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TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes
Open accessAbstract
PURPOSE: Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved for the treatment of human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer (MBC) in germline (g) BRCA1/ 2 mutation carriers. Olaparib Expanded, an investigator-initiated, phase II study, assessed olaparib response in patients with MBC with somatic (s) BRCA1/ 2 mutations or g/s mutations in homologous recombination (HR)–related genes other than BRCA1/2. METHODS: Eligible patients had MBC with measurable disease and germline mutations in non- BRCA1/ 2 HR-related genes (cohort 1) or somatic mutations in these genes or BRCA1/ 2 (cohort 2). Prior PARPi, platinum-refractory disease, or progression on more than two chemotherapy regimens (metastatic setting) was not allowed. Patients received olaparib 300 mg orally twice a day until progression. A single-arm, two-stage design was used. The primary endpoint was objective response rate (ORR); the null hypothesis (≤ 5% ORR) would be rejected within each cohort if there were four or more responses in 27 patients. Secondary endpoints included clinical benefit rate and progression-free survival (PFS). RESULTS: Fifty-four patients enrolled. Seventy-six percent had estrogen receptor–positive HER2-negative disease. Eighty-seven percent had mutations in PALB2, s BRCA1/ 2, ATM, or CHEK2. In cohort 1, ORR was 33% (90% CI, 19% to 51%) and in cohort 2, 31% (90% CI, 15% to 49%). Confirmed responses were seen only with g PALB2 (ORR, 82%) and s BRCA1/ 2 (ORR, 50%) mutations. Median PFS was 13.3 months (90% CI, 12 months to not available/computable [NA]) for g PALB2 and 6.3 months (90% CI, 4.4 months to NA) for s BRCA1/ 2 mutation carriers. No responses were observed with ATM or CHEK2 mutations alone. CONCLUSION: PARP inhibition is an effective treatment for patients with MBC and g PALB2 or s BRCA1/ 2 mutations, significantly expanding the population of patients with breast cancer likely to benefit from PARPi beyond g BRCA1/ 2 mutation carriers. These results emphasize the value of molecular characterization for treatment decisions in MBC.
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Self-citationOlaparib for Metastatic Castration-Resistant Prostate Cancer
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The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer
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Metadata
- Authors
- Tung, N. M., Robson, M. E., Ventz, S., Santa-Maria, C. A., Nanda, R., Marcom, P. K., Shah, P. D., Ballinger, T. J., Yang, E. S., Vinayak, S., Melisko, M., Brufsky, A., DeMeo, M., Jenkins, C., Domchek, S., D’Andrea, A., Lin, N. U., Hughes, M. E., Carey, L. A., Wagle, N., Wulf, G. M., Krop, I. E., Wolff, A. C., Winer, E. P., & Garber, J. E.
- Venue
- Journal of Clinical Oncology
- Published
- 2020-12-20
- Volume
- 38
- Issue
- 36
- Pages
- 4274-4282
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W3095107109
- Cited by
- 508
- References
- 32
- FWCI
- 24.14
- Type
- journal article
- Language
- en
- Open access
- green
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- Tung, N. M., Robson, M. E., Ventz, S., Santa-Maria, C. A., Nanda, R., Marcom, P. K., Shah, P. D., Ballinger, T. J., Yang, E. S., Vinayak, S., Melisko, M., Brufsky, A., DeMeo, M., Jenkins, C., Domchek, S., D’Andrea, A., Lin, N. U., Hughes, M. E., Carey, L. A., . . . Garber, J. E. (2020). TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes. Journal of Clinical Oncology. https://doi.org/10.1200/jco.20.02151
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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