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)

ATHENA (ClinicalTrials.gov identifier: NCT03522246) was designed to evaluate rucaparib first-line maintenance treatment in a broad patient population, including those without or (BRCA) mutations or other evidence of homologous recombination deficiency (HRD), or high-risk clinical characteristics suc...

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Bibliographic Details
Published in:	Journal of clinical oncology Vol. 40; no. 34; p. 3952
Main Authors:	Monk, Bradley J, Parkinson, Christine, Lim, Myong Cheol, O'Malley, David M, Oaknin, Ana, Wilson, Michelle K, Coleman, Robert L, Lorusso, Domenica, Bessette, Paul, Ghamande, Sharad, Christopoulou, Athina, Provencher, Diane, Prendergast, Emily, Demirkiran, Fuat, Mikheeva, Olga, Yeku, Oladapo, Chudecka-Glaz, Anita, Schenker, Michael, Littell, Ramey D, Safra, Tamar, Chou, Hung-Hsueh, Morgan, Mark A, Drochýtek, Vít, Barlin, Joyce N, Van Gorp, Toon, Ueland, Fred, Lindahl, Gabriel, Anderson, Charles, Collins, Dearbhaile C, Moore, Kathleen, Marme, Frederik, Westin, Shannon N, McNeish, Iain A, Shih, Danny, Lin, Kevin K, Goble, Sandra, Hume, Stephanie, Fujiwara, Keiichi, Kristeleit, Rebecca S
Format:	Journal Article
Language:	English
Published:	United States 01.12.2022
Subjects:	Carcinoma, Ovarian Epithelial - drug therapy Carcinoma, Ovarian Epithelial - genetics Female Humans Indoles - adverse effects Maintenance Chemotherapy Ovarian Neoplasms - drug therapy Ovarian Neoplasms - genetics Ovarian Neoplasms - surgery Poly(ADP-ribose) Polymerase Inhibitors - adverse effects
ISSN:	1527-7755, 1527-7755
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Summary:	ATHENA (ClinicalTrials.gov identifier: NCT03522246) was designed to evaluate rucaparib first-line maintenance treatment in a broad patient population, including those without or (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. 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. As of March 23, 2022 (data cutoff), 427 and 111 patients were randomly assigned to rucaparib or placebo, respectively (HRD population: 185 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 = .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 < .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% placebo, 0%) and neutropenia (14.6% 0.9%). Rucaparib monotherapy is effective as first-line maintenance, conferring significant benefit versus placebo in patients with advanced ovarian cancer with and without HRD.
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ISSN:	1527-7755 1527-7755
DOI:	10.1200/JCO.22.01003