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  • [J Clin Oncol.] Positron Emission Tomography-Guided Therapy of Aggressive Non-Hodgkin Lymphomas (PETAL): A Multicenter, Randomized Phase III Trial.

    University Hospital Essen Hufelandstrasse / Dührsen U*

  • 출처
    J Clin Oncol.
  • 등재일
    2018 Jul 10
  • 저널이슈번호
    36(20):2024-2034. doi: 10.1200/JCO.2017.76.8093. Epub 2018 May 11.
  • 내용

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    Abstract
    Purpose Interim positron emission tomography (PET) using the tracer, [18F]fluorodeoxyglucose, may predict outcomes in patients with aggressive non-Hodgkin lymphomas. We assessed whether PET can guide therapy in patients who are treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Patients and Methods Newly diagnosed patients received two cycles of CHOP-plus rituximab (R-CHOP) in CD20-positive lymphomas-followed by a PET scan that was evaluated using the ΔSUVmax method. PET-positive patients were randomly assigned to receive six additional cycles of R-CHOP or six blocks of an intensive Burkitt's lymphoma protocol. PET-negative patients with CD20-positive lymphomas were randomly assigned or allocated to receive four additional cycles of R-CHOP or the same treatment with two additional doses rituximab. The primary end point was event-free survival time as assessed by log-rank test. Results Interim PET was positive in 108 (12.5%) and negative in 754 (87.5%) of 862 patients treated, with statistically significant differences in event-free survival and overall survival. Among PET-positive patients, 52 were randomly assigned to R-CHOP and 56 to the Burkitt protocol, with 2-year event-free survival rates of 42.0% (95% CI, 28.2% to 55.2%) and 31.6% (95% CI, 19.3% to 44.6%), respectively (hazard ratio, 1.501 [95% CI, 0.896 to 2.514]; P = .1229). The Burkitt protocol produced significantly more toxicity. Of 754 PET-negative patients, 255 underwent random assignment (129 to R-CHOP and 126 to R-CHOP with additional rituximab). Event-free survival rates were 76.4% (95% CI, 68.0% to 82.8%) and 73.5% (95% CI, 64.8% to 80.4%), respectively (hazard ratio, 1.048 [95% CI, 0.684 to 1.606]; P = .8305). Outcome prediction by PET was independent of the International Prognostic Index. Results in diffuse large B-cell lymphoma were similar to those in the total group. Conclusion Interim PET predicted survival in patients with aggressive lymphomas treated with R-CHOP. PET-based treatment intensification did not improve outcome.

     


    Author information

    Dührsen U1, Müller S1, Hertenstein B1, Thomssen H1, Kotzerke J1, Mesters R1, Berdel WE1, Franzius C1, Kroschinsky F1, Weckesser M1, Kofahl-Krause D1, Bengel FM1, Dürig J1, Matschke J1, Schmitz C1, Pöppel T1, Ose C1, Brinkmann M1, La Rosée P1, Freesmeyer M1, Hertel A1, Höffkes HG1, Behringer D1, Prange-Krex G1, Wilop S1, Krohn T1, Holzinger J1, Griesshammer M1, Giagounidis A1, Raghavachar A1, Maschmeyer G1, Brink I1, Bernhard H1, Haberkorn U1, Gaska T1, Kurch L1, van Assema DME1, Klapper W1, Hoelzer D1, Geworski L1, Jöckel KH1, Scherag A1, Bockisch A1, Rekowski J1, Hüttmann A1; PETAL Trial Investigators.
    1
    Ulrich Dührsen, Stefan Müller, Jan Dürig, Johannes Matschke, Christine Schmitz, Thorsten Pöppel, Andreas Bockisch, and Andreas Hüttmann, Universitätsklinikum Essen; Claudia Ose, Marcus Brinkmann, Karl-Heinz Jöckel, André Scherag, and Jan Rekowski, Universität Duisburg-Essen, Essen; Bernd Hertenstein and Henrike Thomssen, Klinikum Bremen Mitte; Christiane Franzius, Zentrum für moderne Diagnostik, Bremen; Jörg Kotzerke and Frank Kroschinsky, Universitätsklinikum Carl Gustav Carus; Gabriele Prange-Krex, Onkologische Gemeinschaftspraxis, Dresden; Rolf Mesters, Wolfgang E. Berdel, and Matthias Weckesser, Universitätsklinikum Münster, Münster; Dorothea Kofahl-Krause, Frank M. Bengel, and Lilli Geworski, Medizinische Hochschule Hannover, Hannover; Paul La Rosée, Martin Freesmeyer, and André Scherag, Universitätsklinikum Jena, Jena; Andreas Hertel and Heinz-Gert Höffkes, Klinikum Fulda, Fulda; Dirk Behringer, Augusta-Kranken-Anstalt, Bochum; Stefan Wilop and Thomas Krohn, Universitätsklinikum Aachen, Aachen; Jens Holzinger and Martin Griesshammer, Johannes Wesling Klinikum, Minden; Aristoteles Giagounidis, Helios St Johannes Klinik, Duisburg; Aruna Raghavachar, Helios Universitätsklinikum, Wuppertal; Georg Maschmeyer and Ingo Brink, Klinikum Ernst von Bergmann, Potsdam; Helga Bernhard, Klinikum Darmstadt, Darmstadt; Uwe Haberkorn, Universitätsklinikum Heidelberg, Heidelberg; Tobias Gaska, Brüderkrankenhaus St Josef, Paderborn; Lars Kurch, Universitätsklinikum Leipzig, Leipzig; Wolfram Klapper, Universitätsklinikum Schleswig-Holstein, Kiel; Dieter Hoelzer, Onkologikum, Frankfurt/Main, Germany; and Daniëlle M.E. van Assema, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.

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