Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation

Litton, Jennifer K.; Rugo, Hope S.; Ettl, Johannes; Hurvitz, Sara A.; Gonçalves, Anthony; Lee, Kyung-Hun; Fehrenbacher, Louis; Yerushalmi, Rinat; Mina, Lida A.; Martin, Miguel; Roché, Henri; Im, Young-Hyuck; Quek, Ruben G.W.; Markova, Denka; Tudor, Iulia C.; Hannah, Alison L.; Eiermann, Wolfgang; Blum, Joanne L.

doi:10.1056/nejmoa1802905

Cited by 2,175PARP inhibition in cancer therapyBRCA gene mutations in cancerAdvanced Breast Cancer Therapies

Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation

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Litton, Jennifer K., Rugo, Hope S., Ettl, Johannes, Hurvitz, Sara A., Gonçalves, Anthony, Lee, Kyung-Hun, Fehrenbacher, Louis, Yerushalmi, Rinat +10 more·2018·New England Journal of Medicine

DOI 10.1056/nejmoa1802905PMC PMC10600918

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Abstract

BACKGROUND: The poly(adenosine diphosphate-ribose) inhibitor talazoparib has shown antitumor activity in patients with advanced breast cancer and germline mutations in BRCA1 and BRCA2 ( BRCA1/2). METHODS: We conducted a randomized, open-label, phase 3 trial in which patients with advanced breast cancer and a germline BRCA1/2 mutation were assigned, in a 2:1 ratio, to receive talazoparib (1 mg once daily) or standard single-agent therapy of the physician's choice (capecitabine, eribulin, gemcitabine, or vinorelbine in continuous 21-day cycles). The primary end point was progression-free survival, which was assessed by blinded independent central review. RESULTS: Of the 431 patients who underwent randomization, 287 were assigned to receive talazoparib and 144 were assigned to receive standard therapy. Median progression-free survival was significantly longer in the talazoparib group than in the standard-therapy group (8.6 months vs. 5.6 months; hazard ratio for disease progression or death, 0.54; 95% confidence interval [CI], 0.41 to 0.71; P<0.001). The interim median hazard ratio for death was 0.76 (95% CI, 0.55 to 1.06; P=0.11 [57% of projected events]). The objective response rate was higher in the talazoparib group than in the standard-therapy group (62.6% vs. 27.2%; odds ratio, 5.0; 95% CI, 2.9 to 8.8; P<0.001). Hematologic grade 3-4 adverse events (primarily anemia) occurred in 55% of the patients who received talazoparib and in 38% of the patients who received standard therapy; nonhematologic grade 3 adverse events occurred in 32% and 38% of the patients, respectively. Patient-reported outcomes favored talazoparib; significant overall improvements and significant delays in the time to clinically meaningful deterioration according to both the global health status-quality-of-life and breast symptoms scales were observed. CONCLUSIONS: Among patients with advanced breast cancer and a germline BRCA1/2 mutation, single-agent talazoparib provided a significant benefit over standard chemotherapy with respect to progression-free survival. Patient-reported outcomes were superior with talazoparib. (Funded by Medivation [Pfizer]; EMBRACA ClinicalTrials.gov number, NCT01945775 .).

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EMBRACA showed longer progression-free survival with talazoparib versus chemotherapy (8.6 vs 5.6 months, HR 0.54; 95% CI 0.41-0.71, P<0.0001) at a median follow-up of 11.2 months.
“At a median follow-up of 11.2 months, PFS was longer in the talazoparib arm (8.6 versus 5.6 months, HR 0.54; 95% CI 0.41-0.71, P < 0.0001).”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [77]

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Abstract P6-18-12: EMBRACA: Efficacy and safety of talazoparib or physician's choice of therapy in patients with advanced breast cancer and a germline BRCA1/2 mutation: A regional analysis
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Abstract GS6-07: EMBRACA: A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician's choice of therapy in patients with advanced breast cancer and a germline BRCA mutation
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Authors: Litton, J. K., Rugo, H. S., Ettl, J., Hurvitz, S. A., Gonçalves, A., Lee, K.-H., Fehrenbacher, L., Yerushalmi, R., Mina, L. A., Martin, M., Roché, H., Im, Y.-H., Quek, R. G. W., Markova, D., Tudor, I. C., Hannah, A. L., Eiermann, W., & Blum, J. L.
Affiliations: Kaiser Permanente (US)
From the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology–Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) — both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) — all in California; the...
ORCID: Litton, Jennifer K.
Rugo, Hope S.
Ettl, Johannes
Hurvitz, Sara A.
Lee, Kyung-Hun
Fehrenbacher, Louis
Yerushalmi, Rinat
Mina, Lida A.
Im, Young-Hyuck
Quek, Ruben G.W.
Tudor, Iulia C.
Blum, Joanne L.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2018-08-23
Volume: 379
Issue: 8
Pages: 753-763
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1802905
PMC: PMC10600918
OpenAlex: W2886477543
Cited by: 2,175
References: 14
Citations by year: 2026: 195 · 2025: 241 · 2024: 254 · 2023: 312 · 2022: 356 · 2021: 319 · 2020: 280 · 2019: 195 · 2018: 20 · 2017: 1 · 2016: 1
FWCI: 76.58
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
mediaTUM (Technical University of Munich) (submittedVersion)
Funders: Pfizer
Topics: Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › BRCA gene mutations in cancer
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
Keywords: PARP inhibitors, advanced breast cancer, germline BRCA1 mutation, germline BRCA2 mutation, progression-free survival, objective response rate, hematologic adverse events, anemia, patient-reported outcomes, quality of life, single-agent chemotherapy, capecitabine, eribulin, gemcitabine, vinorelbine, PARP inhibitor resistance, PARP inhibitor combination therapy
MeSH terms: Poly(ADP-ribose) Polymerase Inhibitors, Patient Reported Outcome Measures, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Breast Neoplasms, Female, Humans, Middle Aged, Phthalazines, Quality of Life, Survival Analysis, Germ-Line Mutation, Disease-Free Survival, Genes, BRCA1, Genes, BRCA2

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Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation

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