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@article{Monk:2022:10.1200/JCO.22.01003,
author = {Monk, BJ and Parkinson, C and Lim, MC and O'Malley, DM and Wilson, MK and Coleman, RL and Lorusso, D and Bessette, P and Ghamaande, S and Christopoulou, A and Provencher, D and Prendergast, E and Demirkiran, F and Mikheeva, O and Yeku, O and Chudecka-Glaz, A and Schenker, M and Littell, RD and Safra, T and Chou, H-H and Morgan, MA and Drochytek, V and Barlin, JN and Van, Gorp T and Ueland, F and Lindahl, G and Anderson, C and Collins, DC and Moore, K and Marme, F and Westin, SN and McNeish, I and Shih, D and Lin, KK and Goble, S and Hume, S and Fujiwara, K and Kristeleit, RS},
doi = {10.1200/JCO.22.01003},
journal = {Journal of Clinical Oncology},
pages = {3592--3964},
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)},
url = {http://dx.doi.org/10.1200/JCO.22.01003},
volume = {40},
year = {2022}
}

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TY  - JOUR
AB  - 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 ov
AU  - Monk,BJ
AU  - Parkinson,C
AU  - Lim,MC
AU  - O'Malley,DM
AU  - Wilson,MK
AU  - Coleman,RL
AU  - Lorusso,D
AU  - Bessette,P
AU  - Ghamaande,S
AU  - Christopoulou,A
AU  - Provencher,D
AU  - Prendergast,E
AU  - Demirkiran,F
AU  - Mikheeva,O
AU  - Yeku,O
AU  - Chudecka-Glaz,A
AU  - Schenker,M
AU  - Littell,RD
AU  - Safra,T
AU  - Chou,H-H
AU  - Morgan,MA
AU  - Drochytek,V
AU  - Barlin,JN
AU  - Van,Gorp T
AU  - Ueland,F
AU  - Lindahl,G
AU  - Anderson,C
AU  - Collins,DC
AU  - Moore,K
AU  - Marme,F
AU  - Westin,SN
AU  - McNeish,I
AU  - Shih,D
AU  - Lin,KK
AU  - Goble,S
AU  - Hume,S
AU  - Fujiwara,K
AU  - Kristeleit,RS
DO  - 10.1200/JCO.22.01003
EP  - 3964
PY  - 2022///
SN  - 0732-183X
SP  - 3592
TI  - 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)
T2  - Journal of Clinical Oncology
UR  - http://dx.doi.org/10.1200/JCO.22.01003
UR  - https://ascopubs.org/doi/abs/10.1200/JCO.22.01003
UR  - http://hdl.handle.net/10044/1/97380
VL  - 40
ER  -

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