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Search: WFRF:(McNeish Iain A) > (2020-2022) > A Randomized, Phase...

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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)

Monk, Bradley J. (author)
Univ Arizona, AZ USA
Parkinson, Christine (author)
Addenbrookes Hosp, England
Lim, Myong Cheol (author)
Natl Canc Ctr Korea, South Korea
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OMalley, David M. (author)
Ohio State Univ, OH 43210 USA
Oaknin, Ana (author)
Hosp Univ Vall dHebron, Spain
Wilson, Michelle K. (author)
Auckland City Hosp, New Zealand
Coleman, Robert L. (author)
US Oncol Res, TX USA
Lorusso, Domenica (author)
Fdn Policlin Univ A Gemelli IRCCS, Italy; Univ Cattolica Sacro Cuore, Italy
Bessette, Paul (author)
Univ Sherbrooke, Canada
Ghamande, Sharad (author)
Augusta Univ, GA USA
Christopoulou, Athina (author)
St Andrews Gen Hosp, Greece
Provencher, Diane (author)
Ctr Hosp Univ Montreal CHUM, Canada; Ctr Hosp Univ Montreal CHUM, Canada
Prendergast, Emily (author)
Minnesota Oncol, MN USA; MetroMinnesota Community Oncol Res Consortium, MN USA
Demirkiran, Fuat (author)
Istanbul Univ, Turkey
Mikheeva, Olga (author)
Ltd Liabil Co MedPomosch, Russia
Yeku, Oladapo (author)
Harvard Med Sch, MA 02115 USA
Chudecka-Glaz, Anita (author)
Pomeranian Med Univ, Poland
Schenker, Michael (author)
Sfantul Nectarie Oncol Ctr, Romania
Littell, Ramey D. (author)
Kaiser Permanente Northern Calif, CA USA
Safra, Tamar (author)
Tel Aviv Univ, Israel; Tel Aviv Univ, Israel
Chou, Hung-Hsueh (author)
Chang Gung Mem Hosp Linkou, Taiwan; Natl Tsing Hua Univ, Taiwan
Morgan, Mark A. (author)
Univ Penn Hlth Syst, PA USA
Drochytek, Vit (author)
Charles Univ Prague, Czech Republic
Barlin, Joyce N. (author)
Albany Med Coll, NY 12208 USA
Van Gorp, Toon (author)
Univ Hosp Leuven, Belgium
Ueland, Fred (author)
Univ Kentucky, KY USA
Lindahl, Gabriel (author)
Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US,Nord Soc Gynaecol Oncol, Denmark
Anderson, Charles (author)
Willamette Valley Canc Inst & Res Ctr, OR USA
Collins, Dearbhaile C. (author)
Cork Univ Hosp, Ireland; Cork Univ Hosp, Ireland
Moore, Kathleen (author)
Univ Oklahoma, OK USA
Marme, Frederik (author)
Univ Hosp Mannheim, Germany; Univ Hosp Mannheim, Germany
Westin, Shannon N. (author)
Univ Texas MD Anderson Canc Ctr, TX 77030 USA
McNeish, Iain A. (author)
Imperial Coll London, England
Shih, Danny (author)
Clovis Oncol Inc, CO USA
Lin, Kevin K. (author)
Clovis Oncol Inc, CO USA
Goble, Sandra (author)
Clovis Oncol Inc, CO USA
Hume, Stephanie (author)
Clovis Oncol Inc, CO USA
Fujiwara, Keiichi (author)
Saitama Med Univ, Japan
Kristeleit, Rebecca S. (author)
Guys & St Thomas NHS Fdn Trust, England
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 (creator_code:org_t)
Lippincott, Williams & Wilkins, 2022
2022
English.
In: Journal of Clinical Oncology. - : Lippincott, Williams & Wilkins. - 0732-183X .- 1527-7755. ; 40:34, s. 3952-3964
Related links:
https://liu.diva-por... (primary) (Raw object)
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https://urn.kb.se/re...
https://doi.org/10.1...
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • PURPOSEATHENA (ClinicalTrials.gov identifier: ) 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.METHODSPatients 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.RESULTSAs 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 & GE; 3 treatment-emergent adverse events were anemia (rucaparib, 28.7% v placebo, 0%) and neutropenia (14.6% v 0.9%).CONCLUSIONRucaparib monotherapy is effective as first-line maintenance, conferring significant benefit versus placebo in patients with advanced ovarian cancer with and without HRD.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

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