{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T16:34:35Z","timestamp":1778603675687,"version":"3.51.4"},"reference-count":35,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2023,1,1]],"date-time":"2023-01-01T00:00:00Z","timestamp":1672531200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Hematology"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>REFLECT is the first prospective study of Sandoz biosimilar rituximab (SDZ-RTX) in patients with diffuse large B-cell lymphoma (DLBCL).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To evaluate the 2-year effectiveness and safety of SDZ-RTX as first-line treatment for DLBCL.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Real-world, multicenter, open-label, single-arm, non-interventional, post-approval study of SDZ-RTX in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with treatment-na\u00efve CD20\u2011positive DLBCL.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Treatment-na\u00efve, CD20-positive adult patients (\u2a7e18 years) with DLBCL eligible for therapy with R-CHOP were treated with SDZ-RTX-CHOP every 2 or 3 weeks for 6\u20138 cycles. The effectiveness of SDZ-RTX was measured by the complete response (CR) rate at the end of R-CHOP treatment, as assessed by the treating physician. Progression-free survival (PFS) was assessed at 24 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 169 patients [52.1% female, median (range) age 70 (24\u221294) years] with DLBCL were included in the full analysis set. At baseline, 19.5% and 24.3% of patients had Ann Arbor disease stage III or IV, respectively, and most patients (80.5%) had Eastern Cooperative Oncology Group Performance Status of 0 or 1. A total of 100 (59.2%) patients completed the 24-month observation period. In total, 110 [65.1%; 95% confidence interval (CI): 57.4\u201372.3] patients achieved CR as best response and 50 (29.6%; 95% CI: 22.8\u201337.1) patients achieved partial response. Overall best response rate was 94.7% (95% CI: 90.1\u201397.5). One-year PFS was 84.9% (95% CI: 78.2\u201389.6), while 2-year PFS was 78.5% (95% CI: 70.9\u201384.4); median PFS was not reached within the observational period. A total of 143 (84.6%) patients experienced \u2a7e1 adverse event, 53 (31.4%) of which were suspected to be related to study drug.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This real-world, 2-year study reconfirms that first-line treatment of CD20-positive DLBCL with R-CHOP using SDZ-RTX is effective and well tolerated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration:<\/jats:title>\n                    <jats:p>N\/A<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20406207231183765","type":"journal-article","created":{"date-parts":[[2023,7,22]],"date-time":"2023-07-22T07:48:17Z","timestamp":1690012097000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["REFLECT: prospective multicenter non-interventional study evaluating the effectiveness and safety of Sandoz rituximab (SDZ-RTX; Rixathon\n                    <sup>\u00ae<\/sup>\n                    ) in combination with CHOP for the treatment of patients with previously untreated CD20-positive diffuse large B-cell lymphoma"],"prefix":"10.1177","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3103-0312","authenticated-orcid":false,"given":"Manfred","family":"Welslau","sequence":"first","affiliation":[{"name":"Department of Oncology, Klinikum Aschaffenburg, Am Hasenkopf 1, 63739 Aschaffenburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Boris","family":"Kubuschok","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Augsburg University Medical Centre, Augsburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julian","family":"Topaly","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr H\u00e4matologie und Onkologie, CaritasKlinikum Saarbr\u00fccken, Saarbr\u00fccken, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Burkhard","family":"Otremba","sequence":"additional","affiliation":[{"name":"Onkologische Praxis Oldenburg, Oldenburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Wolff","sequence":"additional","affiliation":[{"name":"OncoResearch Lerchenfeld GmbH, Hamburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Galyna","family":"Bryn","sequence":"additional","affiliation":[{"name":"Sandoz, Holzkirchen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2023,7,22]]},"reference":[{"key":"bibr1-20406207231183765","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdv304"},{"key":"bibr2-20406207231183765","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2005-06-2508"},{"key":"bibr3-20406207231183765","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.2011.450"},{"key":"bibr4-20406207231183765","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.30740"},{"key":"bibr5-20406207231183765","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-014-2271-1"},{"key":"bibr6-20406207231183765","doi-asserted-by":"publisher","DOI":"10.1186\/s13045-020-01011-z"},{"key":"bibr7-20406207231183765","unstructured":"US Food and Drug Administration. 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