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Overall survival with maintenance olaparib in platinum-sensitive relapsed ovarian cancer by somatic or germline BRCA and homologous recombination repair mutation status
S. Pignata, A. Oza, G. Hall, B. Pardo, R. Madry, D. Cibula, J. Klat, A. Montes, R. Glasspool, N. Colombo, I. Pete, A. Herrero Ibáñez, M. Romeo, R. Ilieva, C. Timcheva, M. Di Maio, Z. Bashir, R. Taylor, A. Barnicle, A. Clamp
Language English Country England, Great Britain
Document type Clinical Trial, Phase IV, Journal Article, Multicenter Study
NLK
Open Access Digital Library
from 1947-01-01
Open Access Digital Library
from 1999-01-01
- MeSH
- Adult MeSH
- Phthalazines * administration & dosage therapeutic use adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Recurrence, Local * drug therapy genetics MeSH
- Ovarian Neoplasms * drug therapy genetics mortality pathology MeSH
- Poly(ADP-ribose) Polymerase Inhibitors * administration & dosage therapeutic use MeSH
- Piperazines * administration & dosage therapeutic use adverse effects MeSH
- BRCA1 Protein * genetics MeSH
- BRCA2 Protein * genetics MeSH
- Recombinational DNA Repair genetics MeSH
- Aged MeSH
- Germ-Line Mutation MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase IV MeSH
- Multicenter Study MeSH
BACKGROUND: The open-label, single-arm, multicentre ORZORA trial (NCT02476968) evaluated maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSR OC) with a germline (g) or somatic (s) BRCA1 and/or BRCA2 mutation (BRCAm) or a non-BRCA homologous recombination repair mutation (non-BRCA HRRm). METHODS: Patients were in response to platinum-based chemotherapy after ≥2 prior lines of treatment and underwent prospective central screening for tumour BRCA status, then central gBRCAm testing to determine sBRCAm or gBRCAm status. An exploratory cohort evaluated non-BRCA HRRm in 13 predefined genes. Patients received olaparib 400 mg (capsules) twice daily until investigator-assessed disease progression. Secondary endpoints included overall survival (OS) and safety. RESULTS: 177 patients received olaparib. At the final data cutoff (25 June 2021), median OS from study enrolment was 46.8 (95% confidence interval [CI] 37.9-54.4), 43.2 (31.7-NC [not calculated]), 47.4 (37.9-NC) and 44.9 (28.9-NC) months in the BRCAm, sBRCAm, gBRCAm and non-BRCA HRRm cohorts, respectively. No new safety signals were identified. CONCLUSION: Maintenance olaparib showed consistent clinical activity in the BRCAm and sBRCAm cohorts; exploratory analysis suggested similar activity in the non-BRCA HRRm cohort. These findings highlight that patients with PSR OC, beyond those with gBRCAm, may benefit from maintenance olaparib.
Department of Gynecologic Oncology Medical University Karol Marcinkowski Poznań Poland
Department of Gynecology National Institute of Cancer Budapest Hungary
Department of Oncology Cancer Centre Guy's and St Thomas' NHS Foundation Trust London UK
Department of Oncology University of Turin at Mauriziano Hospital Turin Italy
Division of Medical Oncology and Hematology Princess Margaret Cancer Centre Toronto ON Canada
Global Medical Affairs AstraZeneca Cambridge UK
GMA Payer Biometrics Oncology R and D AstraZeneca Cambridge UK
Leeds Institute of Medical Research St James's University Hospital Leeds UK
Medical Oncology Clinic MHAT Central Onco Hospital OOD Plovdiv Bulgaria
Medical Oncology Clinic MHAT for Women's Health Nadezhda OOD Sofia Bulgaria
Medical Oncology Department ICO Badalona Hospital Universitari Germans Trias i Pujol Badalona Spain
Servico de Oncología Médica Hospital Universitario Miguel Servet Zaragoza Spain
Translational Medicine Oncology R and D AstraZeneca Cambridge UK
References provided by Crossref.org
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- $a BACKGROUND: The open-label, single-arm, multicentre ORZORA trial (NCT02476968) evaluated maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer (PSR OC) with a germline (g) or somatic (s) BRCA1 and/or BRCA2 mutation (BRCAm) or a non-BRCA homologous recombination repair mutation (non-BRCA HRRm). METHODS: Patients were in response to platinum-based chemotherapy after ≥2 prior lines of treatment and underwent prospective central screening for tumour BRCA status, then central gBRCAm testing to determine sBRCAm or gBRCAm status. An exploratory cohort evaluated non-BRCA HRRm in 13 predefined genes. Patients received olaparib 400 mg (capsules) twice daily until investigator-assessed disease progression. Secondary endpoints included overall survival (OS) and safety. RESULTS: 177 patients received olaparib. At the final data cutoff (25 June 2021), median OS from study enrolment was 46.8 (95% confidence interval [CI] 37.9-54.4), 43.2 (31.7-NC [not calculated]), 47.4 (37.9-NC) and 44.9 (28.9-NC) months in the BRCAm, sBRCAm, gBRCAm and non-BRCA HRRm cohorts, respectively. No new safety signals were identified. CONCLUSION: Maintenance olaparib showed consistent clinical activity in the BRCAm and sBRCAm cohorts; exploratory analysis suggested similar activity in the non-BRCA HRRm cohort. These findings highlight that patients with PSR OC, beyond those with gBRCAm, may benefit from maintenance olaparib.
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