{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T14:57:29Z","timestamp":1778857049913,"version":"3.51.4"},"reference-count":20,"publisher":"Wiley","issue":"19","license":[{"start":{"date-parts":[[2019,6,7]],"date-time":"2019-06-07T00:00:00Z","timestamp":1559865600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["U10CA180821, U10CA180882, U10CA180833, U10CA180850, UG1CA189858, NIHK24CA201524"],"award-info":[{"award-number":["U10CA180821, U10CA180882, U10CA180833, U10CA180850, UG1CA189858, NIHK24CA201524"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>This multicenter, randomized phase 2 trial evaluated complete responses (CRs), efficacy, and safety with ofatumumab and bendamustine and with ofatumumab, bendamustine, and bortezomib in patients with untreated, high\u2010risk follicular lymphoma (FL).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with grade 1 to 3a FL and either a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2 with 1 lymph node &gt;6\u00a0cm or an FLIPI score of 3 to 5 were randomized to arm A (ofatumumab, bendamustine, and maintenance ofatumumab) or to arm B (ofatumumab, bendamustine, bortezomib, and maintenance ofatumumab and bortezomib).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One hundred twenty\u2010eight patients (66 in arm A and 62 in arm B) received treatment. The median age was 61\u00a0years, and 61% had disease &gt;6\u00a0cm; 29% had an FLIPI score of 2, and 71% had an FLIPI score of 3 to 5. In arm A, 86% completed induction, and 64% completed maintenance. In arm B, 66% and 52% completed induction and maintenance, respectively. Dose modifications were required in 65% and 89% in arms A and B, respectively. Clinically significant grade 3 to 4 toxicities included neutropenia (A, 36%; B, 31%), nausea\/vomiting (A, 0%; B, 8%), diarrhea (A, 5%; B, 11%), and sensory neuropathy (A, 0%; B, 5%). The estimated CR rates were 62% (95% confidence interval [CI], 50%\u201074%) and 60% (95% CI, 47%\u201072%) in arms A and B, respectively (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.68). With a median follow\u2010up of 3.3\u00a0years, the estimated 2\u2010year progression\u2010free survival (PFS) and overall survival (OS) rates were 80% and 97%, respectively, for arm A and 76% and 91%, respectively, for arm B.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The CR rates, PFS, and OS were not improved with the addition of bortezomib to ofatumumab and bendamustine in patients with high\u2010risk FL. Although grade 3 to 4 toxicities were similar, more patients treated with bortezomib required dose modifications and early discontinuation.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.32289","type":"journal-article","created":{"date-parts":[[2019,6,7]],"date-time":"2019-06-07T17:20:11Z","timestamp":1559928011000},"page":"3378-3389","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high\u2010risk follicular lymphoma: CALGB 50904 (Alliance)"],"prefix":"10.1002","volume":"125","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4229-2569","authenticated-orcid":false,"given":"Kristie A.","family":"Blum","sequence":"first","affiliation":[{"name":"Department of Hematology and Oncology Winship Cancer Institute, Emory University Atlanta Georgia"},{"name":"Comprehensive Cancer Center Ohio State University Columbus Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mei\u2010Yin","family":"Polley","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center Mayo Clinic College of Medicine Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sin\u2010Ho","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Bioinformatics Duke University Durham North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Travis J.","family":"Dockter","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center Mayo Clinic College of Medicine Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Anderson","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center Mayo Clinic College of Medicine Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric D.","family":"Hsi","sequence":"additional","affiliation":[{"name":"Department of Clinical Pathology Cleveland Clinic Cleveland Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nina","family":"Wagner\u2010Johnston","sequence":"additional","affiliation":[{"name":"Siteman Cancer Center Washington University School of Medicine St. Louis Missouri"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beth","family":"Christian","sequence":"additional","affiliation":[{"name":"Comprehensive Cancer Center Ohio State University Columbus Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jim","family":"Atkins","sequence":"additional","affiliation":[{"name":"Southeast Clinical Oncology Research Consortium NCI Community Oncology Research Program Winston\u2010Salem North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce D.","family":"Cheson","sequence":"additional","affiliation":[{"name":"Lombardi Comprehensive Cancer Center Georgetown University Hospital Washington DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John P.","family":"Leonard","sequence":"additional","affiliation":[{"name":"Department of Medicine and Meyer Cancer Center Weill Cornell Medicine New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nancy L.","family":"Bartlett","sequence":"additional","affiliation":[{"name":"Siteman Cancer Center Washington University School of Medicine St. Louis 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