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oai:recercat.cat:11351/105352024-12-13T09:21:04Zcom_2072_378070com_2072_378040col_2072_378092

Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study Colombo, Nicoletta Van Gorp, Toon Grisham, Rachel Fleming, Gini Matulonis, Ursula OAKNIN, ANA Institut Català de la Salut [Colombo N] Gynecologic Oncology Program, European Institute of Oncology, IRCCS, Milan, Italy. Department of Medicine and Surgery, University Milan-Bicocca, Milan, Italy. [Van Gorp T] Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium. [Matulonis UA] Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA. [Oaknin A] Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Grisham RN] Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, USA. [Fleming GF] The University of Chicago, Chicago, USA Vall d'Hebron Barcelona Hospital Campus Ovaris - Càncer - Tractament Quimioteràpia combinada Platí ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Ovarian Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias ováricas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia Relacorilant; Cáncer de ovario recurrente; Platino Relacorilant; Càncer d'ovari recurrent; Platí Relacorilant; Resistant ovarian cancer; Platinum 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 PFS, DOR, and OS compared with nab-paclitaxel monotherapy. On the basis of protocol-prespecified Hochberg step-up multiplicity adjustment, the primary end point did not reach statistical significance (P < .025). A phase III evaluation of this regimen is underway (ClinicalTrials.gov identifier: NCT05257408). 2023-10-30T07:51:36Z 2023-10-30T07:51:36Z 2023-10-20 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Colombo N, Van Gorp T, Matulonis UA, Oaknin A, Grisham RN, Fleming GF, et al. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study. J Clin Oncol. 2023 Oct 20;41(30):4779–89. 1527-7755 https://hdl.handle.net/11351/10535 10.1200/JCO.22.02624 37364223 http://hdl.handle.net/11351/10535 eng Journal of Clinical Oncology;41(30) https://doi.org/10.1200/JCO.22.02624 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf application/pdf American Society of Clinical Oncology Scientia