon
Matulonis, Ursula A
Oaknin, Ana
Grisham, Rachel N
Fleming, Gini F
Olawaiye, Alexander B
Nguyen, Dorothy D
Greenstein, Andrew E
Custodio, Joseph M
Pashova, Hristina I
Tudor, Iulia C
Lorusso, Domenica
Publication Year :
2023

Abstract

PURPOSE: Despite therapeutic advances, outcomes for patients with platinum-resistant/refractory ovarian cancer remain poor. Selective glucocorticoid receptor modulation with relacorilant may restore chemosensitivity and enhance chemotherapy efficacy. METHODS: This three-arm, randomized, controlled, open-label phase II study (ClinicalTrials.gov identifier: NCT03776812) enrolled women with recurrent, platinum-resistant/refractory, high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer, or ovarian carcinosarcoma treated with ≤4 prior chemotherapeutic regimens. Patients were randomly assigned 1:1:1 to (1) nab-paclitaxel (80 mg/m2) + intermittent relacorilant (150 mg the day before, of, and after nab-paclitaxel); (2) nab-paclitaxel (80 mg/m2) + continuous relacorilant (100 mg once daily); or (3) nab-paclitaxel monotherapy (100 mg/m2). Nab-paclitaxel was administered on days 1, 8, and 15 of each 28-day cycle. The primary end point was progression-free survival (PFS) by investigator assessment; objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety were secondary end points. RESULTS: A total of 178 women were randomly assigned. Intermittent relacorilant + nab-paclitaxel improved PFS (hazard ratio [HR], 0.66; log-rank test P = .038; median follow-up, 11.1 months) and DOR (HR, 0.36; P = .006) versus nab-paclitaxel monotherapy, while ORR was similar across arms. At the preplanned OS analysis (median follow-up, 22.5 months), the OS HR was 0.67 (P = .066) for the intermittent arm versus nab-paclitaxel monotherapy. Continuous relacorilant + nab-paclitaxel showed numerically improved median PFS but did not result in significant improvement over nab-paclitaxel monotherapy. Adverse events were comparable across study arms, with neutropenia, anemia, peripheral neuropathy, and fatigue/asthenia being the most common grade ≥3 adverse events. CONCLUSION: Intermittent relacorilant + nab-paclitaxel improved

Details

Database :
OAIster
Notes :
STAMPA, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1394341462
Document Type :
Electronic Resource