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Hazard ratios (HR) and 95% confidence intervals (CIs) were estimated using a multivariate Cox proportional hazards model, adjusted for differences in baseline characteristics. Rituximab-containing regimens were often prescribed in clinical practice. The most frequently prescribed regimens were fludarabine + cyclophosphamide + rituximab (FCR, 29.3%), bendamustine + rituximab (BR, 17.7%), and other rituximab-containing regimens (22.0%) in the treatment-na\u00efve setting (<jats:italic>n<\/jats:italic> = 604), other non-FCR\/BR rituximab-containing regimens (38.7%) and non-rituximab\u2013containing regimens (28.5%) in the relapsed\/refractory setting (<jats:italic>n<\/jats:italic> = 945). Adjusted HRs (95% CI) for progression-free survival (PFS) and overall survival (OS), respectively, with ibrutinib versus real-world regimens were 0.23 (0.14\u20130.37; <jats:italic>p<\/jats:italic> &lt; 0.0001) and 0.40 (0.22\u20130.76; <jats:italic>p<\/jats:italic> = 0.0048) in the treatment-na\u00efve setting, and 0.21 (0.16\u20130.27; <jats:italic>p<\/jats:italic> &lt; 0.0001) and 0.29 (0.21\u20130.41; <jats:italic>p<\/jats:italic> &lt; 0.0001) in the relapsed\/refractory setting. When comparing real-world use of ibrutinib (<jats:italic>n<\/jats:italic> = 53) versus other real-world regimens in relapsed\/refractory CLL (objective 3), adjusted HRs (95% CI) were 0.37 (0.22\u20130.63; <jats:italic>p<\/jats:italic> = 0.0003) for PFS and 0.53 (0.27\u20131.03; <jats:italic>p<\/jats:italic> &lt; 0.0624) for OS. This adjusted analysis, based on nonrandomized patient data, suggests ibrutinib to be more effective than other commonly used regimens for CLL.<\/jats:p>","DOI":"10.1007\/s00277-019-03830-8","type":"journal-article","created":{"date-parts":[[2019,11,19]],"date-time":"2019-11-19T07:01:36Z","timestamp":1574146896000},"page":"2749-2760","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Single-agent ibrutinib in RESONATE-2\u2122 and RESONATE\u2122 versus treatments in the real-world PHEDRA databases for patients with chronic lymphocytic leukemia"],"prefix":"10.1007","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9541-8666","authenticated-orcid":false,"given":"Gilles","family":"Salles","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Bachy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lukas","family":"Smolej","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Simkovic","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lucile","family":"Baseggio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Panovska","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Herv\u00e9","family":"Besson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nollaig","family":"Healy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jamie","family":"Garside","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wafae","family":"Iraqi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joris","family":"Diels","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corinna","family":"Pick-Lauer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Spacek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Renata","family":"Urbanova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Lysak","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruben","family":"Hermans","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Lundbom","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Evelyne","family":"Callet-Bauchu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Doubek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,11,19]]},"reference":[{"issue":"3","key":"3830_CR1","doi-asserted-by":"publisher","first-page":"561","DOI":"10.1093\/annonc\/mds517","volume":"24","author":"M Ghielmini","year":"2013","unstructured":"Ghielmini M, Vitolo U, Kimby E, Montoto S, Walewski J, Pfreundschuh M, Federico M, Hoskin P, McNamara C, Caligaris-Cappio F, Stilgenbauer S, Marcus R, Trneny M, Dreger P, Montserrat E, Dreyling M (2013) ESMO guidelines consensus conference on malignant lymphoma 2011 part 1: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). 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PLD were fully anonymized for analyses; re-identification was not permitted by the database owners.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}