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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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Main Authors: Emens, Leisha Ann (Author) , Adams, S. (Author) , Barrios, C. H. (Author) , Diéras, V. (Author) , Iwata, H. (Author) , Loi, S. (Author) , Rugo, H. S. (Author) , Schneeweiss, Andreas (Author) , Winer, E. P. (Author) , Patel, S. (Author) , Henschel, V. (Author) , Swat, A. (Author) , Kaul, M. (Author) , Molinero, L. (Author) , Chui, S. Y. (Author) , Schmid, P. (Author)
Format: Article (Journal)
Language:English
Published: 1 July 2021
In: Annals of oncology
Year: 2021, Volume: 32, Issue: 8, Pages: 983-993
ISSN:1569-8041
DOI:10.1016/j.annonc.2021.05.355
Online Access: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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Author Notes: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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Summary: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.
Item Description:Gesehen am 02.11.2021
Physical Description:Online Resource
ISSN:1569-8041
DOI:10.1016/j.annonc.2021.05.355

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