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Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Background - In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-bound-paclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed...

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Hauptverfasser: Miles, David W. (VerfasserIn) , Gligorov, J. (VerfasserIn) , André, F. (VerfasserIn) , Cameron, D. (VerfasserIn) , Schneeweiss, Andreas (VerfasserIn) , Barrios, C. (VerfasserIn) , Xu, B. (VerfasserIn) , Wardley, A. (VerfasserIn) , Kaen, D. (VerfasserIn) , Andrade, L. (VerfasserIn) , Semiglazov, V. (VerfasserIn) , Reinisch, M. (VerfasserIn) , Patel, S. (VerfasserIn) , Patre, M. (VerfasserIn) , Morales, L. (VerfasserIn) , Patel, S. L. (VerfasserIn) , Kaul, M. (VerfasserIn) , Barata, T. (VerfasserIn) , O’Shaughnessy, J. (VerfasserIn) , Zhang, Q. (VerfasserIn) , Shao, Z. (VerfasserIn) , Wang, X. (VerfasserIn) , Geng, C. (VerfasserIn) , Yan, X. (VerfasserIn) , Tong, Z. (VerfasserIn) , Shen, K. (VerfasserIn) , Yin, Y. (VerfasserIn) , Sun, T. (VerfasserIn) , Yang, J. (VerfasserIn) , Feng, J. (VerfasserIn) , Yan, M. (VerfasserIn) , Wang, Y. (VerfasserIn) , Liu, Q. (VerfasserIn) , Zhang, S. (VerfasserIn) , De Laurentiis, M. (VerfasserIn) , Santoro, A. (VerfasserIn) , Guarneri, V. (VerfasserIn) , Colleoni, M. (VerfasserIn) , Natoli, C. (VerfasserIn) , Cortesi, L. (VerfasserIn) , Placido, S. (VerfasserIn) , Gianni, L. (VerfasserIn) , Ferrau, F. (VerfasserIn) , Livi, L. (VerfasserIn) , Zambelli, A. (VerfasserIn) , Del Mastro, L. (VerfasserIn) , Tonini, G. (VerfasserIn) , Montemurro, F. (VerfasserIn) , Bianchi, G. (VerfasserIn) , Pedersini, R. (VerfasserIn) , Prete, S. (VerfasserIn) , Allegrini, G. (VerfasserIn) , Naso, G. (VerfasserIn) , Vici, P. (VerfasserIn) , Loirat, D. (VerfasserIn) , Mailliez, A. (VerfasserIn) , Priou, F. (VerfasserIn) , Tredan, O. (VerfasserIn) , Dalenc, F. (VerfasserIn) , Perrin, C. (VerfasserIn) , Timar David, M. (VerfasserIn) , Dohollou, N. (VerfasserIn) , Teixeira, L. (VerfasserIn) , Brocard, F. (VerfasserIn) , Arnaud, A. (VerfasserIn) , Delaloge, S. (VerfasserIn) , Spano, J. -P. (VerfasserIn) , Mansi, L. (VerfasserIn) , Damian, F. (VerfasserIn) , Pedrini, J. (VerfasserIn) , Aleixo, S. (VerfasserIn) , Hegg, R. (VerfasserIn) , Junior, R. (VerfasserIn) , Schmidt, M. (VerfasserIn) , Wenzel, C. (VerfasserIn) , Grischke, E. -M. (VerfasserIn) , Schneeweiss, A. (VerfasserIn) , Just, M. (VerfasserIn) , Harbeck, N. (VerfasserIn) , Schumacher, C. (VerfasserIn) , Peters, U. (VerfasserIn) , Fischer, D. (VerfasserIn) , Forstbauer, H. (VerfasserIn) , Liersch, R. (VerfasserIn) , Warner, E. (VerfasserIn) , Bouganim, N. (VerfasserIn) , Doyle, C. (VerfasserIn) , Price Hiller, J. (VerfasserIn) , Vandenberg, T. (VerfasserIn) , Pavic, M. (VerfasserIn) , Robinson, A. (VerfasserIn) , Roldan Urgoiti, G. (VerfasserIn) , Califaretti, N. (VerfasserIn) , Alacacioglu, A. (VerfasserIn) , Gumus, M. (VerfasserIn) , Yalcin, B. (VerfasserIn) , Cicin, I. (VerfasserIn) , Kose, F. (VerfasserIn) , Uygun, K. (VerfasserIn) , Kaplan, M. (VerfasserIn) , Cubukcu, E. (VerfasserIn) , Harries, M. (VerfasserIn) , Miles, D. (VerfasserIn) , Doval, D. (VerfasserIn) , Gupta, S. (VerfasserIn) , Mohapatra, P. (VerfasserIn) , Chatterjee, S. (VerfasserIn) , Ghadyalpatil, N. (VerfasserIn) , Singhal, M. (VerfasserIn) , Nag, S. (VerfasserIn) , Agarwal, A. (VerfasserIn) , Wolf, I. (VerfasserIn) , Gal Yam, E. (VerfasserIn) , Yerushalmi, R. (VerfasserIn) , Peretz, T. (VerfasserIn) , Fried, G. (VerfasserIn) , Ben Baruch, N. (VerfasserIn) , Katz, D. (VerfasserIn) , Hamilton, E. (VerfasserIn) , Kayali, F. (VerfasserIn) , Brufsky, A. (VerfasserIn) , Telli, M. (VerfasserIn) , Wright, G. (VerfasserIn) , Oyola, R. (VerfasserIn) , Rakowski, T. (VerfasserIn) , Graff, S. (VerfasserIn) , Tjulandin, S. (VerfasserIn) , Aparicio, A. (VerfasserIn) , Ruiz Borrego, M. (VerfasserIn) , Merino, L. (VerfasserIn) , Guerra Martinez, J. (VerfasserIn) , Lopez, E. (VerfasserIn) , Yamashita, T. (VerfasserIn) , Ohtani, S. (VerfasserIn) , Inoue, K. (VerfasserIn) , Ito, Y. (VerfasserIn) , Niikura, N. (VerfasserIn) , Nakayama, T. (VerfasserIn) , Sagara, Y. (VerfasserIn) , Yanagita, Y. (VerfasserIn) , Kamada, Y. (VerfasserIn) , Kaneko, K. (VerfasserIn) , Nervo, A. (VerfasserIn) , Eniu, A. (VerfasserIn) , Schenker, M. (VerfasserIn) , Priester, P. (VerfasserIn) , Melichar, B. (VerfasserIn) , Zimovjanova, M. (VerfasserIn) , Sormova, P. (VerfasserIn) , Sufliarsky, J. (VerfasserIn) , Kakalejcik, M. (VerfasserIn) , Belbaraka, R. (VerfasserIn) , Errihani, H. (VerfasserIn) , Le Than, D. (VerfasserIn) , Pham, D. (VerfasserIn) , Aravantinos, G. (VerfasserIn) , Papadimitriou, C. (VerfasserIn) , Koumakis, G. (VerfasserIn) , Papandreou, C. (VerfasserIn) , Podolski, P. (VerfasserIn) , Tabane, K. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 1 July 2021
In: Annals of oncology
Year: 2021, Jahrgang: 32, Heft: 8, Pages: 994-1004
ISSN:1569-8041
DOI:10.1016/j.annonc.2021.05.801
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.annonc.2021.05.801
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753421020263
Volltext
Verfasserangaben:D. Miles, J. Gligorov, F. André, D. Cameron, A. Schneeweiss, C. Barrios, B. Xu, A. Wardley, D. Kaen, L. Andrade, V. Semiglazov, M. Reinisch, S. Patel, M. Patre, L. Morales, S.L. Patel, M. Kaul, T. Barata & J.O’Shaughnessy, on behalf of the IMpassion131 investigators

MARC

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100 1 |a Miles, David W.  |e VerfasserIn  |0 (DE-588)1244965286  |0 (DE-627)1776049624  |4 aut 
245 1 0 |a Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer  |c D. Miles, J. Gligorov, F. André, D. Cameron, A. Schneeweiss, C. Barrios, B. Xu, A. Wardley, D. Kaen, L. Andrade, V. Semiglazov, M. Reinisch, S. Patel, M. Patre, L. Morales, S.L. Patel, M. Kaul, T. Barata & J.O’Shaughnessy, on behalf of the IMpassion131 investigators 
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520 |a Background - In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-bound-paclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed death-ligand 1 (PD-L1)-positive populations, and a clinically meaningful overall survival (OS) effect in PD-L1-positive aTNBC. The phase III KEYNOTE-355 trial adding pembrolizumab to chemotherapy for aTNBC showed similar PFS effects. IMpassion131 evaluated first-line atezolizumab-paclitaxel in aTNBC. - Patients and methods - Eligible patients [no prior systemic therapy or ≥12 months since (neo)adjuvant chemotherapy] were randomised 2:1 to atezolizumab 840 mg or placebo (days 1, 15), both with paclitaxel 90 mg/m2 (days 1, 8, 15), every 28 days until disease progression or unacceptable toxicity. Stratification factors were tumour PD-L1 status, prior taxane, liver metastases and geographical region. The primary endpoint was investigator-assessed PFS, tested hierarchically first in the PD-L1-positive [immune cell expression ≥1%, VENTANA PD-L1 (SP142) assay] population, and then in the ITT population. OS was a secondary endpoint. - Results - Of 651 randomised patients, 45% had PD-L1-positive aTNBC. At the primary PFS analysis, adding atezolizumab to paclitaxel did not improve investigator-assessed PFS in the PD-L1-positive population [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.60-1.12; P = 0.20; median PFS 6.0 months with atezolizumab-paclitaxel versus 5.7 months with placebo-paclitaxel]. In the PD-L1-positive population, atezolizumab-paclitaxel was associated with more favourable unconfirmed best overall response rate (63% versus 55% with placebo-paclitaxel) and median duration of response (7.2 versus 5.5 months, respectively). Final OS results showed no difference between arms (HR 1.11, 95% CI 0.76-1.64; median 22.1 months with atezolizumab-paclitaxel versus 28.3 months with placebo-paclitaxel in the PD-L1-positive population). Results in the ITT population were consistent with the PD-L1-positive population. The safety profile was consistent with known effects of each study drug. - Conclusion - Combining atezolizumab with paclitaxel did not improve PFS or OS versus paclitaxel alone. - ClinicalTrials.gov - NCT03125902. 
650 4 |a advanced breast cancer 
650 4 |a atezolizumab 
650 4 |a immune checkpoint inhibitor 
650 4 |a paclitaxel 
650 4 |a PD-L1 
650 4 |a triple-negative breast cancer 
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700 1 |a Barrios, C.  |e VerfasserIn  |4 aut 
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700 1 |a Semiglazov, V.  |e VerfasserIn  |4 aut 
700 1 |a Reinisch, M.  |e VerfasserIn  |4 aut 
700 1 |a Patel, S.  |e VerfasserIn  |4 aut 
700 1 |a Patre, M.  |e VerfasserIn  |4 aut 
700 1 |a Morales, L.  |e VerfasserIn  |4 aut 
700 1 |a Patel, S. L.  |e VerfasserIn  |4 aut 
700 1 |a Kaul, M.  |e VerfasserIn  |4 aut 
700 1 |a Barata, T.  |e VerfasserIn  |4 aut 
700 1 |a O’Shaughnessy, J.  |e VerfasserIn  |4 aut 
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773 1 8 |g volume:32  |g year:2021  |g number:8  |g pages:994-1004  |g extent:11  |a Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer 
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856 4 0 |u https://www.sciencedirect.com/science/article/pii/S0923753421020263  |x Verlag  |z lizenzpflichtig  |3 Volltext 
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