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      First-line PARP inhibitors in ovarian cancer: summary of an ESMO Open - Cancer Horizons round-table discussion

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          Abstract

          Poly(ADP-ribose) polymerase (PARP) inhibitor maintenance therapy is the latest breakthrough in the management of newly diagnosed advanced ovarian cancer. The results of the SOLO-1 trial in 2018 led to European Medicines Agency and Food and Drug Administration approval of olaparib as first-line maintenance therapy in patients with BRCA1/2 mutation, establishing a new standard of care. Subsequently, the results of three phase III trials (PRIMA, PAOLA-1, VELIA) evaluating the use of first-line PARP inhibitors beyond patients with BRCA1/2 mutations and as combination strategies were presented in 2019, leading to the recent approval of maintenance niraparib irrespective of biomarker status and olaparib in combination with bevacizumab in homologous recombination deficiency-positive-associated advanced ovarian cancer. An ESMO Open - Cancer Horizons round-table expert panel discussed the four phase III trials of first-line PARP inhibitor therapy and how they are changing the clinical management of advanced ovarian cancer.

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          Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

          Kathleen Moore, Nicoletta Colombo, Giovanni Scambia … (2018)
          Most women with newly diagnosed advanced ovarian cancer have a relapse within 3 years after standard treatment with surgery and platinum-based chemotherapy. The benefit of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor olaparib in relapsed disease has been well established, but the benefit of olaparib as maintenance therapy in newly diagnosed disease is uncertain.
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            Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

            Antonio González-Martín, Bhavana Pothuri, Ignace Vergote … (2019)
            Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of BRCA mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to first-line platinum-based chemotherapy is unknown.
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              Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

              Mansoor R. Mirza, Bradley J. Monk, Jørn Herrstedt … (2016)
              Background Niraparib is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) 1/2 inhibitor that has shown clinical activity in patients with ovarian cancer. We sought to evaluate the efficacy of niraparib versus placebo as maintenance treatment for patients with platinum-sensitive, recurrent ovarian cancer. Methods In this randomized, double-blind, phase 3 trial, patients were categorized according to the presence or absence of a germline BRCA mutation (gBRCA cohort and non-gBRCA cohort) and the type of non-gBRCA mutation and were randomly assigned in a 2:1 ratio to receive niraparib (300 mg) or placebo once daily. The primary end point was progression-free survival. Results Of 553 enrolled patients, 203 were in the gBRCA cohort (with 138 assigned to niraparib and 65 to placebo), and 350 patients were in the non-gBRCA cohort (with 234 assigned to niraparib and 116 to placebo). Patients in the niraparib group had a significantly longer median duration of progression-free survival than did those in the placebo group, including 21.0 vs. 5.5 months in the gBRCA cohort (hazard ratio, 0.27; 95% confidence interval [CI], 0.17 to 0.41), as compared with 12.9 months vs. 3.8 months in the non-gBRCA cohort for patients who had tumors with homologous recombination deficiency (HRD) (hazard ratio, 0.38; 95% CI, 0.24 to 0.59) and 9.3 months vs. 3.9 months in the overall non-gBRCA cohort (hazard ratio, 0.45; 95% CI, 0.34 to 0.61; P<0.001 for all three comparisons). The most common grade 3 or 4 adverse events that were reported in the niraparib group were thrombocytopenia (in 33.8%), anemia (in 25.3%), and neutropenia (in 19.6%), which were managed with dose modifications. Conclusions Among patients with platinum-sensitive, recurrent ovarian cancer, the median duration of progression-free survival was significantly longer among those receiving niraparib than among those receiving placebo, regardless of the presence or absence of gBRCA mutations or HRD status, with moderate bone marrow toxicity. (Funded by Tesaro; ClinicalTrials.gov number, NCT01847274 .).
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                Author and article information

                Journal
                Journal ID (nlm-ta): ESMO Open
                Journal ID (iso-abbrev): ESMO Open
                Journal ID (hwp): esmoopen
                Journal ID (publisher-id): esmoopen
                Title: ESMO Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2059-7029
                Publication date Collection: 2020
                Publication date (Electronic): 11 December 2020
                Volume: 5
                Issue: 6
                Electronic Location Identifier: e001110
                Affiliations
                [1 ] departmentGynaecology Unit , The Royal Marsden NHS Foundation Trust and Institute of Cancer Research , London, UK
                [2 ] Clínica Universidad de Navarra , Madrid, Spain
                [3 ] departmentDepartment of Gynaecology and Gynaecological Oncology , Ev. Kliniken Essen-Mitte , Essen, Germany
                [4 ] departmentScientific Directorate and Gynecologic Oncology Unit , Fondazione Policlinico Universitario Agostino Gemelli , Rome, Italy
                [5 ] departmentStephenson Cancer Center , University of Oklahoma , Norman, Oklahoma, USA
                [6 ] departmentMedical Oncology Department , Vall d'Hebron Institute of Oncology (VHIO) , Barcelona, Spain
                [7 ] departmentUniversité Claude Bernard Lyon , Centre Leon Berard , Lyon, France
                Author notes
                [Correspondence to ] Dr Susana Banerjee; Susana.Banerjee@ 123456rmh.nhs.uk
                Article
                Publisher ID: esmoopen-2020-001110
                DOI: 10.1136/esmoopen-2020-001110
                PMC ID: 7783599
                PubMed ID: 33310779
                SO-VID: f06ae005-6146-4528-8e59-4f13c4b2c8ec
                Copyright © © Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, any changes made are indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 11 October 2020
                Date revision received : 16 November 2020
                Date accepted : 25 November 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004325, AstraZeneca;
                Award ID: Unrestricted educational grant for the roundtable
                Categories
                Subject: Review
                Subject: 1506
                Custom metadata
                special-feature unlocked

                Keywords: parp inhibitors,advanced ovarian cancer
                Data availability:
                Keywords: parp inhibitors, advanced ovarian cancer

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