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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): original reports

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 cli...

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Main Authors: Monk, Bradley J. (Author) , Parkinson, Christine (Author) , Lim, Myong Cheol (Author) , O'Malley, David M. (Author) , Oaknin, Ana (Author) , Wilson, Michelle K. (Author) , Coleman, Robert L. (Author) , Lorusso, Domenica (Author) , Bessette, Paul (Author) , Ghamande, Sharad (Author) , Christopoulou, Athina (Author) , Provencher, Diane (Author) , Prendergast, Emily (Author) , Demirkiran, Fuat (Author) , Mikheeva, Olga (Author) , Yeku, Oladapo (Author) , Chudecka-Glaz, Anita (Author) , Schenker, Michael (Author) , Littell, Ramey D. (Author) , Safra, Tamar (Author) , Chou, Hung-Hsueh (Author) , Morgan, Mark A. (Author) , Drochýtek, Vít (Author) , Barlin, Joyce N. (Author) , Van Gorp, Toon (Author) , Ueland, Fred (Author) , Lindahl, Gabriel (Author) , Anderson, Charles (Author) , Collins, Dearbhaile C. (Author) , Moore, Kathleen (Author) , Marmé, Frederik (Author) , Westin, Shannon N. (Author) , McNeish, Iain A. (Author) , Shih, Danny (Author) , Lin, Kevin K. (Author) , Goble, Sandra (Author) , Hume, Stephanie (Author) , Fujiwara, Keiichi (Author) , Kristeleit, Rebecca S. (Author)
Format: Article (Journal)
Language:English
Published: June 6, 2022
In: Journal of clinical oncology
Year: 2022, Volume: 40, Issue: 34, Pages: 3952-3964
ISSN:1527-7755
DOI:10.1200/JCO.22.01003
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.22.01003
Verlag, lizenzpflichtig, Volltext: http://ascopubs.org/doi/10.1200/JCO.22.01003
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Author Notes:Bradley J. Monk, Christine Parkinson, Myong Cheol Lim, David M. O'Malley, Ana Oaknin, Michelle K. Wilson, Robert L. Coleman, Domenica Lorusso, Paul Bessette, Sharad Ghamande, Athina Christopoulou, Diane Provencher, Emily Prendergast, Fuat Demirkiran, Olga Mikheeva, Oladapo Yeku, Anita Chudecka-Glaz, Michael Schenker, Ramey D. Littell, Tamar Safra, Hung-Hsueh Chou, Mark A. Morgan, Vít Drochýtek, Joyce N. Barlin, Toon Van Gorp, Fred Ueland, Gabriel Lindahl, Charles Anderson, Dearbhaile C. Collins, Kathleen Moore, Frederik Marme, Shannon N. Westin, Iain A. McNeish, Danny Shih, Kevin K. Lin, Sandra Goble, Stephanie Hume, Keiichi Fujiwara, and Rebecca S. Kristeleit
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Summary: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.
Item Description:Gesehen am 20.06.2023
Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.22.01003

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