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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorSolomon, Benjamin
dc.contributor.authorCallejo Perez, Ana
dc.contributor.authorBar, Jair
dc.contributor.authorBerchem, Guy
dc.contributor.authorBazhenova, Lyudmila
dc.contributor.authorSaintigny, Pierre
dc.contributor.authorFelip Font, Enriqueta
dc.date.accessioned2022-08-12T10:47:07Z
dc.date.available2022-08-12T10:47:07Z
dc.date.issued2022-07
dc.identifier.citationSolomon B, Callejo A, Bar J, Berchem G, Bazhenova L, Saintigny P, et al. A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer. Cancer Med. 2022 Jul;11(14):2790–800.
dc.identifier.issn2045-7634
dc.identifier.urihttp://hdl.handle.net/11351/8001
dc.descriptionGenomics; Transcriptomics; Lung cancer
dc.description.abstractBackground The Worldwide Innovative Network (WIN) Consortium has developed the Simplified Interventional Mapping System (SIMS) to better define the cancer molecular milieu based on genomics/transcriptomics from tumor and analogous normal tissue biopsies. SPRING is the first trial to assess a SIMS-based tri-therapy regimen in advanced non-small cell lung cancer (NSCLC). Methods Patients with advanced NSCLC (no EGFR, ALK, or ROS1 alterations; PD-L1 unrestricted; ≤2 prior therapy lines) received avelumab, axitinib, and palbociclib (3 + 3 dose escalation design). Results Fifteen patients were treated (five centers, four countries): six at each of dose levels 1 (DL1) and DL2; three at DL3. The most common ≥Grade 3 adverse events were neutropenia, hypertension, and fatigue. The recommended Phase II dose (RP2D) was DL1: avelumab 10 mg/kg IV q2weeks, axitinib 3 mg po bid, and palbociclib 75 mg po daily (7 days off/21 days on). Four patients (27%) achieved a partial response (PR) (progression-free survival [PFS]: 14, 24, 25 and 144+ weeks), including two after progression on pembrolizumab. Four patients attained stable disease (SD) that lasted ≥24 weeks: 24, 27, 29, and 64 weeks. At DL1 (RP2D), four of six patients (66%) achieved stable disease (SD) ≥6 months/PR (2 each). Responders included patients with no detectable PD-L1 expression and low tumor mutational burden. Conclusions Overall, eight of 15 patients (53%) achieved clinical benefit (SD ≥ 24 weeks/PR) on the avelumab, axitinib, and palbociclib combination. This triplet showed antitumor activity in NSCLC, including in tumors post-pembrolizumab progression, and was active at the RP2D, which was well tolerated.
dc.language.isoeng
dc.publisherWiley
dc.relation.ispartofseriesCancer Medicine;11(14)
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectPulmons - Càncer - Tractament
dc.subjectQuimioteràpia combinada
dc.subject.meshCarcinoma, Non-Small-Cell Lung
dc.subject.mesh/drug therapy
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.titleA WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1002/cam4.4635
dc.subject.decscarcinoma de pulmón de células no pequeñas
dc.subject.decs/farmacoterapia
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.relation.publishversionhttps://doi.org/10.1002/cam4.4635
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Solomon B] Avera Cancer Institute, Sioux Falls, South Dakota, USA. [Callejo A, Felip E] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Bar J] Chaim Sheba Medical Center, Tel Hashomer, Israel. [Berchem G] Centre Hospitalier de Luxembourg, Luxembourg Institute of Health, Luxembourg City, Luxemburg. [Bazhenova L] University of California San Diego, Moores Cancer Center, San Diego, California, USA. [Saintigny P] Centre Léon Bérard, Cancer Research Center of Lyon, University of Lyon, Lyon, France
dc.identifier.pmid35307972
dc.identifier.wos000776243800001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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