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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)
BJ. Monk, C. Parkinson, MC. Lim, DM. O'Malley, A. Oaknin, MK. Wilson, RL. Coleman, D. Lorusso, P. Bessette, S. Ghamande, A. Christopoulou, D. Provencher, E. Prendergast, F. Demirkiran, O. Mikheeva, O. Yeku, A. Chudecka-Glaz, M. Schenker, RD....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu randomizované kontrolované studie, klinické zkoušky, fáze III, časopisecké články, práce podpořená grantem
Grantová podpora
BRC-1215-20,014
Department of Health - United Kingdom
NLK
Free Medical Journals
od 2004 do Před 1 rokem
Open Access Digital Library
od 1999-01-01
PubMed
35658487
DOI
10.1200/jco.22.01003
Knihovny.cz E-zdroje
- MeSH
- epiteliální ovariální karcinom farmakoterapie genetika MeSH
- indoly škodlivé účinky MeSH
- lidé MeSH
- nádory vaječníků * farmakoterapie genetika chirurgie MeSH
- PARP inhibitory * škodlivé účinky MeSH
- udržovací chemoterapie MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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.
AGO and Department Obstetrics and Gynecology University Hospital Mannheim Mannheim Germany
Biostatistics Clovis Oncology Inc Boulder CO
Cancer Trials Ireland and Department of Medical Oncology Cork University Hospital Cork Ireland
Clinical Development Clovis Oncology Inc Boulder CO
Clinical Operations Clovis Oncology Inc Boulder CO
College of Life Science National Tsing Hua University Hsinchu Taiwan
Department of Cancer and Blood Auckland City Hospital Auckland New Zealand
Department of Gynecologic Oncology Willamette Valley Cancer Institute and Research Center Eugene OR
Department of Medical Oncology Sfantul Nectarie Oncology Center Dolj Romania
Department of Obstetrics and Gynecology Augusta University Augusta GA
Department of Obstetrics and Gynecology Chang Gung Memorial Hospital Tao Yuan Taiwan
Department of Obstetrics and Gynecology University of Sherbrooke Sherbrooke Quebec Canada
Department of Oncology Guy's and St Thomas' NHS Foundation Trust London United Kingdom
Department of Oncology Linköping University Linköping Sweden
Department of Surgery and Cancer Imperial College London London United Kingdom
Division of Gynecologic Oncology The Ohio State University James Cancer Center Columbus OH
Division of Gynecologic Oncology University of Pennsylvania Health System Philadelphia PA
Gynecologic Cancers Program Massachusetts General Hospital Harvard Medical School Boston MA
Gynecologic Oncology Department Medical Faculty Istanbul University Cerrahpaşa Istanbul Turkey
Gynecologic Oncology National Cancer Center Korea Goyang si Gyeonggi do South Korea
Kaiser Permanente Northern California Gynecologic Cancer Program San Francisco CA
Limited Liability Company MedPomosch Saint Petersburg Russia
Medical Oncology Addenbrooke's Hospital Cambridge United Kingdom
Medical Oncology St Andrews General Hospital Patras Greece
Molecular Diagnostics Clovis Oncology Inc Boulder CO
Nordic Society of Gynaecological Oncology Copenhagen Denmark
US Oncology Research The Woodlands TX
Women's Cancer Care Associates Division of Gynecologic Oncology Albany Medical College Albany NY
Citace poskytuje Crossref.org
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