{"id":15201,"date":"2021-09-01T15:20:07","date_gmt":"2021-09-01T13:20:07","guid":{"rendered":"https:\/\/convergences.online\/hemato\/?p=15201"},"modified":"2024-12-11T14:00:25","modified_gmt":"2024-12-11T13:00:25","slug":"umbralisib-un-essai-de-phase-2-dans-les-lnh-b-indolents-en-rechute-ou-refractaires","status":"publish","type":"post","link":"https:\/\/www.hematostat.net\/en\/umbralisib-un-essai-de-phase-2-dans-les-lnh-b-indolents-en-rechute-ou-refractaires\/","title":{"rendered":"Umbralisib, un essai de phase 2 dans les LNH B indolents en rechute ou r\u00e9fractaires"},"content":{"rendered":"

R\u00e9f. : HematoStat.net ; 2 (3) : R24<\/p>\n

Fowler NH, Samaniego F, Jurczak W, Ghosh N, Derenzini E, Reeves JA, Knopi\u0144ska-Pos\u0142uszny W, Cheah CY, Phillips T, Lech-Maranda E, Cheson BD, Caimi PF, Grosicki S, Leslie LA, Chavez JC, Fonseca G, Babu S, Hodson DJ, Shao SH, Burke JM, Sharman JP, Law JY, Pagel JM, Miskin HP, Sportelli P, O’Connor OA, Weiss MS, Zinzani PL. Umbralisib, a Dual PI3K\u03b4\/CK1\u03b5Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2021 May 20;39(15):1609-1618. doi: 10.1200\/JCO.20.03433. Epub 2021 Mar 8. PMID: 33683917; PMCID: PMC8148421.<\/a><\/p>\n

R\u00e9sum\u00e9<\/h3>\n

Dans un essai de phase 2b multicentrique, 208 patients (lymphomes de la zone marginale (MZL) 69, lymphomes folliculaires (FL) 117, lymphomes lymphocytiques (SLL) 22) en rechute ou r\u00e9fractaires (R\/R) ont re\u00e7u de l\u2019umbralisib, un inhibiteur de PI3K\u03b4\/CK1\u03b5, \u00e0 la dose de 800 mg par jour jusqu\u2019\u00e0 progression ou toxicit\u00e9 inacceptable. L\u2019\u00e2ge m\u00e9dian \u00e9tait de 66 ans et le suivi m\u00e9dian de 27,7 mois. Le nombre m\u00e9dian de traitements ant\u00e9rieurs \u00e9tait de 2 (rang 1-10). Le taux de r\u00e9ponse globale (ORR, crit\u00e8re principal de jugement) \u00e9tait de 49,3 %, 45,3 % et 50,0 % pour les patients MZL, FL et SLL, respectivement, en majorit\u00e9 des r\u00e9ponses partielles. La dur\u00e9e m\u00e9diane de r\u00e9ponse (DOR) \u00e9tait non atteinte, 11,1 mois et 18,3 mois, respectivement. La survie sans progression (PFS) m\u00e9diane \u00e9tait non atteinte, 10,6 mois et 20,9 mois, respectivement. La tol\u00e9rance \u00e9tait tr\u00e8s bonne, avec peu d\u2019arr\u00eats pour cause de toxicit\u00e9 et peu d\u2019effets ind\u00e9sirables immunologiques.<\/p>\n

Dans nos pratiques<\/h3>\n

En \u00e9tant plus s\u00e9lectif pour l\u2019isoforme delta de PI3K et en inhibant CK1\u03b5, l\u2019umbralisib, s\u2019il semble offrir une efficacit\u00e9 similaire dans les LNH B indolents R\/R que les inhibiteurs de PI3K de premi\u00e8re g\u00e9n\u00e9ration comme l\u2019id\u00e9lalisib ou le copanlisib, semble \u00eatre mieux tol\u00e9r\u00e9 avec moins d\u2019effets ind\u00e9sirables immunologiques. Il s\u2019agira de voir quelle est sa valeur en association \u00e0 d\u2019autres mol\u00e9cules.<\/p>\n

Le regard du statisticien<\/h3>\n

Cet essai de phase 2b au recrutement \u00e0 l\u2019\u00e9chelle internationale a pour int\u00e9r\u00eat d\u2019avoir \u00e9tudi\u00e9 trois cohortes de patients (MZL, FL et SLL), avec pour chacune un calcul d\u2019\u00e9chantillon et des analyses qui leur \u00e9taient propres. La population SLL a recrut\u00e9 22 patients alors qu\u2019il devait y en avoir 25 d\u2019apr\u00e8s le dimensionnement et le potentiel effet centre n\u2019a pas \u00e9t\u00e9 discut\u00e9.<\/p>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":14610,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[36],"tags":[164,165],"ppma_author":[442],"class_list":["post-15201","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-revue-de-presse","tag-lnh-b-indolents","tag-umbralisib","author-marion"],"aioseo_notices":[],"authors":[{"term_id":442,"user_id":2,"is_guest":0,"slug":"marion","display_name":"HematoStat.net (M)","avatar_url":{"url":"https:\/\/www.hematostat.net\/wp-content\/uploads\/2024\/01\/favicon-hematoStat.png","url2x":"https:\/\/www.hematostat.net\/wp-content\/uploads\/2024\/01\/favicon-hematoStat.png"},"first_name":"HematoStat.net (M)","last_name":"","user_url":"","description":""}],"_links":{"self":[{"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/posts\/15201","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/comments?post=15201"}],"version-history":[{"count":1,"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/posts\/15201\/revisions"}],"predecessor-version":[{"id":18191,"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/posts\/15201\/revisions\/18191"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hematostat.net\/en\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/media?parent=15201"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/categories?post=15201"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/tags?post=15201"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.hematostat.net\/en\/wp-json\/wp\/v2\/ppma_author?post=15201"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}