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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
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
Annals of Oncology, Volume 32, No. 8, Year 2021
Notification
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Description
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. © 2021 The Authors
Authors & Co-Authors
Miles, David W.
United Kingdom, Stevenage
East and North Hertfordshire Nhs Trust
Gligorov, Joseph
France, Paris
Sorbonne Université
André, Fabrice
France, Gif-sur-yvette
Université Paris-saclay
Cameron, David A.
United Kingdom, Edinburgh
The University of Edinburgh
Schneeweiß, Andreas
Germany, Heidelberg
German Cancer Research Center
Barrios, Carlos Henrique Escosteguy
Unknown Affiliation
Wardley, Andrew M.
United Kingdom, Manchester
The Christie Nhs Foundation Trust
Semiglazov, Vladimir Fedorovich
Russian Federation, Saint Petersburg
N.n. Petrov Research Institute of Oncology of the Ussr Ministry of Health
O'Shaughnessy, Joyce Ann
United States, Dallas
Texas Oncology
Zhang, Qingjiong
Unknown Affiliation
Wang, Xiuwen
Unknown Affiliation
Yan, Xiyun
Unknown Affiliation
Tong, Zhongsheng
Unknown Affiliation
Shen, Kunwei
Unknown Affiliation
De Laurentiis, Michelino
Unknown Affiliation
Santoro, Armando
Unknown Affiliation
Guarneri, Valentina
Unknown Affiliation
Colleoni, Marco Angelo
Unknown Affiliation
Cortesi, Laura Md
Unknown Affiliation
Gianni, Luca
Unknown Affiliation
Del Mastro, L. Md
Unknown Affiliation
Montemurro, Filippo
Unknown Affiliation
Bianchi, Giulia Valeria
Unknown Affiliation
Mailliez, Audrey
Unknown Affiliation
Trédan, Olívier
Unknown Affiliation
Dalenc, Florence
Unknown Affiliation
Perrin, Christophe
Unknown Affiliation
Dohollou, Nadine
Unknown Affiliation
Delaloge, Suzette
Unknown Affiliation
Spano, Jean Philippe
Unknown Affiliation
Hegg, Robberto
Unknown Affiliation
Schmidt, Marcus
Unknown Affiliation
Harbeck, Nadia
Unknown Affiliation
Schumacher, Claudia
Unknown Affiliation
Warner, Ellen
Unknown Affiliation
Robinson, Anne C.R.
Unknown Affiliation
Califaretti, Nadia
Unknown Affiliation
Yalçin, Bülent
Unknown Affiliation
Çiçin, Ïrfan
Unknown Affiliation
Doval, Dinesh Chandra
Unknown Affiliation
Brufsky, Adam M.
Unknown Affiliation
Tjulandin, Sergei A.
Unknown Affiliation
Eniu, Alexandru E.
Unknown Affiliation
Schenker, M.
Unknown Affiliation
Melichar, Bohuslav
Unknown Affiliation
Ŝufliarsky, Jozef
Unknown Affiliation
Belbaraka, Rhizlane
Unknown Affiliation
Errihani, Hassan H.
Unknown Affiliation
Aravantinos, Gerasimos
Unknown Affiliation
Podolski, Paula
Unknown Affiliation
Tabane, Keo
Unknown Affiliation
Statistics
Citations: 330
Authors: 51
Affiliations: 13
Identifiers
Doi:
10.1016/j.annonc.2021.05.801
ISSN:
09237534
Research Areas
Cancer
Disability
Environmental
Study Design
Cross Sectional Study