First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis
Background - Guidelines recommend atezolizumab plus nab-paclitaxel (A + nP) for first-line treatment of unresectable, locally advanced, or metastatic triple-negative breast cancer expressing programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (IC), based on IMpassion130. We report t...
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| Hauptverfasser: | , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
1 July 2021
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| In: |
Annals of oncology
Year: 2021, Jahrgang: 32, Heft: 8, Pages: 983-993 |
| ISSN: | 1569-8041 |
| DOI: | 10.1016/j.annonc.2021.05.355 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.annonc.2021.05.355 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753421015556 
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| Verfasserangaben: | L.A. Emens, S. Adams, C.H. Barrios, V. Diéras, H. Iwata, S. Loi, H.S. Rugo, A. Schneeweiss, E.P. Winer, S. Patel, V. Henschel, A. Swat, M. Kaul, L. Molinero, S. Patel, S.Y. Chui & P. Schmid |
MARC
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| 245 | 1 | 0 | |a First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis |c L.A. Emens, S. Adams, C.H. Barrios, V. Diéras, H. Iwata, S. Loi, H.S. Rugo, A. Schneeweiss, E.P. Winer, S. Patel, V. Henschel, A. Swat, M. Kaul, L. Molinero, S. Patel, S.Y. Chui & P. Schmid |
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| 500 | |a Gesehen am 02.11.2021 | ||
| 520 | |a Background - Guidelines recommend atezolizumab plus nab-paclitaxel (A + nP) for first-line treatment of unresectable, locally advanced, or metastatic triple-negative breast cancer expressing programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (IC), based on IMpassion130. We report the final overall survival (OS) and safety of that study as per the prespecified analysis plan. - Patients and methods - Patients were randomized to nP 100 mg/m2 (days 1, 8, and 15 of a 28-day cycle) with atezolizumab 840 mg (A + nP) or placebo (P + nP; days 1 and 15), until progression or unacceptable toxicity. Coprimary endpoints were progression-free survival [intention-to-treat (ITT) and PD-L1 IC-positive populations] and OS (tested hierarchically in the ITT population and, if significant, in the PD-L1 IC-positive population). - Results - Each arm comprised 451 patients; 666 (73.8%) had died by the final OS analysis cut-off (median follow-up, 18.8 months; interquartile range, 8.9-34.7 months). Median OS in the ITT population was 21.0 months [95% confidence interval (CI), 19.0-23.4 months] with A + nP, and 18.7 months (95% CI, 16.9-20.8 months) with P + nP [stratified hazard ratio (HR), 0.87; 95% CI, 0.75-1.02; P = 0.077]. Exploratory analysis in the PD-L1 IC-positive population showed a median OS of 25.4 months (95% CI, 19.6-30.7 months) with A + nP (n = 185) and 17.9 months (95% CI, 13.6-20.3 months) with P + nP (n = 184; stratified HR, 0.67; 95% CI, 0.53-0.86). Safety outcomes were consistent with previous analyses and the known toxicity profiles of each agent. Immune-mediated adverse events of special interest were reported in 58.7% and 41.6% of patients treated with A + nP and P + nP, respectively. - Conclusion - Although the OS benefit in the ITT population was not statistically significant, precluding formal testing, clinically meaningful OS benefit was observed with A + nP in PD-L1 IC-positive patients, consistent with prior interim analyses. This combination remained safe and tolerable with longer follow-up. | ||
| 650 | 4 | |a atezolizumab | |
| 650 | 4 | |a first-line treatment | |
| 650 | 4 | |a immune checkpoint inhibitor | |
| 650 | 4 | |a metastatic | |
| 650 | 4 | |a nab-paclitaxel | |
| 650 | 4 | |a triple-negative breast cancer | |
| 700 | 1 | |a Adams, S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Barrios, C. H. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Diéras, V. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Iwata, H. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Loi, S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Rugo, H. S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Schneeweiss, Andreas |d 1961- |e VerfasserIn |0 (DE-588)109972554 |0 (DE-627)632849630 |0 (DE-576)327251859 |4 aut | |
| 700 | 1 | |a Winer, E. P. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Patel, S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Henschel, V. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Swat, A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kaul, M. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Molinero, L. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Chui, S. Y. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Schmid, P. |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Annals of oncology |d Amsterdam [u.a.] : Elsevier, 1990 |g 32(2021), 8 vom: Aug., Seite 983-993 |h Online-Ressource |w (DE-627)320428796 |w (DE-600)2003498-2 |w (DE-576)098134345 |x 1569-8041 |7 nnas |a First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis |
| 773 | 1 | 8 | |g volume:32 |g year:2021 |g number:8 |g month:08 |g pages:983-993 |g extent:11 |a First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis |
| 787 | 0 | 8 | |i Errata |a Emens, Leisha Ann |t Corrigendum to "First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer IMpassion130 final overall survival analysis" |d 2021 |w (DE-627)1788427807 |
| 787 | 0 | 8 | |i Errata |a Emens, Leisha Ann |t Corrigendum to "First-line atezolizumab plus nab-paclitaxel for unresectable locally advanced or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis" |d 2021 |w (DE-627)1788429648 |
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