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      Pharmacokinetics and clinical response to single agent rucaparib in a dialysis dependent patient with BRCA associated breast and recurrent ovarian cancer

      case-report
      Author(s): a , b , a , *
      Publication date (Electronic):
      Journal: Gynecologic Oncology Reports
      Publisher: Elsevier

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          Abstract

          A 56-year old woman with BRCA-associated breast cancer and recurrent ovarian cancer was treated with a poly (ADP-ribose) polymerase enzyme (PARP) inhibitor, rucaparib, in the setting of dialysis-dependence which required dose modification. Rucaparib trough levels were obtained before and after dialysis and a clinically significant disease response was appreciated.

          Highlights

          • •

            PARPi can be used safely in a dialysis dependent BRCA mutated patient with breast and ovarian cancer.

          • •

            PK levels below those described in clinical trials are associated with clinical benefit.

          • •

            Toxicities seen are similar to those in subjects with normal GFR.

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          Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas.

          Kathryn P Pennington, Tom Walsh, Maria I Harrell … (2014)
          Hallmarks of germline BRCA1/2-associated ovarian carcinomas include chemosensitivity and improved survival. The therapeutic impact of somatic BRCA1/2 mutations and mutations in other homologous recombination DNA repair genes is uncertain.
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            PARP inhibitor treatment in ovarian and breast cancer.

            Marcie Weil, Alice Chen (2011)
            Article 0 comments Cited 56 times – based on 0 reviews     Review now
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              FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer.

              Xing Wang, Kirsten B Goldberg, Rajeshwari Sridhara … (2017)
              On December 19, 2016, the FDA granted accelerated approval to rucaparib (RUBRACA; Clovis Oncology, Inc.) for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer who have been treated with two or more chemotherapies. The FDA also approved the FoundationFocus CDx BRCA test (Foundation Medicine, Inc.), the first next-generation sequencing-based companion diagnostic, for identifying patients with advanced ovarian cancer eligible for treatment with rucaparib based on detection of deleterious BRCA1 and/or BRCA2 mutations in tumor tissue. Rucaparib's approval was based primarily on efficacy data from 106 patients with BRCA mutation-associated ovarian cancer who had prior treatment with two or more chemotherapies and safety data from 377 patients with ovarian cancer treated with rucaparib 600 mg orally twice daily on two open-label, single-arm trials. Investigator-assessed objective response rate was 54% [57/106; 95% confidence interval (CI), 44-64], and median duration of response was 9.2 months (95% CI, 6.6-11.7). The approved companion diagnostic verified tumor BRCA mutation status retrospectively in 96% (64/67) of patients. Common adverse reactions (≥20%) to rucaparib were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. This article summarizes the FDA review and data supporting rucaparib's accelerated approval. Clin Cancer Res; 23(23); 1-6. ©2017 AACR.See related commentary by Kohn et al., p. xxx.
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                Author and article information

                Contributors
                William H. Bradley
                Journal
                Journal ID (nlm-ta): Gynecol Oncol Rep
                Journal ID (iso-abbrev): Gynecol Oncol Rep
                Title: Gynecologic Oncology Reports
                Publisher: Elsevier
                ISSN (Electronic): 2352-5789
                Publication date PMC-release: 28 October 2018
                Publication date Collection: November 2018
                Publication date (Electronic): 28 October 2018
                Volume: 26
                Pages: 91-93
                Affiliations
                [a ]Department of Obstetrics and Gynecology, Medical College of Wisconsin, United States
                [b ]Department of Pharmacy, Froedtert Hospital, United States
                Author notes
                [* ]Corresponding author at: Medical College of Wisconsin and Froedtert Hospital, Department of Obstetrics and Gynecology, 9200 West Wisconsin Avenue, Milwaukee, WI 53226, United States. wbradley@ 123456mcw.edu
                Article
                Publisher ID: S2352-5789(18)30100-0
                DOI: 10.1016/j.gore.2018.10.011
                PMC ID: 6223187
                PubMed ID: 30426062
                SO-VID: 69399068-96a7-4b70-8ca4-bad3f2e648f8
                Copyright © © 2018 Published by Elsevier Inc.
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 11 September 2018
                Date revision received : 23 October 2018
                Date accepted : 25 October 2018
                Categories
                Subject: Case Report

                Data availability:

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