dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Monk, Bradley J. |
dc.contributor.author | Parkinson, Christine |
dc.contributor.author | Lim, Myong Cheol |
dc.contributor.author | O’Malley, David M. |
dc.contributor.author | Oaknin Benzaquen, Ana Mazaltob |
dc.contributor.author | Wilson, Michelle |
dc.date.accessioned | 2022-12-29T12:08:27Z |
dc.date.available | 2022-12-29T12:08:27Z |
dc.date.issued | 2022-12-01 |
dc.identifier.citation | Monk BJ, Parkinson C, Lim MC, O’Malley DM, Oaknin A, Wilson MK, et al. A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Cinical Oncol. 2022 Dec 1;40(34):3952–64. |
dc.identifier.issn | 1527-7755 |
dc.identifier.uri | https://hdl.handle.net/11351/8726 |
dc.description | Ovarian cancer; Monotherapy |
dc.description.abstract | PURPOSE
ATHENA (ClinicalTrials.gov identifier: NCT03522246) was designed to evaluate rucaparib first-line maintenance treatment in a broad patient population, including those without BRCA1 or BRCA2 (BRCA) mutations or other evidence of homologous recombination deficiency (HRD), or high-risk clinical characteristics such as residual disease. We report the results from the ATHENA–MONO comparison of rucaparib versus placebo.
METHODS
Patients with stage III-IV high-grade ovarian cancer undergoing surgical cytoreduction (R0/complete resection permitted) and responding to first-line platinum-doublet chemotherapy were randomly assigned 4:1 to oral rucaparib 600 mg twice a day or placebo. Stratification factors were HRD test status, residual disease after chemotherapy, and timing of surgery. The primary end point of investigator-assessed progression-free survival was assessed in a step-down procedure, first in the HRD population (BRCA-mutant or BRCA wild-type/loss of heterozygosity high tumor), and then in the intent-to-treat population.
RESULTS
As of March 23, 2022 (data cutoff), 427 and 111 patients were randomly assigned to rucaparib or placebo, respectively (HRD population: 185 v 49). Median progression-free survival (95% CI) was 28.7 months (23.0 to not reached) with rucaparib versus 11.3 months (9.1 to 22.1) with placebo in the HRD population (log-rank P = .0004; hazard ratio [HR], 0.47; 95% CI, 0.31 to 0.72); 20.2 months (15.2 to 24.7) versus 9.2 months (8.3 to 12.2) in the intent-to-treat population (log-rank P < .0001; HR, 0.52; 95% CI, 0.40 to 0.68); and 12.1 months (11.1 to 17.7) versus 9.1 months (4.0 to 12.2) in the HRD-negative population (HR, 0.65; 95% CI, 0.45 to 0.95). The most common grade ≥ 3 treatment-emergent adverse events were anemia (rucaparib, 28.7% v placebo, 0%) and neutropenia (14.6% v 0.9%).
CONCLUSION
Rucaparib monotherapy is effective as first-line maintenance, conferring significant benefit versus placebo in patients with advanced ovarian cancer with and without HRD. |
dc.language.iso | eng |
dc.publisher | Lippincott Williams & Wilkins |
dc.relation.ispartofseries | Journal of Cinical Oncology;40(34) |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Ovaris - Càncer - Tractament |
dc.subject | Medicaments antineoplàstics - Ús terapèutic |
dc.subject | Avaluació de resultats (Assistència sanitària) |
dc.subject.mesh | Ovarian Neoplasms |
dc.subject.mesh | /drug therapy |
dc.subject.mesh | Treatment Outcome |
dc.subject.mesh | Antineoplastic Agents |
dc.subject.mesh | /therapeutic use |
dc.title | A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA–MONO/GOG-3020/ENGOT-ov45) |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1200/JCO.22.01003 |
dc.subject.decs | neoplasias ováricas |
dc.subject.decs | /farmacoterapia |
dc.subject.decs | resultado del tratamiento |
dc.subject.decs | antineoplásicos |
dc.subject.decs | /uso terapéutico |
dc.relation.publishversion | http://dx.doi.org/10.1200/JCO.22.01003 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Monk BJ] GOG Foundation, HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ. [Parkinson C] Medical Oncology, Addenbrooke's Hospital, Cambridge, United Kingdom. [Lim MC] Gynecologic Oncology, National Cancer Center Korea, Goyang-si, Gyeonggi-do, South Korea. [O'Malley DM] Division of Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, OH. [Oaknin A] Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Wilson MK] Department of Cancer and Blood, Auckland City Hospital, Auckland, New Zealand |
dc.identifier.pmid | 35658487 |
dc.identifier.wos | 000892205500007 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |