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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorTabernero Caturla, Josep
dc.contributor.authorAndré, Fabrice
dc.contributor.authorBlay, Jean-Yves
dc.contributor.authorBustillos, A.
dc.contributor.authorFear, S.
dc.contributor.authorGanta, S.
dc.date.accessioned2022-08-10T06:26:17Z
dc.date.available2022-08-10T06:26:17Z
dc.date.issued2022-04
dc.identifier.citationTabernero J, Andre F, Blay JY, Bustillos A, Fear S, Ganta S, et al. Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers. ESMO Open. 2022 Apr;7(2):100419.
dc.identifier.issn2059-7029
dc.identifier.urihttp://hdl.handle.net/11351/7976
dc.descriptionPD-L1 checkpoint inhibitor; Atezolizumab; Solid tumors
dc.description.abstractBackground The programmed death-ligand 1 inhibitor atezolizumab had shown clinical activity against several advanced malignancies. Patients and methods This phase II, open-label basket study (NCT02458638) was conducted in 16 main cohorts of patients aged ≥18 years with stage III or IV solid tumors. In stage I, 12 patients were enrolled into each cohort. Treatment was atezolizumab 1200 mg intravenously every 3 weeks until loss of clinical benefit or unacceptable toxicity. The primary efficacy endpoint was the non-progression rate (NPR) at 18 weeks in treated, assessable patients. NPR ≤20% was not of interest for development as monotherapy, and NPR ≥40% was defined as the threshold of benefit/success. If ≥3 patients had non-progressive disease in stage I (interim analysis), 13 additional patients could be enrolled into stage II (final analysis). Secondary efficacy and safety endpoints were also evaluated. Results Overall, 474 patients were enrolled and treated; 433 were included in the efficacy set. Due partly to slow recruitment because of competing trials and limited efficacy at interim analyses, enrollment was stopped early, including in cohorts that passed stage I boundaries of success. NPR was >20% in five cohorts: cervical cancer {n = 27; NPR 44.4% [95% confidence interval (CI) 25.5% to 64.7%]}; follicular/papillary thyroid cancer [n = 11; 54.5% (95% CI 23.4% to 83.3%)]; thymoma [n = 13; 76.9% (95% CI: 46.2% to 95.0%)]; gastroenteropancreatic (GEP) and lung neuroendocrine tumors [NETs; n = 24; 41.7% (95% CI 22.1% to 63.4%)], and low/intermediate grade carcinoid GEP and lung NETs [n = 12; 58.3% (95% CI 27.7% to 84.8%)]. Treatment-related adverse events occurred in 55.3% of patients overall, and at grade 3, 4, and 5 in 10.3%, 1.7%, and 0.4%, respectively. Conclusions Atezolizumab monotherapy was effective in the cervical cancer cohort. The interim benefit threshold was crossed in patients with follicular/papillary thyroid cancer, thymoma, and GEP and lung NETs, but recruitment was stopped before these signals could be confirmed in stage II. Safety was consistent with previous findings.
dc.language.isoeng
dc.publisherElsevier
dc.relation.ispartofseriesESMO Open;7(2)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectCàncer - Tractament
dc.subjectAnticossos monoclonals
dc.subject.meshNeoplasms
dc.subject.mesh/drug therapy
dc.subject.meshAntibodies, Monoclonal, Humanized
dc.titlePhase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1016/j.esmoop.2022.100419
dc.subject.decsneoplasias
dc.subject.decs/farmacoterapia
dc.subject.decsanticuerpos monoclonales humanizados
dc.relation.publishversionhttps://doi.org/10.1016/j.esmoop.2022.100419
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Tabernero J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IOB-Quiron, Barcelona, Spain. [Andre F] Gustave Roussy Cancer Campus Grand Paris, Villejuif, France. [Blay JY] Centre Léon Bérard, Lyon, France. [Bustillos A, Fear S] Global Product Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland. [Ganta S] Product Development Safety, F. Hoffmann-La Roche Ltd, Basel, Switzerland
dc.identifier.pmid35305400
dc.identifier.wos000797892800010
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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