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Friedrichs, Birte; Nickelsen, Maike; Ziepert, Marita; Altmann, Bettina; Haenel, Mathias; Viardot, Andreas; Schmidt, Christian; Ruebe, Christian; Loeffler, Markus; Pfreundschuh, Michael; Rosenwald, Andreas; Glass, Bertram; Lenz, Georg; Schmitz, Norbert

Doubling rituximab in high‐risk patients with aggressive B‐cell lymphoma ‐results of the DENSE‐R‐MegaCHOEP trial

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  • Media type: E-Article
  • Title: Doubling rituximab in high‐risk patients with aggressive B‐cell lymphoma ‐results of the DENSE‐R‐MegaCHOEP trial
  • Contributor: Friedrichs, Birte; Nickelsen, Maike; Ziepert, Marita; Altmann, Bettina; Haenel, Mathias; Viardot, Andreas; Schmidt, Christian; Ruebe, Christian; Loeffler, Markus; Pfreundschuh, Michael; Rosenwald, Andreas; Glass, Bertram; Lenz, Georg; Schmitz, Norbert
  • imprint: Wiley, 2019
  • Published in: British Journal of Haematology
  • Language: English
  • DOI: 10.1111/bjh.15710
  • ISSN: 0007-1048; 1365-2141
  • Keywords: Hematology
  • Origination:
  • Footnote:
  • Description: <jats:title>Summary</jats:title><jats:p>To further improve outcome in young high‐risk patients with diffuse large B‐cell lymphoma (<jats:styled-content style="fixed-case">DLBCL</jats:styled-content>) the number of rituximab (R) infusions was doubled in combination with standard <jats:styled-content style="fixed-case">CHOEP</jats:styled-content> (cyclophosphamide, doxorubicin, etoposide, vincristine, prednisone) chemotherapy. Seventy‐seven patients (aged 18–60 years) with an age‐adjusted International Prognostic Index of 2–3 received 12 × R (375 mg/m<jats:sup>2</jats:sup>) on days 0, 1, 4, 8, 15, 22, 29, 43, 57, 71, 85 and 99 together with eight cycles of <jats:styled-content style="fixed-case">CHOEP</jats:styled-content>‐14. Results were retrospectively compared to those of patients receiving 6 × R and 8 × <jats:styled-content style="fixed-case">CHOEP</jats:styled-content>‐14 in the standard arm of the randomized R‐Mega<jats:styled-content style="fixed-case">CHOEP</jats:styled-content> trial.</jats:p><jats:p>Two‐year overall survival (<jats:styled-content style="fixed-case">OS</jats:styled-content>) was 82% [95% confidence interval (<jats:styled-content style="fixed-case">CI</jats:styled-content>) 73%–92%]; 2‐year event‐free (<jats:styled-content style="fixed-case">EFS</jats:styled-content>) and progression‐free survival (<jats:styled-content style="fixed-case">PFS</jats:styled-content>) was 69% (95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 59–80%) and 76% (95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 66%‐–6%), respectively. Comparing 12 to six doses of R revealed no differences (univariate/multivariate) in <jats:styled-content style="fixed-case">EFS</jats:styled-content> (at 2 years: 69% vs. 71%), <jats:styled-content style="fixed-case">PFS</jats:styled-content> (76% vs. 75%) and <jats:styled-content style="fixed-case">OS</jats:styled-content> (82% vs. 85%), with <jats:italic>P </jats:italic>=<jats:italic> </jats:italic>0·766, <jats:italic>P </jats:italic>=<jats:italic> </jats:italic>0·871 and <jats:italic>P </jats:italic>=<jats:italic> </jats:italic>0·843, respectively. Doubling the number of R infusions concomitant to <jats:styled-content style="fixed-case">CHOEP</jats:styled-content> did not improve treatment outcomes. Nonetheless, <jats:styled-content style="fixed-case">OS</jats:styled-content> and <jats:styled-content style="fixed-case">PFS</jats:styled-content> of young high‐risk patients who received only six infusions of R combined with <jats:styled-content style="fixed-case">CHOEP</jats:styled-content> remain excellent and were confirmed in an independent cohort of patients.</jats:p>