Positron Emission Tomography–Guided Therapy of Aggressive Non-Hodgkin Lymphomas (PETAL): A Multicenter, Randomized Phase III Trial

作者：Ulrich Dührsen, Stefan P Müller, Bernd Hertenstein, Henrike Thomssen, Jörg Kotzerke, Rolf Michael Mesters, Wolfgang E. Berdel, Christiane Franzius, Frank Kroschinsky, Matthias Weckesser, Dorothea Kofahl-Krause, Frank Michael Bengel, Jan Dürig, Johannes Matschke, Christine Schmitz, Thorsten Dirk Pöppel, Claudia Ose, Marcus Brinkmann, Paul La Rosée, Martin G. Freesmeyer, Andreas Hertel, Heinz‐Gert Höffkes, Dirk M. Behringer, Gabriele Prange‐Krex, Stefan Wilop, Thomas Krohn, Jens Holzinger, Martin Grießhammer, Aristoteles A. N. Giagounidis, Aruna Raghavachar, Georg Maschmeyer, Ingo Brink, Helga Bernhard, Uwe Haberkorn, Tobias Gaska, Lars Kurch, Daniëlle M. E. van Assema, Wolfram Klapper, Dieter F. Hoelzer, Lilli Geworski, Karl‐Heinz Jöckel, André Scherag, Andreas Bockisch, Jan Rekowski, Andreas Hüttmann, on behalf of the PETAL Trial Investigators · 发表于：Journal of Clinical Oncology · 年份：2018 · DOI：10.1200/jco.2017.76.8093 · 被引用次数：254 · 研究领域：Lymphoma Diagnosis and Treatment、CNS Lymphoma Diagnosis and Treatment、CAR-T cell therapy research

Purpose Interim positron emission tomography (PET) using the tracer, [ 18 F]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 ΔSUV max 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 as...