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Blood, 15 November 2008, Vol. 112, No. 10, pp. 3989-3994.
Prepublished online as a Blood First Edition Paper on August 29, 2008; DOI 10.1182/blood-2008-06-155820.
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CLINICAL TRIALS AND OBSERVATIONS
Positron emission tomography has a high negative predictive value for progression or early relapse for patients with residual disease after first-line chemotherapy in advanced-stage Hodgkin lymphoma
Carsten Kobe1,
Markus Dietlein1,
Jeremy Franklin2,
Jana Markova3,
Andreas Lohri4,
Holger Amthauer5,
Susanne Klutmann6,
Wolfram H. Knapp7,
Josee M. Zijlstra8,
Andreas Bockisch9,
Matthias Weckesser10,
Reinhard Lorenz11,
Mathias Schreckenberger12,
Roland Bares13,
Hans T. Eich14,
Rolf-Peter Mueller14,
Michael Fuchs2,15,
Peter Borchmann2,15,
Harald Schicha1,
Volker Diehl2, and
Andreas Engert2,15
1 Department of Nuclear Medicine, University of Cologne, Cologne, Germany;
2 German Hodgkin Study Group, University of Cologne, Cologne, Germany;
3 Department of Clinical Hematology, Third Faculty of Medicine, Charles University, Prague, Czech Republic;
4 Schweizer Arbeitsgruppe für Klinische Krebsforschung, Bern, Switzerland;
5 Klinik für Strahlenheilkunde, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany;
6 Department of Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;
7 Department of Nuclear Medicine, Hanover University Medical School, Hanover, Germany;
8 Department of Hematology, VU University Medical Centre, Amsterdam, The Netherlands;
9 Department of Nuclear Medicine, University of Duisburg-Essen, Essen, Germany;
10 Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany;
11 Department of Nuclear Medicine, University of Wuerzburg, Wuerzburg, Germany;
12 Department of Nuclear Medicine, Gutenberg University Hospital, Mainz, Germany;
13 Department of Nuclear Medicine, University of Tuebingen, Tuebingen, Germany;
14 Department of Radiation Oncology, University of Cologne, Cologne, Germany; and
15 Department I of Internal Medicine, University of Cologne, Cologne, Germany
In the HD15 trial of the German Hodgkin Study Group, the negative predictive value (NPV) of positron emission tomography (PET) using [18F]-fluorodeoxyglucose in advanced-stage Hodgkin lymphoma (HL) was evaluated. A total of 817 patients were enrolled and randomly assigned to receive BEACOPP-based chemotherapy. After completion of chemotherapy, residual disease measuring more than or equal to 2.5 cm in diameter was assessed by PET in 311 patients. The NPV of PET was defined as the proportion of PET– patients without progression, relapse, or irradiation within 12 months after PET review panel. The progression-free survival was 96% for PET– patients (95% confidence interval [CI], 94%-99%) and 86% for PET+ patients (95% CI, 78%-95%, P = .011). The NPV for PET in this analysis was 94% (95% CI, 91%-97%). Thus, consolidation radiotherapy can be omitted in PET– patients with residual disease without increasing the risk for progression or early relapse compared with patients in complete remission. The impact of this finding on the overall survival at 5 years must be awaited. Until then, response adapted therapy guided by PET for HL patients seems to be a promising approach that should be further evaluated in clinical trials. This trial is registered at http://isrctn.org study as #ISRCTN32443041
[controlled-trials.com]
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