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Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
Open accessAbstract
BACKGROUND: Unresectable locally advanced or metastatic triple-negative (hormone-receptor-negative and human epidermal growth factor receptor 2 [HER2]-negative) breast cancer is an aggressive disease with poor outcomes. Nanoparticle albumin-bound (nab)-paclitaxel may enhance the anticancer activity of atezolizumab. METHODS: In this phase 3 trial, we randomly assigned (in a 1:1 ratio) patients with untreated metastatic triple-negative breast cancer to receive atezolizumab plus nab-paclitaxel or placebo plus nab-paclitaxel; patients continued the intervention until disease progression or an unacceptable level of toxic effects occurred. Stratification factors were the receipt or nonreceipt of neoadjuvant or adjuvant taxane therapy, the presence or absence of liver metastases at baseline, and programmed death ligand 1 (PD-L1) expression at baseline (positive vs. negative). The two primary end points were progression-free survival (in the intention-to-treat population and PD-L1-positive subgroup) and overall survival (tested in the intention-to-treat population; if the finding was significant, then it would be tested in the PD-L1-positive subgroup). RESULTS: Each group included 451 patients (median follow-up, 12.9 months). In the intention-to-treat analysis, the median progression-free survival was 7.2 months with atezolizumab plus nab-paclitaxel, as compared with 5.5 months with placebo plus nab-paclitaxel (hazard ratio for progression or death, 0.80; 95% confidence interval [CI], 0.69 to 0.92; P=0.002); among patients with PD-L1-positive tumors, the median progression-free survival was 7.5 months and 5.0 months, respectively (hazard ratio, 0.62; 95% CI, 0.49 to 0.78; P<0.001). In the intention-to-treat analysis, the median overall survival was 21.3 months with atezolizumab plus nab-paclitaxel and 17.6 months with placebo plus nab-paclitaxel (hazard ratio for death, 0.84; 95% CI, 0.69 to 1.02; P=0.08); among patients with PD-L1-positive tumors, the median overall survival was 25.0 months and 15.5 months, respectively (hazard ratio, 0.62; 95% CI, 0.45 to 0.86). No new adverse effects were identified. Adverse events that led to the discontinuation of any agent occurred in 15.9% of the patients who received atezolizumab plus nab-paclitaxel and in 8.2% of those who received placebo plus nab-paclitaxel. CONCLUSIONS: Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patients with metastatic triple-negative breast cancer in both the intention-to-treat population and the PD-L1-positive subgroup. Adverse events were consistent with the known safety profiles of each agent. (Funded by F. Hoffmann-La Roche/Genentech; IMpassion130 ClinicalTrials.gov number, NCT02425891 .).
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“Thus, PD-L1 status by SP142 is the companion test for the use of atezolizumab in combination with a taxane for first-line therapy in triple-negative ABC, with a cut-off of 1% positive staining on immune cells.”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]
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“an analysis was conducted and presented, and showed an OS of 25 months versus 15.1 months favouring the atezolizumab arm.”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]
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“In the PD-L1 positive group, atezolizumab provided a PFS benefit of 7.5 versus 5 months with a HR of 0.62 (95% CI 0.49-0.78, P < 0.001).”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]
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“In the ITT population, atezolizumab provided a benefit in PFS of 7.2 versus 5.5 months with a HR of 0.8 (95% CI 0.69-0.92, P = 0.002).”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]
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“In the ITT population, there was no significant benefit in OS with the addition of atezolizumab; median OS was 21.3 months versus 17.6 months (HR 0.84; 95% CI 0.69-1.02, P = 0.08).”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [68]
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“to date, atezolizumab, in combination with chemotherapy, has been approved by the FDA for the treatment of squamous and nonsquamous NSCLC, small cell lung cancer, and PD-L1-positive triple-negative breast cancer (66)(67)(68)(69).”
From Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance (2021) · cites this paper as [69]
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- Adams S Diamond JR Hamilton E et al. Atezolizumab plus nab-paclitaxel in the treatment of metastatic triple-negative breast cancer with 2-year survival follow-up: a phase 1b clinical trial. JAMA Oncol (in press).
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Metadata
- Authors
- Schmid, P., Adams, S., Rugo, H. S., Schneeweiss, A., Barrios, C. H., Iwata, H., Diéras, V., Hegg, R., Im, S.-A., Shaw Wright, G., Henschel, V., Molinero, L., Chui, S. Y., Funke, R., Husain, A., Winer, E. P., Loi, S., & Emens, L. A.
- Affiliations
- Queen Mary University of London (GB)
- From the Barts Cancer Institute, Queen Mary University of London, London (P.S.); Perlmutter Cancer Center, New York University School of Medicine, New York (S.A.); the Department of Medicine, University of California, San Francisco, San Francisco (H.S.R.), and Genentech, South San Francisco (L.M., S.Y.C., R.F.) — both in California; University Hospital Heidelberg, Heidelberg, Germany (A.S.); Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul,...
- Seoul National University (KR)
- F. Hoffmann-La Roche AG (CH)
- The University of Melbourne (AU)
- Johns Hopkins University (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-11-29
- Volume
- 379
- Issue
- 22
- Pages
- 2108-2121
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2897422388
- Cited by
- 4,350
- References
- 32
- Citations by year
- 2026: 310 · 2025: 409 · 2024: 453 · 2023: 562 · 2022: 648 · 2021: 825 · 2020: 723 · 2019: 397 · 2018: 17
- FWCI
- 148.10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- F. Hoffmann-La Roche/Genentech
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
- Keywords
- atezolizumab, nab-paclitaxel, triple-negative breast cancer, metastatic breast cancer, PD-L1 expression, immune checkpoint inhibitors, combination chemotherapy, progression-free survival, overall survival, liver metastasis, immune-related adverse events, PD-1/PD-L1 inhibitors
- MeSH terms
- Progression-Free Survival, Adult, Aged, Albumins, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Middle Aged, Survival Analysis, Paclitaxel, Intention to Treat Analysis, Antibodies, Monoclonal, Humanized, Triple Negative Breast Neoplasms
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