作者
Viola Poeschel, Gerhard Held, Marita Ziepert, Mathias Witzens-Harig, Harald Holte, Lorenz Thurner, Peter Borchmann, Andreas Viardot, Martin Soekler, Ulrich Keller, Christian Schmidt, Lorenz Truemper, Rolf Mahlberg, Reinhard Marks, Heinz-Gert Hoeffkes, Bernd Metzner, Judith Dierlamm, Norbert Frickhofen, Mathias Haenel, Andreas Neubauer, Michael Kneba, Francesco Merli, Alessandra Tucci, Peter de Nully Brown, Massimo Federico, Eva Lengfelder, Alice di Rocco, Ralf Trappe, Andreas Rosenwald, Christian Berdel, Martin Maisenhoelder, Ofer Shpilberg, Josif Amam, Konstantinos Christofyllakis, Frank Hartmann, Niels Murawski, Stephan Stilgenbauer, Maike Nickelsen, Gerald Wulf, Bertram Glass, Norbert Schmitz, Bettina Altmann, Markus Loeffler, Michael Pfreundschuh
发表日期
2019/12/21
期刊
The Lancet
卷号
394
期号
10216
页码范围
2271-2281
出版商
Elsevier
简介
Background
Six cycles of R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) are the standard treatment for aggressive B-cell non-Hodgkin lymphoma. In the FLYER trial, we assessed whether four cycles of CHOP plus six applications of rituximab are non-inferior to six cycles of R-CHOP in a population of patients with B-cell non-Hodgkin lymphoma with favourable prognosis.
Methods
This two-arm, open-label, international, multicentre, prospective, randomised phase 3 non-inferiority trial was done at 138 clinical sites in Denmark, Israel, Italy, Norway, and Germany. We enrolled patients aged 18–60 years, with stage I–II disease, normal serum lactate dehydrogenase concentration, ECOG performance status 0–1, and without bulky disease (maximal tumour diameter <7·5 cm). Randomisation was computer-based and done centrally in a 1:1 ratio using the Pocock minimisation …
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V Poeschel, G Held, M Ziepert, M Witzens-Harig… - The Lancet, 2019