dc.contributor.author | Røssevold, Andreas Hagen | |
dc.contributor.author | Andresen, Nikolai Kragøe | |
dc.contributor.author | Bjerre, Christina Annette | |
dc.contributor.author | Gilje, Bjørnar | |
dc.contributor.author | Jakobsen, Erik Hugger | |
dc.contributor.author | Raj, Sunil Xavier | |
dc.contributor.author | Falk, Ragnhild Sørum | |
dc.contributor.author | Russnes, Hege Elisabeth Giercksky | |
dc.contributor.author | Jahr, Thea | |
dc.contributor.author | Ruud, Randi Margit | |
dc.contributor.author | Lømo, Jon | |
dc.contributor.author | Garred, Øystein | |
dc.contributor.author | Chauhan, Sudhir Kumar | |
dc.contributor.author | Lereim, Ragnhild Reehorst | |
dc.contributor.author | Dunn, Claire | |
dc.contributor.author | Naume, Bjørn | |
dc.contributor.author | Kyte, Jon A | |
dc.date.accessioned | 2023-03-17T12:04:57Z | |
dc.date.available | 2023-03-17T12:04:57Z | |
dc.date.created | 2022-12-25T11:29:03Z | |
dc.date.issued | 2022 | |
dc.identifier.citation | Nature Medicine. 2022, 1-28. | en_US |
dc.identifier.issn | 1078-8956 | |
dc.identifier.uri | https://hdl.handle.net/11250/3059007 | |
dc.description.abstract | Immune checkpoint inhibitors have shown efficacy against metastatic triple-negative breast cancer (mTNBC) but only for PD-L1positive disease. The randomized, placebo-controlled ALICE trial (NCT03164993, 24 May 2017) evaluated the addition of atezolizumab (anti-PD-L1) to immune-stimulating chemotherapy in mTNBC. Patients received pegylated liposomal doxorubicin (PLD) and low-dose cyclophosphamide in combination with atezolizumab (atezo-chemo; n = 40) or placebo (placebo-chemo; n = 28). Primary endpoints were descriptive assessment of progression-free survival in the per-protocol population (>3 atezolizumab and >2 PLD doses; n = 59) and safety in the full analysis set (FAS; all patients starting therapy; n = 68). Adverse events leading to drug discontinuation occurred in 18% of patients in the atezo-chemo arm (7/40) and in 7% of patients in the placebo-chemo arm (2/28). Improvement in progression-free survival was indicated in the atezo-chemo arm in the per-protocol population (median 4.3 months versus 3.5 months; hazard ratio (HR) = 0.57; 95% confidence interval (CI) 0.33–0.99; log-rank P = 0.047) and in the FAS (HR = 0.56; 95% CI 0.33–0.95; P = 0.033). A numerical advantage was observed for both the PD-L1positive (n = 27; HR = 0.65; 95% CI 0.27–1.54) and PD-L1negative subgroups (n = 31; HR = 0.57, 95% CI 0.27–1.21). The progression-free proportion after 15 months was 14.7% (5/34; 95% CI 6.4–30.1%) in the atezo-chemo arm versus 0% in the placebo-chemo arm. The addition of atezolizumab to PLD/cyclophosphamide was tolerable with an indication of clinical benefit, and the findings warrant further investigation of PD1/PD-L1 blockers in combination with immunomodulatory chemotherapy. | en_US |
dc.language.iso | eng | en_US |
dc.publisher | Nature Portfolio | en_US |
dc.rights | Navngivelse 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/deed.no | * |
dc.title | Atezolizumab plus anthracycline-based chemotherapy in metastatic triple-negative breast cancer: the randomized, double-blind phase 2b ALICE trial | en_US |
dc.title.alternative | Atezolizumab plus anthracycline-based chemotherapy in metastatic triple-negative breast cancer: the randomized, double-blind phase 2b ALICE trial | en_US |
dc.type | Peer reviewed | en_US |
dc.type | Journal article | en_US |
dc.description.version | publishedVersion | en_US |
dc.source.pagenumber | 1-28 | en_US |
dc.source.journal | Nature Medicine | en_US |
dc.identifier.doi | 10.1038/s41591-022-02126-1 | |
dc.identifier.cristin | 2097357 | |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 2 | |