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IMpassion132 double-blind randomised phase III trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer
DC Field | Value | Language |
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dc.contributor.author | Dent, R. | - |
dc.contributor.author | Andre, F. | - |
dc.contributor.author | Goncalves, A. | - |
dc.contributor.author | Martin, M. | - |
dc.contributor.author | Schmid, P. | - |
dc.contributor.author | Schutz, F. | - |
dc.contributor.author | Kummel, S. | - |
dc.contributor.author | Swain, S.M. | - |
dc.contributor.author | Bilici, A. | - |
dc.contributor.author | Loirat, D. | - |
dc.contributor.author | Villalobos, Valencia R. | - |
dc.contributor.author | Im, S.-A. | - |
dc.contributor.author | Park, Y.H. | - |
dc.contributor.author | De, Laurentis M. | - |
dc.contributor.author | Colleoni, M. | - |
dc.contributor.author | Guarneri, V. | - |
dc.contributor.author | Bianchini, G. | - |
dc.contributor.author | Li, H. | - |
dc.contributor.author | Kirchmayer, Machackova Z. | - |
dc.contributor.author | Mouta, J. | - |
dc.contributor.author | Deurloo, R. | - |
dc.contributor.author | Gan, X. | - |
dc.contributor.author | Fan, M. | - |
dc.contributor.author | Mani, A. | - |
dc.contributor.author | Swat, A. | - |
dc.contributor.author | Cortes, J. | - |
dc.date.accessioned | 2024-08-08T01:19:20Z | - |
dc.date.available | 2024-08-08T01:19:20Z | - |
dc.date.created | 2024-07-24 | - |
dc.date.issued | 2024-07 | - |
dc.identifier.citation | Annals of Oncology, Vol.35 No.7, pp.630-642 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://hdl.handle.net/10371/205028 | - |
dc.description.abstract | Background: Immune checkpoint inhibitors improve the efficacy of first-line chemotherapy for patients with programmed death-ligand 1 (PD-L1)-positive unresectable locally advanced/metastatic triple-negative breast cancer (aTNBC), but randomised data in rapidly relapsing aTNBC are scarce. Patients and methods: IMpassion132 (NCT03371017) enrolled patients with aTNBC relapsing <12 months after last chemotherapy dose (anthracycline and taxane required) or surgery for early TNBC. PD-L1 status was centrally assessed using SP142 before randomisation. Initially patients were enrolled irrespective of PD-L1 status. From August 2019, enrolment was restricted to PD-L1-positive (tumour immune cell ≥1%) aTNBC. Patients were randomised 1:1 to placebo or atezolizumab 1200 mg every 21 days with investigator-selected chemotherapy until disease progression or unacceptable toxicity. Stratification factors were chemotherapy regimen (carboplatin plus gemcitabine or capecitabine monotherapy), visceral (lung and/or liver) metastases and (initially) PD-L1 status. The primary endpoint was overall survival (OS), tested hierarchically in patients with PD-L1-positive tumours and then, if positive, in the modified intent-to-treat (mITT) population (all-comer patients randomised pre-August 2019). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR) and safety. Results: Among 354 patients with rapidly relapsing PD-L1-positive aTNBC, 68% had a disease-free interval of <6 months and 73% received carboplatin/gemcitabine. The OS hazard ratio was 0.93 (95% confidence interval 0.73-1.20, P = 0.59; median 11.2 months with placebo versus 12.1 months with atezolizumab). mITT and subgroup results were consistent. Median PFS was 4 months across treatment arms and populations. ORRs were 28% with placebo versus 40% with atezolizumab. Adverse events (predominantly haematological) were similar between arms and as expected with atezolizumab plus carboplatin/gemcitabine or capecitabine following recent chemotherapy exposure. Conclusions: OS, which is dismal in patients with TNBC relapsing within <12 months, was not improved by adding atezolizumab to chemotherapy. A biology-based definition of intrinsic resistance to immunotherapy in aTNBC is urgently needed to develop novel therapies for these patients in next-generation clinical trials. | - |
dc.language | 영어 | - |
dc.publisher | Elsevier Ltd | - |
dc.title | IMpassion132 double-blind randomised phase III trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.annonc.2024.04.001 | - |
dc.citation.journaltitle | Annals of Oncology | - |
dc.identifier.scopusid | 2-s2.0-85194586344 | - |
dc.citation.endpage | 642 | - |
dc.citation.number | 7 | - |
dc.citation.startpage | 630 | - |
dc.citation.volume | 35 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, S.-A. | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordAuthor | disease-free interval | - |
dc.subject.keywordAuthor | immune checkpoint | - |
dc.subject.keywordAuthor | PD-L1 | - |
dc.subject.keywordAuthor | prognosis | - |
dc.subject.keywordAuthor | rapid relapse | - |
dc.subject.keywordAuthor | triple-negative breast cancer | - |
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